At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of de novo glioblastoma multiforme, anaplastic astrocytoma, anaplastic oligodendrogliomas, mixed anaplastic oligoastrocytomas, or gliosarcoma of the brain (not involving brainstem or optic chiasm), confirmed by biopsy or tumor removal
- ✓Age greater than 18 years
- ✓Hemoglobin >10 g/dL, absolute neutrophil count >1500/mm³, platelets >100,000/mm³
- ✓BUN <24 mg/dL and creatinine <1.3 mg/dL
- ✕Karnofsky score <60
- ✕Prior chemotherapy for glioblastoma or related brain tumors
- ✕Prior radiotherapy for glioblastoma or related brain tumors
- ✕Prior radiation therapy to the brain
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I Trial of Hypofraction Radiotherapy + Temozolomide in the Treatment of Patients With Glioblastoma Multiforme and Anaplastic Astrocytoma of the Brain
In Brief
A Phase 1 clinical trial evaluating temozolomide, Hypofractionated radiation therapy, and 1 other intervention for Glioblastoma Multiforme/Anaplastic Astrocytoma. Completed, enrolled 9 participants across 1 site.
Detailed 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 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.
Study Details
Timeline
Interventions
Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy. Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment
Patients will undergo HIMRT
Patients undergo HIMRT