Durham, North Carolina 27710

  • Brain and Central Nervous System Tumors


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.

Study summary:

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.


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 is Available At:

Original ID:




Secondary ID:


Study Acronym:

Brief Title:

Temozolomide in Treating Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme

Official Title:

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

Overall Status:


Study Phase:

Phase 2



Minimum Age:

18 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Duke University

Oversight Authority:

United States: Federal Government

Reasons Why Stopped:

Study Type:


Study Design:

Primary Purpose: Treatment

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

Official Name:Henry S. Friedman, MD
Study Chair
Duke University

Study Dates

Start Date:September 1997
Completion Date:August 2003
Completion Type:Actual
Verification Date:October 2009
Last Changed Date:June 19, 2013
First Received Date:November 1, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Intervention Type:Radiation
Name:radiation therapy

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Duke University
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 27, 2021

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