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Safety and Immunogenicity of a Melan-A VLP Vaccine in Advanced Stage Melanoma Patients

Sponsor
Cytos Biotechnology AG (Industry)
Overall Status
Completed
CT.gov ID
NCT00306553
Collaborator
(none)
2
Locations

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: CYT004-MelQbG10
 Phase 2

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 0 Years
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dept. of Dermatology, USZ Zuerich Switzerland 8091
    2 Dept. of Oncology, USZ Zuerich Switzerland 8091

    Sponsors and Collaborators

    • Cytos Biotechnology AG

    Investigators

    • Principal Investigator: Alexander Knuth, MD, Dept. of Oncology, Univerity Hospital Zuerich, CH

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00306553
    Other Study ID Numbers:
    • CYT004-MelQbG10 03
    First Posted:
    Mar 24, 2006
    Last Update Posted:
    Sep 19, 2006
    Last Verified:
    Sep 1, 2006
    Additional relevant MeSH terms:
    Melanoma

    Study Results

    No Results Posted as of Sep 19, 2006