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

Melanoma Clinical Trial

Official title:

Immunotherapy of HLA-A2 Positive Stage III/IV Melanoma Patients With CpG7909, Tumor Antigenic Peptides and Montanide

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00112229
• Other study ID #: LUD 2000-018
• Status: Completed
• Phase: Phase 1
• First received: May 31, 2005
• Last updated: April 19, 2013
• Start date: April 2003
• Est. completion date: June 2012

Study information

• Verified date: April 2013
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma

Intervention

Biological:
• group 1
Melan-A analog peptide + CpG + Montanide
• group 2
Melan-A natural peptide + CpG + Montanide
• group 3
Melan-A natural peptide + Tyrosinase YMD peptide + CpG + Montanide
• group 4
Melan-A analog peptide + Tyrosinase YMD peptide + CpG + Montanide

Locations

Country	Name	City	State
Switzerland	Ludwig Institute for Cancer Research + Multidisciplinary Oncology Center at the Centre Hospitalier Universitaire Vaudois	Lausanne	Vaud

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois	Ludwig Institute for Cancer Research

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

Baumgaertner P, Jandus C, Rivals JP, Derré L, Lövgren T, Baitsch L, Guillaume P, Luescher IF, Berthod G, Matter M, Rufer N, Michielin O, Speiser DE. Vaccination-induced functional competence of circulating human tumor-specific CD8 T-cells. Int J Cancer. 2 — View Citation

Speiser DE, Liénard D, Rufer N, Rubio-Godoy V, Rimoldi D, Lejeune F, Krieg AM, Cerottini JC, Romero P. Rapid and strong human CD8+ T cell responses to vaccination with peptide, IFA, and CpG oligodeoxynucleotide 7909. J Clin Invest. 2005 Mar;115(3):739-46. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Safety of vaccination will be assessed according to National Cancer Institute Common Toxicity Criteria (NCI CTC) scale		Change from baseline to day 375	Yes
Secondary	In patients with measurable disease, tumor response will be assessed radiologically		Change from baseline in tumor response at day 375	No