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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 Recurrent Melanoma Studies:
1. Surgery in Treating Patients With Metastatic Melanoma
2. PET and CT Scans to Evaluate Patients With Stage III or Stage IV Melanoma
3. Chemotherapy With or Without Immunotherapy in Treating Patients With Stage III or Stage IV Melanoma
4. Interferon gamma in Treating Patients With Recurrent or Metastatic Melanoma or Other Solid Tumors
5. Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Small Cell Lung, Breast, Testicular, or Kidney Cancer That is Metastatic or That Cannot Be Treated With Surgery
Related Studies:
Other Recurrent Melanoma Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Boron Neutron Capture Therapy in Treating Patients With Melanoma
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