Status:
TERMINATED
Phase I/II Trial of Redox Regulation in Patients With Relapsed or Refractory CD20+ NHL
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Robert H. Lurie Cancer Center
Conditions:
Non-Hodgkin's Lymphoma (NHL)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 norm...
Detailed 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 cellul...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 28 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 20 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00089284
Start Date
October 28 2003
End Date
August 20 2008
Last Update
August 14 2019
Active Locations (2)
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1
Northwestern University
Chicago, Illinois, United States, 60611-3013
2
Jesse B. Brown Veterans Affairs Medical Center
Chicago, Illinois, United States, 60611