Peptide-based vaccine in combination or not with chemotherapy in melanoma patients: a phase II randomized clinical study. - ND
- Conditions
- advanced melanomaMedDRA version: 12.0Level: HLTClassification code 10027156Term: Skin melanomas (excl ocular)
- Registration Number
- EUCTR2008-008211-26-IT
- Lead Sponsor
- ISTITUTO SUPERIORE DI SANITA`
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Histologically confirmed AJCC stage IIIb or IIIc or IV (M1a or M1b) disease-free HLA- A*0201melanoma; Adult subjects of >18 years of age; ECOG score 0-1; Life expectancy of at least 6 months; Hematopoietic, liver and renal normal functions defined as follows: WBC > 3 x 103/μl; platelets > 100 x 103/μl; Hb >10 g/dl; absolute neutrophil count > 1,5 x 103/μl; bilirubin ≤ 2.0 mg/dl; AST, ALT and LDH less than 3 times upper limit of normal; serum creatinine ≤ 2 mg /dl; Fertile females have to practice adequate contraception; Signed informed consent;
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
Current other malignancy at other sites or previous other cancer within the last 5 years, with the exception of adequately treated con-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin; Concurrent chemotherapy or immunotherapy; Prior chemotherapy, immunotherapy or radiotherapy, unless ended at least 4, 4 and 4 weeks, respectively before admission to the present study; Significant cardiovascular diseases requiring medical intervention or prior myocardial infarction within the last 2 years; Primary or secondary immunodeficiency, including immunosuppressive disease, or use of immunosuppressive medications; Active or chronic infection (including HIV, HBV, HCV) Women must not be pregnant or breast-feeding; Simultaneous participation in another clinical trial, or participation in any clinical trial involving investigational drugs within 3 months from enrolment into the present study; Any physical or psychological impediment in a patient that could let the investigator to suspect his/her poor compliance
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method