Immunotherapy of HLA-A2 Positive Stage III/IV Melanoma Patients
This study has been completed.
Sponsor:
Centre Hospitalier Universitaire Vaudois
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
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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
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 June 17, 2013