Clinical trial · Interventional
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
NCT00085059CI-TRIAL-00007471terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| boronophenylalanine-fructose complex | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Best response to treatment as measured by RECIST every 8 weeks at completion of study treatment
Secondary outcomes (5)
- measure
- Overall survival as measured every 8 weeks at completion of study treatment
- measure
- Duration of local response as measured by Kaplan Meier every 8 weeks after completion of study treatment
- measure
- Time to local progression measured every 8 weeks after completion of study treatment
- measure
- Acute toxicity as measured by Common Toxicity Criteria AE v 3.0 1- 6 weeks after completion of treatment
- measure
- Late toxicity as measured by RTOG and EORTC week 6 and thereafter upon completion of study treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 drugsReferences
Publications (1)
- BACKGROUNDWittig A, Moss RL, Stecher-Rasmussen F, Appelman K, Rassow J, Roca A, Sauerwein W. Neutron activation of patients following boron neutron capture therapy of brain tumors at the high flux reactor (HFR) Petten (EORTC Trials 11961 and 11011). Strahlenther Onkol. 2005 Dec;181(12):774-82. doi: 10.1007/s00066-005-1433-4. PMID 16362787