Overview

Temozolomide in Treating Patients With Anaplastic Oligodendroglioma

Status:
Completed
Trial end date:
2001-02-01
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. PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients with anaplastic oligodendroglioma.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Duke University
Collaborator:
National Cancer Institute (NCI)
Treatments:
Temozolomide
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed supratentorial anaplastic
oligodendroglioma or anaplastic oligoastrocytoma not requiring immediate radiotherapy Newly
diagnosed, progressive, or recurrent disease Bidimensionally measurable disease At least
1.5 cm2 by MRI

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: More than 12 weeks Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet
count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin less than 1.5
times upper limit of normal (ULN) SGOT/SGPT less than 2.5 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: Neurologically stable No nonmalignant systemic disease No acute infection treated
with intravenous antibiotics No frequent vomiting No medical condition (e.g., partial bowel
obstruction) that would interfere with oral medication intake No other prior or concurrent
malignancy except surgically cured carcinoma in situ of the cervix or basal cell or
squamous cell carcinoma of the skin No AIDS-related illness HIV negative Not pregnant or
nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No more than 1 prior biologic therapy No
concurrent biologic therapy No concurrent growth factors (e.g., epoetin alfa) Chemotherapy:
No more than 1 prior chemotherapy regimen No other concurrent chemotherapy Endocrine
therapy: Must be on stable dose of steroids for at least 1 week prior to study Concurrent
steroids allowed Radiotherapy: See Disease Characteristics No concurrent radiotherapy
Surgery: At least 2 weeks since prior surgical resection (newly diagnosed patients must be
enrolled within 28 days of surgery or biopsy) Recovered from prior major surgery Other: No
other concurrent investigational drugs