Efaproxiral Plus Carmustine in Treating Patients With Progressive or Recurrent Malignant Glioma

NCT00005855 | Completed Phase 1

• 3 other identifiers: CDR0000067881NABTT-9806JHOC-NABTT-9806
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 9

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of efaproxiral when given with carmustine and to see how well they work in treating patients with progressive or recurrent malignant glioma.

Conditions

Brain and Central Nervous System Tumors

Keywords

adult glioblastoma; adult anaplastic astrocytoma; adult anaplastic oligodendroglioma; recurrent adult brain tumor; adult giant cell glioblastoma; adult gliosarcoma

Outcome Measures

Primary Outcomes (4)

• Safety and tolerability

• Maximum tolerated dose

• Pharmacokinetic profile

• Efficacy

Interventions

carmustine DRUG

efaproxiral DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed malignant glioma that is progressive or recurrent after radiotherapy with or without chemotherapy * Anaplastic astrocytoma * Anaplastic oligodendroglioma * Glioblastoma multiforme * Prior low-grade glioma allowed provided progression has occurred after radiotherapy with or without chemotherapy and then high-grade glioma is found on biopsy * Measurable disease by serial MRI or CT scan PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Hemoglobin at least 10 g/dL * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 2.0 mg/dL * Alkaline phosphatase no greater than 3 times upper limit of normal (ULN) * SGOT and SGPT no greater than 3 times ULN Renal: * Creatinine no greater than 2.0 mg/dL Pulmonary: * Resting oxygen saturation on room air at least 90% by pulse oximetry * FVC, DLCO, and FEV\_1 at least 50% of normal Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other serious concurrent medical illness that would preclude study compliance * No other prior malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 3 weeks since prior investigational biologics Chemotherapy: * See Disease Characteristics * No prior nitrosoureas for glioma * No more than 1 prior chemotherapy regimen * At least 4 weeks since prior chemotherapy * No prior efaproxiral Endocrine therapy: * Concurrent corticosteroids (e.g., dexamethasone) allowed Radiotherapy: * See Disease Characteristics * At least 90 days since prior radiotherapy Surgery: * Not specified Other: * At least 3 weeks since other prior investigational drugs or devices

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

Sponsors & Collaborators

• New Approaches to Brain Tumor Therapy Consortium: lead
• National Cancer Institute (NCI): collaborator

Study Sites (9)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Tampa, Florida, 33612-9497, United States

Location

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229-3900, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Glioblastoma; Astrocytoma; Oligodendroglioma; Brain Neoplasms; Gliosarcoma

Interventions

Carmustine; efaproxiral

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds

Study Officials

• Pamela Z. New, MD

  The University of Texas Health Science Center, Houston

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 2, 2000
• First Posted: January 27, 2003
• Study Start: July 1, 2000
• Study Completion: October 1, 2006
• Last Updated: June 21, 2013

Record last verified: 2003-12

Locations

US (9)