Phase I/II Trial of Redox Regulation in Patients With Relapsed or Refractory CD20+ NHL
Non-Hodgkin's Lymphoma (NHL)
About this trial
This is an interventional treatment trial for Non-Hodgkin's Lymphoma (NHL)
Eligibility 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
Sites / Locations
- Northwestern University
- Jesse B. Brown Veterans Affairs Medical Center
Arms of the Study
Arm 1
Experimental
Rituxan and 90Yttrium-Zevalin plus MGd
Patients receive motexafin gadolinium IV over 30-60 minutes on days 1-4 and 8-11. At least 1 hour after motexafin gadolinium administration, patients receive rituximab IV over 3-4 hours on days 1 and 8. After rituximab administration, patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo gamma camera scanning on days 1, 2*, 4*, and 7 and dosimetry on days 2, 4, and 7. If safe biodistribution is demonstrated, patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes (after rituximab administration) on day 8.