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PROCEDURES FOR BNCT PHASE-I STUDY OF MELANOMA IN THE EXTREMITIES


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Melanoma (Skin)

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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 CenterBoston, Massachusetts  02215
Boston University School of MedicineBoston, Massachusetts  02118