Isolated Limb Perfusion of Melphalan for Melanoma and Sarcoma Treatment (ILI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01920516|
Recruitment Status : Unknown
Verified February 2019 by Giammaria Fiorentini, International Group of Endovascular Oncology.
Recruitment status was: Recruiting
First Posted : August 12, 2013
Last Update Posted : February 27, 2019
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 limb. In this circumstance, treatment by isolated limb perfusion or isolated limb infusion can be a remarkably effective regional treatment option. Isolated limb infusion (ILI) was introduced in 1992 and is a technique used to deliver regional chemotherapy to treat advanced melanoma confined to a limb. Regional chemotherapy with melphalan delivered by isolated limb perfusion (ILP) or ILI are effective treatment options for in-transit melanoma and are generally well tolerated.
ILI is a less invasive and simpler alternative to ILP. Complete response rates are 45- 69% for ILP and 23-44% for ILI. The limb is often warmed to lower temperatures in ILI compared to ILP and the limb becomes progressively more hypoxic and acidotic during ILI, each of these parameters potentially having an effect on outcome. ILP & ILI are used primarily as palliative options when excision of in-transit metastases is unfeasible but can be used as an adjunctive procedure to surgery, for other tumour types such as merkel cell carcinoma, and can be repeated if indicated. For ILI correction of melphalan dose for ideal body weight has been shown to substantially decrease the rates of severe local toxicity while maintaining complete response rates, but overall response rate is reduced.
Response to ILI, moreover, is different in upper and lower limbs. ILI for Upper limbs disease is associated with similar complete response rates but lower toxicity than ILI for Lower limbs E disease and with different physiologic sequelae despite comparable methods. The Upper limbs appears relatively resistant to toxic effects of melphalan-based ILI as currently performed, which suggests a potential for further optimization of drug dosing for Upper limbs ILI.
Regional therapy is an excellent therapeutic modality for disease limited to a limb and furthermore serves as an excellent model for scientific investigation, both clinical and translational. In this study we want to collect data on isolated limb infusion of chemotherapy to monitor efficacy and tolerability in patients with melanoma metastases of the arm or leg that cannot be removed by surgery.
|Condition or disease||Intervention/treatment|
|Metastatic Melanoma||Drug: Melphalan|
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Prospective Observational Study on Isolated Limb Perfusion of Melphalan in Treating Patients With Metastasis or Recidivism of Limb Melanoma or Sarcoma That Are Not Operable|
|Study Start Date :||July 2013|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||July 2020|
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.
Melphalan 1mg/kgr is rapidly infused into the isolated limb via the arterial catheter after the inflation of venous baloon catheter.
Other Name: Alkeran
- Tumor response [ Time Frame: 12 months ]
Response must be assessed by repeating the following examinations, at Day 30, Day 90 and Day 120 after start of treatment:
Chest-abdomen CAT scan with and without contrast medium (refer to Section 4). Evaluation will be based on RECIST criteria [18-22 ] cancer markers (CEA, CA 19.9)
- survival rate [ Time Frame: 12 months ]percentage of patients alive
- time to progression [ Time Frame: 12 months ]time from treatment start to progression
- number of adverse events [ Time Frame: 4 months ]number of adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920516
|Contact: Donatella Sarti, PhD||+39072136 ext firstname.lastname@example.org|
|Azienda Ospedaliera Ospedali Riuniti Marche Nord, Presidio Ospedaliero San Salvatore||Recruiting|
|Pesaro, PU, Italy, 61122|
|Contact: Giammaria Fiorentini, MD +39072136 ext 4124 email@example.com|
|Principal Investigator: Giammaria Fiorentini, MD|
|Principal Investigator:||Giammaria Fiorentini, MD||International Group of Endovascular Oncology|