NCT00306566

Brief Summary

The purpose of this study is to monitor a specific cellular immune response in melanoma patients at an early stage of the disease, that have been vaccinated with a Melan-A VLP vaccine.

Trial Health

80
On Track

Trial Health Score

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

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

First Submitted

Initial submission to the registry

March 23, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 24, 2006

Completed
Last Updated

September 20, 2007

Status Verified

September 1, 2007

First QC Date

March 23, 2006

Last Update Submit

September 19, 2007

Conditions

Malignant Melanoma

Interventions

CYT004-MelQbG10BIOLOGICAL

Eligibility Criteria

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

You may qualify if:

  • Able to provide written informed consent
  • Able and willing to complete all protocol requirements
  • Age: 18 years and older
  • Histological confirmed stage II melanoma
  • HLA-A\*0201 haplotype
  • Expected survival of at least 6 months
  • ECOG performance status of 0 or 1
  • Full recovery from surgery
  • Adequate organ and bone marrow functions
  • Sexually active males should use adequate contraception throughout the study period and 3 months thereafter.
  • Females of child bearing potential should use adequate contraception throughout the study period and 3 months thereafter, that can be oral contraception or a double-barrier local contraception (intra-uterine device plus condom or spermicidal gel plus condom), and have a negative serum pregnancy test within 4 weeks prior to the first dose of the vaccine.

You may not qualify if:

  • Pregnant or nursing
  • Use of an investigational drug within 30 days before enrolment
  • Active malignancy in the 5 years prior to enrollment other than melanoma, basal cell carcinoma or cervical carcinoma in situ.
  • Major surgery within 4 weeks prior to enrollment.
  • Current use of an immunosuppressive drug or any concomitant medication that could potentially interfere with the study drug (e.g. steroids, antihistamine drugs; topical or inhalational steroids are permitted).
  • Presence of significant cardiovascular, renal, pulmonary, endocrine, infectious, or neurological disorders.
  • Serum tests positive for HIV, HBV, HCV.
  • Active autoimmune diseases or severe allergies.
  • Current diagnosis or history of relevant and severe psychiatric disorder that compromises the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol or to complete the study.
  • Abuse of alcohol or other recreational drugs.
  • Previous vaccination with a Melan-A analog peptide.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Pluridisciplinaire d'Oncologie & LICR, CHUV

Lausanne, Vaude, 1011, Switzerland

Location

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

  • Danielle Lienard, MD

    Centre Pluridisciplinaire d'Oncologie & LICR, CHUV

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 23, 2006

First Posted

March 24, 2006

Last Updated

September 20, 2007

Record last verified: 2007-09

Locations

CH(1)