Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00045474 |
RATIONALE: Brachytherapy uses radioactive material to kill cancer cells remaining after surgery.
PURPOSE: Phase I trial to study the effectiveness of brachytherapy in treating patients who have recurrent malignant glioma.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors |
Procedure: adjuvant therapy Radiation: iodine I 125 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Brachytherapy Dose Escalating Study Using the Proxima Therapeutics, Inc. GliaSite RTS in Patients With Recurrent Malignant Gliomas |
Study Start Date: | October 2002 |
OBJECTIVES:
OUTLINE: This is a dose-escalation, multicenter study.
Within 3-21 days after surgical resection, patients receive brachytherapy using an intracavity balloon application (GliaSite) with iodine I 125 solution for a total of 5-7 days.
Cohorts of 5-10 patients receive escalating doses of brachytherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 10 patients experience dose-limiting toxicity.
Patients are followed at 4 weeks and then every 2 months for 1 year.
PROJECTED ACCRUAL: Approximately 20-30 patients will be accrued for 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
Anaplastic astrocytoma, anaplastic oligodendroglioma, or glioblastoma multiforme
Progressive or recurrent after radiotherapy with or without chemotherapy
Candidate for maximal surgical resection
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
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, 35294-3295 | |
United States, Florida | |
H. Lee Moffitt Cancer Center and Research Institute | |
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 | |
Comprehensive Cancer Center at Wake Forest University | |
Winston-Salem, North Carolina, United States, 27157-1030 | |
United States, Ohio | |
Cleveland Clinic Taussig Cancer Center | |
Cleveland, Ohio, United States, 44195 | |
United States, Pennsylvania | |
Abramson Cancer Center at University of Pennsylvania Medical Center | |
Philadelphia, Pennsylvania, United States, 19104-4283 |
Study Chair: | Larry Kleinberg, MD | Sidney Kimmel Comprehensive Cancer Center |
Study ID Numbers: | CDR0000256587, NABTT-2106, JHOC-NABTT-2106 |
Study First Received: | September 6, 2002 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00045474 History of Changes |
Health Authority: | United States: Federal Government |
adult anaplastic astrocytoma adult anaplastic oligodendroglioma adult glioblastoma |
recurrent adult brain tumor adult giant cell glioblastoma adult gliosarcoma |
Glioblastoma Astrocytoma Adjuvants, Immunologic Central Nervous System Neoplasms Recurrence Brain Neoplasms Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Iodine Neuroepithelioma Oligodendroglioma Glioma Gliosarcoma Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Neuroectodermal Tumors Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue |
Nervous System Diseases Glioma Central Nervous System Neoplasms Neoplasms, Neuroepithelial Nervous System Neoplasms Neoplasms, Glandular and Epithelial |