Phase II Treatment of Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme With Temodal
18 Years
N/A
Both
Brain and Central Nervous System Tumors
Trial Information
Phase II Treatment of Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme With Temodal
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Henry S. Friedman, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Duke University
Authority:
United States: Federal Government
Study ID:
1171
NCT ID:
NCT00003464
Start Date:
September 1997
Completion Date:
August 2003
Related Keywords:
- Brain and Central Nervous System Tumors
- adult glioblastoma
- adult giant cell glioblastoma
- adult gliosarcoma
- Glioblastoma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
Name | Location |
|---|---|
| Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
