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)
Rituxan
+ motexafin gadolinium
+ 111Indium-Zevalin and 90Yttrium-Zevalin
Immune System Diseases+5
+ Immunoproliferative Disorders
+ Lymphatic Diseases
Treatment Study
Summary
Study start date: October 28, 2003
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Jesse B. Brown Veterans Affairs Medical Center
Chicago, United States