Temozolomide Compared to Procarbazine, Lomustine, and Vincristine in Treating Patients With Recurrent Malignant Glioma

• Status: Completed
• Trial end date: 2010-09-01
• 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. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of chemotherapy is more effective in treating recurrent malignant glioma.

PURPOSE: Randomized phase III trial to compare the effectiveness of temozolomide alone to that of procarbazine, lomustine, and vincristine in treating patients who have recurrent malignant glioma.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Cancer Research, United Kingdom
• Treatments: Dacarbazine; Lomustine; Procarbazine; Temozolomide; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed anaplastic astrocytoma, glioblastoma multiforme, or gliosarcoma

• WHO grade III or IV at diagnosis or relapse

• Must have undergone primary therapy including radiotherapy

• Must be in first recurrence confirmed by CT scan or MRI

• Evaluable disease by CT scan or MRI

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• WHO 0-3

Life expectancy

• At least 1 month

Hematopoietic

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

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

Hepatic

• Total and direct bilirubin less than 1.5 times upper limit of normal (ULN)

• SGOT or SGPT less than 3 times ULN

• Alkaline phosphatase less than 2 times ULN

Renal

• BUN less than 1.5 times ULN

• Creatinine less than 1.5 times ULN

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other concurrent serious illness

• Considered fit to receive chemotherapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy for glioma

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics

• At least 2 months since prior radiotherapy

• No prior radiosurgery, interstitial radiotherapy, or brachytherapy for glioma

Surgery

• Prior debulking surgery for recurrent disease allowed