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.

Condition	Treatment or Intervention	Phase
Stage IV Melanoma Recurrent Melanoma	Drug: boronophenylalanine-fructose complex  Procedure: boron neutron capture therapy  Procedure: radiation therapy	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Germany
      Universitaetsklinikum Essen, ESSEN,  D-45122,  Germany; Recruiting

Study chairs or principal investigators

Andrea Wittig,  Universitaetsklinikum Essen   

Study ID Numbers:  CDR0000367229; EORTC-11011; NCT00085059
Record last reviewed:  May 2004
Last Updated:  March 10, 2005
Record first received:  June 10, 2004
ClinicalTrials.gov Identifier:  NCT00085059
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08