A Phase I/II Trial of CPT-11 With Carboplatin in Patients With Glioblastoma Multiforme Prior to Radiation Therapy
18 Years
N/A
Both
Brain and Central Nervous System Tumors
Trial Information
A Phase I/II Trial of CPT-11 With Carboplatin in Patients With Glioblastoma Multiforme Prior to Radiation Therapy
OBJECTIVES:
- Determine the maximum tolerated dose (MTD) of carboplatin and irinotecan in patients
with glioblastoma multiforme. (Phase I closed to accrual as of 6/24/02)
- Determine the toxic effects of this regimen in these patients.
- Determine the objective response in patients treated with the established MTD of this
regimen.
- Determine time to tumor progression and survival of patients treated with this regimen.
OUTLINE: This is a dose-escalation study. Patients in the phase II portion of the study are
stratified according to age (under 60 vs 60 and over), ECOG performance status (0-1 vs 2),
and extent of resection (total vs subtotal). (Phase I closed to accrual as of 6/24/02)
Within 4 weeks of surgery, patients receive carboplatin IV over 30 minutes followed by
irinotecan IV over 90 minutes on day 1. Treatment repeats every 4 weeks for a maximum of 6
courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of carboplatin and irinotecan 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 irinotecan at the
recommended phase II dose. (Phase I closed to accrual as of 6/24/02)
After chemotherapy, all patients undergo radiotherapy.
Patients are followed for 30 days.
PROJECTED ACCRUAL: A total of 24-107 patients (3-54 for phase I and 21-53 for phase II) will
be accrued for this study. (Phase I closed to accrual as of 6/24/02)
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed glioblastoma multiforme
- Measurable disease
- No CNS metastases or carcinomatous meningitis
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2 OR
- Karnofsky 70-100%
Life expectancy:
- At least 12 weeks
Hematopoietic:
- Granulocyte count greater than 1,500/mm^3
- Platelet count greater than 100,000/mm^3
- Hemoglobin at least 9.0 g/dL
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- SGOT no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver
involvement)
- No known Gilbert's syndrome
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:
- HIV negative
- No active or uncontrolled infection
- No psychiatric disorder that would preclude study
- 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 uncontrolled diabetes mellitus (i.e., random blood sugar of 200 mg or more)
- No other severe disease that would preclude study
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior immunotherapy or biologic therapy
- No concurrent sargramostim (GM-CSF)
- No concurrent filgrastim (G-CSF) with course 1
- No concurrent immunotherapy
Chemotherapy:
- No prior chemotherapy
- No other concurrent chemotherapy
Endocrine therapy:
- Must have maintained a stable or decreasing dose of corticosteroids for 2 weeks prior
to study
- Concurrent corticosteroids for cerebral edema allowed
- No concurrent anticancer hormonal therapy
Radiotherapy:
- No prior radiotherapy
- No concurrent radiotherapy
Surgery:
- At least 2 weeks since prior surgery
Other:
- No other concurrent investigational agent or participation on any other clinical
study
- No concurrent immunosuppressive drugs
- No concurrent phenobarbital or valproic acid
- No concurrent anticonvulsants except carbamazepine or gabapentin
- No concurrent prochlorperazine on day of irinotecan treatment
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Michael L. Gruber, MD
Investigator Role:
Study Chair
Investigator Affiliation:
New York University School of Medicine
Authority:
United States: Federal Government
Study ID:
CDR0000068435
NCT ID:
NCT00010036
Start Date:
May 1999
Completion Date:
Related Keywords:
- Brain and Central Nervous System Tumors
- adult glioblastoma
- adult giant cell glioblastoma
- adult gliosarcoma
- Glioblastoma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
Name | Location |
|---|---|
| NYU School of Medicine's Kaplan Comprehensive Cancer Center | New York, New York 10016 |
