NCT00112229

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2003

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 1, 2005

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

April 22, 2013

Status Verified

April 1, 2013

Enrollment Period

8.3 years

First QC Date

May 31, 2005

Last Update Submit

April 19, 2013

Conditions

Melanoma

Keywords

ImmunotherapyVaccinationMelanomaMelan-A/Mart-1 peptideTyrosinase peptideCpGMontanide

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • In patients with measurable disease, tumor response will be assessed radiologically

    Change from baseline in tumor response at day 375

Study Arms (4)

group 1

EXPERIMENTAL

Melan-A analog peptide + CpG + Montanide

Biological: group 1

group 2

EXPERIMENTAL

Melan-A natural peptide + CpG + Montanide

Biological: group 2

group 3

EXPERIMENTAL

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

Biological: group 3

group 4

EXPERIMENTAL

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

Biological: group 4

Interventions

group 1BIOLOGICAL

Melan-A analog peptide + CpG + Montanide

group 1
group 2BIOLOGICAL

Melan-A natural peptide + CpG + Montanide

group 2
group 3BIOLOGICAL

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

group 3
group 4BIOLOGICAL

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

group 4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed stage III or stage IV melanoma
  • Tumor expression of Melan-A +/- Tyrosinase
  • Human leukocyte antigen-A2 (HLA-A2) positive

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ludwig Institute for Cancer Research + Multidisciplinary Oncology Center at the Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (2)

  • Speiser DE, Lienard 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. doi: 10.1172/JCI23373.

    PMID: 15696196RESULT

  • Baumgaertner P, Jandus C, Rivals JP, Derre L, Lovgren 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. 2012 Jun 1;130(11):2607-17. doi: 10.1002/ijc.26297. Epub 2011 Aug 24.

    PMID: 21796616RESULT

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Olivier Michielin, MD

    Ludwig Institute for Cancer Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 31, 2005

First Posted

June 1, 2005

Study Start

April 1, 2003

Primary Completion

August 1, 2011

Study Completion

June 1, 2012

Last Updated

April 22, 2013

Record last verified: 2013-04

Locations

CH(1)