Status:
TERMINATED
Temozolomide During and After Radiation Therapy in Treating Patients Who Have Undergone Previous Surgery and Placement of Gliadel Wafers for Newly Diagnosed Glioblastoma Multiforme
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy ...
Detailed Description
OBJECTIVES: * Determine the efficacy of adjuvant temozolomide when administered during and after external beam radiotherapy, in terms of survival, in patients with newly diagnosed glioblastoma multif...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme)
- Underwent gross total resection within the past 6 weeks
- Postoperative contrast-enhancing tumor extends ≤ 1 cm from the margin of the surgical cavity
- 6-8 polifeprosan 20 with carmustine implants (Gliadel® wafers) were placed in the surgical resection cavity at time of surgery
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- Karnofsky 60-100%
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hepatic
- Bilirubin ≤ 1.5 mg/dL
- Transaminases ≤ 4 times upper limit of normal
- Renal
- Creatinine ≤ 1.7 mg/dL
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No known hypersensitivity reaction to temozolomide
- No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No prior immunotherapy for the brain tumor
- No prior biologic agents (e.g., immunotoxins, immunoconjugates, antisense agents, peptide-receptor agonists, interferons, interleukins, tumor-infiltrating lymphocyte therapy, lymphokine-activated killer cell therapy, or gene therapy) for the brain tumor
- Chemotherapy
- See Disease Characteristics
- No other prior chemotherapy for the brain tumor
- Endocrine therapy
- No prior hormonal therapy for the brain tumor
- Prior glucocorticoid therapy allowed
- Radiotherapy
- No prior radiotherapy for the brain tumor
- Surgery
- See Disease Characteristics
Exclusion
Key Trial Info
Start Date :
February 15 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2007
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00238277
Start Date
February 15 2005
End Date
December 11 2007
Last Update
June 27 2018
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410