IMMUNOTHERAPY OF MAINTENANCE IN THE PATIENTS WITH METASTATIC MELANOMA, CLINICAL BENEFIT AFTER CHEMOTHERAPY - ND

• Conditions: There is a preclinical and clinical rational that supports a synergic effect of the combination of IL-2, RA and PEG-IFN. Maintenance therapy prolongs time to progression. It is also to note the low cost of the therapy. These considerations warrant a study aimed at assessing whether a long-term treatment with immune therapy offers an advantage in terms of extension of time to progression of patients with metastatic melanoma.; MedDRA version: 12.0Level: LLTClassification code 10027480Term: Metastatic malignant melanoma

• Registration Number: EUCTR2008-006366-29-IT
• Lead Sponsor: ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-24
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Signed written informed consent. Histologic or cytologic diagnosis of metastatic melanoma. Any type of chemotherapy is admitted, but a complete response (CR), partial response (PR), or stable disease (SD) must be observed after chemotherapy, and/or chemo-immunotherapy, and/or immunotherapy. At least one line of therapy for advanced disease. The clinical responses (CR, PR, SD) should be evaluated at the end of the forseen scheduled treatment (chemo- or chemoimmunotherapeutic regimen), after at least 2 cicles. PS (ECOG) <= 2. Age included between 18 and 75 years.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

No metastatic tumors. Woman of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 12 weeks after the study. Women who are pregnant or breastfeeding. Sexually active fertile men who are unwilling or unable to use an acceptable method of birth control, if their sexual partners are WOCBP. Severe autoimmune disease (Lupus, Erithema nodosum, thyroiditis). All the contraindicatrions that exist for IL-2, RA and PEG-IFN administration. Reduced left ventricular ejection fraction (FE < lower limit of institution normality. Corionary artery diseaese with symptoms < 1 year. Concomitant disease of respiratory, renal, metabolic, psychiatric or neurologic that limit compliance with the treatment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate if treatment with low dose Interleukin-2 (IL-2), 13-cis Retinoic Acid (RA) and a pegylated form of alfa-Interferon (PEG-IFN) is able to improve the time to progression of patients with metastatic melanoma that has shown a clinical benefit from the chemotherapy.;Secondary Objective: Overall Survival (OS). Failure Free Survival (FFS) to 4 months, as the cumulative impact of: - Progression; - Death by any cause; - Final interruption of treatment for severe toxicity. Biological evaluation of T-Reg: - Typization of peripheral lymphocytes by cytoflurimetric assay: CD4/25, CD3/16/56, CD8/28/62L, CD8/107A - Cytokines serum levels evaluation: IL-10, IL-8, IL-2, IL-12, IL-4, VEGF, TGF-β, TNF-β, IFN-γ, SIL-2R. - Evaluation of lymphocyte CD4+ CD25+: FoxP3 (Real Time PCR and / or Western Blot), GITR and CTLA-4 (cytofluorometric assay).;Primary end point(s): Progression free survival (PFS)