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Multiepitope Peptide Vaccination in Melanoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Charite University, Berlin, Germany.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00153569
First received: September 8, 2005
Last updated: May 25, 2010
Last verified: September 2005
History of Changes
  Purpose

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


Condition Intervention Phase
Metastatic Melanoma
 Biological: Tyrosinase, MAGE-3, GnTV
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Multiepitope Peptide Vaccination in Combination With Adjuvants GM-CSF and KLH in Metastatic Melanoma

Resource links provided by NLM:

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Clinical efficacy

Secondary Outcome Measures:
  • Immune response
  • Safety

Estimated Enrollment: 25
Study Start Date: March 2003
Estimated Study Completion Date: September 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00153569

Locations
Germany
Hem&Onc Charité CBF
Berlin, Germany, 12200
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Ulrich Keilholz, MD Charité, CBF
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00153569     History of Changes
Other Study ID Numbers: HaemaCBFMM03
Study First Received: September 8, 2005
Last Updated: May 25, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on May 22, 2013