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| ID | Type | Description | Link |
|---|---|---|---|
| 11-C-0123 |
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Background:
- An experimental treatment for metastatic melanoma involves cell therapy, in which researchers take white blood cells (lymphocytes) from the tumor tissue, grow them in the laboratory in large numbers, and then use the cells to attack the tumor tissue. Before receiving the cells, chemotherapy is needed to temporarily suppress the immune system to improve the chances that the tumor-fighting cells will be able to survive in the body. In some studies of cell therapy, individuals who have received total body irradiation (TBI) in addition to the chemotherapy (in order to increase the length of time that they do not produce white blood cells) seem to have a slightly better response to the treatment, but it is not known if adding radiation to the cell therapy will cause a better response for all individuals. Researchers are interested in comparing cell therapy given with the usual chemotherapy to cell therapy given with the usual chemotherapy and TBI.
Objectives:
- To compare the effectiveness of cell therapy given with chemotherapy to cell therapy given with chemotherapy and total body irradiation in individuals with metastatic melanoma.
Eligibility:
- Individuals at least 18 years of age who have been diagnosed with metastatic melanoma.
Design:
Background:
Objectives:
-To determine, in a prospective randomized trial, the complete response rate and survival of patients with metastatic melanoma receiving adoptive cell transfer (ACT) using young TIL plus aldesleukin treatment following either a chemotherapy preparative regimen alone, or the same chemotherapy preparative regimen plus TBI.
Eligibility:
-Patients who are 18 years or older must have:
Design:
-Patients with metastatic melanoma will have lesions resected and after TIL growth is established patients with will be prospectively randomized to receive ACT with young TIL plus aldesleukin following either a non-myeloablative chemotherapy preparative regimen or this same regimen plus TBI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1/Adoptive Cell Therapy (ACT) | Experimental | Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin |
|
| Arm 2/Adoptive Cell Therapy (ACT) + Total Body Irradiation (TBI) | Experimental | Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aldesleukin | Drug | Arm 1 and Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression) | Percentage of participants who have a clinical response to treatment (objective tumor regression) was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete Response (CR) is disappearance of all target lesions. Partial Response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as refence the baseline sum LD. Progressive Disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD. The appearance of one or more new lesions is also considered progressions. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD. | Participants were followed from treatment to progression of disease or until principal investigator (PI) discretion (average 91.8 months). |
| Overall Survival (OS) | OS is defined as the time to death following the start of treatment. | Participants were followed from treatment until death (median 14 months) or until principal investigator (PI) discretion (median 99.0 months) for participants alive at study closure. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | PFS is defined as time to disease progression following the start of treatment. Disease progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v3.0. Progressive Disease is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD. The appearance of one or more new lesions is also considered progression. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0) | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
INCLUSION CRITERIA:
Absolute neutrophil count greater than 1000/mm(3)
Hemoglobin greater than 8.0 g/dl
Platelet count greater than 100,000/mm(3)
j. Serology:
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, or hepatitis C antibody or antigen.
k. Chemistry:
Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less than three times the upper limit of normal.
Calculated creatinine clearance (eGFR) > 50 ml/min.
Total bilirubin less than or equal to 2 mg/dl, except in patients with
Gilbert's Syndrome who must have a total bilirubin less than 3 mg/dl.
l. More than four weeks must have elapsed since any prior systemic therapy at the time of randomization, and patient's toxicities must have recovered to a grade 1 or less (except for alopecia or vitiligo). Patients must have stable or progressing disease after prior treatment.
Note: Patients may have undergone minor surgical procedures within the past 3 weeks, as long as all toxicities have recovered to grade 1 or less or as specified in the inclusion criteria.
m. Six weeks must have elapsed since any prior anti-cytotoxic T-lymphocyte associated protein 4 (CTLA4) antibody therapy to allow antibody levels to decline.
Note: Patients who have previously received ipilimumab or tremelimumab, anti-programmed cell death protein 1 (PD1) or anti-programmed cell death ligand 1 (PD-L1) antibodies and have documented gastrointestinal (GI) toxicity must have a normal colonoscopy with normal colonic biopsies.
EXCLUSION CRITERIA:
Prior cell transfer therapy which included a non-myeloablative or myeloablative chemotherapy regimen.
Women of child-bearing potential who are pregnant or breastfeeding because 10 of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
Systemic steroid therapy requirement.
Active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, as evidenced by a positive stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease.
Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease and acquired immunodeficiency syndrome (AIDS).
Opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities.)
History of severe immediate hypersensitivity reaction to any of the agents used in this study.
History of coronary revascularization or ischemic symptoms.
Any patient known to have a left ventricular ejection fraction (LVEF) less than or equal to 45%.
In patients > 60 years old, documented LVEF of less than or equal to 45%.
Documented forced expiratory volume in one second (FEV1) less than or equal to 60% predicted tested in patients with:
Prior radiation therapy that, in the judgment of the radiation oncologist, precludes the administration of total body irradiation.
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| Name | Affiliation | Role |
|---|---|---|
| Steven A Rosenberg, M.D. | National Cancer Institute (NCI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18809613 | Background | Dudley ME, Yang JC, Sherry R, Hughes MS, Royal R, Kammula U, Robbins PF, Huang J, Citrin DE, Leitman SF, Wunderlich J, Restifo NP, Thomasian A, Downey SG, Smith FO, Klapper J, Morton K, Laurencot C, White DE, Rosenberg SA. Adoptive cell therapy for patients with metastatic melanoma: evaluation of intensive myeloablative chemoradiation preparative regimens. J Clin Oncol. 2008 Nov 10;26(32):5233-9. doi: 10.1200/JCO.2008.16.5449. Epub 2008 Sep 22. | |
| 10561265 |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request.
Clinical data available during the study and indefinitely.
Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI).
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin Aldesleukin: Arm 1 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses). Cyclophosphamide: Arm 1 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Fludarabine: Arm 1 - Days -7 to -3: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days. Young TIL: Arm 1 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 15, 2022 |
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| Cyclophosphamide | Drug | Arm 1 and Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. |
|
|
| Fludarabine | Drug | Arm 1 and Arm 2 - Days -7 to -3: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days. |
|
|
| Young TIL | Biological | Arm 1 and Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes. |
|
|
| Total Body Irradiation (TBI) | Radiation | Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology. |
|
|
| Participants were followed from treatment until death or until principal investigator (PI) discretion. A median of 91.8 months. |
| Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Here is the number of Grades 2, 3, 4, and/or 5 serious adverse events possibly and/or probably related to treatment. Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event. | Time of registration through 6 years after the last treatment. |
| Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Here is the number of Grades 1, 2, 3, 4, and/or 5 non-serious adverse events possibly and/or probably related to treatment. Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event. | 30 days after end of treatment, up to 6 years |
| Participants will be followed for adverse events from registration through 30 days after the last treatment, up to 6 years |
| Background |
| Atkins MB, Lotze MT, Dutcher JP, Fisher RI, Weiss G, Margolin K, Abrams J, Sznol M, Parkinson D, Hawkins M, Paradise C, Kunkel L, Rosenberg SA. High-dose recombinant interleukin 2 therapy for patients with metastatic melanoma: analysis of 270 patients treated between 1985 and 1993. J Clin Oncol. 1999 Jul;17(7):2105-16. doi: 10.1200/JCO.1999.17.7.2105. |
| 8028037 | Background | Rosenberg SA, Yannelli JR, Yang JC, Topalian SL, Schwartzentruber DJ, Weber JS, Parkinson DR, Seipp CA, Einhorn JH, White DE. Treatment of patients with metastatic melanoma with autologous tumor-infiltrating lymphocytes and interleukin 2. J Natl Cancer Inst. 1994 Aug 3;86(15):1159-66. doi: 10.1093/jnci/86.15.1159. |
| 27217459 | Background | Goff SL, Dudley ME, Citrin DE, Somerville RP, Wunderlich JR, Danforth DN, Zlott DA, Yang JC, Sherry RM, Kammula US, Klebanoff CA, Hughes MS, Restifo NP, Langhan MM, Shelton TE, Lu L, Kwong ML, Ilyas S, Klemen ND, Payabyab EC, Morton KE, Toomey MA, Steinberg SM, White DE, Rosenberg SA. Randomized, Prospective Evaluation Comparing Intensity of Lymphodepletion Before Adoptive Transfer of Tumor-Infiltrating Lymphocytes for Patients With Metastatic Melanoma. J Clin Oncol. 2016 Jul 10;34(20):2389-97. doi: 10.1200/JCO.2016.66.7220. Epub 2016 May 23. |
| 34413159 | Background | Seitter SJ, Sherry RM, Yang JC, Robbins PF, Shindorf ML, Copeland AR, McGowan CT, Epstein M, Shelton TE, Langhan MM, Franco Z, Danforth DN, White DE, Rosenberg SA, Goff SL. Impact of Prior Treatment on the Efficacy of Adoptive Transfer of Tumor-Infiltrating Lymphocytes in Patients with Metastatic Melanoma. Clin Cancer Res. 2021 Oct 1;27(19):5289-5298. doi: 10.1158/1078-0432.CCR-21-1171. |
| 25432172 | Derived | Crompton JG, Sukumar M, Roychoudhuri R, Clever D, Gros A, Eil RL, Tran E, Hanada K, Yu Z, Palmer DC, Kerkar SP, Michalek RD, Upham T, Leonardi A, Acquavella N, Wang E, Marincola FM, Gattinoni L, Muranski P, Sundrud MS, Klebanoff CA, Rosenberg SA, Fearon DT, Restifo NP. Akt inhibition enhances expansion of potent tumor-specific lymphocytes with memory cell characteristics. Cancer Res. 2015 Jan 15;75(2):296-305. doi: 10.1158/0008-5472.CAN-14-2277. Epub 2014 Nov 28. |
| FG001 | Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI) Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses). Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days. Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes. Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology. |
| FG002 | Arm 1X: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Arm 1X: Compassionate Exemption. Participant received young tumor infiltrating lymphocytes (TIL) and Interleukin-2 (IL-2), but not cyclophosphamide or fludarabine (they were administered before the participant enrolled onto this protocol). Young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin Aldesleukin: Arm 1 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses). Young TIL: Arm 1 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes. |
| COMPLETED |
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| NOT COMPLETED |
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|
One participant on Arm 1X is not reported for privacy concerns (n=1).
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin Aldesleukin: Arm 1 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses). Cyclophosphamide: Arm 1 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Fludarabine: Arm 1 - Days -7 to -3: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days. Young TIL: Arm 1 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes. |
| BG001 | Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI) Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses). Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days. Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes. Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Percentage of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression) | Percentage of participants who have a clinical response to treatment (objective tumor regression) was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete Response (CR) is disappearance of all target lesions. Partial Response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as refence the baseline sum LD. Progressive Disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD. The appearance of one or more new lesions is also considered progressions. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD. | 99/102 participants were analyzed. Two participants were not treated due to rapidly progressive disease after enrollment but before treatment. One participant on Arm 1X is not reported for privacy concerns (n=1). | Posted | Number | Percentage of participants | Participants were followed from treatment to progression of disease or until principal investigator (PI) discretion (average 91.8 months). |
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| Primary | Overall Survival (OS) | OS is defined as the time to death following the start of treatment. | 99/102 participants were analyzed. Two participants were enrolled and not treated due to rapid disease progression prior to start of treatment (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). | Posted | Median | Full Range | Months | Participants were followed from treatment until death (median 14 months) or until principal investigator (PI) discretion (median 99.0 months) for participants alive at study closure. |
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| Secondary | Progression-free Survival (PFS) | PFS is defined as time to disease progression following the start of treatment. Disease progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v3.0. Progressive Disease is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD. The appearance of one or more new lesions is also considered progression. | 99/102 participants were analyzed. Two participants were enrolled and not treated due to rapid disease progression prior to start of treatment (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). | Posted | Median | Full Range | Months | Participants were followed from treatment until death or until principal investigator (PI) discretion. A median of 91.8 months. |
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| Secondary | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Here is the number of Grades 2, 3, 4, and/or 5 serious adverse events possibly and/or probably related to treatment. Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event. | 99/102 participants were analyzed. Two participants were enrolled and not treated due to disease progression prior to start of treatment (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). *Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events. | Posted | Number | adverse events | Time of registration through 6 years after the last treatment. |
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| Secondary | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Here is the number of Grades 1, 2, 3, 4, and/or 5 non-serious adverse events possibly and/or probably related to treatment. Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event. | 99/102 participants were analyzed. Two participants were enrolled and not treated due to disease progression prior to start of treatment (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). *Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events. | Posted | Number | adverse events | 30 days after end of treatment, up to 6 years |
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| Other Pre-specified | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0) | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. | 99/102 participants were analyzed. Two participants were enrolled and not treated due to disease progression prior to start of treatment (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). *Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events. | Posted | Count of Participants | Participants | Participants will be followed for adverse events from registration through 30 days after the last treatment, up to 6 years |
|
All-Cause Mortality was monitored/assessed from treatment to study closure (median 12.3 years). Adverse events were monitored/assessed from start of treatment until 30 days after the last treatment, up to 6 years.
99/102 participants were analyzed for Adverse Events. Two participants were enrolled/not treated (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). *Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin Aldesleukin: Arm 1 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses). Cyclophosphamide: Arm 1 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Fludarabine: Arm 1 - Days -7 to -3: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days. Young TIL: Arm 1 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes. | 23 | 51 | 2 | 51 | 51 | 51 |
| EG001 | Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI) Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses). Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days. Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes. Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology. | 23 | 50 | 17 | 48 | 48 | 48 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Calcium, serum-low (hypocalcemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cardiopulmonary arrest, cause unknown (non-fatal) | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Creatinine | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Death not associated with CTCAE term | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Death not associated with CTCAE term::Disease progression NOS | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)::Blood |
|
| Left ventricular diastolic dysfunction | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neurology - Other (Specify, __): HYDROCEPHALUS | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pleural effusion (non-malignant) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Secondary Malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Systematic Assessment | - possibly related to cancer treatment (Specify, __): Myelodysplastic syndrome versus acute myeloid leukemia |
|
| Seizure | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Somnolence/depressed level of consciousness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Supraventricular and nodal arrhythmia::Sinus tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Syncope (fainting) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombosis/embolism (vascular access-related) | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombotic microangiopathy | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | (e.g., thrombotic thrombocytopenic purpura [TTP] or hemolytic uremic syndrome [HUS]) |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| AST, SGOT(serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Acidosis (metabolic or respiratory) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Acute vascular leak syndrome | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Alkaline phosphatase | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bilirubin (hyperbilirubinemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Calcium, serum-low (hypocalcemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cardiac troponin I (cTnI) | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Colitis, infectious (e.g., Clostridium difficile) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Confusion | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Creatinine | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry mouth/salivary gland (xerostomia) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema: head and neck | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Febrile neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (fever of unknown origin without clinically or microbiologically documented infection)(ANC <1.0 x 10e9/L, fever >=38.5 degrees C) |
|
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage, GI::Ileum | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage, GU::Bladder | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypopigmentation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypotension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Incontinence, urinary | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)::Blood |
|
| Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)::Urinary tract NOS |
|
| Infection with normal ANC or Grade 1 or 2 neutrophils::Blood | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Trachea | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with unknown ANC::Nerve-peripheral | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mental status | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mood alteration::Agitation | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis/stomatitis (clinical exam)::Oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muscle weakness, generalized or specific area (not due to neuropathy)::Extremity-upper | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy: sensory | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ocular/Visual - Other (Specify, __): Corneal Edema, OU | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ocular/Visual - Other (Specify, __): VISION CHANGES (R EYE) | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| PTT (Partial Thromboplastin Time) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain::Abdomen NOS | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain::Back | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain::Bladder | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain::Breast | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain::Chest wall | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain::Chest/thorax NOS | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain::Extremity-limb | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain::Face | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain::Head/headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain::Joint | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain::Muscle | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain::Neuralgia/peripheral nerve | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain::Pain NOS | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain::Pelvis | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain::Sinus | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain::Tumor pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Phosphate, serum-low (hypophosphatemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Platelets | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pleural effusion (non-malignant) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Potassium, serum-low (hypokalemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pruritus/itching | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Psychosis (hallucinations/delusions) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Renal/Genitourinary - Other (Specify, __): Low urine output | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Renal/Genitourinary - Other (Specify, __): Low urine output (nonoliguric renal insufficiency) | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Renal/Genitourinary - Other (Specify, __): Lower urine output | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Renal/Genitourinary - Other (Specify, __): Oliguria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Renal/Genitourinary - Other (Specify, __): low urine output | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Retinopathy | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rigors/chills | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Somnolence/depressed level of consciousness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Supraventricular and nodal arrhythmia::Atrial fibrillation | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Supraventricular and nodal arrhythmia::Sinus bradycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Supraventricular and nodal arrhythmia::Sinus tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Syncope (fainting) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombotic microangiopathy | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | (e.g., thrombotic thrombocytopenic purpura [TTP] or hemolytic uremic syndrome [HUS]) |
|
| Urinary frequency/urgency | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Uveitis | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ventricular arrhythmia::Ventricular tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vision-blurred vision | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vision-flashing lights/floaters | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
Grade 1/2 adverse events were only captured in conjunction with serious adverse events or when attributed to TIL.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Steven A. Rosenberg | National Cancer Institute | 240-858-3080 | sar@mail.nih.gov |
| May 14, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 9, 2019 | May 14, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D012878 | Skin Neoplasms |
| 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 |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C082598 | aldesleukin |
| D007376 | Interleukin-2 |
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| C042382 | fludarabine phosphate |
| D014916 | Whole-Body Irradiation |
| 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 |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Ethnicity Unknown or Not Reported |
|
| American Indian or Alaska Native |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Race Unknown or Not Reported |
|
| Stable Disease |
|
| Progressive Disease |
|
Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI) Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses). Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days. Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes. Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology. |
|
|
| OG001 | Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI) Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses). Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days. Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes. Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology. |
|
|
| OG001 | Arm 1: Related to Tumor Infiltrating Lymphocytes (TIL) | Arm 1: Tumor Infiltrating lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin Aldesleukin: Arm 1 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses). Cyclophosphamide: Arm 1 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Fludarabine: Arm 1 - Days -7 to -3: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days. Young TIL: Arm 1 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes. |
| OG002 | Arm 1: Related to Fludarabine | Arm 1: Tumor Infiltrating lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin Aldesleukin: Arm 1 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses). Cyclophosphamide: Arm 1 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Fludarabine: Arm 1 - Days -7 to -3: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days. Young TIL: Arm 1 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes. |
| OG003 | Arm 1: Related to Cyclophosphamide | Arm 1: Tumor Infiltrating lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin Aldesleukin: Arm 1 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses). Cyclophosphamide: Arm 1 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Fludarabine: Arm 1 - Days -7 to -3: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days. Young TIL: Arm 1 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes. |
| OG004 | Arm 2: Related to Interleukin-2 (IL-2) | Arm 2: Tumor Infiltrating lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI) Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses). Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days. Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes. Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology. |
| OG005 | Arm 2: Related to Tumor Infiltrating Lymphocytes | Arm 2: Tumor Infiltrating lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI) Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses). Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days. Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes. Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology. |
| OG006 | Arm 2: Related to Total Body Irradiation (TBI) | Arm 2: Tumor Infiltrating lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI) Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses). Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days. Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes. Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology. |
| OG007 | Arm 2: Fludarabine | Arm 2: Tumor Infiltrating lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI) Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses). Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days. Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes. Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology. |
| OG008 | Arm 2: Related to Cyclophosphamide | Arm 2: Tumor Infiltrating lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI) Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses). Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days. Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes. Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology. |
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| OG001 | Arm 1: Related to Tumor Infiltrating Lymphocytes (TIL) | Arm 1: Tumor Infiltrating lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin Aldesleukin: Arm 1 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses). Cyclophosphamide: Arm 1 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Fludarabine: Arm 1 - Days -7 to -3: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days. Young TIL: Arm 1 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes. |
| OG002 | Arm 1: Related to Fludarabine | Arm 1: Tumor Infiltrating lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin Aldesleukin: Arm 1 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses). Cyclophosphamide: Arm 1 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Fludarabine: Arm 1 - Days -7 to -3: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days. Young TIL: Arm 1 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes. |
| OG003 | Arm 1: Related to Cyclophosphamide | Arm 1: Tumor Infiltrating lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin Aldesleukin: Arm 1 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses). Cyclophosphamide: Arm 1 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Fludarabine: Arm 1 - Days -7 to -3: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days. Young TIL: Arm 1 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes. |
| OG004 | Arm 2: Related to Interleukin-2 (IL-2) | Arm 2: Tumor Infiltrating lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI) Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses). Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days. Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes. Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology. |
| OG005 | Arm 2: Related to Tumor Infiltrating Lymphocytes | Arm 2: Tumor Infiltrating lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI) Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses). Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days. Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes. Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology. |
| OG006 | Arm 2: Related to Total Body Irradiation (TBI) | Arm 2: Tumor Infiltrating lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI) Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses). Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days. Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes. Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology. |
| OG007 | Arm 2: Fludarabine | Arm 2: Tumor Infiltrating lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI) Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses). Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days. Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes. Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology. |
| OG008 | Arm 2: Related to Cyclophosphamide | Arm 2: Tumor Infiltrating lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI) Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses). Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days. Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes. Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology. |
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| OG001 | Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI) Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses). Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days. Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes. Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology. |
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