Fenretinide in Treating Patients With Recurrent Malignant Glioma

NCT00006080 | Completed Phase 2 FDA Drug

• 3 other identifiers: NABTC-9905CDR0000068068UCLA-0006094
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Brain and Central Nervous System Tumors

Keywords

recurrent adult brain tumor; adult anaplastic astrocytoma; adult anaplastic oligodendroglioma; adult mixed glioma

Interventions

fenretinide DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Cancer Institute (NCI): collaborator

Study Sites (11)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

UCSF Cancer Center and Cancer Research Institute

San Francisco, California, 94143-0128, United States

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0752, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15213-3489, United States

Location

Simmons Cancer Center - Dallas

Dallas, Texas, 75235-9154, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284-7811, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-6164, United States

Location

Related 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 of fenretinide (NSC 374551) in adults with recurrent malignant gliomas: A North American Brain Tumor Consortium study. J Clin Oncol. 2004 Nov 1;22(21):4282-9. doi: 10.1200/JCO.2004.09.096.

  PMID: 15514370 RESULT

MeSH Terms

Conditions

Central Nervous System Neoplasms; Brain Neoplasms; Astrocytoma; Oligodendroglioma; Glioma

Interventions

Fenretinide

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• Vinay K. Puduvalli, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2000
• First Posted: December 23, 2003
• Study Start: September 25, 2000
• Primary Completion: September 14, 2004
• Study Completion: November 1, 2004
• Last Updated: June 27, 2018

Record last verified: 2018-06

Locations

US (11)