Non Hodgkin Lymphoma Clinical Trial
Phase I/II Trial of Redox Regulation in Patients With Relapsed or Refractory CD20+ NHL
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.
Full Description
This is a phase I, dose-escalation study of motexafin gadolinium followed by a phase II study. Patients are stratified according to extent of lymphomatous involvement (≤ 5% vs > 5 but ≤ 24% of cellular elements).
Cohorts of 3-6 patients in each stratum receive escalating doses of motexafin gadolinium until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity (DLT) OR the dose preceding that at which 2 of 3 or 3 of 6 patients experience DLT.
Once the MTD is determined, additional patients are treated at that dose level as in phase I.
Patients are followed weekly for 3 months and then monthly for 5 years.
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
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There is 1 Location for this study
Chicago Illinois, 60611, United States
Chicago Illinois, 60611, United States
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