Clinical trial NCT00059800: Boron Neutron Capture Therapy in Treating Patients With Melanoma
Official title: A Phase II Trial For Neutron Capture Therapy In Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melanoma (Skin)
Keywords: recurrent melanoma
stage 0 melanoma
stage I melanoma
stage II melanoma
stage III melanoma
stage IV melanoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-05-07
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Clinical response
measure: Time course, uniformity, and severity of acute dermal reactions
measure: Late dermal reaction after at least six months
measure: Pharmacokinetics
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Cambridge
country: United States
facility: Massachusetts Institute of Technology
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Paul M. Busse, MD, PhD
role: STUDY_CHAIR
References: