Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2025-12-25 @ 8:55 PM
Study NCT ID:
NCT00264056
Status:
UNKNOWN
Last Update Posted:
2005-12-12
First Post:
2005-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Chemotherapy Combined With Regional Hypothermia in Advanced Malignant Melanoma Patients With Progressive Soft Tissue Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D000084462', 'term': 'Hyperthermia'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D018882', 'term': 'Heat Stress Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003972', 'term': 'Diathermy'}], 'ancestors': [{'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 26}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-11', 'completionDateStruct': {'date': '2007-06'}, 'lastUpdateSubmitDate': '2005-12-08', 'studyFirstSubmitDate': '2005-12-08', 'studyFirstSubmitQcDate': '2005-12-08', 'lastUpdatePostDateStruct': {'date': '2005-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-12', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['malignant melanoma', 'hyperthermia', 'chemotherapy'], 'conditions': ['Advanced Metastastic Malignant Melanoma', 'Refractory to First-Line Chemotherapy Irresectable Progressive Soft Tissue Metastases']}, 'descriptionModule': {'briefSummary': '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.\n\nWhile 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.\n\nTo 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 18 and 70\n* histologically proven malignant melanoma with advanced inoperable soft tissue metastases\n* progressive disease upon systemic first-line chemotherapy\n* 2 or more bidimensionally measurable soft tisue lesions\n* WHO performance status (ECOG) of 2 or more\n* life expectancy of 8 weeks and more\n* prior informed consent\n\nExclusion Criteria:\n\n* participation in other therapy studies\n* pregnancy or breast feeding\n* concomitant clinically significant infection\n* cardiac pacemaker or other medical implants, or implants within the hyperthermia treated region (including a safe distance of 5 cm)\n* lack of physiological heat sensitivity within the hyperthermia treated region (including a safe distance of 5 cm)'}, 'identificationModule': {'nctId': 'NCT00264056', 'briefTitle': 'Efficacy of Chemotherapy Combined With Regional Hypothermia in Advanced Malignant Melanoma Patients With Progressive Soft Tissue Metastases', 'organization': {'class': 'OTHER', 'fullName': 'Fachklinik Hornheide an der Universität Münster'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'HOT-100'}}, 'armsInterventionsModule': {'interventions': [{'name': 'hyperthermia', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-48157', 'city': 'Münster', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jens Atzpodien, MD PhD', 'role': 'CONTACT', 'email': 'jens.atzpodien@fachklinik-hornheide.de', 'phone': '49-251-3287-431'}, {'name': 'Martina Reitz, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Fachklinik Hornheide at the University of Münster, Germany', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}], 'overallOfficials': [{'name': 'Jens Atzpodien, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fachklinik Hornheide an der Universität Münster'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fachklinik Hornheide an der Universität Münster', 'class': 'OTHER'}}}}