Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2025-12-24 @ 2:58 PM
NCT ID:
NCT00085059
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.
Study:
NCT00085059
Study Brief:
Protocol Section:
NCT00085059