Overview

Combination Chemotherapy in Treating Patients With Recurrent Glioblastoma Multiforme

Status:
Unknown status
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. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy in treating patients who have recurrent glioblastoma multiforme.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Atlantic Health System
Treatments:
Carboplatin
Temozolomide
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed recurrent glioblastoma multiforme
Measurable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 OR Karnofsky 70-100%
Life expectancy: At least 15 weeks Hematopoietic: Granulocyte count greater than 1,500/mm3
Hemoglobin at least 10.0 g/dL Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no
greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 3 times ULN Renal:
Creatinine no greater than 1.5 mg/dL Cardiovascular: No myocardial infarction within the
past 6 months No congestive heart failure requiring therapy Other: Not pregnant or nursing
Negative pregnancy test Fertile patients must use effective contraception HIV negative No
active or uncontrolled infection No psychiatric disorders that would preclude study No
other severe concurrent disease that would preclude study No frequent vomiting or other
medical condition that would interfere with oral medication administration (e.g., partial
bowel obstruction) 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

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent sargramostim (GM-CSF)
Chemotherapy: No prior temozolomide No prior platinum-based chemotherapy Endocrine therapy:
Not specified Radiotherapy: Not specified Surgery: Recovered from prior major surgery
Other: Recovered from prior therapy No other concurrent investigational drugs