Phase 1
Completed N=9
Temozolomide and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Anaplastic Astrocytoma
Glioblastoma Multiforme/Anaplastic Astrocytoma
Source: ClinicalTrials.gov NCT00841555 ↗
Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcomePrimary: Maximum Tolerated Dose(MTD)of Temozolomide(TMZ) — 75 mg/m^2
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose(MTD)of Temozolomide(TMZ) |
75 | — |
| SECONDARY Time to Neuroradiological Evidence of Tumor Recurrence or Progression |
— | — |
| SECONDARY Survival Time |
12.7 | — |
| SECONDARY Time Spent in a Karnofsky Performance Status of 60-100% |
8.1 | — |
Eligibility Criteria
Inclusion Criteria
- Patients who have De novo glioblastoma multiforme, anaplastic astrocytoma, anaplastic oligodendrogliomas, mixed anaplastic oligoastrocytomas, gliosarcoma of the Brain, not involving the brain stem or optics chiasm, diagnosed following biopsy or tumor removal.
- Age > 18 years
- Given written consent
- Adequate bone marrow reserve(hemoglobin > 10 grams, Absolute neutrophil count > 1500 / mm3, platelets > 100,000/ mm3)
- Normal renal function(BUN < 24 mg/dL, Creatinine < 1.3 mg/dL)
- Normal liver function(Total Bilirubin < 1.5 mg/dL, SGPT/ALT < 60 U/L)
Exclusion Criteria
- Have a Karnofsky score of < 60 [Appendix B] or age < 18 years.
- Prior chemotherapy and/or radiotherapy of their glioblastomamultiforme, anaplastic astrocytoma, anaplastic oligodendrogliomas, mixed anaplastic oligoastrocytomas, gliosarcoma.
- Tumors located in the brainstem or optic chiasm.
- Prior radiation therapy to the brain
- Prior chemotherapy within the past 6 weeks.
Data sourced from ClinicalTrials.gov (NCT00841555). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.