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


Phase 1
18 Years
N/A
Not Enrolling
Both
Melanoma

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Melan-A and Tyrosinase specific CD8+ T-cell reactivity will be measured by Tetramers and Elispot assays

Outcome Time Frame:

Change from baseline in CD8 T-cells reactivity at day 375

Safety Issue:

No

Principal Investigator

Olivier Michielin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ludwig Institute for Cancer Research

Authority:

Switzerland: Swissmedic

Study ID:

LUD 2000-018

NCT ID:

NCT00112229

Start Date:

April 2003

Completion Date:

June 2012

Related Keywords:

  • Melanoma
  • Immunotherapy
  • Vaccination
  • Melanoma
  • Melan-A/Mart-1 peptide
  • Tyrosinase peptide
  • CpG
  • Montanide
  • Melanoma

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