Completed

Phase II Treatment of Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme With Temodal

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What is being tested

temozolomide

+ radiation therapy

DrugRadiation
Who is being recruted

Astrocytoma+12

+ Glioma

+ Neoplasms

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: September 1997
See protocol details

Summary

Principal SponsorDuke University
Last updated: June 20, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 1997

Actual date on which the first participant was enrolled.

OBJECTIVES: Determine the antitumor activity of temozolomide in adults with newly diagnosed glioblastoma multiforme. Define the relationship between tumor O6-alkylguanine-DNA alkyltransferase activity and tumor response in these patients. Define the relationship between tumor DNA mismatch repair activity and tumor response to temozolomide. OUTLINE: Patients receive temozolomide orally once daily on days 1-5. Treatment courses are repeated every 28 days. In the absence of disease progression and toxicity, patients receive up to 4 courses of treatment prior to radiation therapy. After radiation therapy, patients demonstrating partial or complete response may receive an additional 12 courses of treatment. Patients are followed every 8-12 weeks for 2 years. PROJECTED ACCRUAL: This study will accrue 50 patients.

NCT00003464
Principal SponsorDuke University
Last updated: June 20, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AstrocytomaGliomaNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNervous System DiseasesNervous System NeoplasmsNeuroectodermal TumorsNeoplasms, NeuroepithelialGlioblastomaCentral Nervous System NeoplasmsGliosarcoma

Criteria

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Duke Comprehensive Cancer Center

Durham, United StatesOpen Duke Comprehensive Cancer Center in Google Maps
CompletedOne Study Center