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Boron Neutron Capture Therapy in Treating Patients With Melanoma Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Boron Neutron Capture Therapy in Treating Patients With Melanoma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Boron Neutron Capture Therapy in Treating Patients With Melanoma Clinical research trials and Boron Neutron Capture Therapy in Treating Patients With Melanoma healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Boron Neutron Capture Therapy in Treating Patients With Melanoma. Boron Neutron Capture Therapy in Treating Patients With Melanoma Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Boron Neutron Capture Therapy in Treating Patients With Melanoma clinical trial. Human subjects often receive the most effective healthcare possible for their Boron Neutron Capture Therapy in Treating Patients With Melanoma condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "B" Clinical Trials Conditions > Boron Neutron Capture Therapy in Treating Patients With Melanoma  Boron Neutron Capture Therapy in Treating Patients With Melanoma
Boron Neutron Capture Therapy in Treating Patients With Melanoma
For Condition: Stage 4 Melanoma,stage 0 melanoma,stage 3 melanoma,Recurrent Melanoma,stage 1 melanoma,stage 2 melanoma
Status: Recruiting
Sponsor(s): Beth Israel Deaconess Medical Center ,
Synopsis: 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.
Details: OBJECTIVES: - Determine the clinical response, by serial objective measurements, in patients with melanoma treated with boron neutron capture therapy. - Determine the time course, uniformity, and severity of acute dermal reactions in patients treated with this regimen. - Determine the late dermal reactions in patients who are followed for at least 6 months after treatment with this regimen. - Determine the pharmacokinetics of this regimen in these patients. 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed melanoma - Evaluable disease - Lesion(s) to be irradiated must be located in 1 of the following areas: - On an extremity - On the head or neck (including the scalp) - In the subdermal lymphatics (excluding the proximal axilla) - Area to be irradiated must not exceed a maximum dimension of 10 cm - Maximum tumor depth from the surface of the skin cannot exceed 6 cm PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - More than 6 months Hematopoietic - Not specified Hepatic - Not specified Renal - Creatinine normal Cardiovascular - No history of severe cardiac disease - No uncontrolled arrhythmias or conduction defects - No unstable or newly diagnosed angina pectoris - No recent coronary artery disease - No congestive heart failure Other - Not pregnant - Negative pregnancy test - No history of phenylketonuria - Must have sufficient mental competence PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy to study sites Surgery - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PaulBusse, Study Chair, Beth Israel Deaconess Medical Center
Massachusetts Institute of Technology *Recruiting*
Cambridge, Massachusetts, 02139
United States
Recruiting Otto Harling 617-253-4201
Beth Israel Deaconess Medical Center *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Paul Busse 617-667-2345
Additional Information:
Study ID Numbers: CDR0000287207; BIDMC-2001-P-001946,BIDMC-W-01-0380-FB
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00059800
Other Stage 1 Melanoma Studies:
1. Boron Neutron Capture Therapy in Treating Patients With Melanoma
Related Studies:
Other stage 1 melanoma Clinical Trials
Other Massachusetts Clinical Trials
Other Cambridge Clinical Trials
Boron Neutron Capture Therapy in Treating Patients With Melanoma
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