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Sponsored by: |
Fachklinik Hornheide an der Universität Münster |
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Information provided by: | Fachklinik Hornheide an der Universität Münster |
ClinicalTrials.gov Identifier: | NCT00264056 |
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 |
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Advanced Metastastic Malignant Melanoma Refractory to First-Line Chemotherapy Irresectable Progressive Soft Tissue Metastases |
Device: hyperthermia |
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 |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | Jens Atzpodien, MD, PhD | Fachklinik Hornheide an der Universität Münster |
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 |
malignant melanoma hyperthermia chemotherapy |
Fever Neuroectodermal Tumors Signs and Symptoms Hypothermia Nevus, Pigmented Neoplasms, Germ Cell and Embryonal |
Neoplasm Metastasis Neuroepithelioma Nevus Neuroendocrine Tumors Melanoma |
Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Histologic Type |
Neoplasms, Nerve Tissue Nevi and Melanomas Body Temperature Changes |