A Pilot Study of Ipilimumab (MDX-CTLA4, MDX-010) in Lymphoma
- 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
- 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
- Determine the ability of this drug to produce clinical tumor response in these
- 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.
Masking: Open Label, Primary Purpose: Treatment
Toxicity after every 3 courses of treatment and every month for up to a year after completion of study treatment
John E. Janik, MD
NCI - Metabolism Branch;MET
United States: Food and Drug Administration
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office||Bethesda, Maryland 20892-1182|