Boron Neutron Capture Therapy Using Boronophenylalanine-Fructose Complex in Treating Patients With Metastatic Melanoma

Phase 2

Terminated

• Conditions: Melanoma (Skin)

• Registration Number: NCT00085059
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

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 Timeline

• Study Start: 2004-04
• Study First Submitted: 2004-06-10
• Study First Submitted QC: 2004-06-10
• Study First Posted: 2004-06-11
• Primary Completion: 2006-10
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-17
• Last Update Posted: 2012-07-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Best response to treatment as measured by RECIST every 8 weeks at completion of study treatment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Universitaetsklinikum Essen; 🇩🇪 Essen, Germany