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Sponsored by: |
Beth Israel Deaconess Medical Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00059800 |
RATIONALE: Boron neutron capture therapy may selectively kill tumor cells without harming normal tissue.
PURPOSE: Phase II trial to study the effectiveness of boron neutron capture therapy in treating patients who have melanoma.
Condition | Intervention | Phase |
---|---|---|
Melanoma (Skin) |
Procedure: boron neutron capture therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Active Control |
Official Title: | A Phase II Trial For Neutron Capture Therapy In Melanoma |
Study Start Date: | May 2002 |
OBJECTIVES:
OUTLINE: Patients are stratified according to tumor size (no greater than 15 cc vs greater than 15 cc).
Patients undergo boron neutron capture therapy.
Patients are followed for 3 years.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 3 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Lesion(s) to be irradiated must be located in 1 of the following areas:
Area to be irradiated must not exceed a maximum dimension of 10 cm
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 | |
Massachusetts Institute of Technology | |
Cambridge, Massachusetts, United States, 02139 |
Study Chair: | Paul M. Busse, MD, PhD | Beth Israel Deaconess Medical Center |
Study ID Numbers: | CDR0000287207, BIDMC-W-01-0380-FB, BIDMC-2001-P-001946 |
Study First Received: | May 6, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00059800 |
Health Authority: | United States: Federal Government |
recurrent melanoma stage 0 melanoma stage I melanoma |
stage II melanoma stage III melanoma stage IV melanoma |
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Nevus Recurrence Neuroendocrine Tumors Melanoma |
Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas |