Radiation Therapy, Temozolomide, Tamoxifen, and Carboplatin in Treating Patients With Malignant Gliomas

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Tamoxifen may make tumor cells more sensitive to radiation therapy and chemotherapy. Giving radiation therapy together with temozolomide, tamoxifen, and carboplatin may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects and how well giving radiation therapy together with temozolomide, tamoxifen, and carboplatin works in treating patients with malignant gliomas.

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

Details

• Lead Sponsor: San Diego Pacific Oncology & Hematology Associates
• Treatments: Carboplatin; Dacarbazine; Tamoxifen; Temozolomide

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed glioblastoma multiforme and/or anaplastic astrocytoma

• Supratentorial tumor

• No well-differentiated astrocytoma or glioma with oligodendroglial component

• No multifocal glioma

• Has undergone surgery within the past 6 weeks

• No recurrent glioblastoma multiforme

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Neurological functional status 0-2

• Life expectancy > 12 weeks

• ANC ≥ 1,200/mm³

• Platelet count ≥ 100,000/mm³

• Hemoglobin ≥ 9 g/dL

• Serum creatinine ≤ 1.5 times upper limit of normal (ULN)

• Blood urea nitrogen ≤ 1.5 times ULN

• Total and direct bilirubin ≤ 3 times ULN

• AST and ALT ≤ 3 times ULN

• Alkaline phosphatase ≤ 3 times ULN

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 3 months after study completion

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

• No acquired immune deficiency syndrome (AIDS)

• No major medical illness or psychiatric impairment that would preclude study compliance

PRIOR CONCURRENT THERAPY:

• No prior radiotherapy to the head and neck

• No other concurrent therapy for the tumor