TerminatedPhase 1/2

Fenretinide and Rituximab in Treating Patients With B-Cell Non-Hodgkin Lymphoma

Stopped: NCI stopped supplying fenretinide in November of 2012.

United States32 participantsStarted 2005-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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;…

What they're measuring

Safety, in Terms of Dose-limiting Toxicity (DLT) of 2 Daily Doses of Single Agent Fenretinide (Phase I)

Timeframe: 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)

Timeframe: Up to 7 years

Trial details

NCT IDNCT00288067

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2013-07

Results submitted2014-01-08

View on ClinicalTrials.gov More Adult Nodular Lymphocyte Predominant Hodgkin Lymphoma trials