Status:
TERMINATED
Fenretinide and Rituximab in Treating Patients With B-Cell Non-Hodgkin Lymphoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adult Nodular Lymphocyte Predominant Hodgkin Lymphoma
B-cell Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This phase I/II trial is studying the side effects and best dose of fenretinide and to see how well it works when given together with rituximab in treating patients with B-cell non-Hodgkin lymphoma. D...
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate the safety of fenretinide delivered in a 5 of 7 day regimen. (Phase I) II. To estimate the efficacy (response rates) of fenretinide + rituximab in patients with B-c...
Eligibility Criteria
Inclusion
- Patients must have a confirmed cluster of differentiation (CD) 20+ lymphoid malignancy
- All patients with indolent NHL (including Follicular, Marginal Zone, small lymphocytic lymphoma (SLL)/chronic lymphocytic leukemia (CLL), lymphoplasmacytoid/Waldenström's, nodular lymphocyte predominant Hodgkins) are potentially eligible
- Patients with Aggressive Lymphoma (including diffuse large B-cell, Burkitt's, Burkitt's-like, B-lymphoblastic) may be considered for this protocol only if unable or unwilling to receive potentially curative intensive therapy
- All Mantle Cell Lymphoma patients are potentially eligible
- The World Health Organization (WHO) classification of patient's malignancy must be provided
- Patients must have a Southwest Oncology Group (SWOG)/Eastern Cooperative Oncology Group (ECOG) of =\< 2
- Patients should have an expected survival if untreated of at least 60 days
- Patients must be expected to complete at least 8 weeks of therapy
- Serum bilirubin less than 2 times the upper limit of normal and no other serious medical condition
- Creatinine less than 2 times the upper limit of normal and no other serious medical condition
- Patients must have measurable disease defined as lesions that can be accurately measured in two dimensions by computed tomography (CT), magnetic resonance imaging (MRI), medical photograph (skin or oral lesion), plain x-ray, or other conventional technique and a greatest transverse diameter of 1 cm or greater; or palpable lesions with both diameters \>= 2 cm or evaluable disease in the bone marrow; patients must have a CT of chest, abdomen, and pelvis within 28 days of enrollment; patients with evidence of adenopathy in the neck must have a CT of the neck; (Note: Patients with CLL do not need to have radiographically measurable disease as this is not required to measure response in this disease setting)
- All patients with an unknown prior bone marrow status or history of bone marrow involvement must have a bone marrow aspirate and biopsy within 28 days of enrollment and no intervening anticancer therapy
- All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines
Exclusion
- Patients known to be human immunodeficiency virus (HIV) positive
- Patients with evidence of active central nervous system malignancy
- Pregnant or nursing women
- Men or women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
- Concurrent anti-neoplastic therapy
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00288067
Start Date
October 1 2005
End Date
July 1 2013
Last Update
October 6 2014
Active Locations (1)
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1
University of Washington Medical Center
Seattle, Washington, United States, 98195