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

September 19, 2007 updated by: Cytos Biotechnology AG

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cytos Biotechnology AG

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

March 23, 2006

First Submitted That Met QC Criteria

March 23, 2006

First Posted (Estimate)

March 24, 2006

Study Record Updates

Last Update Posted (Estimate)

September 20, 2007

Last Update Submitted That Met QC Criteria

September 19, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CYT004-MelQbG10 02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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