Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
Phase I/II Study of Anti-CTLA-4 Monoclonal Antibody (MDX-010) in B-cell Non-Hodgkin's Lymphoma
Biological therapies, such as MDX-010, work in different ways to stimulate the immune system and stop cancer cells from growing. This phase I/II trial is studying the side effects and best dose of MDX-010 and to see how well it works in treating patients with recurrent or refractory B-cell non-Hodgkin's lymphoma.
PRIMARY OBJECTIVES:
I. To characterize the safety profile of MDX-010 (ipilimumab) monoclonal antibody and
identify a tolerable immunologically active dose level in B cell lymphoma patients.
II. To evaluate the clinical response rate in B cell lymphoma patients treated with MDX-010.
SECONDARY OBJECTIVES:
I. To evaluate the phenotype and function of memory T cells before and after treatment with
MDX-010 by:
- Quantitation and phenotypic characterization of peripheral blood and tumor infiltrating
T-cells, including cluster of differentiation (CD)4+CD25+ regulatory T cells.
- Measurement of tumor-specific T cells in peripheral blood lymphocytes.
- Measuring proliferation of memory T cells in response to recall antigens (tetanus
toxoid and keyhole limpet hemocyanin [KLH]).
II. Measurement of anti-tumor antibodies in serum pre- and post-therapy. III. To evaluate
the time to progression. IV. To evaluate the duration of response to treatment with MDX-010.
OUTLINE: This is a multicenter, open-label, phase I, dose-escalation study followed by a
phase II study. Patients are grouped according to prior treatment with a vaccine therapy for
lymphoma (yes vs no).
PHASE I: Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal
antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total
of 4 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 6 patients from each group receive escalating doses of MDX-010 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.
PHASE II: Patients receive MDX-010 as in phase I at the MTD.
Patients are followed at 1 and 4 months and then every 6 months for up to 2 years.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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