Study Stopped
NCI stopped supplying fenretinide in November of 2012.
Fenretinide and Rituximab in Treating Patients With B-Cell Non-Hodgkin Lymphoma
A Phase I-II Trial of Fenretinide (4-HPR) + Rituximab in Patients With B-cell Lymphoma
9 other identifiers
interventional
32
1 country
1
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. Drugs used in chemotherapy, such as fenretinide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Giving fenretinide together with rituximab may kill more cancer cells.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2005
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 6, 2006
CompletedFirst Posted
Study publicly available on registry
February 7, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedResults Posted
Study results publicly available
October 6, 2014
CompletedOctober 6, 2014
January 1, 2014
7.8 years
February 6, 2006
January 8, 2014
September 30, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Safety, in Terms of Dose-limiting Toxicity (DLT) of 2 Daily Doses of Single Agent Fenretinide (Phase I)
A group of 3 patients would start treatment ast the dose of 900mg/m\^2 BID, and if none of the 3 experienced a DLT, another 3 would then be treated at that dose. Dose Limiting Toxicity was defined as any related toxicity of grade 4 or 5 on or before the completion of 4 weeks of therapy. Per response evaluation criteria 1999 Cheson Response Criteria for Malignant Lymphoma (CHESON99) for target lesions assessed by either CT or MRI: Complete Response (CR): Complete disappearance of all measurable and non-measurable disease; Complete Response Unconfirmed (CRU): Complete disappearance of all measurable and non-measurable disease, with the exception of all residual nodal masses \>1.5cm in Greatest Transverse Diameter (GTD) reduced by 75% in Sum of the Product of the greatest Diameters (SPD); Partial Response (PR): 50% decrease in the SPD.
Number of participants that experienced a dose-limiting toxicity
Response Rates of B-Non-Hodgkin Lymphoma to the Combination of Rituximab and Fenretinide (Phase II)
The trial was stratified into rituximab-naïve and rituximab pre-treated patients, and the target response rates for these groups were expected to be 30% and 10%, respectively. The numbers reported below are subjects who achieved a response of partial response or better.
Up to 7 years
Study Arms (1)
Treatment (fenretinide, rituximab)
EXPERIMENTALPHASE I: Patients receive fenretinide PO BID on days 1-5. Treatment repeats weekly for at least 4 weeks in the absence of disease progression or unacceptable toxicity. PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8. Treatment continues in the absence of disease progression or unacceptable toxicity.
Interventions
Given IV
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Washington Medical Center
Seattle, Washington, 98195, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Ajay Gopal
- Organization
- University of Washington
Study Officials
- PRINCIPAL INVESTIGATOR
Ajay Gopal
University of Washington
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2006
First Posted
February 7, 2006
Study Start
October 1, 2005
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
October 6, 2014
Results First Posted
October 6, 2014
Record last verified: 2014-01