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| Sponsors and Collaborators: |
Duke University National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002988 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of irinotecan plus carmustine in treating patients who have recurrent primary malignant glioma.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: carmustine Drug: irinotecan hydrochloride |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase I Treatment of Adults With Primary Malignant Glioma With Irinotecan (CPT-11) (NSC #6616348) Plus BCNU (NSC
|
| Estimated Enrollment: | 36 |
| Study Start Date: | April 1997 |
OBJECTIVES: I. Determine the maximum tolerated dose of irinotecan administered in combination with a fixed dose of carmustine in patients with recurrent primary malignant glioma. II. Determine the toxic effects of irinotecan and carmustine in these patients.
OUTLINE: This is a dose escalation study of irinotecan. Patients receive irinotecan IV over 90 minutes weekly on weeks 1-4 and carmustine IV over 1 hour on weeks 1-6. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicities.
PROJECTED ACCRUAL: Approximately 18-36 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven recurrent primary malignant glioma Measurable recurrent or residual primary central nervous system neoplasm confirmed by MRI
PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: Karnofsky 60-100% Hematopoietic: Hematocrit greater than 29% Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 125,000/mm3
Hepatic: SGOT less than 1.5 times upper limit of normal (ULN) Bilirubin less than 1.5 times ULN Renal:
Creatinine less than 1.5 mg/dL BUN less than 25 mg/dL Pulmonary: DLCO at least 60% Other: Not pregnant Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 weeks since prior chemotherapy No prior irinotecan or carmustine treatment failure No more than 1 prior chemotherapy regimen Endocrine therapy: Patients taking corticosteroids must be on a stable dose for at least 1 week prior to study and the dose should not escalate over entry dose level Radiotherapy: At least 6 weeks since prior radiotherapy Surgery: At least 3 weeks since prior surgical resection Other: No concurrent medication that may interfere with study results
Contacts and Locations| United States, North Carolina | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| Study Chair: | Henry S. Friedman, MD | Duke University |
More Information
| Study ID Numbers: | CDR0000065523, DUMC-000564-00-3R3, DUMC-0509-99-3R2, DUMC-0509-99-4R1, DUMC-427-98-3R1, DUMC-461-97-3, NCI-G97-1243 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00002988 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent adult brain tumor |
|
Carmustine Irinotecan Central Nervous System Neoplasms Recurrence Camptothecin Brain Neoplasms Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma Glioma Antineoplastic Agents, Alkylating Antineoplastic Agents, Phytogenic Alkylating Agents Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
|
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Irinotecan Nervous System Diseases Neoplasms, Nerve Tissue Carmustine Enzyme Inhibitors Central Nervous System Neoplasms Pharmacologic Actions Camptothecin Neuroectodermal Tumors |
Neoplasms Neoplasms by Site Therapeutic Uses Neoplasms, Germ Cell and Embryonal Antineoplastic Agents, Alkylating Glioma Neoplasms, Neuroepithelial Antineoplastic Agents, Phytogenic Alkylating Agents Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
