A Phase II Trial For Neutron Capture Therapy In Melanoma
18 Years
N/A
Both
Melanoma (Skin)
Trial Information
A Phase II Trial For Neutron Capture Therapy In Melanoma
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Primary Purpose: Treatment
Outcome Measure:
Clinical response
Safety Issue:
No
Principal Investigator
Paul M. Busse, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Beth Israel Deaconess Medical Center
Authority:
United States: Federal Government
Study ID:
BIDMC-W-01-0380-FB
NCT ID:
NCT00059800
Start Date:
May 2002
Completion Date:
January 2004
Related Keywords:
- Melanoma (Skin)
- recurrent melanoma
- stage 0 melanoma
- stage I melanoma
- stage II melanoma
- stage III melanoma
- stage IV melanoma
- Melanoma
Name | Location |
|---|---|
| Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
| Massachusetts Institute of Technology | Cambridge, Massachusetts 02139 |
