Temozolomide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Anaplastic Oligodendrogliomas or Mixed Anaplastic Oligoastrocytomas

• Status: Completed
• Trial end date: 2018-05-14
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy and radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining temozolomide with radiation therapy in treating patients who have newly diagnosed anaplastic oligodendrogliomas or mixed anaplastic oligoastrocytomas.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radiation Therapy Oncology Group
• Collaborators: National Cancer Institute (NCI); NRG Oncology
• Treatments: Dacarbazine; Temozolomide

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed supratentorial pure or mixed anaplastic oligodendroglioma

• Unifocal or multifocal disease

• Prior suspected or proven low-grade glioma eligible provided biopsy reveals pure or mixed anaplastic oligodendroglioma that has not been previously treated with radiotherapy and/or chemotherapy

• No equivocal oligodendroglial element

• No tumors predominantly located in the posterior fossa (i.e., brainstem or cerebellum)

• No spinal cord tumors

• No evidence of spinal drop metastasis or spread to noncontiguous meninges

PATIENT CHARACTERISTICS:

Age:

• 18 to 65

Performance status:

• Zubrod 0-1

Life expectancy:

• More than 12 weeks

Hematopoietic:

• Absolute granulocyte count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 10 g/dL

Hepatic:

• Bilirubin no greater than 2 times normal

• Aspartate aminotransferase (AST) no greater than 3 times normal

• Alkaline phosphatase no greater than 2 times normal

Renal:

• Creatinine no greater than 1.5 times normal

Other:

• No active infection

• No other medical problems that would preclude study participation

• No other malignancy within the past 3 years except carcinoma in situ of the cervix or nonmelanoma skin cancer

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

• No prior chemotherapy for this malignancy

• No prior temozolomide

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

• No prior radiotherapy to the brain, head, or neck

Surgery:

• At least 14 days since prior surgery requiring general anesthesia