Combination Chemotherapy in Treating Patients With Recurrent Glioblastoma Multiforme
NCT ID: NCT00014105
Last Updated: 2013-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
INTERVENTIONAL
2000-12-31
Brief Summary
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PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy in treating patients who have recurrent glioblastoma multiforme.
Detailed Description
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OUTLINE: This is a dose-escalation study. Patients are stratified according to prior nitrosourea-based chemotherapy (yes vs no). Patients receive carboplatin IV over 30 minutes on day 1 and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients with a persistent response may continue to receive temozolomide only for an additional 6 courses. Cohorts of 3-6 patients receive escalating doses of carboplatin and temozolomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued to receive carboplatin and temozolomide at the recommended phase II dose.
PROJECTED ACCRUAL: A total of 13-70 patients (3-30 for phase I and 10-40 for phase II) will be accrued for this study.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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carboplatin
temozolomide
Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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Atlantic Health System
OTHER
Principal Investigators
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Michael L. Gruber, MD
Role: STUDY_CHAIR
NYU Langone Health
Locations
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Overlook Hospital
Summit, New Jersey, United States
Countries
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Other Identifiers
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NYU-9948
Identifier Type: -
Identifier Source: secondary_id
SPRI-NYU-9948
Identifier Type: -
Identifier Source: secondary_id
NCI-G00-1907
Identifier Type: -
Identifier Source: secondary_id
NCI-V01-1650
Identifier Type: -
Identifier Source: secondary_id
CDR0000068432
Identifier Type: -
Identifier Source: org_study_id