metastatic melanoma BLS+ and BRAF wt MedDRA version: 16.1 Level: PT Classification code 10025670 Term: Malignant melanoma stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Nexium
Product Name: Esomeprazole
Product Code: 034972416/M(40mg)
Pharmaceutical Form: Pastille
INN or Proposed INN: Esomeprazole
CAS Number: 217087-09-7
Other descriptive name: ESOMEPRAZ
Sponsors
Fondazione IRCCS ''IStituto Nazionale dei Tumori''
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age > 18 years; diagnosis of cutaneous melanoma and sentinel node biopsy (SNB) positive for melanoma metastasis; lack of BRAF mutation in melanoma lesions (primary melanoma or SNB); lack of valid adjuvant therapy; performance status of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG); obtainment of a written informed consent prior to any protocol-specific procedure 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Diagnosis of any other tumor within the last 2 years with the exception of basocellular and adequately treated in situ cervical carcinoma; major surgery within 28 days before enrolment in the study; Pregnancy or breast feeding for female patients; severe and documented liver, renal and lung dysfunctions; Evidence of hemorrhagic diatheses and coagulopathy; uncontrolled blood hypertension; Diagnosed epileptic, neurologic or psychiatric disease that might compromised the ability of patients to provide the written informed consent; Severe infection requiring e.v. therapy with antibiotics or under treatment tybercolosis; uncontrolled diabetes or other chronic diseases that might affect patient compliance; known history of immunodeficiencies treatment with drugs whose metabolism is known to be affected by PPI therapy, such as diazepam (Valium, Diastat), ketoconazolo (Nizoral), digossina (Lanoxin), cilostazolo (Pletal), clopidogrel (Plavix) and anti-viral therapy such as saquinar (Invirase, Fortovase), nelfinavir (Viracept) and atazanavir (Reyataz).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the effect of immunomodulatory and anti-tumor effect of treatment with high doses of esomeprazole in patients with metastatic melanoma;Secondary Objective: not applicable;Primary end point(s): 1. Study of changes in the immune profile induced by treatment with PPI in the tumor-draining LN 2. Analysis of the effect of treatment with PPI systemic immunity 3. Analysis of the antitumor activity of PPI in metastatic LN;Timepoint(s) of evaluation of this end point: 1. 1 month 2. 1,2 visit 3. 1 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Assessment of disease-free survival. 2. Anlisi out expression profiling of gene expression in LN obtained from patients treated with PPI vs control;Timepoint(s) of evaluation of this end point: 1. every month 2. 1 month | — |
Countries
Italy
Contacts
Public ContactSegreteria Tecnico Scientifica
Fondazione IRCCS ''IStituto Nazionale dei Tumori''
Outcome results
None listed