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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00306566
First Posted: March 24, 2006
Last Update Posted: September 20, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Cytos Biotechnology AG
  Purpose
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 Intervention Phase
Malignant Melanoma Biological: CYT004-MelQbG10 Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Cytos Biotechnology AG:

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00306566


Locations
Switzerland
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
  More Information

ClinicalTrials.gov Identifier: NCT00306566     History of Changes
Other Study ID Numbers: CYT004-MelQbG10 02
First Submitted: March 23, 2006
First Posted: March 24, 2006
Last Update Posted: September 20, 2007
Last Verified: September 2007

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas