Boron Neutron Capture Therapy Using Boronophenylalanine-Fructose Complex in Treating Patients With Metastatic Melanoma

RATIONALE: Boron neutron capture therapy using boronophenylalanine-fructose complex may kill tumor cells without harming normal tissue.

PURPOSE: This phase II trial is studying how well boron neutron capture therapy using boronophenylalanine-fructose complex works in treating patients with metastatic melanoma.

OBJECTIVES:

Primary

* Determine the therapeutic activity and efficacy of boron neutron capture therapy using boronophenylalanine-fructose complex in patients with metastatic melanoma.
* Determine the objective local response in patients treated with this regimen.

Secondary

* Determine the overall survival of patients treated with this regimen.
* Determine the duration of local response and time to local progression in patients treated with this regimen.
* Determine the dose-response relationship at the per-lesion level in patients treated with this regimen.
* Determine the safety of this regimen in these patients.
* Determine the toxicity of this regimen in these patients.

OUTLINE: This is an open-label study.

Patients receive boronophenylalanine-fructose complex IV over 90 minutes followed by boron neutron capture therapy on days 1 and 2.

Patients are followed at 1 and 6 weeks and then every 8 weeks thereafter. In the event of disease progression, patients are followed every 3 months for survival.

PROJECTED ACCRUAL: A total of 16-24 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed melanoma

  * Metastatic disease

    * Brain metastases, skin metastases, or soft tissue metastases of the head and neck or the extremities
  * Accessible lesion(s) for boron neutron capture therapy (BNCT)
  * No clear progression of disease at other sites than the ones intended for treatment with surgery and/or BNCT
* Measurable disease by MRI within the past 4 weeks

  * Lesion(s) ≥ 10 mm in diameter
* Indication for palliative radiotherapy that is intended to be delivered as BNCT

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* Karnofsky 70-100%

Life expectancy

* Not specified

Hematopoietic

* Neutrophil count ≥ 2,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 10 g/dL

Hepatic

* Bilirubin ≤ 2.5 times upper limit of normal (ULN)\*
* Transaminases ≤ 2.5 times ULN\*
* Alkaline phosphatase ≤ 2.5 times ULN\* NOTE: \*Unless due to reversible reaction to antiseizure medication

Renal

* Creatinine ≤ 2.5 times ULN
* Blood urea nitrogen ≤ 2.5 times ULN

Cardiovascular

* No congestive heart failure
* No newly diagnosed or unstable angina pectoris
* No uncontrolled arrhythmias
* No uncontrolled conduction defects
* No recent coronary artery disease
* No other severe heart disease

Pulmonary

* No severe pulmonary disease, including severe obstructive or restrictive lung disease

Other

* No history of phenylketonuria
* No severe gastrointestinal disease
* No active peptic ulcer disease
* No uncontrolled endocrine disease
* No pre-existing serious mental or organic brain disease (e.g., epilepsy)
* No psychological, familial, sociological, or geographical condition that would preclude study compliance
* Able to travel to the Netherlands via public transportation
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No concurrent immunologic or biologic therapy
* No concurrent colony-stimulating factors (e.g., epoetin alfa or filgrastim \[G-CSF\])

Chemotherapy

* No concurrent chemotherapy

Endocrine therapy

* No concurrent hormonal therapy

Radiotherapy

* No prior radiotherapy to site(s) proposed for study treatment
* No other concurrent radiotherapy

Surgery

* See Disease Characteristics

Other

* Recovered from all prior anti-tumor therapy (excluding alopecia and sensitive peripheral neuropathy ≤ grade 2)
* No other concurrent anticancer therapy
* No other concurrent investigational drugs