NCT00004204

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 temozolomide in treating patients who have recurrent or progressive malignant glioma.

Trial Health

55
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Trial Health Score

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

Geographic Reach
1 country

10 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

First Submitted

Initial submission to the registry

January 21, 2000

Completed
11 days until next milestone

Study Start

First participant enrolled

February 1, 2000

Completed
3.5 years until next milestone

First Posted

Study publicly available on registry

July 18, 2003

Completed
Last Updated

January 6, 2014

Status Verified

April 1, 2006

First QC Date

January 21, 2000

Last Update Submit

January 3, 2014

Conditions

Brain and Central Nervous System Tumors

Keywords

recurrent adult brain tumoradult anaplastic astrocytomaadult anaplastic oligodendroglioma

Interventions

temozolomideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically proven recurrent or progressive malignant glioma of one of the following types: * Anaplastic oligodendroglioma or oligoastrocytoma * Anaplastic astrocytoma * Glioblastoma multiforme (stratum closed to accrual 11/30/01) * Patients who have failed radiotherapy are eligible * Measurable disease by CT scan or MRI PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 70-100% Life expectancy: * At least 12 weeks Hematopoietic: * Absolute neutrophil count greater than 1,500/mm\^3 * Platelet count greater than 100,000/mm\^3 * Hemoglobin greater than 10 g/dL Hepatic: * SGOT or SGPT less than 3 times upper limit of normal (ULN) * Alkaline phosphatase less than 2 times ULN (if greater than 2 times ULN then a gamma glutamyl transferase test must be performed) Renal: * BUN less than 1.5 times ULN * Creatinine less than 1.5 times ULN Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception * No other serious concurrent infection or other medical illness that would preclude study entry * No frequent vomiting or partial bowel obstruction * HIV negative * No AIDS-related illness * No other concurrent malignancy except carcinoma in situ of the cervix or basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent epoetin alfa Chemotherapy: * At least 6 weeks since other prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * At least 3 months since prior radiotherapy (exceptions allowed for recurrent/progressive disease at discretion of primary investigator) Surgery: * Recovered from prior surgery Other: * No other concurrent investigational agents * Concurrent anticonvulsant therapy allowed

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

Sponsors & Collaborators

Study Sites (10)

Stanford University Medical Center

Stanford, California, 94305-5408, United States

Location

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140, United States

Location

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Cancer Center of Albany Medical Center

Albany, New York, 12208, United States

Location

Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

Location

Nalitt Institute for Cancer And Blood Related Diseases

Staten Island, New York, 10305, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Neurological Clinic

Portland, Oregon, 97210, United States

Location

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Froedtert Memorial Lutheran Hospital

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsBrain NeoplasmsAstrocytomaOligodendroglioma

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

DacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Casilda Balmaceda, MD

    Herbert Irving Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 21, 2000

First Posted

July 18, 2003

Study Start

February 1, 2000

Last Updated

January 6, 2014

Record last verified: 2006-04

Locations

US(10)