Phase I/II Trial of Redox Regulation in Patients With Relapsed or Refractory CD20+ NHL

• Status: Terminated
• Trial end date: 2008-08-20
• Target enrollment: 0
• Participant gender: All

Summary

Monoclonal antibodies such as rituximab and yttrium Y 90 ibritumomab tiuxetan can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Motexafin gadolinium may increase the effectiveness of yttrium Y 90 ibritumomab tiuxetan by making the cancer cells more sensitive to the drug.

This phase I/II trial is studying the side effects and best dose of motexafin gadolinium when administered with rituximab and yttrium Y 90 ibritumomab tiuxetan and to see how well they work in treating patients with stage II, stage III, or stage IV relapsed or refractory non-Hodgkin's lymphoma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Collaborator: Robert H. Lurie Cancer Center
• Treatments: Antibodies, Monoclonal; Motexafin gadolinium; Rituximab

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed diagnosis of one of the following:

• Low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL)

• The following histologies are eligible:

• Small lymphocytic lymphoma

• Lymphoplasmacytoid lymphoma

• Follicular center grades 1, 2, or 3 lymphoma

• Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue type

• Nodal marginal zone B-cell lymphoma

• Relapsed or refractory after 2 prior treatment regimens or 1 anthracycline regimen

• Diffuse large B-cell NHL or mantle cell lymphoma in first or second relapse

• Transformed NHL, defined as low-grade NHL transformed to diffuse large B-cell lymphoma, with no more than 1 relapse since transformation

Age 18 and over Recovered from prior immunotherapy Life expectancy At least 3 months Recovered from prior chemotherapy

• More than 4 weeks since prior major surgery and recovered

• More than 4 weeks since prior anticancer therapy recovered from prior radiotherapy

Exclusion criteria:

No major bleeding within the past 4 weeks No uncontrolled hypertension No stroke within the past 4 weeks

• No active infection

• No other active nonmalignant disease

• No known G6PD deficiency

• No history of porphyria

• No other condition that would preclude study participation

• No human anti-mouse antibodies

• No known history of HIV

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No prior radioimmunoconjugate therapy

• No prior exposure to murine antibodies other than rituximab

• More than 4 weeks since prior rituximab

• No history of failed stem cell collection