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

The Ohio State University

Status and phase: Completed; Phase 1

Conditions: Glioblastoma Multiforme/Anaplastic Astrocytoma

Treatments: Drug: temozolomide; Radiation: Hypofractionated radiation therapy; Radiation: Intensity-modulated radiation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00841555

NCI-2011-03149 (Registry Identifier)

OSU-08119

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Hypofractionation Radiotherapy+Temozolomide

Experimental group

Description:

Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.

Treatment:

Radiation: Intensity-modulated radiation therapy

Drug: temozolomide

Radiation: Hypofractionated radiation therapy