Efficacy of Chemotherapy Combined With Regional Hypothermia in Advanced Malignant Melanoma Patients With Progressive Soft Tissue Metastases

Not Applicable

• Conditions: Advanced Metastastic Malignant Melanoma; Refractory to First-Line Chemotherapy Irresectable Progressive Soft Tissue Metastases

• Registration Number: NCT00264056
• Lead Sponsor: Fachklinik Hornheide an der Universität Münster

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 aggressive since it may spread both through the lymphatic system and the bloodstream at an early stage of disease.

While treatment of localized disease is mostly surgical, in patients with extensive disease, prognosis remains poor; the primary standard therapy of metastastic disease comprises dacarbazine (DTIC) eventually combined with other chemotherapeutic agents e.g., cisplatin or BCNU. The duration of response to systemic chemotherapy is generally short and so far, no standard second-line treatment has been established.

To study the potential additional therapeutic effects of regional hyperthermia in advanced malignant melanoma patients with progressive chemotherapy refractory soft tissue metastases, in the present trial, we sought to compine local hyperthermia with concomitant systemic second-line chemotherapy.

Detailed Description

Not available

Study Timeline

• Status Verified: 2005-11
• Study Start: 2005-12
• Study First Submitted: 2005-12-08
• Study First Submitted QC: 2005-12-08
• Last Update Submitted: 2005-12-08
• Study First Posted: 2005-12-12
• Last Update Posted: 2005-12-12
• Study Completion: 2007-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 26

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (1)

Fachklinik Hornheide at the University of Münster, Germany; 🇩🇪 Münster, Germany