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

Phase 1

Completed

• Conditions: Melanoma
• Interventions: Biological: group 1; Biological: group 2; Biological: group 3; Biological: group 4

• Registration Number: NCT00112229
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

Brief Summary

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.

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.

Study Timeline

• Study Start: 2003-04
• Study First Submitted: 2005-05-31
• Study First Submitted QC: 2005-05-31
• Study First Posted: 2005-06-01
• Primary Completion: 2011-08
• Study Completion: 2012-06
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-19
• Last Update Posted: 2013-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 1	group 1	Melan-A analog peptide + CpG + Montanide
group 2	group 2	Melan-A natural peptide + CpG + Montanide
group 3	group 3	Melan-A natural peptide + Tyrosinase YMD peptide + CpG + Montanide
group 4	group 4	Melan-A analog peptide + Tyrosinase YMD peptide + CpG + Montanide

Primary Outcome Measures

Name	Time	Method
Melan-A and Tyrosinase specific CD8+ T-cell reactivity will be measured by Tetramers and Elispot assays	Change from baseline in CD8 T-cells reactivity at day 375
Safety of vaccination will be assessed according to National Cancer Institute Common Toxicity Criteria (NCI CTC) scale	Change from baseline to day 375

Secondary Outcome Measures

Name	Time	Method
In patients with measurable disease, tumor response will be assessed radiologically	Change from baseline in tumor response at day 375

Trial Locations

Locations (1)

Ludwig Institute for Cancer Research + Multidisciplinary Oncology Center at the Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Vaud, Switzerland