NCT00009854

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I/II trial to study the effectiveness of carmustine followed by surgery in treating patients who have recurrent supratentorial malignant glioma or metastatic brain neoplasm.

Trial Health

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Trial Health Score

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

Geographic Reach
1 country

2 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
8 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2001

Completed
2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

November 6, 2013

Status Verified

March 1, 2003

First QC Date

February 2, 2001

Last Update Submit

November 5, 2013

Conditions

Brain and Central Nervous System TumorsMetastatic Cancer

Keywords

adult glioblastomatumors metastatic to brainadult anaplastic astrocytomaadult anaplastic ependymomaadult anaplastic oligodendrogliomaadult 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 confirmed recurrent supratentorial malignant glioma with clear evidence of progression by MRI * Glioblastoma multiforme * Anaplastic ependymoma * Anaplastic astrocytoma * Anaplastic oligodendroglioma OR * Metastatic tumor to the brain other than melanoma * Planned resection of tumor (must be first surgery for recurrent disease) * Tumor volume of each tumor component or residual tumor must be at least 4 cm3 and no greater than 33.4 cm3 * Tumor shape and surrounding structure(s) unlikely to cause an irregular distribution of the injected study drug * Tumor is spherical, spheroid, or ovoid * No tumors shaped into 3 or more components (e.g., multicentric or multilobulated) * No tumors extending into the ventricular system * Tumor has an intact stroma (i.e., tumor mass not partially incised or punctured) * Central necrosis and/or central cystic areas allowed if an enhancing rim with a thickness of more than 5 mm is present * No tumors in the following locations of the brain: * Brainstem (pons or medulla) * Midbrain (mesencephalon) * Primary sensorimotor cortex in the dominant hemisphere * Within 1.5 cm of the optic chiasm, either optic nerve, or any other cranial nerve 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 and 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 OR * BUN no greater than 30 mg/dL Other: * No active uncontrolled infection * Afebrile (37.5 degrees C) unless fever due to tumor * No other unstable or severe medical condition * No complicating medical or psychiatric problem that would preclude study * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 4 weeks since prior systemic chemotherapy (6 weeks for nitrosoureas, mitomycin, or Gliadel wafers) and recovered * No anti-tumor chemotherapy within 12 weeks after study drug unless tumor volume increases by more than 25% by MRI Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since prior radiotherapy and recovered * No prior intracranial brachytherapy * No anti-tumor radiotherapy within 12 weeks after study drug unless tumor volume increases by more than 25% by MRI Surgery: * See Disease Characteristics * Prior surgery allowed * No anti-tumor surgery within 12 weeks after study drug Other: * No concurrent 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 (2)

UCSF Cancer Center and Cancer Research Institute

San Francisco, California, 94143-0128, United States

Location

Massey Cancer Center

Richmond, Virginia, 23298-0631, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsNeoplasm MetastasisGlioblastomaBrain NeoplasmsAstrocytomaEpendymomaOligodendrogliomaGliosarcoma

Interventions

CarmustineEthanol

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueBrain DiseasesCentral Nervous System Diseases

Intervention Hierarchy (Ancestors)

Nitrosourea CompoundsUreaAmidesOrganic ChemicalsNitroso CompoundsAlcohols

Study Officials

  • Gene David Resnick, MD

    Millennix

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 2, 2001

First Posted

January 27, 2003

Study Start

June 1, 2000

Last Updated

November 6, 2013

Record last verified: 2003-03

Locations

US(2)