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Efficacy of Chemotherapy Combined With Regional Hypothermia in Advanced Malignant Melanoma Patients With Progressive Soft Tissue Metastases
This study is currently recruiting participants.
Verified by Fachklinik Hornheide an der Universität Münster, November 2005
Sponsored by: Fachklinik Hornheide an der Universität Münster
Information provided by: Fachklinik Hornheide an der Universität Münster
ClinicalTrials.gov Identifier: NCT00264056
  Purpose

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 Intervention
Advanced Metastastic Malignant Melanoma
Refractory to First-Line Chemotherapy Irresectable Progressive Soft Tissue Metastases
Device: hyperthermia

MedlinePlus related topics: Fever Hypothermia Melanoma
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Fachklinik Hornheide an der Universität Münster:

Estimated Enrollment: 26
Study Start Date: December 2005
Estimated Study Completion Date: June 2007
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00264056

Locations
Germany
Fachklinik Hornheide at the University of Münster, Germany Recruiting
MÜNSTER, Germany, D-48157
Contact: Jens Atzpodien, MD PhD     49-251-3287-431     jens.atzpodien@fachklinik-hornheide.de    
Sub-Investigator: Martina Reitz, Dr            
Sponsors and Collaborators
Fachklinik Hornheide an der Universität Münster
Investigators
Principal Investigator: Jens Atzpodien, MD, PhD Fachklinik Hornheide an der Universität Münster
  More Information

Study ID Numbers: HOT-100
Study First Received: December 8, 2005
Last Updated: December 8, 2005
ClinicalTrials.gov Identifier: NCT00264056  
Health Authority: Germany: Regulatory Authorities, Northrhine-Westfalia

Keywords provided by Fachklinik Hornheide an der Universität Münster:
malignant melanoma
hyperthermia
chemotherapy

Study placed in the following topic categories:
Fever
Neuroectodermal Tumors
Signs and Symptoms
Hypothermia
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neoplasm Metastasis
Neuroepithelioma
Nevus
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Body Temperature Changes

ClinicalTrials.gov processed this record on January 16, 2009