Spots Global Cancer Trial Database for Monoclonal Antibody Therapy in Treating Patients With Recurrent or Refractory Lymphoma

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Trial Identification

Brief Title: Monoclonal Antibody Therapy in Treating Patients With Recurrent or Refractory Lymphoma

Official Title: A Phase I Study Of Therapy With Mono-dgA-RFB4 In Patients With Relapsed And Refractory CD22+ B-Cell Lymphoma

Study ID: NCT00007956

Conditions

Lymphoma

Interventions

monoclonal antibody mono-dgA-RFB4

Study Description

Brief Summary: RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have recurrent or refractory lymphoma.

Detailed Description: OBJECTIVES: * Determine the maximum tolerated dose and dose-limiting toxicity of monoclonal antibody mono-dgA-RFB4 in patients with recurrent or refractory B-cell lymphoma expressing CD22 antigen. * Determine the pharmacokinetic profile of this drug in these patients. * Correlate the pharmacokinetic parameters with the biologic effects and/or toxicity of this drug in these patients. * Determine whether clinical responses in these patients occur at lower, equal, or higher doses than historical responses induced by a similar drug. OUTLINE: This is a dose-escalation study. Patients are stratified according to number of circulating tumor cells in peripheral blood (more than 50/mm3 vs 50/mm3 or less). Patients receive monoclonal antibody Mono-dgA-RFB4 IV over 4 hours on days 1, 3, and 5. Patients achieving complete, partial, or minimal remission receive additional courses of therapy every 4 weeks in the absence of unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of monoclonal antibody mono-dgA-RFB4 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients achieving complete remission or stable partial remission are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 20-25 patients will be accrued for this study within 12-18 months.