Phase I/II Trial of Redox Regulation in Patients With Relapsed or Refractory CD20+ NHL
This trial is active, not recruiting.
|Condition||non-hodgkin's lymphoma (nhl)|
|Treatments||rituxan, motexafin gadolinium, 111indium-zevalin and 90yttrium-zevalin|
|Phase||phase 1/phase 2|
|Start date||September 2003|
|End date||December 2007|
|Trial size||30 participants|
|Trial identifier||NCT00089284, 1346001, NU 02H8|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Maximum tolerated dose
time frame: On each treatment day (2, 3, 4, 9, 10, 11) and Day 7 evaluation
time frame: At 1, 3 and 6 months
Study location of tumor through MRIs
time frame: At 1,3 and 6 months
Correlative laboratory studies
time frame: On Day 1 and 4
Male or female participants at least 18 years old.
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
|Official title||A Phase I/II Trial of Redox Regulation in Patients With Relapsed or Refractory CD20 Positive Non-Hodgkin's Lymphoma (NHL): Combining 90-Yttrium- Zevalin and the Redox- Modulating Agent, Motexafin Gadolinium (MGd)|
|Principal investigator||Andrew M. Evens, DO, MS|
|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.|
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