Temozolomide and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Anaplastic Astrocytoma

Completed · Phase 1

Conditions studied: Glioblastoma Multiforme/Anaplastic Astrocytoma

In brief

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.

Key facts

Study ID

NCT00841555

Run by

Ohio State University Comprehensive Cancer Center

People needed

9

Starts

2009-02-13

Expected to finish

2014-11-25

Last updated by the study team

2018-04-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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