Carboplatin Plus Irinotecan in Treating Patients With Glioblastoma Multiforme
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Purpose
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 II trial to study the effectiveness of combining carboplatin with irinotecan in treating patients who have glioblastoma multiforme.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: carboplatin Drug: irinotecan hydrochloride Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase I/II Trial of CPT-11 With Carboplatin in Patients With Glioblastoma Multiforme Prior to Radiation Therapy |
| Study Start Date: | May 1999 |
| Primary Completion Date: | October 2001 (Final data collection date for primary outcome measure) |
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)
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, New York | |
| NYU School of Medicine's Kaplan Comprehensive Cancer Center | |
| New York, New York, United States, 10016 | |
| Study Chair: | Michael L. Gruber, MD | New York University School of Medicine |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00010036 History of Changes |
| Other Study ID Numbers: | CDR0000068435, P30CA016087, NYU-9902, P-UPJOHN-986475197, NCI-G00-1909 |
| Study First Received: | February 2, 2001 |
| Last Updated: | March 25, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by New York University School of Medicine:
|
adult glioblastoma adult giant cell glioblastoma adult gliosarcoma |
Additional relevant MeSH terms:
|
Glioblastoma Nervous System Neoplasms Central Nervous System Neoplasms Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases |
Irinotecan Carboplatin Camptothecin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Phytogenic Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013