Boron Neutron Capture Therapy Using Boronophenylalanine-Fructose Complex in Treating Patients With Metastatic Melanoma
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Early Phase II Study On BNCT In Metastatic Malignant Melanoma Using The Boron Carrier BPA|
- Best response to treatment as measured by RECIST every 8 weeks at completion of study treatment
- Overall survival as measured every 8 weeks at completion of study treatment
- Duration of local response as measured by Kaplan Meier every 8 weeks after completion of study treatment
- Time to local progression measured every 8 weeks after completion of study treatment
- Acute toxicity as measured by Common Toxicity Criteria AE v 3.0 1- 6 weeks after completion of treatment
- Late toxicity as measured by RTOG and EORTC week 6 and thereafter upon completion of study treatment
|Study Start Date:||April 2004|
|Primary Completion Date:||October 2006 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00085059
|Essen, Germany, D-45122|
|Study Chair:||Andrea Wittig||Universitaetsklinikum Essen|