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

December 8, 2005 updated by: Fachklinik Hornheide an der Universität Münster

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Münster, Germany, D-48157
        • Recruiting
        • Fachklinik Hornheide at the University of Münster, Germany
        • Contact:
        • Sub-Investigator:
          • Martina Reitz, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fachklinik Hornheide an der Universität Münster

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Study Completion

June 1, 2007

Study Registration Dates

First Submitted

December 8, 2005

First Submitted That Met QC Criteria

December 8, 2005

First Posted (ESTIMATE)

December 12, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

December 12, 2005

Last Update Submitted That Met QC Criteria

December 8, 2005

Last Verified

November 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOT-100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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