Monoclonal Antibody Therapy in Treating Patients With Lym... | NCT00047164 | Trialant
NCT00047164
Sponsor
National Institutes of Health Clinical Center (CC)
Status
Completed
Last Update Posted
Sep 26, 2016Estimated
Enrollment
89Actual
Phase
Phase 1
Conditions
Lymphoma
Interventions
ipilimumab
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
No data available
No data is available for this block.
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
NCT00047164
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
020284
Secondary IDs
ID
Type
Description
Link
02-C-0284
NCI-5744
CDR0000257563
Brief Title
Monoclonal Antibody Therapy in Treating Patients With Lymphoma or Colon Cancer That Has Not Responded to Vaccine Therapy
Official Title
A Pilot Study of Ipilimumab (MDX-CTLA4, MDX-010) in Lymphoma
Acronym
Not provided
Organization
National Institutes of Health Clinical Center (CC)NIH
Status Module
Record Verification Date
Mar 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
Not provided
Start Date
Sep 2002
Primary Completion Date
Sep 2010Actual
Completion Date
Nov 2010Actual
First Submitted Date
Oct 3, 2002
First Submission Date that Met QC Criteria
Jan 26, 2003
First Posted Date
Jan 27, 2003Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
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
Sep 23, 2016
Last Update Posted Date
Sep 26, 2016Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
National Institutes of Health Clinical Center (CC)NIH
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
RATIONALE: Monoclonal antibodies such as anti-cytotoxic T-lymphocyte-associated antigen-4 can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: This phase II trial is studying anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody to see how well it works in treating patients with lymphoma or colon cancer that has not responded to vaccine therapy.
Detailed Description
OBJECTIVES:
Primary
Determine the toxicity of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody in patients with follicular or mantle cell lymphoma, colon cancer, or prostate cancer refractory to vaccine therapy. (part I) (prostate cancer and mantle cell lymphoma closed to accrual as of 3/10/2005; colon cancer closed to accrual as of 9/28/05)
Determine the toxicity of this drug at escalating doses in patients with follicular lymphoma. (part II)
Determine the toxicity of this drug at escalating doses in patients with non-Hodgkin's lymphoma or Hodgkin's lymphoma. (part III)
Secondary
Determine the ability of this drug to increase tumor-specific T-cell responses in these patients.
Determine the ability of this drug to produce clinical tumor response in these patients.
Determine the effect of this drug on suppressor T-cell populations (CD4+ and CD25+ cells) in these patients.
OUTLINE: This is a pilot, partial dose-escalation study.
Part I (patients with prostate or colon cancer or follicular or mantle cell lymphomas) (prostate cancer and mantle cell lymphoma closed to accrual as of 3/10/2005; colon cancer closed to accrual as of 9/28/05): Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-CTLA4) IV over 90 minutes on day 1. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Part II (dose-escalation) (patients with follicular lymphomas only): Patients receive MDX-CTLA4 as in part I. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of MDX-CTLA4 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Part III (dose-escalation*) (patients with non-Hodgkin's or Hodgkin's lymphoma): Patients receive MDX-CTLA4 as in part II.
NOTE: No dose-escalation for lymphoma patients who have previously been treated with an allogeneic stem cell transplantation.
Patients are followed every other month.
PROJECTED ACCRUAL: A total of 89 patients will be accrued for this study.
Conditions Module
Conditions
Lymphoma
Keywords
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
contiguous stage II adult lymphoblastic lymphoma
noncontiguous stage II adult lymphoblastic lymphoma
recurrent adult lymphoblastic lymphoma
stage I adult lymphoblastic lymphoma
stage III adult lymphoblastic lymphoma
stage IV adult lymphoblastic lymphoma
noncontiguous stage II grade 3 follicular lymphoma
recurrent grade 3 follicular lymphoma
stage I grade 3 follicular lymphoma
stage III grade 3 follicular lymphoma
stage IV grade 3 follicular lymphoma
contiguous stage II grade 3 follicular lymphoma
contiguous stage II grade 2 follicular lymphoma
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 1
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
89Actual
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
ipilimumab
Biological
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Toxicity after every 3 courses of treatment and every month for up to a year after completion of study treatment
Secondary Outcomes
Measure
Description
Time Frame
T-cell response after every 3 courses of treatment and every month for up to a year after completion of study treatment
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed prostate cancer (closed to accrual as of 3/9/2005)
Prior therapy on protocol NCI-00-C-0137 or NCI-00-C-0154
Progressive disease (2 consecutively rising PSA levels, new bone scan lesion, or progression of soft tissue)
PSA at least 5 ng/mL
Progressive androgen-independent disease
Disease progression at least 4 weeks after flutamide withdrawal OR
Disease progression at least 6 weeks after bicalutamide or nilutamide withdrawal OR
Histologically confirmed follicular or mantle cell non-Hodgkin's lymphoma (mantle cell lymphoma closed to accrual as of 3/9/2005)
Prior therapy on protocol NCI-00-C-0133, NCI-01-C-0169, or NCI-00-C-0050
Progressive disease after standard treatment
Relapsed disease OR
Histologically confirmed colon cancer (colon cancer closed to accrual as of 9/28/05)
Prior therapy on protocol NCI-99-C-0023
Progressive disease OR
Histologically confirmed non-Hodgkin's lymphoma or Hodgkin's lymphoma
Progressive disease after standard treatment
No curative therapy exists
Prior allogeneic stem cell transplantation from a matched sibling or matched unrelated donor for an aggressive lymphoma allowed
Last infusion of allogeneic cells (either hematopoietic stem cells or donor lymphocytes) must have occurred > 90 days prior to study enrollment
No other standard therapy available or refused such therapy
No symptomatic or rapidly progressive malignancy requiring therapy
No symptomatic CNS metastases
PATIENT CHARACTERISTICS:
Age
18 and over
Performance status
Karnofsky 80-100%
Life expectancy
More than 2 months
Hematopoietic
WBC at least 2,500/mm^3
Granulocyte count at least 1,500/mm^3
Platelet count at least 50,000/mm^3
Hemoglobin at least 10 g/dL
Hematocrit at least 30%
Hepatic
Bilirubin no greater than 3.0 mg/dL (unless due to Gilbert's disease)
SGOT and SGPT no greater than 3 times upper limit of normal
Hepatitis B surface antigen negative
Hepatitis C antibody negative
Renal
Creatinine no greater than 2.0 mg/dL
Immunologic
HIV negative
Rheumatoid factor negative if history or evidence of arthritis
Anti-nuclear antibody (ANA) titer no greater than 1:80 if history or clinical signs or symptoms of connective tissue disease
No prior or active autoimmune disease (e.g., uveitis, rheumatoid arthritis, lupus erythematosus, autoimmune hemolytic anemia, ulcerative and hemorrhagic colitis, endocrine disorders [e.g., thyroiditis, hyperthyroidism, hypothyroidism, autoimmune hypophysitis/hypopituitarism, or adrenal insufficiency], sarcoid granuloma, myasthenia gravis, polymyositis,or Guillain-Barre syndrome)
No positive antibody titers to autoimmune diseases
Rheumatoid factor positive allowed unless ANA titer is greater than 1:80 and there is a history of or clinical signs or symptoms of connective tissue disease
No active infection
Other
No other active malignancy within the past 5 years except adequately treated squamous cell or basal cell skin cancer, carcinoma in situ of the cervix, or superficial bladder cancer
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 4 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
See Disease Characteristics
Recovered from prior vaccine therapy
No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-CTLA4) for patients in part I of study
Patients in part II of study may have had up to 4 prior treatments with MDX-CTLA4
No concurrent vaccine therapy
No concurrent infliximab
Chemotherapy
At least 4 weeks since prior cytotoxic chemotherapy
No concurrent mercaptopurine, methotrexate, or cyclophosphamide
Endocrine therapy
See Disease Characteristics
At least 4 weeks since prior steroids
No concurrent systemic, inhaled, or topical steroids
Radiotherapy
At least 4 weeks since prior radiotherapy
Surgery
At least 4 weeks since prior major surgery
Other
Prior intervening therapy for prostate cancer, non-Hodgkin's lymphoma or colon cancer allowed
No other concurrent investigational therapy
No other concurrent immunosuppressants (e.g., cyclosporine or its analog)
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
120 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
John E. Janik, MD
NCI - Metabolism Branch;MET
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda
Maryland
20892-1182
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D008223
Lymphoma
D008224
Lymphoma, Follicular
D054198
Precursor Cell Lymphoblastic Leukemia-Lymphoma
D008228
Lymphoma, Non-Hodgkin
D016403
Lymphoma, Large B-Cell, Diffuse
D016400
Lymphoma, Large-Cell, Immunoblastic
D002051
Burkitt Lymphoma
D020522
Lymphoma, Mantle-Cell
D006689
Hodgkin Disease
D018442
Lymphoma, B-Cell, Marginal Zone
D015451
Leukemia, Lymphocytic, Chronic, B-Cell
D054218
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
D016410
Lymphoma, T-Cell, Cutaneous
Ancestor Terms
ID
Term
D009370
Neoplasms by Histologic Type
D009369
Neoplasms
D008232
Lymphoproliferative Disorders
D008206
Lymphatic Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
D000074324
Ipilimumab
Ancestor Terms
ID
Term
D061067
Antibodies, Monoclonal, Humanized
D000911
Antibodies, Monoclonal
D000906
Antibodies
D007136
Immunoglobulins
Browse Leaves
Not provided
Browse Branches
Not provided
contiguous stage II grade 1 follicular lymphoma
contiguous stage II adult diffuse mixed cell lymphoma
noncontiguous stage II adult diffuse mixed cell lymphoma
recurrent adult diffuse mixed cell lymphoma
stage I adult diffuse mixed cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage IV adult diffuse mixed cell lymphoma
contiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
recurrent adult diffuse large cell lymphoma
stage I adult diffuse large cell lymphoma
stage III adult diffuse large cell lymphoma
stage IV adult diffuse large cell lymphoma
contiguous stage II adult immunoblastic large cell lymphoma
noncontiguous stage II adult immunoblastic large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
stage I adult immunoblastic large cell lymphoma
stage III adult immunoblastic large cell lymphoma
stage IV adult immunoblastic large cell lymphoma
contiguous stage II adult Burkitt lymphoma
noncontiguous stage II adult Burkitt lymphoma
recurrent adult Burkitt lymphoma
stage I adult Burkitt lymphoma
stage III adult Burkitt lymphoma
stage IV adult Burkitt lymphoma
contiguous stage II mantle cell lymphoma
noncontiguous stage II mantle cell lymphoma
recurrent mantle cell lymphoma
stage I mantle cell lymphoma
stage III mantle cell lymphoma
stage IV mantle cell lymphoma
recurrent adult Hodgkin lymphoma
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
recurrent adult diffuse small cleaved cell lymphoma
stage I adult diffuse small cleaved cell lymphoma
stage II adult diffuse small cleaved cell lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage IV adult diffuse small cleaved cell lymphoma
contiguous stage II marginal zone lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue