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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005855 |
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: This phase I/II trial is studying the side effects and best dose of efaproxiral when given with carmustine and to see how well they work in treating patients with progressive or recurrent malignant glioma.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Drug: carmustine Drug: efaproxiral |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control |
Official Title: | A Phase I/II Study to Evaluate the Safety and Tolerance of Escalating Doses of RSR13 Administered With a Fixed Dose of BCNU Every Six Weeks in Patients With Recurrent Malignant Glioma |
Estimated Enrollment: | 48 |
Study Start Date: | July 2000 |
OBJECTIVES:
OUTLINE: This is a nonrandomized, open-label, multicenter, dose-escalation study of efaproxiral (RSR13).
Patients receive RSR13 IV over 30 minutes followed 30 minutes later by carmustine IV over 1-2 hours on day 1. Treatment repeats every 6 weeks for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression.
Cohorts of 6-12 patients receive escalating doses of RSR13 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 or 5 of 12 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued to receive treatment with RSR13 and carmustine at the recommended phase II dose.
Patients are followed at 6 weeks and then every 2 months thereafter.
PROJECTED ACCRUAL: A maximum of 48 patients will be accrued for the phase I portion of this study. A maximum of 47 patients will be accrued for the phase II portion of this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed malignant glioma that is progressive or recurrent after radiotherapy with or without chemotherapy
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Alabama | |
University of Alabama at Birmingham Comprehensive Cancer Center | |
Birmingham, Alabama, United States, 35294 | |
United States, Florida | |
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | |
Tampa, Florida, United States, 33612-9497 | |
United States, Georgia | |
Winship Cancer Institute of Emory University | |
Atlanta, Georgia, United States, 30322 | |
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
Baltimore, Maryland, United States, 21231-2410 | |
United States, Massachusetts | |
Massachusetts General Hospital Cancer Center | |
Boston, Massachusetts, United States, 02114 | |
United States, Michigan | |
Josephine Ford Cancer Center at Henry Ford Hospital | |
Detroit, Michigan, United States, 48202 | |
United States, North Carolina | |
Wake Forest University Comprehensive Cancer Center | |
Winston-Salem, North Carolina, United States, 27157-1096 | |
United States, Pennsylvania | |
Abramson Cancer Center of the University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104-4283 | |
United States, Texas | |
University of Texas Health Science Center at San Antonio | |
San Antonio, Texas, United States, 78229-3900 |
Study Chair: | Pamela Z. New, MD | The University of Texas Health Science Center, Houston |
Study ID Numbers: | CDR0000067881, NABTT-9806, JHOC-NABTT-9806 |
Study First Received: | June 2, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00005855 History of Changes |
Health Authority: | United States: Federal Government |
adult glioblastoma adult anaplastic astrocytoma adult anaplastic oligodendroglioma |
recurrent adult brain tumor adult giant cell glioblastoma adult gliosarcoma |
Glioblastoma Astrocytoma Carmustine Central Nervous System Neoplasms Recurrence Efaproxiral Brain Neoplasms Neuroectodermal Tumors Radiation-Sensitizing Agents |
Neoplasms, Germ Cell and Embryonal Neuroepithelioma Oligodendroglioma Antineoplastic Agents, Alkylating Glioma Gliosarcoma Alkylating Agents Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Antisickling Agents Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hematologic Agents Nervous System Diseases Neoplasms, Nerve Tissue Carmustine Central Nervous System Neoplasms Pharmacologic Actions Efaproxiral |
Neuroectodermal Tumors Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Neoplasms, Germ Cell and Embryonal Antineoplastic Agents, Alkylating Glioma Neoplasms, Neuroepithelial Alkylating Agents Nervous System Neoplasms Neoplasms, Glandular and Epithelial |