Lymphocyte Re-infusion During Immune Suppression to Treat... | NCT00001832 | Trialant
NCT00001832
Sponsor
National Cancer Institute (NCI)
Status
Completed
Last Update Posted
Dec 21, 2012Estimated
Enrollment
170Actual
Phase
Phase 2
Conditions
Melanoma
Neoplasm Metastasis
Interventions
gp100:209-217 (210M)
Montanide ISA-51
IL-2
MART-1:26-35(27L)
Abl cells
Fludarabine
Cyclophosphamide
GCSF (Growth colony stimulating factor)
Apheresis
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00001832
Obsolete or Duplicate NCT IDs
NCT00019942
Organization Study
990158
Secondary IDs
ID
Type
Description
Link
99-C-0158
Brief Title
Lymphocyte Re-infusion During Immune Suppression to Treat Metastatic Melanoma
Official Title
Treatment of Patients With Metastatic Melanoma Using Cloned Lymphocytes Following the Administration of a Non-Myeloablative But Lymphocyte Depleting Regimen
Acronym
Not provided
Organization
National Institutes of Health Clinical Center (CC)NIH
Status Module
Record Verification Date
Dec 2012
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 1999
Primary Completion Date
May 2010Actual
Completion Date
May 2010Actual
First Submitted Date
Nov 3, 1999
First Submission Date that Met QC Criteria
Nov 3, 1999
First Posted Date
Nov 4, 1999Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 7, 2012
Results First Submitted that Met QC Criteria
Dec 19, 2012
Results First Posted Date
Dec 21, 2012Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 19, 2012
Last Update Posted Date
Dec 21, 2012Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Steven Rosenberg, Dr. Steven Rosenberg, National Institutes of Health Clinical Center (CC)Principal Investigator
Lead Sponsor
National Cancer Institute (NCI)NIH
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This experiment will test the safety and effectiveness of a treatment for melanoma in which certain lymphocytes (a type of white blood cell) are taken from the patient, grown in the laboratory, and returned after the patient's immune system has been weakened with immune-suppressing drugs. Some patients will also receive interleukin-2 (IL-2), a drug that may enhance the activity of the re-infused lymphocytes.
Patients with metastatic melanoma (melanoma whose tumor has spread) who have been treated unsuccessfully with gp100 vaccination may participate in this study. They will undergo apheresis or a tumor biopsy, or both, to collect lymphocytes. In apheresis, whole blood is drawn through a needle in the arm. A machine separates the blood components and removes the white cells. The rest of the blood is returned to the donor through a needle in the other arm. A biopsy is a surgical procedure to remove a small piece of tumor tissue.
Several weeks before the lymphocytes are collected, patients will receive injections of growth colony stimulating factor (G-CSF) every day for five days. This drug stimulates white cell production, permitting as many cells as possible to be obtained during collection. The lymphocytes will then be grown in larger numbers in the laboratory.
Seven days before the cells are re-infused, the patient is admitted to the hospital and a catheter (small tube) is placed in a large vein in the chest or neck. Two drugs, cyclophosphamide and fludarabine, are given through the tube. These drugs suppress the immune system so that it will not interfere with the work of the reinfused lymphocytes. The lymphocytes are then injected through the catheter over a 30-minute period. After the infusion, patients who receive IL-2 will be given the drug in a high dose over a 15-minute period every eight hours for up to five days. Patients whose condition does not permit high-dose IL-2, such as those with a heart condition or lung problem, may receive a low-dose regimen, with the drug given as a shot under the skin of the thigh or abdomen for five days followed by a 2-day break, continuing for a total of six weeks. These patients receive a higher dose the first week and then half that dose the next five weeks.
Blood and tissue samples will be taken before and during the study to evaluate the size of the tumor and assess treatment. If, 3-5 weeks after therapy is completed, the patient's tumor has stabilized or shrunk, the entire treatment, except for chemotherapy, may be repeated two more times.
Detailed Description
Patients with metastatic melanoma who are human immunodeficiency virus (HIV) and Hepatitis B negative and who have previously progressed after receiving standard therapy will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine and then will be treated by the adoptive transfer of lymphocytes reactive with shared antigens on their tumors. This study will evaluate the toxicity, immunologic effects and potential therapeutic role of this treatment.
Conditions Module
Conditions
Melanoma
Neoplasm Metastasis
Keywords
Immunotherapy
Adoptive Transfer
IL-2
Toxicity
Clinical Response
Breast Cancer
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
170Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Abl Cells in culture
Experimental
Peripheral blood mononuclear cells (PBMC) and/or tumor infiltrating lymphocytes (TIL) obtained by apheresis or lesion excision to be cloned and expanded in the lab.The patients underwent an apheresis and/or an excision of their tumor.
They didn't receive any drugs.
Procedure: Apheresis
Abl Cells IV + Cyclophosphamide 30 mg/kg
Experimental
Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x30mg/kg + Cells intravenous (IV) Abl cells intravenous (IV) = Lymphocytes 10^9-10^11 IV over 30 minutes on day 0, repeated in 14 to 21 days
Biological: Abl cells
Drug: Fludarabine
Drug: Cyclophosphamide
Abl Cells IV + Cyclophosphamide 60 mg/kg
Experimental
Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) Abl cells IV = Lymphocytes 10^9-10^11 IV over 30 minutes on day 0, repeated in 14 to 21 days
Biological: Abl cells
Drug: Fludarabine
Drug: Cyclophosphamide
Abl Cells IV+Low Dose IV IL-2 (Initial)
Experimental
Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (72,000 IU/kg q8h for a maximum of 15 doses) Abl cells IV = Lymphocytes 10^9-10^11 IV over 30 minutes on day 0, repeated in 14 to 21 days
Interventions
Name
Type
Description
Arm Group Labels
Other Names
gp100:209-217 (210M)
Drug
gp100 = gp100:209-217(210M) peptide - 1 mg in IFA SQ (in the subcutaneous tissue of each thigh) on the morning of the cell infusion, plus gp100:209-217(210M) peptide, 1 mg, in IFA injected into the subcutaneous tissue in two equal volumes, 1.0 mL for each injection, within 2cm of each other, in the thigh daily for five days starting on the morning of the cell infusion and then weekly for 3 more injections.
MART-1 = MART-1:26-35(27L) peptide- 1 mg in IFA SQ (in the subcutaneous tissue of each thigh) on the morning of the cell infusion, plus MART-1:26-35(27L) peptide, 1 mg, in IFA injected into the subcutaneous tissue in two equal volumes, 1.0 mL for each injection, within 2cm of each other, in the thigh daily for five days starting on the morning of the cell infusion and then weekly for 3 more injections.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Clinical Response
Complete response (CR) is defined as the disappearance of all clinical evidence of disease. Partial response (PR) is a 50% or greater decrease in the sum of the products of perpendicular diameters of all measurable lesions for at least one month. No new lesions may appear, and none may increase. Minor response (MR) is a 25-49% decrease in the sum of the products of the perpendicular diameters of all measurable lesions. Appearance of new lesions following a PR or CR are considered relapses. Patients with progressive disease (PD) and no evidence of stable disease will be taken off study after receiving IL-2.
Every three to four weeks after the treatment, for up to 5 years.
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With Adverse Events
Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.
10.5 months
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
INCLUSION CRITERIA
Patients must have evaluable metastatic melanoma that is refractory to standard therapy.
Age greater than or equal to 16 years.
Patients of both genders must be willing to practice birth control for four months after receiving the preparative regimen.
Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0, 1 at entry to the trial and at the time of chemotherapy induction.
Absolute neutrophil count greater than 1000/mm^3.
Platelet count greater than 100,000/mm^3.
Hemoglobin greater than 8.0 g/dl.
Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less than two times the upper limit of normal.
Serum creatinine less than or equal to 1.6 mg/dl.
Total bilirubin less than or equal to 1.6 mg/dl, except for patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl.
More than four weeks must have elapsed since any prior therapy at the time the patient receives the preparative regimen.
Women of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the preparative chemotherapy on the fetus.
Life expectancy of greater than three months.
No steroid therapy required.
Seronegative for human immunodeficiency virus (HIV) antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune competence and thus be less responsive to the experimental treatment and more susceptible to its toxicities.)
Seronegative for hepatitis B antigen.
Patients to receive high dose interleukin 2 (IL-2) must have no active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system.
Patients who will receive high dose IL-2 as part of the phase I portion of this study or who will be randomized must be eligible to receive high dose IL-2.
Any patient receiving IL-2 must sign a durable power of attorney.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
7 Years
Maximum Age
Not provided
Standard Ages
ChildAdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Steven Rosenberg, M.D.
National Cancer Institute, National Institutes of Health
Kawakami Y, Eliyahu S, Delgado CH, Robbins PF, Rivoltini L, Topalian SL, Miki T, Rosenberg SA. Cloning of the gene coding for a shared human melanoma antigen recognized by autologous T cells infiltrating into tumor. Proc Natl Acad Sci U S A. 1994 Apr 26;91(9):3515-9. doi: 10.1073/pnas.91.9.3515.
Peripheral blood mononuclear cells (PBMC) and/or tumor infiltrating lymphocytes (TIL) obtained by apheresis or lesion excision to be cloned and expanded in the lab. All patients were enrolled on Arm 0 and their cells were then sent to the lab. If the lab was able to manufacture the cell product then the patient was enrolled on one of the treatment arms.
Periods
Title
Milestones
Reasons Not Completed
Apheresis Period
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: IL-2
Biological: Abl cells
Drug: Fludarabine
Drug: Cyclophosphamide
Abl Cells IV+High Dose IV IL-2 (Initial)
Experimental
Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) Abl cells IV = Lymphocytes 10^9-10^11 IV over 30 minutes on day 0, repeated in 14 to 21 days
Drug: IL-2
Biological: Abl cells
Drug: Fludarabine
Drug: Cyclophosphamide
Abl Cells IV + MTD IL-2
Experimental
Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery) Abl cells IV = Lymphocytes 10^9-10^11 IV over 30 minutes on day 0, repeated in 14 to 21 days
Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) Prior Cells IV + growth colony stimulating factor (G-CSF) Abl cells IA = Lymphocytes 10^9-10^11 IA over 30 minutes on day 0, repeated in 14 to 21 days
Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) Abl cells IA = Lymphocytes 10^9-10^11 IA over 30 minutes on day 0, repeated in 14 to 21 days
Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) + melanoma- associated antigen recognized by T cells (MART-1):26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells Abl cells IA = Lymphocytes 10^9-10^11 IA over 30 minutes on day 0, repeated in 14 to 21 days gp100 = gp100:209-217(210M) peptide - 1 mg in IFA SQ (in the subcutaneous tissue of each thigh) on the morning of the cell infusion, plus gp100:209-217(210M) peptide, 1 mg, in IFA injected into the subcutaneous tissue in two equal volumes, 1.0 mL for each injection, within 2cm of each other, in the thigh daily for five days starting on the morning of the cell infusion and then weekly for 3 more injections.
Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without growth colony stimulating factor (G-CSF) (to determine if G-CSF has harmful effects when adoptively transferring lymphocytes following a nonmyeloablative chemotherapy regimen) Abl cells IV = Lymphocytes 10^9-10^11 IV over 30 minutes on day 0, repeated in 14 to 21 days
Drug: IL-2
Biological: Abl cells
Drug: Fludarabine
Drug: Cyclophosphamide
Abl Cells IV+MTD IL-2 no GCSF
Experimental
Abl Cells intravenous (IV) + maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF)(gp100 reactive).
Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + gp100:209-217(210M) 1mg/day (2-8 days) in patients with gp100 reactive cells Abl cells IV = Lymphocytes 10^9-10^11 IV over 30 minutes on day 0, repeated in 14 to 21 days
Drug: gp100:209-217 (210M)
Drug: IL-2
Biological: Abl cells
Drug: Fludarabine
Drug: Cyclophosphamide
Abl Cells IV+MTD IL-2
Experimental
Abl Cells intravenous (IV)+ maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1)reactive).
Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells Abl cells IV = Lymphocytes 10^9-10^11 IV over 30 minutes on day 0, repeated in 14 to 21 days
Drug: IL-2
Drug: MART-1:26-35(27L)
Biological: Abl cells
Drug: Fludarabine
Drug: Cyclophosphamide
Abl Cells IV + SQ IL-2 with GCSF
Experimental
Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery), reactivity not specified Abl cells IV = Lymphocytes 10^9-10^11 IV over 30 minutes on day 0, repeated in 14 to 21 days
Abl Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) with growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1) reactive) Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells Abl cells IV = Lymphocytes 10^9-10^11 IV over 30 minutes on day 0, repeated in 14 to 21 days
Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 ( IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) in patients with no reactivity Abl cells IV = Lymphocytes 10^9-10^11 IV over 30 minutes on day 0, repeated in 14 to 21 days
MART-1 = MART-1:26-35(27L) peptide- 1 mg in IFA SQ (in the subcutaneous tissue of each thigh) on the morning of the cell infusion, plus MART-1:26-35(27L) peptide, 1 mg, in IFA injected into the subcutaneous tissue in two equal volumes, 1.0 mL for each injection, within 2cm of each other, in the thigh daily for five days starting on the morning of the cell infusion and then weekly for 3 more injections.
Abl Cells IA+MTD IL-2 (MART-1 reactive)
IFA
IL-2
Drug
125,000 IU/kg dose intravenous for 5 days for 6 weeks with 2 days rest per week.
720,000 IU/kg intravenous every 8 hours for a maximum of 12 doses.
Abl Cells IA + MTD (prior cells IV on 6)
Abl Cells IA + MTD IL-2
Abl Cells IV + MTD IL-2 no GCSF
Abl Cells IV + SQ
Abl Cells IV + SQ IL-2 with GCSF
Abl Cells IV + SQ IL-2 with GCSF (no reactivity)
Abl Cells IV+High Dose IV IL-2 (Initial)
Abl Cells IV+Low Dose IV IL-2 (Initial)
Abl Cells IV+MTD IL-2
Abl Cells IV+MTD IL-2 no GCSF
Interleukin-2
MART-1:26-35(27L)
Drug
MART-1 = MART-1:26-35(27L) peptide- 1 mg in IFA SQ (in the subcutaneous tissue of each thigh) on the morning of the cell infusion, plus MART-1:26-35(27L) peptide, 1 mg, in IFA injected into the subcutaneous tissue in two equal volumes, 1.0 mL for each injection, within 2cm of each other, in the thigh daily for five days starting on the morning of the cell infusion and then weekly for 3 more injections.
Abl Cells IA+MTD IL-2 (MART-1 reactive)
Abl Cells IV + SQ
Abl Cells IV+MTD IL-2
melanoma-associated antigen recognized by T cells
Abl cells
Biological
Abl cells IV = Lymphocytes 10^9-10^11 IV over 30 minutes on day 0, repeated in 14 to 21 days Abl cells IA = Lymphocytes 10^9-10^11 IA over 30 minutes on day 0, repeated in 14 to 21 days
Abl Cells IA + MTD (prior cells IV on 6)
Abl Cells IA + MTD IL-2
Abl Cells IA+MTD IL-2 (MART-1 reactive)
Abl Cells IV + Cyclophosphamide 30 mg/kg
Abl Cells IV + Cyclophosphamide 60 mg/kg
Abl Cells IV + MTD IL-2
Abl Cells IV + MTD IL-2 no GCSF
Abl Cells IV + SQ
Abl Cells IV + SQ IL-2 with GCSF
Abl Cells IV + SQ IL-2 with GCSF (no reactivity)
Abl Cells IV+High Dose IV IL-2 (Initial)
Abl Cells IV+Low Dose IV IL-2 (Initial)
Abl Cells IV+MTD IL-2
Abl Cells IV+MTD IL-2 no GCSF
Fludarabine
Drug
5x25 mg/m^2 intravenous
Abl Cells IA + MTD (prior cells IV on 6)
Abl Cells IA + MTD IL-2
Abl Cells IA+MTD IL-2 (MART-1 reactive)
Abl Cells IV + Cyclophosphamide 30 mg/kg
Abl Cells IV + Cyclophosphamide 60 mg/kg
Abl Cells IV + MTD IL-2
Abl Cells IV + MTD IL-2 no GCSF
Abl Cells IV + SQ
Abl Cells IV + SQ IL-2 with GCSF
Abl Cells IV + SQ IL-2 with GCSF (no reactivity)
Abl Cells IV+High Dose IV IL-2 (Initial)
Abl Cells IV+Low Dose IV IL-2 (Initial)
Abl Cells IV+MTD IL-2
Abl Cells IV+MTD IL-2 no GCSF
Fludara
Cyclophosphamide
Drug
2x30 mg/kg, 2x60 mg/kg intravenous
Abl Cells IA + MTD (prior cells IV on 6)
Abl Cells IA + MTD IL-2
Abl Cells IA+MTD IL-2 (MART-1 reactive)
Abl Cells IV + Cyclophosphamide 30 mg/kg
Abl Cells IV + Cyclophosphamide 60 mg/kg
Abl Cells IV + MTD IL-2
Abl Cells IV + MTD IL-2 no GCSF
Abl Cells IV + SQ
Abl Cells IV + SQ IL-2 with GCSF
Abl Cells IV + SQ IL-2 with GCSF (no reactivity)
Abl Cells IV+High Dose IV IL-2 (Initial)
Abl Cells IV+Low Dose IV IL-2 (Initial)
Abl Cells IV+MTD IL-2
Abl Cells IV+MTD IL-2 no GCSF
Cytoxan
GCSF (Growth colony stimulating factor)
Biological
Beginning on day 1 or 2, GCSF will be administered subcutaneously at a dose of 5mcg/kg/day (not to exceed 300 mcg/day. Filgrastim administration will continue daily until neutrophil count > 1.0 x10^9/L x 3 days or > 5.0 x10^9/L.
Abl Cells IA + MTD (prior cells IV on 6)
Abl Cells IA + MTD IL-2
Abl Cells IA+MTD IL-2 (MART-1 reactive)
Abl Cells IV + MTD IL-2
Abl Cells IV + SQ
Abl Cells IV + SQ IL-2 with GCSF
Abl Cells IV + SQ IL-2 with GCSF (no reactivity)
Filgrastim
Apheresis
Procedure
Abl Cells in culture
Yao X, Ahmadzadeh M, Lu YC, Liewehr DJ, Dudley ME, Liu F, Schrump DS, Steinberg SM, Rosenberg SA, Robbins PF. Levels of peripheral CD4(+)FoxP3(+) regulatory T cells are negatively associated with clinical response to adoptive immunotherapy of human cancer. Blood. 2012 Jun 14;119(24):5688-96. doi: 10.1182/blood-2011-10-386482. Epub 2012 May 3.
Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (72,000 IU/kg q8h for a maximum of 15 doses)
FG004
Abl Cells IV+High Dose IV IL-2 (Initial)
Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses)
FG005
Abl Cells IV + MTD IL-2
Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery)
FG006
Abl Cells IA + MTD (Prior Cells IV on 6)
Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) Prior Cells IV + growth colony stimulating factor (G-CSF)
FG007
Abl Cells IA + MTD IL-2
Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF)
FG008
Abl Cells IA+MTD IL-2 (MART-1 Reactive)
Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) + melanoma- associated antigen recognized by T cells (MART-1):26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
FG009
Abl Cells IV + MTD IL-2 no GCSF
Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without growth colony stimulating factor (G-CSF) (to determine if G-CSF has harmful effects when adoptively transferring lymphocytes following a nonmyeloablative chemotherapy regimen)
FG010
Abl Cells IV+MTD IL-2 no GCSF(gp100 Reactive)
Abl Cells intravenous (IV) + maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF)(gp100 reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + gp100:209-217(210M) 1mg/day (2-8 days) in patients with gp100 reactive cells
FG011
Abl Cells IV+MTD IL-2 no GCSF (MART-1reactive)
Abl Cells intravenous (IV)+ maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1)reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
FG012
Abl Cells IV + SQ IL-2 With GCSF
Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery), reactivity not specified
FG013
Abl Cells IV + SQ IL-2 With GCSF (MART-1 Reactive)
Abl Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) with growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1) reactive) Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
FG014
Abl Cells IV + SQ IL-2 With GCSF (no Reactivity)
Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 ( IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) in patients with no reactivity
Phase 1 IL-2 Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (72,000 IU/kg q8h for a maximum of 15 doses)
BG003
Cells IV + High-Dose IV IL-2 (Initial)
Phase 1 IL-2 Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses)
BG004
Cells IV + MTD IL-2
Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) + G-CSF (to shorten time to neutrophil recovery)
BG005
Cells IA + MTD IL-2 (Prior Cells IV on 6)
Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IA + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) Prior Cells IV + G-CSF
BG006
Cells IA + MTD IL-2
Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IA + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) + G-CSF
BG007
Cells IA + MTD IL-2 (MART-1 Reactive)
Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IA + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
BG008
Cells IV + MTD IL-2 no GCSF
Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF (to determine if G-CSF has harmful effects when adoptively transferring lymphocytes following a nonmyeloablative chemotherapy regimen)
BG009
Cells IV + MTD IL-2 no GCSF (gp100 Reactive)
Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + gp100:209-217(210M) 1mg/day (2-8 days) in patients with gp100 reactive cells
BG010
Cells IV + MTD IL-2 no GCSF (MART-1 Reactive)
Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
BG011
Cells IV + SQ IL-2 w/GCSF
Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF (to shorten time to neutrophil recovery), reactivity not specified
BG012
Cells IV + SQ IL-2 w/GCSF (MART-1 Reactive)
Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
BG013
Cells IV + SQ IL-2 w/GCSF (no Reactivity)
Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF in patients with no reactivity
BG014
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0013
BG0023
BG0036
BG00451
BG0054
BG0067
BG0078
BG0086
BG0091
BG0107
BG0116
BG0123
BG0132
BG014110
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00041.3± 9.3
BG00152.3± 4.5
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0011
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG0003
BG0013
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Clinical Response
Complete response (CR) is defined as the disappearance of all clinical evidence of disease. Partial response (PR) is a 50% or greater decrease in the sum of the products of perpendicular diameters of all measurable lesions for at least one month. No new lesions may appear, and none may increase. Minor response (MR) is a 25-49% decrease in the sum of the products of the perpendicular diameters of all measurable lesions. Appearance of new lesions following a PR or CR are considered relapses. Patients with progressive disease (PD) and no evidence of stable disease will be taken off study after receiving IL-2.
Posted
Number
Participants
Every three to four weeks after the treatment, for up to 5 years.
Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (72,000 IU/kg q8h for a maximum of 15 doses)
OG003
Abl Cells IV+High Dose IV IL-2 (Initial)
Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses)
OG004
Abl Cells IV + MTD IL-2
Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery)
OG005
Abl Cells IA + MTD (Prior Cells IV on 6)
Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) Prior Cells IV + growth colony stimulating factor (G-CSF)
OG006
Abl Cells IA + MTD IL-2
Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF)
OG007
Abl Cells IA+MTD IL-2 (MART-1 Reactive)
Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) + melanoma- associated antigen recognized by T cells (MART-1):26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
OG008
Abl Cells IV + MTD IL-2 no GCSF
Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without growth colony stimulating factor (G-CSF) (to determine if G-CSF has harmful effects when adoptively transferring lymphocytes following a nonmyeloablative chemotherapy regimen)
OG009
Abl Cells IV+MTD IL-2 no GCSF(gp100 Reactive)
Abl Cells intravenous (IV) + maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF)(gp100 reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + gp100:209-217(210M) 1mg/day (2-8 days) in patients with gp100 reactive cells
OG010
Abl Cells IV+MTD IL-2 no GCSF (MART-1reactive)
Abl Cells intravenous (IV)+ maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1)reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
OG011
Abl Cells IV + SQ IL-2 With GCSF
Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery), reactivity not specified
OG012
Abl Cells IV + SQ IL-2 With GCSF (MART-1 Reactive)
Abl Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) with growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1) reactive) Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
OG013
Abl Cells IV + SQ IL-2 With GCSF (no Reactivity)
Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 ( IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) in patients with no reactivity
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Complete Response
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Number of Participants With Adverse Events
Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.
Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (72,000 IU/kg q8h for a maximum of 15 doses)
0
3
3
3
EG003
Abl Cells IV+High Dose IV IL-2 (Initial)
Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses)
0
6
6
6
EG004
Abl Cells IV + MTD IL-2
Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery)
9
51
50
51
EG005
Abl Cells IA + MTD (Prior Cells IV on 6)
Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) Prior Cells IV + growth colony stimulating factor (G-CSF)
0
4
4
4
EG006
Abl Cells IA + MTD IL-2
Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF)
2
7
7
7
EG007
Abl Cells IA+MTD IL-2 (MART-1 Reactive)
Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) + melanoma- associated antigen recognized by T cells (MART-1):26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
1
8
8
8
EG008
Abl Cells IV + MTD IL-2 no GCSF
Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without growth colony stimulating factor (G-CSF) (to determine if G-CSF has harmful effects when adoptively transferring lymphocytes following a nonmyeloablative chemotherapy regimen)
0
6
6
6
EG009
Abl Cells IV+MTD IL-2 no GCSF(gp100 Reactive)
Abl Cells intravenous (IV) + maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF)(gp100 reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + gp100:209-217(210M) 1mg/day (2-8 days) in patients with gp100 reactive cells
0
1
1
1
EG010
Abl Cells IV+MTD IL-2 no GCSF (MART-1reactive)
Abl Cells intravenous (IV)+ maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1)reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
0
7
7
7
EG011
Abl Cells IV + SQ IL-2 With GCSF
Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + granulocyte colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery), reactivity not specified
0
6
6
6
EG012
Abl Cells IV + SQ IL-2 With GCSF (MART-1 Reactive)
Abl Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) with granulocyte colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1) reactive) Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
1
3
3
3
EG013
Abl Cells IV + SQ IL-2 With GCSF (no Reactivity)
Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 ( IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) in patients with no reactivity
1
2
2
2
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Lymphocyte count decreased
Blood and lymphatic system disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected6 at risk
EG004
Neutrophil count decreased
Blood and lymphatic system disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Sinus tachycardia
Cardiac disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypotension
Cardiac disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
General symptom
General disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Infection (documented clinically or microbiologically)
Infections and infestations
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Infection/Febrile neutropenia (infection without neutropenia)
Infections and infestations
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Confusion
Nervous system disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hallucinations
Nervous system disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Leukoencephalopathy
Nervous system disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Neurological disorder NOS
Nervous system disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
peripheral sensory neuropathy
Nervous system disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vision blurred
Eye disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Thrombosis
Vascular disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Thrombotic microangiopathy
Blood and lymphatic system disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Creatinine increased
Metabolism and nutrition disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Renal failure
Respiratory, thoracic and mediastinal disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Disseminated intravascular coagulation
Blood and lymphatic system disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Infection (documented clinically or microbiologically)
Infections and infestations
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Peripheral ischemia
Vascular disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected0 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
left ventricular dysfunction
Cardiac disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dyspnea
Respiratory, thoracic and mediastinal disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected0 at risk
EG0010 events0 affected0 at risk
EG0020 events0 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Hemoglobin decreased
Blood and lymphatic system disorders
CTCv2.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0014 events2 affected3 at risk
EG0024 events3 affected3 at risk
EG0035 events4 affected6 at risk
EG00450 events37 affected51 at risk
EG0053 events3 affected4 at risk
EG0068 events5 affected7 at risk
EG0079 events6 affected8 at risk
EG0083 events2 affected6 at risk
EG0091 events1 affected1 at risk
EG01010 events5 affected7 at risk
EG0113 events3 affected6 at risk
EG0121 events1 affected3 at risk
EG0131 events1 affected2 at risk
Leukocyte count decreased
Blood and lymphatic system disorders
CTCv2.0
Systematic Assessment
EG0003 events3 affected3 at risk
EG0013 events3 affected3 at risk
EG0024 events3 affected3 at risk
EG003
Lymphocyte count decreased
Blood and lymphatic system disorders
CTCv2.0
Systematic Assessment
EG0004 events3 affected3 at risk
EG0014 events3 affected3 at risk
EG0026 events3 affected3 at risk
EG003
Neutrophil count decreased
Blood and lymphatic system disorders
CTCv2.0
Systematic Assessment
EG0003 events3 affected3 at risk
EG0013 events3 affected3 at risk
EG0023 events3 affected3 at risk
EG003
Serum albumin decreased
Metabolism and nutrition disorders
CTCv2.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Bilirubin increased
Metabolism and nutrition disorders
CTCv2.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Activated partial thromboplastin time prolonged
Blood and lymphatic system disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Serum calcium decreased
Metabolism and nutrition disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Serum magnesium decreased
Metabolism and nutrition disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Serum phosphate decreased
Metabolism and nutrition disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Platelet count decreased
Blood and lymphatic system disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Sinus tachycardia
Cardiac disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypotension
Cardiac disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
INR increased
Blood and lymphatic system disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Thrombotic microangiopathy
Blood and lymphatic system disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Fatigue
General disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Fever
General disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pigmentation changes (e.g., vitiligo)
Skin and subcutaneous tissue disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Rash desquamating
Skin and subcutaneous tissue disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Anorexia
Gastrointestinal disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Diarrhea
Gastrointestinal disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia
Blood and lymphatic system disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hemorrhage nasal
Respiratory, thoracic and mediastinal disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Febrile Neutropenia
Infections and infestations
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Infection (documented clinically or microbiologically)
Infections and infestations
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Wound infection
Infections and infestations
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Alkaline phosphatase increased
Metabolism and nutrition disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Alanine aminotransferase increased
Metabolism and nutrition disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Aspartate aminotransferase increased
Metabolism and nutrition disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Creatinine increased
Metabolism and nutrition disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Lipase increased
Metabolism and nutrition disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Serum potassium increased
Metabolism and nutrition disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Serum potassium decreased
Metabolism and nutrition disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Serum sodium decreased
Metabolism and nutrition disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Serum triglycerides increased
Metabolism and nutrition disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Blood uric acid increased
Metabolism and nutrition disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Confusion
Nervous system disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Anxiety
Nervous system disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Neurological disorder NOS
Nervous system disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vision blurred
Eye disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pain
General disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Rectal pain
Gastrointestinal disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Tumor pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dyspnea
Respiratory, thoracic and mediastinal disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Respiratory disorder
Respiratory, thoracic and mediastinal disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Irregular menstruation
Reproductive system and breast disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Chills
General disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Weight loss
General disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Injection site reaction
Skin and subcutaneous tissue disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Rectal bleeding/hematochezia
Gastrointestinal disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Catheter-related infection
Infections and infestations
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Headache
Nervous system disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Somnolence/depressed level of consciousness
Nervous system disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Insomnia
General disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Weight gain
General disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Petechiae
Blood and lymphatic system disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Depression
Nervous system disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Syncope
Nervous system disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypertension
Cardiac disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Low urine output
Renal and urinary disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Capillary leak syndrome
Vascular disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Serum magnesium increased
Metabolism and nutrition disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Serum calcium increased
Metabolism and nutrition disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal pain
Reproductive system and breast disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hallucinations
Nervous system disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
General symptom
General disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Autoimmune disorder
Immune system disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hearing loss
Ear and labyrinth disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Psychosis
Nervous system disorders
CTCv2.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Not provided
Results Disclosure Restriction on PI(s)?
No
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Steven A. Rosenberg, M.D.
National Cancer Institute, National Institutes of Health
301-496-4164
sar@mail.nih.gov
ID
Term
D008545
Melanoma
D009362
Neoplasm Metastasis
D001943
Breast Neoplasms
Ancestor Terms
ID
Term
D018358
Neuroendocrine Tumors
D017599
Neuroectodermal Tumors
D009373
Neoplasms, Germ Cell and Embryonal
D009370
Neoplasms by Histologic Type
D009369
Neoplasms
D009380
Neoplasms, Nerve Tissue
D018326
Nevi and Melanomas
D012878
Skin Neoplasms
D009371
Neoplasms by Site
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
D009385
Neoplastic Processes
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
D001941
Breast Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C477385
montanide ISA 51
D007376
Interleukin-2
C024352
fludarabine
C042382
fludarabine phosphate
D003520
Cyclophosphamide
D000069585
Filgrastim
D001781
Blood Component Removal
Ancestor Terms
ID
Term
D007378
Interleukins
D016207
Cytokines
D036341
Intercellular Signaling Peptides and Proteins
D010455
Peptides
D000602
Amino Acids, Peptides, and Proteins
D008222
Lymphokines
D011506
Proteins
D001685
Biological Factors
D010752
Phosphoramide Mustards
D009588
Nitrogen Mustard Compounds
D009150
Mustard Compounds
D006846
Hydrocarbons, Halogenated
D006838
Hydrocarbons
D009930
Organic Chemicals
D063088
Phosphoramides
D009943
Organophosphorus Compounds
D016179
Granulocyte Colony-Stimulating Factor
D003115
Colony-Stimulating Factors
D006023
Glycoproteins
D006001
Glycoconjugates
D002241
Carbohydrates
D016298
Hematopoietic Cell Growth Factors
D013812
Therapeutics
Browse Leaves
Not provided
Browse Branches
Not provided
6 subjects
FG00550 subjects
FG0064 subjects
FG0076 subjects
FG0088 subjects
FG0096 subjects
FG0101 subjects
FG0117 subjects
FG0126 subjects
FG0133 subjects
FG0142 subjects
0 subjects
FG0051 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
0 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
Not treated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
1
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0141
Between 18 and 65 years
BG0003
BG0013
BG0023
BG0035
BG00451
BG0054
BG0067
BG0078
BG0086
BG0091
BG0107
BG0116
BG0123
BG0131
BG014108
>=65 years
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0131
BG0141
42.3
± 13.3
BG00337.8± 14.7
BG00441.9± 12.7
BG00538.0± 14.3
BG00639.7± 11.1
BG00741.8± 11.6
BG00849.0± 10.3
BG00962.0
BG01040.7± 9.9
BG01144.2± 11.2
BG01237.7± 7.1
BG01358.5± 10.6
BG01445.0± 11.4
1
BG0032
BG00422
BG0050
BG0062
BG0075
BG0081
BG0091
BG0101
BG0111
BG0120
BG0130
BG01438
Male
BG0002
BG0012
BG0022
BG0034
BG00429
BG0054
BG0065
BG0073
BG0085
BG0090
BG0106
BG0115
BG0123
BG0132
BG01472
0
BG0030
BG0043
BG0050
BG0060
BG0070
BG0080
BG0090
BG0101
BG0110
BG0120
BG0130
BG0144
Not Hispanic or Latino
BG0003
BG0013
BG0023
BG0036
BG00448
BG0054
BG0067
BG0078
BG0086
BG0091
BG0106
BG0116
BG0123
BG0132
BG014106
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
0
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
Asian
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
Black or African American
BG0000
BG0010
BG0020
BG0030
BG0041
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0141
White
BG0003
BG0013
BG0023
BG0036
BG00450
BG0054
BG0067
BG0078
BG0086
BG0091
BG0107
BG0116
BG0123
BG0132
BG014109
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
3
BG0036
BG00451
BG0054
BG0067
BG0078
BG0086
BG0091
BG0107
BG0116
BG0123
BG0132
BG014110
6
OG00450
OG0054
OG0066
OG0078
OG0086
OG0091
OG0107
OG0116
OG0123
OG0132
0
OG0043
OG0050
OG0061
OG0071
OG0081
OG0090
OG0100
OG0110
OG0120
OG0130
Partial Response
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG00414
OG0050
OG0060
OG0071
OG0081
OG0090
OG0102
OG0113
OG0121
OG0130
Minor Response
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0091
OG0100
OG0110
OG0120
OG0130
Progressive Disease
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
Mixed Response
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0071
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
No Response
Title
Measurements
OG0003
OG0013
OG0023
OG0036
OG00432
OG0054
OG0065
OG0075
OG0084
OG0090
OG0105
OG0113
OG0122
OG0132
Stable Disease
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
OG004
Abl Cells IV + MTD IL-2
Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery)
OG005
Abl Cells IA + MTD (Prior Cells IV on 6)
Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) Prior Cells IV + growth colony stimulating factor (G-CSF)
OG006
Abl Cells IA + MTD IL-2
Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF)
OG007
Abl Cells IA+MTD IL-2 (MART-1 Reactive)
Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) + melanoma- associated antigen recognized by T cells (MART-1):26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
OG008
Abl Cells IV + MTD IL-2 no GCSF
Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without growth colony stimulating factor (G-CSF) (to determine if G-CSF has harmful effects when adoptively transferring lymphocytes following a nonmyeloablative chemotherapy regimen)
OG009
Abl Cells IV+MTD IL-2 no GCSF(gp100 Reactive)
Abl Cells intravenous (IV) + maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF)(gp100 reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + gp100:209-217(210M) 1mg/day (2-8 days) in patients with gp100 reactive cells
OG010
Abl Cells IV+MTD IL-2 no GCSF (MART-1reactive)
Abl Cells intravenous (IV)+ maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1)reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
OG011
Abl Cells IV + SQ IL-2 With GCSF
Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery), reactivity not specified
OG012
Abl Cells IV + SQ IL-2 With GCSF (MART-1 Reactive)
Abl Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) with growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1) reactive) Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
OG013
Abl Cells IV + SQ IL-2 With GCSF (no Reactivity)
Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 ( IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) in patients with no reactivity