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

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. Identifier: NCT00306553
Recruitment Status : Completed
First Posted : March 24, 2006
Last Update Posted : September 19, 2006
Information provided by:
Cytos Biotechnology AG

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
Malignant Melanoma Biological: CYT004-MelQbG10 Phase 2

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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 identifier (NCT number): NCT00306553

Dept. of Dermatology, USZ
Zuerich, Switzerland, 8091
Dept. of Oncology, USZ
Zuerich, Switzerland, 8091
Sponsors and Collaborators
Cytos Biotechnology AG
Principal Investigator: Alexander Knuth, MD Dept. of Oncology, Univerity Hospital Zuerich, CH Identifier: NCT00306553     History of Changes
Other Study ID Numbers: CYT004-MelQbG10 03
First Posted: March 24, 2006    Key Record Dates
Last Update Posted: September 19, 2006
Last Verified: September 2006

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