A Phase I Trial of Hypofraction Radiotherapy + Temozolomide in the Treatment of Patients With Glioblastoma Multiforme and Anaplastic Astrocytoma of the Brain
18 Years
N/A
Both
Glioblastoma Multiforme/Anaplastic Astrocytoma
Trial Information
A Phase I Trial of Hypofraction Radiotherapy + Temozolomide in the Treatment of Patients With Glioblastoma Multiforme and Anaplastic Astrocytoma of the Brain
OBJECTIVES:
Primary
- To determine the maximum tolerated dose of temozolomide when given in combination with
hypofractionated intensity-modulated conformal stereotactic radiotherapy in patients
with newly diagnosed de novo glioblastoma multiforme or anaplastic astrocytoma.
Secondary
- To determine the time to neuroradiological evidence of tumor recurrence or progression
in patients treated with this regimen.
- To determine the survival time of patients treated with this regimen.
- To determine the time spent in a Karnofsky performance status of 60-100%.
OUTLINE: This is a dose-escalation study of temozolomide.
Beginning 1-3 weeks following surgery or biopsy, patients receive oral temozolomide once
daily for 5 weeks. Beginning 1 week after starting temozolomide, patients also undergo
hypofractionated intensity-modulated conformal stereotactic radiotherapy once daily 5 days a
week for 3 weeks.
After completion of study treatment, patients are followed at 1 month, 2 months, and 3
months, and then every 3 months thereafter.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed de novo glioblastoma multiforme or anaplastic astrocytoma
after biopsy or tumor removal
- Newly diagnosed disease
- No tumors located in the brainstem or optic chiasm
PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Hemoglobin ≥ 10 g/dL
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Total bilirubin ≤ 1.5 mg/dL
- Creatinine ≤ 1.3 mg/dL
- AST/ALT ≤ 60 U/L
- BUN ≤ 24 mg/dL
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy and/or radiotherapy for this cancer
- No prior radiotherapy to the brain
- At least 6 weeks since prior chemotherapy
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose of temozolomide
Outcome Time Frame:
2009-present
Safety Issue:
Yes
Principal Investigator
Mario Ammirati, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Ohio State University Comprehensive Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
OSU-08119
NCT ID:
NCT00841555
Start Date:
February 2009
Completion Date:
Related Keywords:
- Glioblastoma Multiforme/Anaplastic Astrocytoma
- adult giant cell glioblastoma
- adult gliosarcoma
- adult anaplastic astrocytoma
- adult glioblastoma
- GBM/AA
- Astrocytoma
- Glioblastoma
Name | Location |
|---|---|
| Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus, Ohio 43210-1240 |
