Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
A Phase I-II Trial of Fenretinide (4-HPR) + Rituximab in Patients With B-cell Lymphoma
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.
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-cell
non-Hodgkin lymphoma (NHL). (Phase II)
SECONDARY OBJECTIVES:
I. To perform pharmacokinetic studies on patients receiving fenretinide. (Phase I) II. To
determine the intratumoral concentrations of fenretinide. (Phase I) III. To evaluate the in
vivo mechanism of action of fenretinide. (Phase I) IV. To identify the predictors of
response to fenretinide. (Phase I) V. To estimate the response rates, positron emission
tomography (PET) response, overall survival (OS), progression-free survival (PFS), time to
progression (TTP), and disease-free survival (DFS) of patients treated on this study. (Phase
I) VI. To estimate the overall survival (OS), progression-free survival (PFS), time to
progression (TTP), disease-free survival (DFS), and PET responses of patients treated on
this study. (Phase II) VII. To perform pharmacokinetic studies on patients receiving
fenretinide. (Phase II) VIII. To determine the intratumoral concentration of fenretinide.
(Phase II) IX. To identify the predictors of response to fenretinide and fenretinide +
rituximab in B-NHL. (Phase II) X. To evaluate the in vivo mechanism of action of fenretinide
in B-NHL. (Phase II)
OUTLINE: This is a phase I, dose-escalation study of fenretinide followed by a phase II
study.
PHASE I: Patients receive fenretinide orally (PO) twice daily (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
intravenously (IV) once weekly in weeks 5-8. Treatment continues in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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