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Multiepitope Peptide Vaccination in Melanoma - Article


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Vaccination

Clinical Trial: Multiepitope Peptide Vaccination in Melanoma

This study is no longer recruiting patients.

Sponsored by: Charite University, Berlin, Germany
Information provided by: Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00153569

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
  Vaccine: Tyrosinase, MAGE-3, GnTV
 Phase II

MedlinePlus related topics:  Melanoma

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title: Phase II Study of Multiepitope Peptide Vaccination in Combination with Adjuvants GM-CSF and KLH in Metastatic Melanoma

Further Study Details: 
Primary Outcomes: Clinical efficacy
Secondary Outcomes: Immune response; Safety
Expected Total Enrollment:  25

Study start: March 2003
Last follow-up: September 2005

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Location Information


Germany
      Hem&Onc Charité CBF, Berlin,  12200,  Germany

Study chairs or principal investigators

Ulrich Keilholz, MD,  Principal Investigator,  Charité, CBF   

More Information

Publications

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.

Study ID Numbers:  HaemaCBFMM03
Last Updated:  September 9, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00153569
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-09-13


Source: ClinicalTrials.gov
Cache Date: September 14, 2005


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October 12, 2008


Page Updated: June 12, 2007
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