Suspended

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

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What is being tested

Data Collection

Who is being recruted

Melanoma
+8

+ Neoplasms
+ Neoplasms by Histologic Type
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: April 2004
See protocol details

Summary

Principal SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2004Actual date on which the first participant was enrolled.

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 TitleEarly Phase II Study On BNCT In Metastatic Malignant Melanoma Using The Boron Carrier BPA 
NCT00085059
Principal SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
4 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Skin Diseases
Skin Neoplasms
Neuroectodermal Tumors
Nevi and Melanomas
Neuroendocrine Tumors
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


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Secondary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Universitaetsklinikum EssenEssen, GermanySee the location

SuspendedOne Study Center
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