Patient with metastatic melanoma (stage IV) MedDRA version: 6.1 Level: PT Classification code 10025671
Conditions
Interventions
Trade Name: CISPLATINO TEVA
Product Name: cisplatino
Pharmaceutical Form: Emulsion for infusion
INN or Proposed INN: cis-diamminocloroplatino
CAS Number: 15663-27-1
Concentration unit: mg milligram(s)
Sponsors
ISTITUTO SUPERIORE DI SANITA'
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. age >18 and 1500/microlitres and platelet count >30.000 microlitres, liver functionality (ALT, AST levels and Alkaline phosphatase less or equal to 2.5x upper normal limits, creatinemia within normal range, and particulary cratinin clearance >50 mL/min or creatinemia lesso or equal to 1.5x UNL) 9. Informed Consent written according to Local ethical Committee requests 10. Patient accessibility to treatment and follow-up 11. Complete work-up within 4 weeks before treatment start 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
Exclusion criteria: 1. Previous tumors, diagnosed in last 5 years, with the exception of treated skin carcinomas or in situ, properly treated cervix carcinomas. 2. Pregnancy and breast-feeding. Women in post-menopause must present amenorrea since 12 months at least. Sexually active males and females (in fertile age) who do not want to use contraception during the trial. 3. Recent major surgery interventions (within 28 days before study treatment) 4. Planned radiotherapy for melanoma metastasis 5. Clinical or radiological evidence of metastasis in Central Nervous System (CNS) 6. Positive clinical history for other important pathologies: a. evidence of haemorrhagic diathesis or coagulopathy; b. non-controlled hypertension c. congestitial cardiac insufficiency (NYHA stage more or equal to 2), previous myocardial infarction or cerebrovascular events within 6 months, unstable angina, severe heart arythmia requiring specific treatment; d. History of significant neurological or psychiatric pathologies which would compromise the comprehension and the issuing of the informed consent; e. infection requiring an antibiotic therapy by EV and tuberculosis in treatment at the moment of trial start; f. active peptic ulcer, unstable diabetes mellitus, cyrrosis and other significant pathologies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. Studying the relationship between pharmacologic dose of esomeprazole and clinical response, in terms of objective responses, response duration, time to progression (TTP) 2. Biological objectives (principle trial): analisys of the changes of immunohistochemistry in the expression of V-APTasis and of the in vitro sensitivity to Cisplatinum before and after treatment with esomeprazole.;Secondary Objective: 1. Evaluating the relationship between the dose of trial drug and the onset of side effects (global therapeutic index) 2. Assessing the entity of tumor necrosis evalued as immunohistochemical analisys on a lesion biopsied after treatment compared to a lesion biopsied before treatment with esomeprazole.;Primary end point(s): In case of positive study outcome, expected advantages for treated and future patients are identified not only in a better clinical response, but also in a better tolerability of the patient to chemiotherapic treatment. Moreover, the study drug?s way of use does not require to modify the habitual use of chemiotherapic drugs. | — |
Countries
Italy
Outcome results
None listed