Temozolomide in Treating Patients With Recurrent Glioblastoma Multiforme or Other Malignant Glioma

• Status: Completed
• Trial end date: 2013-12-01
• 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.

PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with recurrent glioblastoma multiforme or other malignant glioma.

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

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: National Cancer Institute (NCI); Schering-Plough; Weill Medical College of Cornell University
• Treatments: Dacarbazine; Temozolomide

Criteria

DISEASE CHARACTERISTICS:

• Pathologically diagnosed glioblastoma multiforme or other malignant glioma

• Recurrent disease

• Must have received prior temozolomide

PATIENT CHARACTERISTICS:

• Karnofsky performance status 60-100%

• Granulocyte count ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• SGOT ≤ 2.5 times upper limit of normal (ULN)

• Creatinine ≤ 2 times ULN

• Bilirubin ≤ 2 times ULN

• No other active malignancy except for cervical carcinoma in situ or basal cell carcinoma of the skin

• No serious medical or psychiatric illness that, in the opinion of the investigator, would preclude study treatment

• No medical condition that precludes swallowing pills

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Recovered from all prior therapy