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Multiepitope Peptide Vaccination in Melanoma

Primary Purpose

Metastatic Melanoma

Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Tyrosinase, MAGE-3, GnTV
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Metastatic melanoma HLA-A1, -A2, -A24, -B44 Exclusion Criteria:

Sites / Locations

  • Hem&Onc Charité CBF

Outcomes

Primary Outcome Measures

Clinical efficacy

Secondary Outcome Measures

Immune response
Safety

Full Information

First Posted
September 8, 2005
Last Updated
May 25, 2010
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT00153569
Brief Title
Multiepitope Peptide Vaccination in Melanoma
Official Title
Phase II Study of Multiepitope Peptide Vaccination in Combination With Adjuvants GM-CSF and KLH in Metastatic Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
March 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Tyrosinase, MAGE-3, GnTV
Primary Outcome Measure Information:
Title
Clinical efficacy
Secondary Outcome Measure Information:
Title
Immune response
Title
Safety

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Metastatic melanoma HLA-A1, -A2, -A24, -B44 Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrich Keilholz, MD
Organizational Affiliation
Charité, CBF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hem&Onc Charité CBF
City
Berlin
ZIP/Postal Code
12200
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
12569574
Citation
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.
Results Reference
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Learn more about this trial

Multiepitope Peptide Vaccination in Melanoma

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