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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00264056

Enrollment

Registered

2005-12-12

Start date

2005-12-31

Completion date

2007-06-30

Last updated

2005-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

malignant melanoma, hyperthermia, chemotherapy

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.

Interventions

DEVICEhyperthermia

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026