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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Early Phase II Study On BNCT In Metastatic Malignant Melanoma Using The Boron Carrier BPA

Conditions
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Melanoma (Skin)

Intervention / Treatment
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* Drug: boronophenylalanine-fructose complex


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: boronophenylalanine-fructose complex|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best response to treatment as measured by RECIST every 8 weeks at completion of study treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival as measured every 8 weeks at completion of study treatment |  |  | 
| Duration of local response as measured by Kaplan Meier every 8 weeks after completion of study treatment |  |  | 
| Time to local progression measured every 8 weeks after completion of study treatment |  |  | 
| Acute toxicity as measured by Common Toxicity Criteria AE v 3.0 1- 6 weeks after completion of treatment |  |  | 
| Late toxicity as measured by RTOG and EORTC week 6 and thereafter upon completion of study treatment |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV melanoma, recurrent melanoma