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Status:

COMPLETED

Fenretinide in Treating Patients With Refractory or Relapsed Hematologic Cancer

Lead Sponsor:

California Cancer Consortium

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Chronic Myeloproliferative Disorders

Leukemia

Eligibility:

All Genders

18-120 years

Phase:

PHASE1

Brief 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...

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 i...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically or cytologically confirmed diagnosis of 1 of the following hematologic malignancies:
  • Non-Hodgkin's lymphoma (NHL)
  • Hodgkin's lymphoma
  • Multiple myeloma
  • Acute lymphoblastic leukemia
  • Acute myeloid leukemia
  • Chronic hematologic malignancy with a poor prognosis (e.g., failed 3 prior standard therapies), including any of the following:
  • Chronic lymphocytic leukemia
  • Chronic myelogenous leukemia
  • Indolent NHL
  • Myeloproliferative disorders
  • Refractory or relapsed disease, as defined by 1 of the following:
  • Resistant to standard therapy for refractory or relapsed disease
  • Progressed after standard therapy for advanced disease
  • No effective treatment exists
  • Measurable or evaluable disease
  • No active CNS disease
  • Previously treated leptomeningeal disease or brain metastases allowed provided there is no evidence of remaining cancer by positron-emission tomography, MRI, or spinal fluid cytology
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • ECOG 0-2
  • Life expectancy
  • At least 3 months
  • Hematopoietic
  • Absolute neutrophil count ≥ 1,500/mm\^3 (unless due to bone marrow involvement of disease)
  • Platelet count ≥ 75,000/mm\^3 (unless due to bone marrow involvement of disease)
  • Hemoglobin ≥ 8.0 g/dL (transfusion allowed)
  • No coagulation disorders
  • Hepatic
  • AST and ALT \< 2.5 times upper limit of normal (ULN) (≤ 5 times ULN for patients with liver metastasis)
  • Bilirubin ≤ 1.5 times ULN
  • Renal
  • Creatinine ≤ 1.5 times ULN
  • Cardiovascular
  • No major cardiovascular disease
  • Pulmonary
  • No major respiratory disease
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective double-method contraception prior to study entry, during study, and for at least 6 months after study participation
  • No uncontrolled systemic infection
  • No uncontrolled hypertriglyceridemia (i.e., triglyceride level \> 500 mg/dL)
  • No known HIV positivity
  • No known allergy to egg products
  • No known familial hyperlipidemia disorders
  • No previously undiscovered hypertriglyceridemia
  • No poorly controlled diabetes
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • Not specified
  • Chemotherapy
  • More than 2 weeks since prior chemotherapy except hydroxyurea
  • No concurrent hydroxyurea during study drug administration
  • No other concurrent anticancer chemotherapy
  • Endocrine therapy
  • No concurrent hormone-ablative agents
  • No concurrent steroids
  • No concurrent tamoxifen or any of its analogues
  • Radiotherapy
  • No prior cranial radiotherapy
  • More than 2 weeks since prior radiotherapy
  • Surgery
  • More than 20 days since prior surgery except for biopsy
  • Other
  • Recovered from all prior therapy
  • More than 2 weeks since prior investigational agents
  • No other concurrent investigational agents
  • No other concurrent antineoplastic therapy
  • No other concurrent antioxidants
  • No concurrent herbal or other alternative therapies
  • No concurrent vitamin supplements (e.g., vitamin A, ascorbic acid, or vitamin E)
  • Standard dose multivitamin allowed
  • No other concurrent medications that may act as modulators of intracellular ceramide levels or ceramide cytotoxicity, sphingolipid transport, or p-glycoprotein or multidrug resistance protein 1 (MRP1) drug/lipid transporters, including any of the following:
  • Cyclosporine or any of its analogues
  • Verapamil
  • Ketoconazole
  • Chlorpromazine
  • Mifepristone
  • Indomethacin
  • Sulfinpyrazone
  • No concurrent medications that may cause pseudotumor cerebri, including any of the following:
  • Tetracycline
  • Nalidixic acid
  • Nitrofurantoin
  • Phenytoin
  • Sulfonamides
  • Lithium
  • Amiodarone
  • No concurrent medication to control hypertriglyceridemia

Exclusion

    Key Trial Info

    Start Date :

    February 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    April 1 2017

    Estimated Enrollment :

    29 Patients enrolled

    Trial Details

    Trial ID

    NCT00104923

    Start Date

    February 1 2005

    End Date

    April 1 2017

    Last Update

    July 19 2017

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    1

    USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, United States, 90089-9181

    2

    Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

    Bethesda, Maryland, United States, 20892-1182

    3

    M. D. Anderson Cancer Center at University of Texas

    Houston, Texas, United States, 77030-4009

    4

    Joe Arrington Cancer Research and Treatment Center

    Lubbock, Texas, United States, 79410-1894