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


Phase 2
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

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Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Vinay K. Puduvalli, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068068

NCT ID:

NCT00006080

Start Date:

November 2000

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • adult anaplastic astrocytoma
  • adult anaplastic oligodendroglioma
  • adult mixed glioma
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Simmons Cancer Center - DallasDallas, Texas  75235-9154
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182