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

Sponsor
Cytos Biotechnology AG (Industry)
Overall Status
Completed
CT.gov ID
NCT00306566
Collaborator
(none)
1
Location

Study Details

Study Description

Brief Summary

The purpose of this study is to monitor a specific cellular immune response in melanoma patients at an early stage of the disease, that have been vaccinated with a Melan-A VLP vaccine.

Condition or Disease Intervention/Treatment Phase
  • Biological: CYT004-MelQbG10
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Official Title:
A Phase IIa Study to Evaluate Safety, Tolerability, and Immunogenicity of a Melan-A VLP Vaccine in HLA-A2 Positive Patients With Stage II Malignant Melanoma

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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 II melanoma

    • HLA-A*0201 haplotype

    • Expected survival of at least 6 months

    • ECOG performance status of 0 or 1

    • Full recovery from surgery

    • Adequate organ and bone marrow functions

    • 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

    • Active malignancy in the 5 years prior to enrollment other than melanoma, basal cell carcinoma or cervical carcinoma in situ.

    • Major surgery within 4 weeks prior to enrollment.

    • Current use of an immunosuppressive drug or any concomitant medication that could potentially interfere with the study drug (e.g. steroids, antihistamine drugs; topical or inhalational steroids are permitted).

    • Presence of significant cardiovascular, renal, pulmonary, endocrine, infectious, or neurological 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.

    • Blood donation or loss of > 500mL within 8 weeks prior to inclusion.

    • 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 Centre Pluridisciplinaire d'Oncologie & LICR, CHUV Lausanne Vaude Switzerland 1011

    Sponsors and Collaborators

    • Cytos Biotechnology AG

    Investigators

    • Principal Investigator: Danielle Lienard, MD, Centre Pluridisciplinaire d'Oncologie & LICR, CHUV

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00306566
    Other Study ID Numbers:
    • CYT004-MelQbG10 02
    First Posted:
    Mar 24, 2006
    Last Update Posted:
    Sep 20, 2007
    Last Verified:
    Sep 1, 2007
    Additional relevant MeSH terms:
    Melanoma

    Study Results

    No Results Posted as of Sep 20, 2007