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Sponsored by: |
Duke University |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002986 |
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 topotecan plus carmustine in patients with recurrent primary malignant glioma.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors |
Drug: carmustine Drug: topotecan hydrochloride |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Treatment of Adults With Primary Malignant Glioma With Topotecan (NSC #609699) Plus BCNU (NSC #409962) |
Estimated Enrollment: | 36 |
Study Start Date: | February 1997 |
OBJECTIVES:
OUTLINE: Topotecan is administered by an ambulatory infusion pump for 72 hours each week. Topotecan dose escalation is carried out in cohorts of three patients. Dose escalation is continued until toxic effects or disease progression is observed in these patients. Carmustine is administered over 1 hour every 6 weeks, on the same day as the first topotecan dose for that week.
Three patients will be treated at an initial dose level of topotecan, and if one of these patients experience dose limiting toxicity (DLT), an additional
3 patients must be treated at this dose level without further DLT in order for dose escalation to proceed. The MTD is the highest dose at which DLT occurs in no more than 1 of 6 patients.
Patients are evaluated after every 6 week cycle.
PROJECTED ACCRUAL: An estimated 18-36 patients will be entered.
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
PATIENT CHARACTERISTICS:
Age:
Performance Status:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, North Carolina | |
Duke Comprehensive Cancer Center | |
Durham, North Carolina, United States, 27710 | |
United States, Tennessee | |
Saint Jude Children's Research Hospital | |
Memphis, Tennessee, United States, 38105-2794 |
Study Chair: | Henry S. Friedman, MD | Duke University |
Study ID Numbers: | CDR0000065521, DUMC-000224-01-1R4, DUMC-000224-00-2R3, DUMC-0348-99-2R2, DUMC-223-97-2, DUMC-229-98-2R1, SB-DUMC-229-98-2R1, NCI-G97-1242 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00002986 |
Health Authority: | United States: Federal Government |
recurrent adult brain tumor |
Neuroectodermal Tumors Brain Neoplasms Neoplasms, Germ Cell and Embryonal Carmustine Neuroepithelioma Glioma |
Central Nervous System Neoplasms Topotecan Recurrence Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Nervous System Diseases Neoplasms, Nerve Tissue Enzyme Inhibitors Pharmacologic Actions |
Neoplasms Neoplasms by Site Therapeutic Uses Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Alkylating Agents |