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

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

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00085059
Enrollment
4
Registered
2004-06-11
Start date
2004-04-30
Completion date
Unknown
Last updated
2012-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma (Skin)

Keywords

stage IV melanoma, recurrent melanoma

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.

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.

Interventions

Sponsors

European Organisation for Research and Treatment of Cancer - EORTC
Lead SponsorNETWORK

Study design

Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Best response to treatment as measured by RECIST every 8 weeks at completion of study treatment

Secondary

MeasureTime 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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026