Patients with metastatic melanoma non pre-treated for advanced disease MedDRA version: 12.1 Level: LLT Classification code 10027481 Term: Metastatic melanoma
Conditions
Interventions
Trade Name: MUPHORAN
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Fotemustine
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Co
Sponsors
GOIM GRUPPO ONCOLOGICO MERIDIONALE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ?Histologically confirmed, unresectable, stage IV metastatic melanoma; ?Measurable disease (based on RECIST criteria) including patients with brain stabilized metastases; ?No prior treatments for metastatc disease ?Patients of at list 18 years of age; ?Performance status of 0-2 (ECOG); ?Adequate hepatic and bone function (Hb >10 g/dL, ANC >2000/uL, PLT >100.000/uL; AST and ALT =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ?History of prior malignancies within the past 5 years other than carcinoma in situ of the cervix and non-melanomatous skin cancers; ?History of myocardial infarction within 12 months prior to randomization; ?History of psychological disorders might not permit the patient to complete the study or sign the informed consent; ?Active infections; ?Use od concomitant experimental drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Overall response;Secondary Objective: -Toxicity profile; -Inpact on Quality of life; -Time to progression; -Response duration; -Overall survival;Primary end point(s): To avuate if the pre-treament with low dose of Temozolomide is able to increase the activity of Fotemustine inducing a O6-alkylguanine-DNA alkyltransferase depletion in MM patients | — |
Countries
Italy
Outcome results
None listed