EUCTR2005-005775-15-IT
Active, not recruiting
Not Applicable
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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Metastatic stage III e IV M1a melanoma
- Sponsor
- ISTITUTO EUROPEO DI ONCOLOGIA
- Enrollment
- 43
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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