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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2005 by Fachklinik Hornheide an der Universität Münster.
Recruitment status was  Recruiting
Information provided by:
Fachklinik Hornheide an der Universität Münster
ClinicalTrials.gov Identifier:
First received: December 8, 2005
Last updated: NA
Last verified: November 2005
History: No changes posted

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

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

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

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00264056

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
Principal Investigator: Jens Atzpodien, MD, PhD Fachklinik Hornheide an der Universität Münster
  More Information

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

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

Additional relevant MeSH terms:
Neoplasm Metastasis
Body Temperature Changes
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neoplastic Processes
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on May 26, 2016