Advanced Metastastic Malignant MelanomaNCT00264056
Efficacy of Chemotherapy Combined With Regional Hypothermia in Advanced Malignant Melanoma Patients With Progressive Soft Tissue Metastases
A study testing hyperthermia in people with Advanced Metastastic Malignant Melanoma and Refractory to First-Line Chemotherapy Irresectable Progressive Soft Tissue Metastases, run by Fachklinik Hornheide an der Universität Münster at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Metastastic Malignant Melanoma, Refractory to First-Line Chemotherapy Irresectable Progressive Soft Tissue Metastases
- What is being tested?
- hyperthermia
- Type of treatment
- Medical device
- How many people
- 26 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2005to Jun 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Fachklinik Hornheide at the University of Münster, Germany
Münster, D-48157
Jens Atzpodien, MD PhD, 49-251-3287-431, jens.atzpodien@fachklinik-hornheide.de
Martina Reitz, Dr
About this 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
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
- Being tested
- hyperthermia
- Keywords
- malignant melanoma, hyperthermia, chemotherapy
- Medical subject headings
- Melanoma, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyperthermiaDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2005 (estimated)
- Study startDec 2005
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Metastastic Malignant MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants
Sponsor and investigators
- Lead sponsor
- Fachklinik Hornheide an der Universität Münster
- Sponsor type
- University, hospital or other
- Investigators
- Jens Atzpodien, MD, PhD, Principal investigator, Fachklinik Hornheide an der Universität Münster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00264056
- Sponsor's protocol ID
- HOT-100
- Status last verified
- Nov 2005
- First submitted
- 8 Dec 2005
- Last updated
- 12 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00264056
- Acronym / sponsor ID
- HOT-100
- Conditions
- Advanced Metastastic Malignant Melanoma, Refractory to First-Line Chemotherapy Irresectable Progressive Soft Tissue Metastases
- Keywords
- malignant melanoma, hyperthermia, chemotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants
- Lead sponsor
- Fachklinik Hornheide an der Universität MünsterUniversity, hospital or other
- Study start
- Dec 2005
- Study completion
- Jun 2007
- First posted
- 12 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hyperthermia | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2005.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fachklinik Hornheide at the University of Münster, Germany
Münster, Germany
Jens Atzpodien, MD, PhD principal investigator
Fachklinik Hornheide an der Universität Münster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hyperthermia in people with Advanced Metastastic Malignant Melanoma and Refractory to First-Line Chemotherapy Irresectable Progressive Soft Tissue Metastases, run by Fachklinik Hornheide an der Universität Münster at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2005.