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Vaccination of Patients With Advanced Melanoma, Pancreatic, Colon and Cervical Cancer With HLA-A1, -A2 and -B35 Restricted Survivin Peptides

This study is currently Recruiting

June 2005 By Julius-Maximilians University

First Recieved on April 19, 2005

Last Updated on July 27, 2006

Sponsor: Julius-Maximilians University
Collaborators:
Information provided by: Julius-Maximilians University
Identifier: NCT00108875

Purpose

This study evaluates the safety, the immunological response and the clinical outcome of a vaccination with survivin peptides for patients with advanced melanoma, pancreatic, colon and cervical carcinoma.

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

Eligibility

Ages Eligible for Study:19 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

Inclusion Criteria: - Advanced melanoma, pancreatic, colon and cervical cancer - At least 1 prior postoperative conventional therapy (chemotherapy, radiation, immunotherapy) - HLA-A1, -A2, -B35 - More than 4 weeks since last chemo-, immune- or radiotherapy - ECOG-PS (Eastern Cooperative Oncology Group- Performance Status) of 0-1 - Sufficient renal, hepatic and bone marrow function: thrombocytes > 75.000/ul; hb > 9 g/dl; leucocytes > 2.500/ul; creatinine < 2 mg/dl; GOT/GPT < twice the normal value - negative for HIV and Hbs - Older than 18 years - Informed consent Exclusion Criteria: - Acute/chronic infections - Positive for HIV, Hbs - Autoimmune disorders - Pregnancy, breast feeding

Investigators

  • Investigator: Juergen C Becker, MD - Principal Investigator - Department of Dermatology, University of Wuerzburg, Germany

Locations

  • Julius-Maximilians-University of Wuerzburg, Germany, Department of Dermatology

    Wuerzburg, Bavaria 97080 Germany

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