Immunotherapy of HLA-A2 Positive Stage III/IV Melanoma Patients

This study has been completed.
Sponsor:
Collaborator:
Ludwig Institute for Cancer Research
Information provided by (Responsible Party):
Prof Olivier Michielin, M.D., Ph.D., Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier:
NCT00112229
First received: May 31, 2005
Last updated: April 19, 2013
Last verified: April 2013
  Purpose

The purpose of this study is to determine whether vaccination with tumor antigenic peptides and both CpG and Montanide adjuvants can induce an immune response in melanoma patients and to assess the safety of this vaccination.


Condition Intervention Phase
Melanoma
Biological: group 1
Biological: group 2
Biological: group 3
Biological: group 4
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Immunotherapy of HLA-A2 Positive Stage III/IV Melanoma Patients With CpG7909, Tumor Antigenic Peptides and Montanide

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire Vaudois:

Primary Outcome Measures:
  • Melan-A and Tyrosinase specific CD8+ T-cell reactivity will be measured by Tetramers and Elispot assays [ Time Frame: Change from baseline in CD8 T-cells reactivity at day 375 ] [ Designated as safety issue: No ]
  • Safety of vaccination will be assessed according to National Cancer Institute Common Toxicity Criteria (NCI CTC) scale [ Time Frame: Change from baseline to day 375 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • In patients with measurable disease, tumor response will be assessed radiologically [ Time Frame: Change from baseline in tumor response at day 375 ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: April 2003
Study Completion Date: June 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: group 1
Melan-A analog peptide + CpG + Montanide
Biological: group 1
Melan-A analog peptide + CpG + Montanide
Experimental: group 2
Melan-A natural peptide + CpG + Montanide
Biological: group 2
Melan-A natural peptide + CpG + Montanide
Experimental: group 3
Melan-A natural peptide + Tyrosinase YMD peptide + CpG + Montanide
Biological: group 3
Melan-A natural peptide + Tyrosinase YMD peptide + CpG + Montanide
Experimental: group 4
Melan-A analog peptide + Tyrosinase YMD peptide + CpG + Montanide
Biological: group 4
Melan-A analog peptide + Tyrosinase YMD peptide + CpG + Montanide

Detailed Description:

Immune therapy with tumor antigenic peptides is generally quite well tolerated. However, immune activation is often only weak or even undetectable, and clinical responses (supposedly corresponding to protective immunity) are unfortunately infrequent. Further progress is required to improve the vaccines, with the goal to increase the strength of immune activation.

The tumor antigenic peptides Melan-A/Mart-1 (EAA and ELA) and Tyrosinase (YMD) are combined with two drugs in this study, both of which are known to enhance immune responses: first, CpG 7909 oligodeoxynucleotides, and second, Montanide ISA-51.

  • Group 1: vaccination with Melan-A analog peptide + CpG and Montanide adjuvants;
  • Group 2: vaccination with Melan-A natural peptide + CpG and Montanide adjuvants;
  • Group 3 : vaccination with Melan-A natural and Tyrosinase peptides + CpG and Montanide adjuvants;
  • Group 4 : vaccination with Melan-A analog and Tyrosinase peptides + CpG and Montanide adjuvants.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed stage III or stage IV melanoma
  • Tumor expression of Melan-A +/- Tyrosinase
  • Human leukocyte antigen-A2 (HLA-A2) positive

Exclusion Criteria:

  • Clinically significant heart disease
  • Serious illnesses, eg, serious infections requiring antibiotics, bleeding disorders or uncontrolled peptic ulcer, or seizure or central nervous system disorders
  • History of immunodeficiency disease or autoimmune disease
  • Coagulation or bleeding disorders
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00112229

Locations
Switzerland
Ludwig Institute for Cancer Research + Multidisciplinary Oncology Center at the Centre Hospitalier Universitaire Vaudois
Lausanne, Vaud, Switzerland, 1011
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
Ludwig Institute for Cancer Research
Investigators
Principal Investigator: Olivier Michielin, MD Ludwig Institute for Cancer Research
  More Information

Publications:
Responsible Party: Prof Olivier Michielin, M.D., Ph.D., Professor, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT00112229     History of Changes
Other Study ID Numbers: LUD 2000-018
Study First Received: May 31, 2005
Last Updated: April 19, 2013
Health Authority: Switzerland: Swissmedic

Keywords provided by Centre Hospitalier Universitaire Vaudois:
Immunotherapy
Vaccination
Melanoma
Melan-A/Mart-1 peptide
Tyrosinase peptide
CpG
Montanide

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

ClinicalTrials.gov processed this record on July 29, 2014