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

This study has been completed.
Sponsor:
Information provided by:
Cytos Biotechnology AG
ClinicalTrials.gov Identifier:
NCT00651703
First received: April 1, 2008
Last updated: November 11, 2010
Last verified: November 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Head Clinical Development, Cytos Biotechnology AG
ClinicalTrials.gov Identifier: NCT00651703     History of Changes
Other Study ID Numbers: CYT004-MelQbG10 04
Study First Received: April 1, 2008
Last Updated: November 11, 2010
Health Authority: Switzerland: Swissmedic

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
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Interferon Inducers

ClinicalTrials.gov processed this record on April 15, 2014