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: NCT00306514
Recruitment Status : Completed
First Posted : March 24, 2006
Last Update Posted : September 20, 2007
Information provided by:
Cytos Biotechnology AG

Brief Summary:
The purpose of this study is to evaluate whether vaccination with a Melan-A VLP vaccine leads to a specific cellular immune response in patients with malignant melanoma at advanced stage of the disease.

Condition or disease Intervention/treatment Phase
Melanoma Biological: CYT004-MelQbG10 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel 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 III/IV Malignant Melanoma

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
  • Histologically confirmed stage III or IV melanoma
  • HLA-A*0201 haplotype
  • Expected survival of at least 6 months
  • ECOG performance status of 0 or 1
  • At least one and no more than 2 previous systemic therapies for metastatic melanoma
  • Able to undergo computed tomography (CT) scan/ magnetic resonance imaging (MRI) scan for tumor assessment.
  • Lack of response to or progression after most recent systemic therapy for metastatic melanoma.
  • Adequate organ and bone marrow functions
  • All adverse events (AEs) from 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 enrollment
  • Known or suspected brain metastases
  • 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.
  • Presence of significant cardiovascular, renal, pulmonary, endocrine, infectious, or neurological disorders.
  • Serum tests positive for HIV, hepatitis B virus (HBV), hepatitis C virus (HCV).
  • Active autoimmune diseases or severe allergies.
  • Known type 1 allergy.
  • 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 > 400mL within 8 weeks prior to inclusion.
  • Hemoglobin (Hb) < 10g/dL
  • Abuse of alcohol or other recreational drugs.
  • Previous vaccination with a Melan-A peptide analogue.

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): NCT00306514

Dept. of Dermatology, Venerology and Allergy
Berlin, Germany, 10117
Sponsors and Collaborators
Cytos Biotechnology AG
Principal Investigator: Wolfram Sterry, MD University Hospital Charite, Berlin, D Identifier: NCT00306514     History of Changes
Other Study ID Numbers: CYT004-MelQbG10 01
First Posted: March 24, 2006    Key Record Dates
Last Update Posted: September 20, 2007
Last Verified: September 2007

Keywords provided by Cytos Biotechnology AG:
metastatic malignant melanoma of the skin

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