Fenretinide in Treating Patients With Refractory or Relapsed Hematologic Cancer
Condition: Chronic Myeloproliferative Disorders; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm
MeSH terms: Lymphoma; Leukemia; Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma; Myeloproliferative Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: 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.
      Giving fenretinide in a different way may kill more cancer cells.

      PURPOSE: This phase I trial is studying the side effects and best dose of intravenous
      fenretinide in treating patients with refractory or relapsed hematologic cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the maximum tolerated dose of intravenous emulsified fenretinide in patients
           with refractory or relapsed hematologic malignancies.

        -  Determine the toxic effects of this drug in these patients.

        -  Determine the pharmacokinetics and in vivo activity of this drug in these patients.

        -  Determine, preliminarily, disease or tumor response in patients treated with this drug.

      OUTLINE: This is a pilot, dose-escalation, multicenter study.

      Patients receive emulsified fenretinide IV continuously over 5 days. Treatment repeats every
      21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
      Patients who achieve a complete or partial response may continue to receive fenretinide at
      the discretion of the study chair.

      Cohorts of 1 patient receive accelerated escalating doses of fenretinide until 2 patients
      experience moderate toxicity (cumulative across all dose levels) OR 1 patient experiences
      dose-limiting toxicity (DLT). After completion of the accelerated dose-escalation portion,
      the standard dose-escalation portion begins. Cohorts of 3-6 patients receive escalating doses
      of fenretinide until the maximum tolerated dose (MTD) is determined. The MTD is defined as
      the dose preceding that at which 2 of 6 patients experience DLT. At least 6 patients are
      treated at the MTD. An additional 12 patients are treated at the MTD.

      After completion of study treatment, patients are followed every 3 months for 2 years, every
      6 months for 3 years, and then annually thereafter.

      PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study.
    

Intervention name(s): fenretinide
Intervention type(s): Drug
Intervention description(s): Current dose level as an IV continuous infusion via central line over 5 days. Cycle is repeated every 3 weeks for up to 6 cycles
Intervention MeSH terms: Fenretinide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with t(15;17)(q22;q12); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with t(8;21)(q22;q22); recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma; recurrent small lymphocytic lymphoma; recurrent mantle cell lymphoma; Waldenstrom macroglobulinemia; adult grade III lymphomatoid granulomatosis; recurrent adult grade III lymphomatoid granulomatosis; secondary acute myeloid leukemia; recurrent adult Burkitt lymphoma; recurrent adult immunoblastic large cell lymphoma; refractory chronic lymphocytic leukemia; recurrent adult lymphoblastic lymphoma; recurrent adult Hodgkin lymphoma; refractory multiple myeloma; recurrent adult acute lymphoblastic leukemia; relapsing chronic myelogenous leukemia; chronic eosinophilic leukemia; primary myelofibrosis; chronic neutrophilic leukemia; essential thrombocythemia; polycythemia vera; stage II multiple myeloma; stage III multiple myeloma; recurrent adult diffuse large cell lymphoma; recurrent adult diffuse mixed cell lymphoma; recurrent adult diffuse small cleaved cell lymphoma; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; nodal marginal zone B-cell lymphoma; recurrent marginal zone lymphoma; splenic marginal zone lymphoma; recurrent adult acute myeloid leukemia