Pilot phase II study of a combined immunotherapy protocol based on oral vaccination and direct intratumoral injection of Salmonella Typhi Ty21a Vivotif in metastatic cutaneous melanoma patients. - ND
- Conditions
- Metastatic stage III e IV M1a melanomaMedDRA version: 6.1Level: PTClassification code 10042551
- Registration Number
- EUCTR2005-005775-15-IT
- Lead Sponsor
- ISTITUTO EUROPEO DI ONCOLOGIA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 43
stage III and IV M1A melanoma patients with at least three non resectable superficial metastatic lesions, aged at least 18 years with HLA-A 0201 allele; adequate bone-marrow reserve, renal and hepatic functions and cardiac function.
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
Principal exclusion criteria presence of visceral metastases; relevant medical history including primary or secondary immune deficiencies or known significant autoimmune disease, serious cardiac, gastrointestinal, hepatic or pulmonary disease which would reduce life expectancy to 5 years, coagulation disorders, other malignancies within 5 years and need for immunosuppressants.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Safety according to the common toxicity criteria CTC version 3.0. The rate of objective clinical response CR, PR and MR .;Secondary Objective: Monitoring of immune-response Progression-free survival;Primary end point(s): The rate of grade 3 / 4 toxicity. Objective clinical response CR or PR .
- Secondary Outcome Measures
Name Time Method