Advanced Metastastic Malignant Melanoma Clinical Trial
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
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.
| Status | Recruiting |
| Enrollment | 26 |
| Est. completion date | June 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
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) |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | Fachklinik Hornheide at the University of Münster, Germany | Münster |
| Lead Sponsor | Collaborator |
|---|---|
| Fachklinik Hornheide an der Universität Münster |
Germany,