Status:
UNKNOWN
Isolated Limb Perfusion of Melphalan for Melanoma and Sarcoma Treatment
Lead Sponsor:
International Group of Endovascular Oncology
Conditions:
Metastatic Melanoma
Eligibility:
All Genders
18+ years
Brief Summary
In-transit metastases occur in approximately 3% of melanoma patients, can be very symptomatic and the survival in this group may be prolonged. In-transit melanoma metastases are often confined to a li...
Detailed Description
This is an observational study and the treatment is related to the experiences and economical availability of each center. Study Design: Prospective observational study . Primary objective: To collec...
Eligibility Criteria
Inclusion
- Histologically proven primary or recurrent, regional melanoma or soft tissue sarcoma that is not amenable to surgical resection
- Majority (greater than 95%) of disease must be distal to the apex of the femoral triangle in the lower limb and the deltoid insertion in the upper limb
- Bidimensionally measurable disease in the extremity
- Patients with disease beyond the limb are eligible if their extremity disease requires palliative treatment in the judgment of their physician
- Age: more than 18
- Karnofsky 70-100%
- Life expectancy: At least 6 months
- Hematopoietic: WBC at least 3,000/mm\^3
- Renal: Creatinine less than 2.0 mg/dL
- At least 4 weeks since prior antitumor therapy and recovered
- At least 2 weeks since prior antibiotics
Exclusion
- Signs or symptoms of vascular insufficiency (no history of claudication or other ischemic peripheral vascular disease)
- pregnant or nursing
- other concurrent serious illness
- severe diabetes
- prior extremity complications due to diabetes
Key Trial Info
Start Date :
July 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01920516
Start Date
July 1 2013
End Date
July 1 2020
Last Update
February 27 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Azienda Ospedaliera Ospedali Riuniti Marche Nord, Presidio Ospedaliero San Salvatore
Pesaro, PU, Italy, 61122