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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


N/A
18 Years
70 Years
Open (Enrolling)
Both
Advanced Metastastic Malignant Melanoma, Refractory to First-Line Chemotherapy Irresectable Progressive Soft Tissue Metastases

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Trial Information

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


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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Jens Atzpodien, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fachklinik Hornheide an der Universit√§t M√ľnster

Authority:

Germany: Regulatory Authorities, Northrhine-Westfalia

Study ID:

HOT-100

NCT ID:

NCT00264056

Start Date:

December 2005

Completion Date:

June 2007

Related Keywords:

  • Advanced Metastastic Malignant Melanoma
  • Refractory to First-Line Chemotherapy Irresectable Progressive Soft Tissue Metastases
  • malignant melanoma
  • hyperthermia
  • chemotherapy
  • Hypothermia
  • Melanoma
  • Neoplasm Metastasis

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