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Isolated Limb Perfusion of Melphalan for Melanoma and Sarcoma Treatment (ILI)

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ClinicalTrials.gov Identifier: NCT01920516
Recruitment Status : Recruiting
First Posted : August 12, 2013
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Giammaria Fiorentini, International Group of Endovascular Oncology

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 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

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
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


Group/Cohort 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.
Other Name: Alkeran




Primary Outcome Measures :
  1. 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)



Secondary Outcome Measures :
  1. survival rate [ Time Frame: 12 months ]
    percentage of patients alive

  2. time to progression [ Time Frame: 12 months ]
    time from treatment start to progression

  3. number of adverse events [ Time Frame: 4 months ]
    number of adverse events



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic
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

Information from the National Library of Medicine

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


Contacts
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Contact: Donatella Sarti, PhD +39072136 ext 4018 igevo.datamanager@libero.it

Locations
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Italy
Azienda Ospedaliera Ospedali Riuniti Marche Nord, Presidio Ospedaliero San Salvatore Recruiting
Pesaro, PU, Italy, 61122
Contact: Giammaria Fiorentini, MD    +39072136 ext 4124    giammaria.fiorentini@ospedalimarchenord.it   
Principal Investigator: Giammaria Fiorentini, MD         
Sponsors and Collaborators
International Group of Endovascular Oncology
Investigators
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Principal Investigator: Giammaria Fiorentini, MD International Group of Endovascular Oncology

Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Giammaria Fiorentini, Dr., International Group of Endovascular Oncology
ClinicalTrials.gov Identifier: NCT01920516     History of Changes
Other Study ID Numbers: ILI01
ILI100513 ( Other Identifier: IGEVO )
First Posted: August 12, 2013    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019

Keywords provided by Giammaria Fiorentini, International Group of Endovascular Oncology:
Isolated limb infusion
Melphalan
Limb Melanoma
Tumor response

Additional relevant MeSH terms:
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Melanoma
Sarcoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms, Connective and Soft Tissue
Melphalan
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs