Status:
UNKNOWN
Efficacy of Chemotherapy Combined With Regional Hypothermia in Advanced Malignant Melanoma Patients With Progressive Soft Tissue Metastases
Lead Sponsor:
Fachklinik Hornheide an der Universität Münster
Conditions:
Advanced Metastastic Malignant Melanoma
Refractory to First-Line Chemotherapy Irresectable Progressive Soft Tissue Metastases
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The incidence of malignant melanoma continues to rise throughout the world. Approximately 12 in 100,000 Germans are diagnosed with malignant melanoma per year. Malignant melanoma is often very aggress...
Eligibility Criteria
Inclusion
- age between 18 and 70
- histologically proven malignant melanoma with advanced inoperable soft tissue metastases
- progressive disease upon systemic first-line chemotherapy
- 2 or more bidimensionally measurable soft tisue lesions
- WHO performance status (ECOG) of 2 or more
- life expectancy of 8 weeks and more
- prior informed consent
Exclusion
- participation in other therapy studies
- pregnancy or breast feeding
- concomitant clinically significant infection
- cardiac pacemaker or other medical implants, or implants within the hyperthermia treated region (including a safe distance of 5 cm)
- lack of physiological heat sensitivity within the hyperthermia treated region (including a safe distance of 5 cm)
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
End Date :
June 1 2007
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00264056
Start Date
December 1 2005
End Date
June 1 2007
Last Update
December 12 2005
Active Locations (1)
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1
Fachklinik Hornheide at the University of Münster, Germany
Münster, Germany, D-48157