Efficacy of Chemotherapy Combined With Regional Hypothermia in Advanced Malignant Melanoma Patients With Progressive Soft Tissue Metastases
|ClinicalTrials.gov Identifier: NCT00264056|
Recruitment Status : Unknown
Verified November 2005 by Fachklinik Hornheide an der Universität Münster.
Recruitment status was: Recruiting
First Posted : December 12, 2005
Last Update Posted : December 12, 2005
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|
|Advanced Metastastic Malignant Melanoma Refractory to First-Line Chemotherapy Irresectable Progressive Soft Tissue Metastases||Device: hyperthermia|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||December 2005|
|Estimated Study Completion Date :||June 2007|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00264056
|Fachklinik Hornheide at the University of Münster, Germany||Recruiting|
|Münster, Germany, D-48157|
|Contact: Jens Atzpodien, MD PhD 49-251-3287-431 firstname.lastname@example.org|
|Sub-Investigator: Martina Reitz, Dr|
|Principal Investigator:||Jens Atzpodien, MD, PhD||Fachklinik Hornheide an der Universität Münster|