NCT00006656

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 carmustine in treating patients who have progressive or recurrent glioblastoma multiforme.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

12 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2000

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2000

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

November 6, 2013

Status Verified

August 1, 2003

First QC Date

December 6, 2000

Last Update Submit

November 5, 2013

Conditions

Brain and Central Nervous System Tumors

Keywords

recurrent adult brain tumoradult glioblastomaadult giant cell glioblastomaadult gliosarcoma

Interventions

carmustine in ethanolDRUG
conventional surgeryPROCEDURE

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically proven supratentorial malignant glioblastoma multiforme * Clear evidence of disease progression by MRI * Unresectable tumor that has spherical, spheroid, or ovoid shape (not multicentric or multilobulated) * Central necrosis and/or central cystic areas allowed in the presence of enhancing rim thickness greater than 5 mm * No brainstem (pons or medulla) or midbrain (mesencephalon) involvement * No involvement of primary sensorimotor cortex in the dominant hemisphere or within 1.5 cm of the optic chiasm, either optic nerve, or any other cranial nerve * No tumor extension into the ventricular system * Tumor volume no greater than 33.4 cm3 * At least one prior radiotherapy PATIENT CHARACTERISTICS: Age: * 18 to 75 Performance status: * Karnofsky 60-100% Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * No evidence of bleeding diathesis Hepatic: * Bilirubin no greater than 2.0 mg/dL * SGOT/SGPT no greater than 2.5 times normal Renal: * Creatinine no greater than 2.0 mg/dL OR * Creatinine clearance at least 40 mL/min * BUN no greater than 30 mg/dL Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active uncontrolled infection * Afebrile unless fever due to presence of tumor * No other concurrent serious medical or psychiatric illness that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin including Gliadel wafer therapy) and recovered Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * At least 4 weeks since prior radiotherapy and recovered * No prior intracranial brachytherapy Surgery: * Recovered from any prior surgery Other: * No prior anticoagulants * No other concurrent investigational agents

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

Sponsors & Collaborators

Study Sites (12)

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90033-0804, United States

Location

UCSF Cancer Center and Cancer Research Institute

San Francisco, California, 94143-0128, United States

Location

Stanford University Medical Center

Stanford, California, 94305-5408, United States

Location

University of Colorado Cancer Center

Denver, Colorado, 80262, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9416, United States

Location

Emory University Hospital - Atlanta

Atlanta, Georgia, 30322, United States

Location

Evanston Northwestern Health Care

Evanston, Illinois, 60201, United States

Location

John F. Kennedy Medical Center

Edison, New Jersey, 08820, United States

Location

Barrett Cancer Center

Cincinnati, Ohio, 45219, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Massey Cancer Center

Richmond, Virginia, 23298-0631, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsBrain NeoplasmsGlioblastomaGliosarcoma

Interventions

CarmustineEthanol

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesBrain DiseasesCentral Nervous System DiseasesAstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Nitrosourea CompoundsUreaAmidesOrganic ChemicalsNitroso CompoundsAlcohols

Study Officials

  • Gene David Resnick, MD

    Millennix

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 6, 2000

First Posted

January 27, 2003

Study Start

June 1, 2000

Last Updated

November 6, 2013

Record last verified: 2003-08

Locations

US(12)