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NCT00153569 Clinical Trial

Multiepitope Peptide Vaccination in Melanoma

Metastatic Melanoma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00153569
Other study ID # HaemaCBFMM03
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received September 8, 2005
Last updated May 25, 2010
Start date March 2003
Est. completion date September 2005

Study information
Verified date September 2005
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 25
Est. completion date September 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Metastatic melanoma

- HLA-A1, -A2, -A24, -B44

Exclusion Criteria:

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• Tyrosinase, MAGE-3, GnTV

Locations
Country Name City State
Germany Hem&Onc Charité CBF Berlin

Sponsors (1)
Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical efficacy
Secondary Immune response
Secondary Safety
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