Evaluation of the Safety and Efficacy of Systemic Chemotherapy Combined With Regional Hypothermia in Advanced Malignant Melanoma Patients With Locally Inoperable Progressive Soft Tissue Metastases
N/A
18 Years
70 Years
18 Years
70 Years
Open (Enrolling)
Both
Advanced Metastastic Malignant Melanoma, Refractory to First-Line Chemotherapy Irresectable Progressive Soft Tissue Metastases
Both
Advanced Metastastic Malignant Melanoma, Refractory to First-Line Chemotherapy Irresectable Progressive Soft Tissue Metastases
Trial Information
Evaluation of the Safety and Efficacy of Systemic Chemotherapy Combined With Regional Hypothermia in Advanced Malignant Melanoma Patients With Locally Inoperable Progressive Soft Tissue Metastases
Inclusion Criteria:
- 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 Criteria:
- 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)
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Jens Atzpodien, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Fachklinik Hornheide an der Universität Münster
Authority:
Germany: Regulatory Authorities, Northrhine-Westfalia
Study ID:
HOT-100
NCT ID:
NCT00264056
Start Date:
December 2005
Completion Date:
June 2007
Related Keywords:
- Advanced Metastastic Malignant Melanoma
- Refractory to First-Line Chemotherapy Irresectable Progressive Soft Tissue Metastases
- malignant melanoma
- hyperthermia
- chemotherapy
- Hypothermia
- Melanoma
- Neoplasm Metastasis
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