NCT00153569

Brief Summary

This trial assesses the clinical efficacy of a multiepitope peptide vaccine with GM-CSF and KLH as immunological adjuvants in stage IV melanoma patients

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2003

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2003

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

May 26, 2010

Status Verified

September 1, 2005

First QC Date

September 8, 2005

Last Update Submit

May 25, 2010

Conditions

Metastatic Melanoma

Outcome Measures

Primary Outcomes (1)

  • Clinical efficacy

Secondary Outcomes (2)

  • Immune response

  • Safety

Interventions

Tyrosinase, MAGE-3, GnTVBIOLOGICAL

Eligibility Criteria

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

You may qualify if:

  • Metastatic melanoma
  • HLA-A1, -A2, -A24, -B44

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hem&Onc Charité CBF

Berlin, 12200, Germany

Location

Related Publications (1)

  • Scheibenbogen C, Schadendorf D, Bechrakis NE, Nagorsen D, Hofmann U, Servetopoulou F, Letsch A, Philipp A, Foerster MH, Schmittel A, Thiel E, Keilholz U. Effects of granulocyte-macrophage colony-stimulating factor and foreign helper protein as immunologic adjuvants on the T-cell response to vaccination with tyrosinase peptides. Int J Cancer. 2003 Mar 20;104(2):188-94. doi: 10.1002/ijc.10961.

    PMID: 12569574BACKGROUND

MeSH Terms

Conditions

Melanoma

Interventions

Monophenol MonooxygenaseMAGEA3 protein, human

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

Intervention Hierarchy (Ancestors)

Catechol OxidaseMixed Function OxygenasesOxygenasesOxidoreductasesEnzymesEnzymes and Coenzymes

Study Officials

  • Ulrich Keilholz, MD

    Charité, CBF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

March 1, 2003

Study Completion

September 1, 2005

Last Updated

May 26, 2010

Record last verified: 2005-09

Locations

DE(1)