Safety and Immunogenicity of CYT004-MelQbG10 Vaccine With and Without Adjuvant in Advanced Stage Melanoma Patients
The purpose of this study is to evaluate a specific cellular immune response in melanoma patients that have been vaccinated with a Melan-A VLP vaccine alone or in combination with different adjuvants...
Brief Summary
Official Title: “Safety, Tolerability, and Immunogenicity of CYT004-MelQbG10 Vaccine With or Without Immunostimulating Adjuvant in HLA-A2 Positive Patients With Stage III/IV Malignant Melanoma”
The purpose of this study is to evaluate a specific cellular immune response in melanoma patients that have been vaccinated with a Melan-A VLP vaccine alone or in combination with different adjuvants.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: December 2009
Intervention(s) in this Clinical Trial
- Biological: CYT004-MelQbG10 + Montanide
- Biological: CYT004-MelQbG10 + Montanide + Imiquimod
- Biological: CYT004-MelQbG10 + Imiquimod
- Biological: CYT004-MelQbG10 intra nodal injection
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Experimental: 2
- Experimental: 3
- Experimental: 4
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Histological confirmed Stage III or IV malignant melanoma
- HLA-A*0201 haplotype
- Expected survival of at least 9 months
- Willing and able to comply with all trial requirements (e.g. diaries, CTs)
- Given written informed consent
- Females only if non-reproductive or if they agree to consistently practice an effective and accepted method of contraception
Exclusion Criteria:
- Any contraindication to any study related test or assessment
- Current or planned use of contraindicated concomitant medication
- Presence or history of relevant cardiovascular, renal, pulmonary, endocrine, autoimmune, neurological and psychiatric disease
- Infection with HIV, HBV or HCV
- Pregnancy or lactation or females planning to become pregnant during the study
- Abuse of alcohol or other drugs
- Use of investigational drug within 30 days before enrolment
- Previous participation in a clinical trial with a Qb-based Cytos vaccine.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Cytos Biotechnology AG Industry
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00651703
Study ID Number: CYT004-MelQbG10 04
ClinicalTrials.gov Identifier: NCT00651703
Health Authority: Switzerland: Swissmedic
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00651703
