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

Vaud University Hospital Center

Status and phase: Completed; Phase 1

Conditions: Melanoma

Treatments: Biological: group 1; Biological: group 4; Biological: group 3; Biological: group 2

Study type: Interventional

Funder types: Other

Identifiers

NCT00112229

LUD 2000-018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 4 patient groups

group 1

Experimental group

Description:

Melan-A analog peptide + CpG + Montanide

Treatment:

Biological: group 1

group 2

Experimental group

Description:

Melan-A natural peptide + CpG + Montanide

Treatment:

Biological: group 2

group 3

Experimental group

Description:

Melan-A natural peptide + Tyrosinase YMD peptide + CpG + Montanide

Treatment:

Biological: group 3

group 4

Experimental group

Description:

Melan-A analog peptide + Tyrosinase YMD peptide + CpG + Montanide

Treatment:

Biological: group 4