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A Phase II Trial For Neutron Capture Therapy In Melanoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Melanoma (Skin)

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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 CenterBoston, Massachusetts  02215
Massachusetts Institute of TechnologyCambridge, Massachusetts  02139