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

Study Overview
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Brief Summary
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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.

Official Title
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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

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

Intervention / Treatment
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* Device: hyperthermia


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: hyperthermia|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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malignant melanoma, hyperthermia, chemotherapy