Multiepitope Peptide Vaccination in Melanoma - Full Text View

Multiepitope Peptide Vaccination in Melanoma

This study is ongoing, but not recruiting participants.

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	Biological: Tyrosinase, MAGE-3, GnTV	Phase II

MedlinePlus related topics:

Melanoma

ChemIDplus related topics:

Sargramostim Granulocyte-macrophage colony-stimulating factor Tyrosinase

U.S. FDA Resources

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 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:

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
First Received:	September 8, 2005
Last Updated:	February 13, 2006
ClinicalTrials.gov Identifier:	NCT00153569
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Neuroectodermal Tumors

Nevus, Pigmented

Neoplasms, Germ Cell and Embryonal

Neuroepithelioma

Nevus

Neuroendocrine Tumors

Melanoma

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevi and Melanomas

ClinicalTrials.gov processed this record on October 07, 2008