Boron Neutron Capture Therapy in Treating Patients With Melanoma

Beth Israel Lahey Health

Status and phase: Completed; Phase 2

Conditions: Melanoma (Skin)

Treatments: Radiation: boron neutron capture therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00059800

BIDMC-W-01-0380-FB

CDR0000287207 (Registry Identifier)

BIDMC-2001-P-001946

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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