Metastatic Cutaneous and Subcutaneous Melanoma MedDRA version: 15.0 Level: LLT Classification code 10027481 Term: Metastatic melanoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Pharmaceutical Form: Orodispersible tablet
INN or Proposed INN: LANSOPRAZOLE
CAS Number: 103577-45-3
Current Sponsor code: LANS
Concentration unit: mg/g milligram(s)/gram
Concentration type: up to
Con
Sponsors
ISTITUTO NAZIONALE PER LA CURA TUMORI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with metastatic melanoma IIIC / IV M1a meeting the following inclusion criteria will be eligible for the study. 1. Age> 18 2. Melanoma skin histo-and / or cytologically confirmed. 3. Non- Ocular melanoma in advanced stage IIIC / IV M1 with the presence of multiple measurable cutaneous and/or subcutaneous lesions, suitable for biopsy, and for the application of electrodes; 4. Number of lesions equal to or greater than six with a minimum size of the lesions of 0.5 cm. 5. Performance status 0-2 (ECOG). 6. Life expectancy ? 3 months. 7. Locations of measurable and / or assessed metastases according to RECIST criteria confirmed by imaging. However, the evaluation of the lesions may be carried out using the clinical examination with digital photography and / or by ultrasound. 8. A previous chemo-and/or immune/bio-chemotherapy and/or vaccination are allowed (however, a washout period of at least 4 weeks is required). 9. Normal blood count (neutrophils > 1500/µL and platelet count> 130,000/mL), liver function (ALT, AST and alkaline phosphatase =2.5 x upper of normal limits [UNL], and total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 13
Exclusion criteria
Exclusion criteria: 1. Previous cancers diagnosed within the last 2 years, with the exception of treated basal cell carcinomas or carcinomas in situ of the cervix treated properly. 2. Recent major surgery (within 28 days before the start of study treatment). 3. Previous treatment with bleomycin at maximum dosage, and different cancer therapies administered within 4 weeks prior to ECT. 4. Pregnancy and lactation. Post-menopausal women should be with amenorrhea for at least 12 months. 5. Serious diseases of the liver or lung. 6. Short life expectancy (<3 months) in relation to the evolutionary picture of the disease. 7. Evidence of bleeding diathesis or coagulopathy. 8. Uncontrolled hypertension; 9. Congestive heart failure (NYHA grade ? 2), previous myocardial infarction or cerebrovascular events within 6 months, pulmonary hypertension, unstable angina, cardiac arrhythmia not adequately controlled by medical treatment which cause decisive alteration in severe cardiac hemodynamics requiring specific treatment; 10. Presence of epilepsy or history of significant neurological or psychiatric illness that would compromise the understanding and giving informed consent; 11. Chronic renal failure 12. Infection that requires intravenous antibiotic therapy and tuberculosis treatment upon entering the trial; 13. Active peptic ulcer, unstable diabetes mellitus and other uncontrolled significant diseases, at the investigator discretion. 14. A positive HIV test. 15. Significant alterations of complete blood count (CBC) and / or of the of hepatic/renal function indices (mentioned above).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. Significant increase in the systemic anti-tumor immune response (evaluated as IFN gamma Elispost in response to autologous melanoma cells or HLA-compatible antigenic peptides and phenotypic profile leukocyte, including of immunosoppressorie subpopulations immunosoppressorie as Treg and MDSC) in the arms of combination ECT IL2 and ECT LANS, compared to ECT as a single treatment; 2. Increase of pathological tumor response and of the anti-tumor immune infiltrate T, possibly associated with a decrease of negative regulatory cells (Treg and MDSC) in ECT treated lesions, in the arms of combination ECT IL2 and ECT LANS, compared to ECT as a single treatment;Secondary Objective: 1. Improvement of clinical response (assessed as % regression and TTR or TTP) in the arms of combination ECT IL2 and ECT LANS, compared to ECT as a single treatment; 2. Achievement of clinical response in untreated lesions, as a sign of systemic acquired effecacy in the arms of combination ECT IL2 and ECT LANS, compared to ECT as a single treatment, assessed clinically or pathologically; 3. Reduction of frequency and / or activity of negative regulation immune cells to, as MDSC and Treg in the peripheral blood of patients enrolled in the arms of combination ECT IL2 and ECT LANS, compared to ECT as a single treatment;Primary end point(s): 1. Significant increase in the systemic anti-tumor immune response (evaluated as IFN gamma Elispost in response to autologous melanoma cells or HLA-compatible antigenic peptides and phenotypic profile leukocyte, including of immunosoppressorie subpopulations immunosoppressorie as Treg and MDSC) in the arms of combination ECT IL2 and ECT LANS, compared to ECT as a single treatment; 2. Increase of pathological tumor response and of the anti-tumor immune infiltrate T, possibly associated with a decrease of negative regulatory cells (Treg and MDSC) in ECT treated lesions, in the arms of combination ECT IL2 and ECT LANS, compared to ECT as a single tr | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Improvement of clinical response (assessed as % regression and TTR or TTP) in the arms of combination ECT IL2 and ECT LANS, compared to ECT as a single treatment; 2. Achievement of clinical response in untreated lesions, as a sign of systemic acquired effecacy in the arms of combination ECT IL2 and ECT LANS, compared to ECT as a single treatment, assessed clinically or pathologically; 3. Reduction of frequency and / or activity of negative regulation immune cells to, as MDSC and Treg in the peripheral blood of patients enrolled in the arms of combination ECT IL2 and ECT LANS, compared to ECT as a single treatment;Timepoint(s) of evaluation of this end point: The metabolic response in all patients will be assessed by performing the PET scan at baseline and 3 months after treatment in each of three treatment arms. | — |
Countries
Italy
Contacts
Public ContactCHIRURGIA GENERALE 4 CMS
FONDAZIONE IRCCS ISTITUTO NAZIONALE DEI TUMORI
Outcome results
None listed