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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. The completion date has passed and the status has not been verified in more than two years.
Verified November 2005 by Fachklinik Hornheide an der Universität Münster.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00264056
First Posted: December 12, 2005
Last Update Posted: December 12, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Fachklinik Hornheide an der Universität Münster
  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

Study Type: Interventional
Study Design: 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

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00264056     History of Changes
Other Study ID Numbers: HOT-100
First Submitted: December 8, 2005
First Posted: December 12, 2005
Last Update Posted: December 12, 2005
Last Verified: November 2005

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

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