Overview

Temozolomide Plus Carboplatin in Treating Patients With Recurrent Glioblastoma Multiforme

Status:
Withdrawn
Trial end date:
2002-04-01
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. PURPOSE: Phase I/II trial to study the effectiveness of temozolomide plus carboplatin in treating patients who have recurrent glioblastoma multiforme.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fox Chase Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Carboplatin
Dacarbazine
Temozolomide
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed recurrent glioblastoma multiforme
Measurable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: Granulocyte count greater than 1,500/mm3 Platelet count
greater than 100,000/mm3 Hemoglobin at least 10.0 g/dL Hepatic: Bilirubin no greater than
1.5 times normal SGOT no greater than 3 times upper limit of normal Renal: Creatinine
clearance greater than 50 mL/min Cardiovascular: No myocardial infarction within the past 6
months No congestive heart failure requiring therapy Other: HIV negative No active or
uncontrolled infection No other malignancy within the past 5 years except adequately
treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No
frequent vomiting No medical condition that would interfere with oral medication intake
(e.g., partial bowel obstruction) No known or suspected psychiatric disorder that would
preclude study No other severe concurrent disease that would preclude study Not pregnant or
nursing Negative pregnancy test Fertile patients must use effective contraception during
and for at least 3 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent sargramostim (GM-CSF) No
concurrent prophylactic filgrastim (G-CSF) Chemotherapy: No prior temozolomide No prior
platinum-based chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified
Surgery: Recovered from prior major surgery No more than 2 weeks since prior subtotal tumor
resection Other: Recovered from prior therapy No other concurrent investigational drugs