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Status:

COMPLETED

Fenretinide in Treating Patients With Metastatic or Unresectable Malignant Solid Tumors

Lead Sponsor:

California Cancer Consortium

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Unspecified Adult Solid Tumor, Protocol Specific

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as fenretinide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phas...

Detailed Description

OBJECTIVES: * Determine the maximum tolerated dose of fenretinide in patients with metastatic or unresectable malignant solid tumors. * Determine the toxic effects of this drug in these patients. * D...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically or cytologically confirmed solid tumor malignancy
  • Metastatic and/or unresectable disease
  • No standard curative or palliative measures exist or remain effective
  • Measurable or evaluable disease
  • No known brain metastases unless previously resected or irradiated with no treatment with steroids for more than 1 month
  • PATIENT CHARACTERISTICS:
  • ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
  • Life expectancy \> 3 months
  • WBC ≥ 3,000/mm³
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 75,000/mm³
  • Bilirubin \< 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN (5 times ULN for patients with known liver metastases)
  • Creatinine normal OR creatinine clearance ≥ 60 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception prior to, during, and for ≥ 6 months after completion of study treatment
  • No uncontrolled diabetes mellitus at high risk for hypertriglyceridemia (i.e., fasting serum glucose concentration \> 200 mg/dL OR hemoglobin A1C \> 7.5%)
  • No egg allergy
  • No history of allergic reactions to compounds of similar chemical or biologic composition to fenretinide (e.g., isotretinoin, vitamin A, or tretinoin)
  • No uncontrolled intercurrent illness including, but not limited to, any of the following:
  • Ongoing or active infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • Psychiatric illness or social situation that would preclude compliance with study requirements
  • No known hypertriglyceridemia requiring medication
  • No identified familial hyperlipidemia disorder
  • PRIOR CONCURRENT THERAPY:
  • Recovered from all prior therapy
  • Prior treatment with oral fenretinide is allowed provided no severe toxicity occurred
  • At least 2 weeks since prior major surgery
  • More than 4 weeks since prior chemotherapy or radiotherapy
  • At least 6 weeks since prior nitrosoureas or mitomycin C
  • No other concurrent investigational agents
  • No other concurrent anticancer chemotherapy
  • No other concurrent antioxidants\*
  • No concurrent hormone-ablative agents, including steroids, except for adrenal replacement or anti-inflammatory indications
  • No other concurrent anticancer agents or therapies
  • 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, p-glycoprotein, multidrug resistance protein 1 (MRP1), or MRP1 drug/lipid transporters, including any of the following\*:
  • Cyclosporine or any of its analogues
  • Verapamil
  • Tamoxifen or its analogue
  • Ketoconazole
  • Chlorpromazine
  • Mifepristone
  • Indomethacin
  • Sulfinpyrazone NOTE: \*Patients who have discontinued these drugs for ≥ 1 week are eligible
  • No concurrent medications that may cause pseudotumor cerebri, including any of the following:
  • Tetracycline
  • Nalidixic acid
  • Nitrofurantoin
  • Phenytoin
  • Sulfonamides
  • Lithium
  • Amiodarone
  • No concurrent total parenteral nutrition (TPN) with intralipids
  • No concurrent combination antiretroviral therapy for HIV-positive patients

Exclusion

    Key Trial Info

    Start Date :

    November 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    21 Patients enrolled

    Trial Details

    Trial ID

    NCT00387504

    Start Date

    November 1 2006

    Last Update

    September 12 2013

    Active Locations (7)

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

    Page 1 of 2 (7 locations)

    1

    City of Hope Comprehensive Cancer Center

    Duarte, California, United States, 91010-3000

    2

    Childrens Hospital Los Angeles

    Los Angeles, California, United States, 90027-0700

    3

    USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, United States, 90089-9181

    4

    Contra Costa Regional Medical Center

    Martinez, California, United States, 94553