Boron Neutron Capture Therapy Using Boronophenylalanine-Fructose Complex in Treating Patients With Metastatic Melanoma
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
OBJECTIVES:
Primary
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Determine the therapeutic activity and efficacy of boron neutron capture therapy using boronophenylalanine-fructose complex in patients with metastatic melanoma.
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Determine the objective local response in patients treated with this regimen.
Secondary
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Determine the overall survival of patients treated with this regimen.
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Determine the duration of local response and time to local progression in patients treated with this regimen.
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Determine the dose-response relationship at the per-lesion level in patients treated with this regimen.
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Determine the safety of this regimen in these patients.
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- Best response to treatment as measured by RECIST every 8 weeks at completion of study treatment []
Secondary Outcome Measures
- 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 []
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Histologically confirmed melanoma
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Metastatic disease
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Brain metastases, skin metastases, or soft tissue metastases of the head and neck or the extremities
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Accessible lesion(s) for boron neutron capture therapy (BNCT)
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No clear progression of disease at other sites than the ones intended for treatment with surgery and/or BNCT
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Measurable disease by MRI within the past 4 weeks
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Lesion(s) ≥ 10 mm in diameter
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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
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Neutrophil count ≥ 2,000/mm^3
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Platelet count ≥ 100,000/mm^3
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Hemoglobin ≥ 10 g/dL
Hepatic
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Bilirubin ≤ 2.5 times upper limit of normal (ULN)*
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Transaminases ≤ 2.5 times ULN*
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Alkaline phosphatase ≤ 2.5 times ULN* NOTE: *Unless due to reversible reaction to antiseizure medication
Renal
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Creatinine ≤ 2.5 times ULN
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Blood urea nitrogen ≤ 2.5 times ULN
Cardiovascular
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No congestive heart failure
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No newly diagnosed or unstable angina pectoris
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No uncontrolled arrhythmias
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No uncontrolled conduction defects
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No recent coronary artery disease
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No other severe heart disease
Pulmonary
- No severe pulmonary disease, including severe obstructive or restrictive lung disease
Other
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No history of phenylketonuria
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No severe gastrointestinal disease
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No active peptic ulcer disease
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No uncontrolled endocrine disease
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No pre-existing serious mental or organic brain disease (e.g., epilepsy)
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No psychological, familial, sociological, or geographical condition that would preclude study compliance
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Able to travel to the Netherlands via public transportation
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Not pregnant or nursing
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Negative pregnancy test
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Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
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No concurrent immunologic or biologic therapy
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No concurrent colony-stimulating factors (e.g., epoetin alfa or filgrastim [G-CSF])
Chemotherapy
- No concurrent chemotherapy
Endocrine therapy
- No concurrent hormonal therapy
Radiotherapy
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No prior radiotherapy to site(s) proposed for study treatment
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No other concurrent radiotherapy
Surgery
- See Disease Characteristics
Other
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Recovered from all prior anti-tumor therapy (excluding alopecia and sensitive peripheral neuropathy ≤ grade 2)
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No other concurrent anticancer therapy
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No other concurrent investigational drugs
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Universitaetsklinikum Essen | Essen | Germany | D-45122 |
Sponsors and Collaborators
- European Organisation for Research and Treatment of Cancer - EORTC
Investigators
- Study Chair: Andrea Wittig, Universitaetsklinikum Essen
Study Documents (Full-Text)
None provided.More Information
Publications
- EORTC-11011
- EORTC-11011