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

NCT00264056 | Unknown

• 1 other identifier: HOT-100
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Metastastic Malignant Melanoma; Refractory to First-Line Chemotherapy Irresectable Progressive Soft Tissue Metastases

Keywords

malignant melanoma; hyperthermia; chemotherapy

Interventions

hyperthermia DEVICE

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 18 and 70
• histologically proven malignant melanoma with advanced inoperable soft tissue metastases
• progressive disease upon systemic first-line chemotherapy
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fachklinik Hornheide an der Universität Münster: lead

Study Sites (1)

Fachklinik Hornheide at the University of Münster, Germany

Münster, D-48157, Germany

RECRUITING

MeSH Terms

Conditions

Melanoma; Hyperthermia

Interventions

Diathermy

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Hyperthermia, Induced; Therapeutics

Study Officials

• Jens Atzpodien, MD, PhD

  Fachklinik Hornheide an der Universität Münster

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 8, 2005
• First Posted: December 12, 2005
• Study Start: December 1, 2005
• Study Completion: June 1, 2007
• Last Updated: December 12, 2005

Record last verified: 2005-11

Locations

DE (1)