Clinical trial · Interventional
Boron Neutron Capture Therapy in Treating Patients With Melanoma
A Phase II Trial For Neutron Capture Therapy In Melanoma
NCT00059800CI-TRIAL-00011091completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Boron neutron capture therapy may selectively kill tumor cells without harming normal tissue. PURPOSE: Phase II trial to study the effectiveness of boron neutron capture therapy in treating patients who have 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 |
|---|---|---|---|
| boron neutron capture therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Clinical response
- measure
- Time course, uniformity, and severity of acute dermal reactions
- measure
- Late dermal reaction after at least six months
- measure
- Pharmacokinetics
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed melanoma * Evaluable disease * Lesion(s) to be irradiated must be located in 1 of the following areas: * On an extremity * On the head or neck (including the scalp) * In the subdermal lymphatics (excluding the proximal axilla) * Area to be irradiated must not exceed a maximum dimension of 10 cm * Maximum tumor depth from the surface of the skin cannot exceed 6 cm PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * More than 6 months Hematopoietic * Not specified Hepatic * Not specified Renal * Creatinine normal Cardiovascular * No history of severe cardiac disease * No uncontrolled arrhythmias or conduction defects * No unstable or newly diagnosed angina pectoris * No recent coronary artery disease * No congestive heart failure Other * Not pregnant * Negative pregnancy test * No history of phenylketonuria * Must have sufficient mental competence PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy to study sites Surgery * Not specified
References
Publications (0)
Data not yet available
No reference posted for this study.