Overview

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