Boron Neutron Capture Therapy in Treating Patients With Melanoma

Melanoma (Skin) Clinical Trial

Official title:

A Phase II Trial For Neutron Capture Therapy In Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00059800
• Other study ID #: BIDMC-W-01-0380-FB
• Secondary ID: CDR0000287207BID
• Status: Completed
• Phase: Phase 2
• First received: May 6, 2003
• Last updated: June 25, 2013
• Start date: May 2002
• Est. completion date: January 2004

Study information

• Verified date: December 2005
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Radiation:
• boron neutron capture therapy

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Massachusetts Institute of Technology	Cambridge	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response			No
Primary	Time course, uniformity, and severity of acute dermal reactions			No
Primary	Late dermal reaction after at least six months			No
Primary	Pharmacokinetics			No