PROCEDURES FOR BNCT PHASE-I STUDY OF MELANOMA IN THE EXTREMITIES
18 Years
N/A
Both
Melanoma (Skin)
Trial Information
PROCEDURES FOR BNCT PHASE-I STUDY OF MELANOMA IN THE EXTREMITIES
OBJECTIVES: I. Estimate the maximum tolerated dose of neutron irradiation that can be given
in combination with borophenylalanine-fructose complex (BPA-F) in patients with stage III
melanoma. II. Evaluate the safety of this regimen. III. Evaluate tumor response to this
regimen.
OUTLINE: This is a dose-finding study. Patients receive a test dose of
borophenylalanine-fructose complex (BPA-F) for biodistribution studies and undergo punch
biopses of tumor and normal tissue to measure B-10 concentration. Later, a treatment dose of
BPA-F over 1 hour is followed by neutron irradiation. Groups of 3 patients receive escalated
doses of neutron irradiation until the maximum tolerated dose is determined. Patients who
complete protocol treatment and continue to meet the eligibility criteria may re-enter the
study, provided at least 6 months has elapsed since the completion of prior therapy and the
field boundary for the new irradiation site is seperated from the boundary of the previously
irradiated site. Patients are followed monthly for 12 months, then every 3-6 months as
needed.
PROJECTED ACCRUAL: Approximately 15 patients will be entered.
Inclusion Criteria
DISEASE CHARACTERISTICS: Biopsy-proven melanoma that is clinical stage III Estimated
clinical tumor depth 1.0-6.0 cm from the epidermis Tumor surface diameter no greater than
10 cm Grossly evident cutaneous or subcutaneous tumor nodules are eligible for irradiation
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70%-100% Life
expectancy: More than 3 months Hematopoietic: Not specified Hepatic: Not specified Renal:
Not specified Other: No history of phenylketonuria Negative serum pregnancy test required
of fertile women Adequate contraception required of fertile women during and for 6 months
after the study
PRIOR CONCURRENT THERAPY: No prior radiotherapy to the target area
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
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:
CDR0000064811
NCT ID:
NCT00002781
Start Date:
April 1996
Completion Date:
Related Keywords:
- Melanoma (Skin)
- stage III melanoma
- recurrent melanoma
- Melanoma
Name | Location |
|---|---|
| Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
| Boston University School of Medicine | Boston, Massachusetts 02118 |
