Monoclonal Antibody Therapy in Treating Patients With Lymphoma or Colon Cancer That Has Not Responded to Vaccine Therapy
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Ipilimumab (MDX-CTLA4, MDX-010) in Lymphoma|
- Toxicity after every 3 courses of treatment and every month for up to a year after completion of study treatment [ Designated as safety issue: Yes ]
- T-cell response after every 3 courses of treatment and every month for up to a year after completion of study treatment [ Designated as safety issue: No ]
|Study Start Date:||September 2002|
|Study Completion Date:||November 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
- 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)
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00047164
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office|
|Bethesda, Maryland, United States, 20892-1182|
|Study Chair:||John E. Janik, MD||NCI - Metabolism Branch;MET|