Overview

Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors

Status:
Completed
Trial end date:
1969-12-31
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. PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients with recurrent oligodendroglial tumors.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Treatments:
Dacarbazine
Temozolomide
Criteria
DISEASE CHARACTERISTICS: Histologically proven oligodendroglioma or oligoastrocytoma with
at least 25% oligodendroglial elements Recurrent or progressive disease following
radiotherapy At least 3 months since prior radiotherapy Measurable disease by MRI or CT
scan Lesion must have a diameter of at least 1 cm No progressive neurological deficits from
the present recurrence No new neurological deficits interfering with daily activities No
tumor causing midline shift or brain stem compression due to which a rapid deterioration is
to be expected in case of no response No signs of increased intracranial pressure No
extracranial disease

PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: WHO 0-2 Life expectancy: At
least 3 months Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least
100,000/mm3 Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN)
AST/ALT no greater than 2 times ULN Alkaline phosphatase no greater than 2 times ULN Renal:
Creatinine clearance at least 60 mL/min Creatinine no greater than 1.25 times ULN
Neurologic: See Disease Characteristics Other: Not pregnant or nursing Fertile patients
must use effective contraception No other malignant or nonmalignant diseases interfering
with follow-up No psychological, familial, sociological, or geographical condition
potentially hampering compliance with the study and follow-up

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics
Surgery: Not specified Other: No other concurrent investigational drugs No other concurrent
antitumor agents