Trials / Terminated
TerminatedNCT00085059
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
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 4 (actual)
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC · Network
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | boronophenylalanine-fructose complex |
Timeline
- Start date
- 2004-04-01
- Primary completion
- 2006-10-01
- First posted
- 2004-06-11
- Last updated
- 2012-07-18
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT00085059. Inclusion in this directory is not an endorsement.