Safety and Immunogenicity of a Melan-A VLP Vaccine in Advanced Stage Melanoma Patients
ClinicalTrials.gov ID
NCT00306553
Lead Sponsor
Cytos Biotechnology AGINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 2
Last Update Posted
Sep 19, 2006Estimated
Brief Summary
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.
Malignant Melanoma
CYT004-MelQbG10
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No data available
Eligibility Criteria
Inclusion Criteria:
Able to provide written informed consent.
Able and willing to complete all protocol requirements.
Age: 18 years and older.
Histological confirmed stage III or IV melanoma.
At least one confirmed detectable target lesion
HLA-A*0201 haplotype
Expected survival of at least 6 months.
Full recovery from surgery.
Able to undergo either CT scan or MRI scan for tumor assessment.
Wash-out period of 4 weeks after chemotherapy
All AEs form prior anticancer therapy have resolved to ≤ Grade 1.
Sexually active males should use adequate contraception throughout the study period and 3 months thereafter.
Females of child bearing potential should use adequate contraception throughout the study period and 3 months thereafter, that can be oral contraception or a double-barrier local contraception (intra-uterine device plus condom or spermicidal gel plus condom), and have a negative serum pregnancy test within 4 weeks prior to the first dose of the vaccine.
Exclusion Criteria:
Pregnant or nursing.
Use of an investigational drug within 30 days before enrolment.
Known or suspected brain metastases.
Current use of an immunosuppressive drug or any concomitant medication that could potentially interfere with the study drug
Presence of significant cardiovascular, renal, pulmonary, endocrine, infectious, neurological or bone marrow function disorders
Serum tests positive for HIV, HBV, HCV.
Active autoimmune diseases or severe allergies.
Current diagnosis or history of relevant and severe psychiatric disorder that compromises the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol or to complete the study.
Abuse of alcohol or other recreational drugs.
Previous vaccination with a Melan-A analog peptide.