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Home > "T" Clinical Trials Conditions > Temozolomide in Treating Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme  Temozolomide in Treating Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme
Temozolomide in Treating Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme
For Condition: Glioblastoma
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Duke Comprehensive Cancer Center
Synopsis: 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.
Details: OBJECTIVES: I. Determine the antitumor activity of temozolomide in adults with newly diagnosed glioblastoma multiforme. II. Define the relationship between tumor O6-alkylguanine-DNA alkyltransferase activity and tumor response in these patients. III. Define the relationship between tumor DNA mismatch repair activity and tumor response to temozolomide. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven, newly diagnosed, supratentorial malignant glioblastoma multiforme not requiring immediate radiation therapy - At least 1 bidimensionally measurable lesion --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 --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 70-100% - Life expectancy: Greater than 12 weeks - Hematopoietic: Absolute neutrophil count at least 1500/mm3 Platelet count at least 100,000/mm3 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HenryFriedman, Study Chair, Duke Comprehensive Cancer Center
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Additional Information:
Study ID Numbers: CDR0000066498; DUMC-1171-01-6R4,NCI-G98-1465,DUMC-1016-97-7,DUMC-1056-98-7R1,DUMC-1058-98-7R1,DUMC-1171-00-6R3,DUMC-1231-99-7R2,DUMC-97081
Study Start Date: September 1997
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003464
Other Glioblastoma Studies:
1. Phase I trial of CC-8490 for the treatment of subjects with recurrent/refractory high-grade gliomas
2. Investigating the Use of Talampanel in Patients with Recurrent High-Grade Gliomas
3. A Study of Motexafin Gadolinium and Temozolomide for the Treatment of Malignant Gliomas
4. Temozolomide in Treating Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme
5. Detecting Malignant Brain Tumor Cells in the Bloodstream During Surgery to Remove the Tumor
Related Studies:
Other Glioblastoma Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
Temozolomide in Treating Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme
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