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Safety and Immunogenicity of CYT004-MelQbG10 Vaccine With and Without Adjuvant in Advanced Stage Melanoma Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00651703
First Posted: April 3, 2008
Last Update Posted: November 15, 2010
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 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 Intervention 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
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Cytos Biotechnology AG:

Enrollment: 21
Study Start Date: April 2008
Study Completion Date: July 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
Accepts Healthy Volunteers:   No
Criteria

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.
  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): NCT00651703


Locations
Switzerland
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
  More Information

Responsible Party: Head Clinical Development, Cytos Biotechnology AG
ClinicalTrials.gov Identifier: NCT00651703     History of Changes
Other Study ID Numbers: CYT004-MelQbG10 04
First Submitted: April 1, 2008
First Posted: April 3, 2008
Last Update Posted: November 15, 2010
Last Verified: November 2010

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
Imiquimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers