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Sponsors and Collaborators: |
Duke University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003463 |
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: | 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.
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:
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 University |
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: | November 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00003463 |
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 |
Glioblastoma Astrocytoma Irinotecan Carmustine Central Nervous System Neoplasms Camptothecin Recurrence Brain Neoplasms |
Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neuroepithelioma Glioma Gliosarcoma Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Nervous System Diseases Enzyme Inhibitors Pharmacologic Actions |
Neoplasms Neoplasms by Site Therapeutic Uses Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Alkylating Agents Antineoplastic Agents, Phytogenic |