Boron Neutron Capture Therapy in Treating Patients With Melanoma

NCT00059800 | Completed Phase 2

• 3 other identifiers: BIDMC-W-01-0380-FBCDR0000287207BIDMC-2001-P-001946
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Melanoma (Skin)

Keywords

recurrent melanoma; stage 0 melanoma; stage I melanoma; stage II melanoma; stage III melanoma; stage IV melanoma

Outcome Measures

Primary Outcomes (4)

• Clinical response

• Time course, uniformity, and severity of acute dermal reactions

• Late dermal reaction after at least six months

• Pharmacokinetics

Interventions

boron neutron capture therapy RADIATION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Massachusetts Institute of Technology

Cambridge, Massachusetts, 02139, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Boron Neutron Capture Therapy

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Neutron Capture Therapy; Radiotherapy, High-Energy; Radiotherapy; Therapeutics

Study Officials

• Paul M. Busse, MD, PhD

  Beth Israel Deaconess Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 6, 2003
• First Posted: May 7, 2003
• Study Start: May 1, 2002
• Study Completion: January 1, 2004
• Last Updated: June 26, 2013

Record last verified: 2005-12

Locations

US (2)