Isolated Limb Perfusion of Melphalan for Melanoma and Sarcoma Treatment
Keywords
Abstract
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 collect data on tumor response and progression free survival after administration of melphalan.
Secondary objectives: To collect data on survival rate, time to progression, morbidity tolerability of treatment, number of treatment required to achieve objective response and improvement of quality of life (Edmonton questionnaire)
Treatment under observation :
Patients undergo fluoroscopic placement of angiographic arterial and venous catheters into the appropriate extremity in order to infuse the drug (artery) and to stop the out flow (venous with balloon catheter). Melphalan 1mg/kgr is rapidly infused into the isolated limb via the arterial catheter after the inflation of venous balloon catheter. Then the circulation of the limb is blocked with a pneumatic cuff at the root of the limb . Patients with little or no response at 8 weeks may receive up to 2 additional treatments at the discretion of the treating physician.
Patients are followed at 1-2 weeks, 3-4 weeks, 6-8 weeks, and then every 3-6 months thereafter as deemed necessary by the treating physician.
Day -1 Melphalan 1mg/ Kgr has been prepared at Pharmacy.
Day 0: prehydration, antibiotic prophylaxis and setting up of a therapeutic scheme appropriate for analgesic prophylaxis (3-day duration) as previously reported (25)
Day +1:
Upon admittance to the radiology room, 1 vial of tropisetron (diluted in 100ml of physiological solution) administered by slow drip.
During infusion of the Melphalan into the artery, 1 vial of morphine hydrochloride diluted in 100 ml i.v. to be repeated one hour after the procedure and if necessary also after 6 hours.
Tropisetron i.v. if needed. Intra-arterial premedication with 1 vial of verapamil diluted in 4 ml of normal saline solution followed by 4 ml of lidocaine.
Intra femoral infusion of Melphalan Second ILI treatment could be repeated at side effects recovery ( following oncologist ' s planning of cure).
Day +30: The above procedure is repeated.
Day +90: In case of response, a third administration following the above procedures will be repeated.
Evaluation of response:
Response must be assessed by repeating the following examinations at Day 30, Day 90 and Day 120 after start of treatment:
Limb-Chest-abdomen CAT scan with and without contrast medium (refer to Section 4). Evaluation will be based on Response Evaluation Criteria in Solid Tumors (RECIST ) criteria [20-24 ] cancer markers (CEA, cancer antigen (CA) 19.9)
Assessment of quality of life The Edmonton Symptom Assessment System (ESAS) is used to monitor health conditions and quality of life.
Assessment of quality of life is performed during the baseline visit and at Day 30, Day 60 and Day 120 from start of treatment.
Dates
| Last Verified: | 01/31/2019 |
| First Submitted: | 08/05/2013 |
| Estimated Enrollment Submitted: | 08/07/2013 |
| First Posted: | 08/11/2013 |
| Last Update Submitted: | 02/25/2019 |
| Last Update Posted: | 02/26/2019 |
| Actual Study Start Date: | 06/30/2013 |
| Estimated Primary Completion Date: | 05/31/2019 |
| Estimated Study Completion Date: | 06/30/2020 |
Condition or disease
Intervention/treatment
Drug: Melphalan
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Melphalan Day +1:
Intra femoral infusion of Melphalan at the dosage 1mg/ Kg
Intra femoral infusion of Melphalan Second ILI treatment can be repeated at side effects recovery ( following oncologist ' s planning of cure).
Day +30: The above procedure is repeated.
Day +90: In case of response, a third administration following the above procedures will be repeated. | Drug: Melphalan Melphalan 1mg/kgr is rapidly infused into the isolated limb via the arterial catheter after the inflation of venous baloon catheter. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Sampling method | Non-Probability Sample |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: 1. Histologically proven primary or recurrent, regional melanoma or soft tissue sarcoma that is not amenable to surgical resection 2. 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 3. Bidimensionally measurable disease in the extremity 4. Patients with disease beyond the limb are eligible if their extremity disease requires palliative treatment in the judgment of their physician 5. Age: more than 18 6. Karnofsky 70-100% 7. Life expectancy: At least 6 months 8. Hematopoietic: WBC at least 3,000/mm^3 9. Renal: Creatinine less than 2.0 mg/dL 10. At least 4 weeks since prior antitumor therapy and recovered 11. At least 2 weeks since prior antibiotics Exclusion Criteria: 1. Signs or symptoms of vascular insufficiency (no history of claudication or other ischemic peripheral vascular disease) 2. pregnant or nursing 3. other concurrent serious illness 4. severe diabetes 5. prior extremity complications due to diabetes |
Outcome
Primary Outcome Measures
1. Tumor response [12 months]
Secondary Outcome Measures
1. survival rate [12 months]
2. time to progression [12 months]
3. number of adverse events [4 months]
