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

Fachklinik Hornheide an der Universität Münster

Status: Unknown

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

Treatments: Device: hyperthermia

Study type: Interventional

Funder types: Other

Identifiers

NCT00264056

HOT-100

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)