Fenretinide in Treating Patients With Recurrent Malignant Glioma

Brain and Central Nervous System Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006080
• Other study ID #: NABTC-9905
• Secondary ID: CDR0000068068UCL
• Status: Completed
• Phase: Phase 2
• Start date: September 25, 2000
• Est. completion date: November 1, 2004

Study information

• Verified date: June 2018
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: November 1, 2004
• Est. primary completion date: September 14, 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Glioma
• Nervous System Neoplasms

Intervention

Drug:
• fenretinide

Locations

Country	Name	City	State
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Simmons Cancer Center - Dallas	Dallas	Texas
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	UCSF Cancer Center and Cancer Research Institute	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Puduvalli VK, Yung WK, Hess KR, Kuhn JG, Groves MD, Levin VA, Zwiebel J, Chang SM, Cloughesy TF, Junck L, Wen P, Lieberman F, Conrad CA, Gilbert MR, Meyers CA, Liu V, Mehta MP, Nicholas MK, Prados M; North American Brain Tumor Consortium. Phase II study o — View Citation