Temozolomide and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Anaplastic Astrocytoma
| Status: | Recruiting |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | February 2009 |
| Contact: | Ohio State University Comprehensive Cancer Center |
| Email: | Jamesline@osumc.edu |
| Phone: | 1-800-293-5066 |
A Phase I Trial of Hypofraction Radiotherapy + Temozolomide in the Treatment of Patients With Glioblastoma Multiforme and Anaplastic Astrocytoma of the Brain
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 uses high-energy x-rays to kill tumor cells. Specialized radiation therapy
that delivers a high dose of radiation directly to the tumor may kill more tumor cells and
cause less damage to normal tissue. Giving chemotherapy together with radiation therapy may
kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of temozolomide when
given together with radiation therapy in treating patients with newly diagnosed glioblastoma
multiforme or anaplastic astrocytoma.
the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy
that delivers a high dose of radiation directly to the tumor may kill more tumor cells and
cause less damage to normal tissue. Giving chemotherapy together with radiation therapy may
kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of temozolomide when
given together with radiation therapy in treating patients with newly diagnosed glioblastoma
multiforme or anaplastic astrocytoma.
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.
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.
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
We found this trial at
1
site
300 West 10th Avenue, Suite 519
Columbus, Ohio 43210
Columbus, Ohio 43210
614-293-5066
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University...
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