Fenretinide in Treating Patients With Recurrent Malignant Glioma

June 25, 2018 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Phase II Evaluation of Fenretinide NSC (374551) as a Single Agent in the Treatment of Adult Patients With Recurrent Malignant Glioma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of fenretinide in treating patients who have recurrent malignant glioma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Determine the efficacy of fenretinide as assessed by 6-month progression- free survival in patients with recurrent malignant glioma. II. Determine the rate of measurable clinical response, time to progression, and overall survival of patients treated with this drug. III. Determine the unexpected toxicity of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to disease type (glioblastoma multiforme (closed to accrual as of 05/31/2001) and gliosarcoma (closed to accrual as of 05/31/2001) vs anaplastic astrocytoma, anaplastic oligodendroglioma, and mixed malignant glioma). Patients receive oral fenretinide twice daily during weeks 1 and 4. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and then before each course of chemotherapy. Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 41-85 patients (21-45 with anaplastic astrocytoma, anaplastic oligodendroglioma, and mixed malignant glioma and 20-40 with glioblastoma multiforme (closed to accrual as of 05/31/2001) and gliosarcoma (closed to accrual as of 05/31/2001)) will be accrued for this study.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095-1781
        • Jonsson Comprehensive Cancer Center, UCLA
      • San Francisco, California, United States, 94143-0128
        • UCSF Cancer Center and Cancer Research Institute
    • Maryland
      • Bethesda, Maryland, United States, 20892-1182
        • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0752
        • University of Michigan Comprehensive Cancer Center
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213-3489
        • University of Pittsburgh Cancer Institute
    • Texas
      • Dallas, Texas, United States, 75235-9154
        • Simmons Cancer Center - Dallas
      • Houston, Texas, United States, 77030-4009
        • University of Texas - MD Anderson Cancer Center
      • San Antonio, Texas, United States, 78284-7811
        • University of Texas Health Science Center at San Antonio
    • Wisconsin
      • Madison, Wisconsin, United States, 53792-6164
        • University of Wisconsin Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Histologically confirmed supratentorial malignant primary glioma Glioblastoma multiforme (closed to accrual as of 05/31/2001) Gliosarcoma (closed to accrual as of 05/31/2001) Anaplastic astrocytoma Anaplastic oligodendroglioma Mixed malignant gliomas Original histological diagnosis of low-grade glioma allowed if a subsequent histological diagnosis of malignant glioma is confirmed Prior treatment for no more than 2 prior relapses allowed Disease progression documented by at least 2 pre-study brain scans Recent prior tumor resection of recurrent or progressive tumor allowed if recovered from the effects of prior surgery

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: More than 8 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL (may be transfusion dependent) Hepatic: Bilirubin less than 2 times upper limit of normal (ULN) SGOT less than 2 times ULN Renal: Creatinine less than 1.5 mg/dL Creatinine clearance at least 60 mL/min Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception during and for at least 2 months after study Able to swallow capsules No active infection No disease or other serious concurrent medical illness that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 1 week since prior interferon At least 1 week since prior thalidomide Chemotherapy: Recovered from prior chemotherapy At least 4 weeks since prior cytotoxic therapy (2 weeks for vincristine, 3 weeks for procarbazine, or 6 weeks for nitrosoureas) Endocrine therapy: At least 1 week since prior tamoxifen Prior steroids allowed if on stable or decreasing dose for at least 5-7 days before baseline MRI If steroid dose is increased between date of baseline MRI and initiation of study drug, a new baseline MRI is required Radiotherapy: Not specified Surgery: See Disease Characteristics No concurrent surgery Other: At least 1 week since any prior noncytotoxic agents (e.g., isotretinoin) No other concurrent anticancer therapy, including other investigational drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Vinay K. Puduvalli, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2000

Primary Completion (Actual)

September 14, 2004

Study Completion (Actual)

November 1, 2004

Study Registration Dates

First Submitted

August 3, 2000

First Submitted That Met QC Criteria

December 22, 2003

First Posted (Estimate)

December 23, 2003

Study Record Updates

Last Update Posted (Actual)

June 27, 2018

Last Update Submitted That Met QC Criteria

June 25, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NABTC-9905
  • CDR0000068068 (Registry Identifier: PDQ (Physician Data Query))
  • UCLA-0006094

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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