Safety and Immunogenicity of CYT004-MelQbG10 Vaccine With and Without Adjuvant 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: NCT00651703
Recruitment Status : Completed
First Posted : April 3, 2008
Last Update Posted : November 15, 2010
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 alone or in combination with different adjuvants.

Condition or disease Intervention/treatment Phase
Malignant Melanoma Biological: CYT004-MelQbG10 + Montanide Biological: CYT004-MelQbG10 + Montanide + Imiquimod Biological: CYT004-MelQbG10 + Imiquimod Biological: CYT004-MelQbG10 intra nodal injection Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety, Tolerability, and Immunogenicity of CYT004-MelQbG10 Vaccine With or Without Immunostimulating Adjuvant in HLA-A2 Positive Patients With Stage III/IV Malignant Melanoma
Study Start Date : April 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: 1 Biological: CYT004-MelQbG10 + Montanide
Experimental: 2 Biological: CYT004-MelQbG10 + Montanide + Imiquimod
Experimental: 3 Biological: CYT004-MelQbG10 + Imiquimod
Experimental: 4 Biological: CYT004-MelQbG10 intra nodal injection

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
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histological confirmed Stage III or IV malignant melanoma
  • HLA-A*0201 haplotype
  • Expected survival of at least 9 months
  • Willing and able to comply with all trial requirements (e.g. diaries, CTs)
  • Given written informed consent
  • Females only if non-reproductive or if they agree to consistently practice an effective and accepted method of contraception

Exclusion Criteria:

  • Any contraindication to any study related test or assessment
  • Current or planned use of contraindicated concomitant medication
  • Presence or history of relevant cardiovascular, renal, pulmonary, endocrine, autoimmune, neurological and psychiatric disease
  • Infection with HIV, HBV or HCV
  • Pregnancy or lactation or females planning to become pregnant during the study
  • Abuse of alcohol or other drugs
  • Use of investigational drug within 30 days before enrolment
  • Previous participation in a clinical trial with a Qb-based Cytos vaccine.

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): NCT00651703

Ludwig Institute for Cancer Research; CHUV
Lausanne, VD, Switzerland, CH-1005
Dermatologische Klinik, UniversitätsSpital Zürich
Zurich, Switzerland, CH-8091
Sponsors and Collaborators
Cytos Biotechnology AG

Responsible Party: Head Clinical Development, Cytos Biotechnology AG Identifier: NCT00651703     History of Changes
Other Study ID Numbers: CYT004-MelQbG10 04
First Posted: April 3, 2008    Key Record Dates
Last Update Posted: November 15, 2010
Last Verified: November 2010

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers