Temozolomide During and After Radiation Therapy in Treating Patients Who Have Undergone Previous Surgery and Placement of Gliadel Wafers for Newly Diagnosed Glioblastoma Multiforme

• Status: Terminated
• Trial end date: 2007-12-11
• Target enrollment: 0
• Participant gender: All

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. Giving temozolomide during and after radiation therapy may kill any tumor cells that remain after surgery and placement of Gliadel wafers.

PURPOSE: This phase II trial is studying how well giving temozolomide during and after radiation therapy works in treating patients who have undergone previous surgery and placement of Gliadel wafers for newly diagnosed glioblastoma multiforme.

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

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carmustine; Dacarbazine; Temozolomide

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme)

• Underwent gross total resection within the past 6 weeks

• Postoperative contrast-enhancing tumor extends ≤ 1 cm from the margin of the surgical cavity

• 6-8 polifeprosan 20 with carmustine implants (Gliadel® wafers) were placed in the surgical resection cavity at time of surgery

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Karnofsky 60-100%

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

Hepatic

• Bilirubin ≤ 1.5 mg/dL

• Transaminases ≤ 4 times upper limit of normal

Renal

• Creatinine ≤ 1.7 mg/dL

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No known hypersensitivity reaction to temozolomide

• No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior immunotherapy for the brain tumor

• No prior biologic agents (e.g., immunotoxins, immunoconjugates, antisense agents, peptide-receptor agonists, interferons, interleukins, tumor-infiltrating lymphocyte therapy, lymphokine-activated killer cell therapy, or gene therapy) for the brain tumor

Chemotherapy

• See Disease Characteristics

• No other prior chemotherapy for the brain tumor

Endocrine therapy

• No prior hormonal therapy for the brain tumor

• Prior glucocorticoid therapy allowed

Radiotherapy

• No prior radiotherapy for the brain tumor

Surgery

• See Disease Characteristics