Non-Hodgkin's Lymphoma (NHL) Clinical Trial
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)
Verified date | April 2019 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 30 |
Est. completion date | August 20, 2008 |
Est. primary completion date | January 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Jesse B. Brown Veterans Affairs Medical Center | Chicago | Illinois |
United States | Northwestern University | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Northwestern University | Robert H. Lurie Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dose Limiting Toxicities (DLT) | The number of Dose Limiting Toxicities (DLT) observed in patients treated with Motexafin Gadolinium at different dose levels in combination with Rituxan, Indium-Zevalin, and 90Yttrium-Zevalin was used to determine the Maximum Tolerated Dose (MTD) to be used for phase II of the study. The number of dose-limiting toxicities observed in each cohort of patients determined whether to continue dose escalation. Each cohort = at least 3 patients. All toxicities will be graded according to the NCI Common Toxicity Criteria, version 2.0, with a DLT defined as any of the following: Grade 3 or 4 non-hematologic toxicity (other than grade 3 nausea or vomiting). Grade 4 vomiting despite maximal antiemetic support. Grade 4 neutropenia and thrombocytopenia either lasting longer than 14 days—Grade 4 duration will be measured (in days) from the first date in grade 4 to last date in grade 4 after nadir (growth factor and transfusion independent, respectively). |
Weekly during treatment and continuing up through Day 90 | |
Primary | Maximum Tolerated Dose (MTD) | The maximum tolerated dose (MTD) of Motexafin Gadolinium in combination with Rituxan, Indium-Zevalin, and 90Yttrium-Zevalin was determined using a modified Fibonacci phase I study design (with patient allocation based on amount of lymphoma bone marrow involvement) and will be used in phase II of the study. The MTD will be that dose at which 0/3 or 1/6 patients or 2/9 experience a Dose Limiting Toxicity (DLT), with the next higher dose level provoking DLT in 2/3 or 3/6 or 4/9 patients. | Weekly during treatment and continuing up through Day 90 | |
Secondary | Anti-lymphoma Efficacy | To assess the anti-lymphoma efficacy of the combination of MGd and 90Yttrium-Zevalin therapy. Disease response to treatment was categorized as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or complete response/unconfirmed (CRu). The overall response rate (ORR) was then calculated. The time to treatment failure (TTF), overall survival (OS), and duration of response were determined. | At 1, 3 and 6 months | |
Secondary | Study and Describe the Bio-locationization of Motexafin Gadolinium (MGd) in Tumors Using MRIs | To study the tumor-specific bio-localization of MGd in lymphoma through magnetic resonance imaging (MRI) in a subset of patients. The first 2 patients of each cohort will have MRI imaging to measure if signal intensity, a correlate for MGd uptake, is increased in known areas of lymphomatous involvement. | At baseline (pre-treatment) and on Day 4 of treatment | |
Secondary | Correlative Laboratory Studies | To explore correlative laboratory studies of MGd (ie, uptake of MGd by peripheral mononuclear cells, effect of MGd upon peripheral lymphocyte subset populations). | On Day 1 and 4 |
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