Boron Neutron Capture Therapy Using Boronophenylalanine-Fructose Complex in Treating Patients With Metastatic Melanoma
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|ClinicalTrials.gov Identifier: NCT00085059|
Recruitment Status : Terminated (low accrual)
First Posted : June 11, 2004
Last Update Posted : July 18, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Drug: boronophenylalanine-fructose complex||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Masking:||None (Open Label)|
|Official Title:||Early Phase II Study On BNCT In Metastatic Malignant Melanoma Using The Boron Carrier BPA|
|Study Start Date :||April 2004|
|Actual Primary Completion Date :||October 2006|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00085059
|Essen, Germany, D-45122|
|Study Chair:||Andrea Wittig||Universitaetsklinikum Essen|