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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00053183 |
RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells.
External-beam radiation therapy uses high-energy x-rays to kill tumor cells. Combining internal radiation with external-beam radiation therapy may kill any remaining tumor cells following surgery.
PURPOSE: Phase I trial to study the effectiveness of combining internal radiation therapy with external-beam radiation therapy in treating patients who have undergone surgery for glioblastoma multiforme.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors |
Procedure: conventional surgery Radiation: brachytherapy Radiation: radiation therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Brachytherapy Dose Escalation Using The GliaSite RTS In Newly Diagnosed Glioblastoma Multiforme In Conjunction With External Beam Radiation Therapy |
Study Start Date: | October 2003 |
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study of brachytherapy.
Patients undergo craniotomy for histologic confirmation of glioblastoma multiforme, surgical resection, and placement of a GliaSite RTS™ applicator that includes Iotrex™.
Beginning 3-21 days after surgery, patients undergo brachytherapy via the GliaSite RTS™ applicator. Within 30 days of brachytherapy (no more than 60 days after resection) patients undergo external beam radiotherapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.
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 5 or 3 of 10 patients experience dose-limiting toxicity.
Patients are followed at 21-35 days, every 2 months for 1 year, and then for survival.
PROJECTED ACCRUAL: A total of 15-100 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:
Candidate for maximal surgical resection of tumor mass
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
No biologic therapy with any of the following prior to, during, or within 90 days after brachytherapy :
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 | |
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, 27157-1082 | |
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 | |
United States, Texas | |
University of Texas Health Science Center at San Antonio | |
San Antonio, Texas, United States, 78284-7811 |
Study Chair: | Volker W. Stieber, MD | Wake Forest University |
Study ID Numbers: | CDR0000269300, NABTT-2105, JHOC-NABTT-2105 |
Study First Received: | January 27, 2003 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00053183 History of Changes |
Health Authority: | United States: Federal Government |
adult glioblastoma adult giant cell glioblastoma adult gliosarcoma |
Neuroectodermal Tumors Glioblastoma Astrocytoma Neoplasms, Germ Cell and Embryonal Neuroepithelioma Glioblastoma Multiforme |
Glioma Central Nervous System Neoplasms Gliosarcoma Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Glioblastoma Neoplasms by Histologic Type Astrocytoma Nervous System Diseases Neoplasms, Nerve Tissue Central Nervous System Neoplasms Neuroectodermal Tumors |
Neoplasms Neoplasms by Site Neoplasms, Germ Cell and Embryonal Glioma Neoplasms, Neuroepithelial Nervous System Neoplasms Neoplasms, Glandular and Epithelial |