NCT00003464

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 adults with newly diagnosed primary malignant glioblastoma multiforme.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 1997

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 1997

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 20, 2003

Completed
Last Updated

June 20, 2013

Status Verified

October 1, 2009

First QC Date

November 1, 1999

Last Update Submit

June 19, 2013

Conditions

Brain and Central Nervous System Tumors

Keywords

adult glioblastomaadult giant cell glioblastomaadult gliosarcoma

Interventions

temozolomideDRUG
radiation therapyRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically proven, newly diagnosed, supratentorial malignant glioblastoma multiforme not requiring immediate radiation therapy * At least 1 bidimensionally measurable lesion PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 70-100% Life expectancy: * Greater than 12 weeks Hematopoietic: * Absolute neutrophil count at least 1500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic: * Bilirubin less than 1.5 times upper limit of normal (ULN) * SGOT and SGPT less than 2.5 times ULN * Alkaline phosphatase less than 2 times ULN Renal: * BUN less than 1.5 times ULN * Creatinine less than 1.5 times ULN Other: * Must be neurologically stable * No systemic disease * No acute infection requiring intravenous antibiotics * No frequent vomiting * No other medical condition that would interfere with oral medication intake such as partial bowel obstruction * No prior or concurrent malignancies except: * Surgically cured carcinoma in situ of the cervix * Basal or squamous cell carcinoma of the skin * HIV negative * No AIDS-related illness * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior biologic therapy * No concurrent biologic therapy (growth factors or erythropoietin) Chemotherapy: * No prior chemotherapy * No other concurrent chemotherapy Endocrine therapy: * Concurrent steroid allowed (must be on stable dose for at least 1 week prior to study) Radiotherapy: * No prior radiation therapy * No prior interstitial brachytherapy * No prior radiosurgery to the brain * Not requiring immediate radiation therapy * No concurrent radiotherapy Surgery: * Recovered from any effects of prior surgery * At least 2 weeks since prior surgical resection Other: * No other concurrent investigational drugs

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

Sponsors & Collaborators

Study Sites (1)

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsGlioblastomaGliosarcoma

Interventions

TemozolomideRadiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

DacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTherapeutics

Study Officials

  • Henry S. Friedman, MD

    Duke University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

August 20, 2003

Study Start

September 1, 1997

Study Completion

August 1, 2003

Last Updated

June 20, 2013

Record last verified: 2009-10

Locations

US(1)