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

Sponsor

Fachklinik Hornheide an der Universität Münster (Other)

Overall Status

Unknown status

CT.gov ID

NCT00264056

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Metastastic Malignant Melanoma Refractory to First-Line Chemotherapy Irresectable Progressive Soft Tissue Metastases	Device: hyperthermia	N/A

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2005

Study Completion Date :

Jun 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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)