Patient case: 58-year-old female with adenoid cystic carcinoma; genetic feature: KIT

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

Summary: 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: 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: 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

Relevance to patient case: not relevant