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| Sponsor: | Duke Cancer Institute |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003463 |
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 I trial to study the effectiveness of carmustine wafers plus irinotecan in treating patients with recurrent supratentorial high grade gliomas.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: carmustine Drug: irinotecan hydrochloride Drug: polifeprosan 20 with carmustine implant Procedure: surgical procedure |
Phase I |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase I Treatment of Adults With Recurrent Supratentorial High Grade Glioma With Gliadel Wafers Plus Irinotecan (CPT-11) |
| Study Start Date: | July 1998 |
OBJECTIVES:
OUTLINE: This is a dose escalation study.
All patients undergo surgical resection. At the time of surgery, up to eight Gliadel wafers (containing carmustine) are implanted in the resected tumor cavity.
Cohorts of 3 patients each receive escalating doses of irinotecan IV over 90 minutes once weekly within 3 weeks after Gliadel wafer implantation. One course of treatment consists of 4 weeks of irinotecan and 2 weeks of rest. If 1 patient experiences dose limiting toxicity (DLT) at a dose level, an additional 3 patients are entered at that same dose level. If 2 patients experience DLT, the maximum tolerated dose (MTD) has been surpassed and a total of 6 patients are treated at the previous dose level. The MTD is defined as the highest dose in which no more than 1 of 6 patients experiences DLT.
Treatment continues for up to 12 courses in the absence of unacceptable toxicity and disease progression.
Patients are followed for at least 4 months.
PROJECTED ACCRUAL: Approximately 18 patients will be accrued into this study over 9 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Neurological:
Other:
HIV negative
Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, California | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| United States, North Carolina | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| Study Chair: | Henry S. Friedman, MD | Duke Cancer Institute |
More Information
| ClinicalTrials.gov Identifier: | NCT00003463 History of Changes |
| Other Study ID Numbers: | CDR0000066497, DUMC-0901-02-5R4, DUMC-0901-02-5R2, DUMC-000901-00-5R2, DUMC-000901-01-5R3, DUMC-0797-99-5RI, DUMC-796-98-5, DUMC-98065, UCLA-9812060, NCI-G98-1464, DUMC-0901-01-5R3 |
| Study First Received: | November 1, 1999 |
| Last Updated: | December 13, 2011 |
| Health Authority: | United States: Federal Government |
|
recurrent adult brain tumor adult brain stem glioma adult glioblastoma adult anaplastic astrocytoma |
adult mixed glioma adult giant cell glioblastoma adult gliosarcoma |
|
Glioma Nervous System Neoplasms Central Nervous System Neoplasms 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 Carmustine Irinotecan |
Camptothecin Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antineoplastic Agents, Phytogenic Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |