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Sponsored by: |
Julius-Maximilians University |
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Information provided by: | Julius-Maximilians University |
ClinicalTrials.gov Identifier: | NCT00108875 |
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.
Condition | Intervention | Phase |
---|---|---|
Malignant Melanoma Pancreatic Cancer Colon Cancer Cervical Cancer |
Biological: Survivin peptide vaccine |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Vaccination of Patients With Advanced Melanoma, Pancreatic, Colon and Cervical Cancer With HLA-A1, -A2 and -B35 Restricted Survivin Peptides |
Estimated Enrollment: | 70 |
Study Start Date: | April 2003 |
As prognosis of advanced melanoma, pancreatic, colon and cervical cancer remains gloomy, new therapeutic modalities have to be developed to improve the patient´s clinical outcome. Immunotherapy, which targets tumor associated antigens of tumor cells or tumor stroma, is currently an intensively investigated, novel therapeutic option. As survivin is expressed both by neoplastic cells as well as by endothelial cells of the tumor vasculature, this antigen is an intriguing target molecule. Spontaneous cytotoxic T-cell responses against different survivin epitopes in cancer patients underline the relevance of survivin-directed immunological trials. This study is comprised of a peptide vaccine with HLA-A1, -A2 and -B35 restricted survivin epitopes in Montanide ISA-51 for patients with stage IV melanoma, advanced pancreatic, colon and cervical carcinoma. The vaccine is applicated as a deep subcutaneous injection. Vaccination is administered for the first 2 months weekly, afterwards every 4 weeks. Standard staging examinations are performed every three months. Clinical, laboratory and immunological monitoring is done every month.Diagnostic leucapheresis is performed before first vaccination and afterwards every 2 months.
Ages Eligible for Study: | 19 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Juergen C Becker, MD, PhD | +49-931-201-26396 | becker_jc@klinik.uni-wuerzburg.de |
Contact: Marion B Wobser | +49-931-201-26722 | wobser_m@klinik.uni-wuerzburg.de |
Germany, Bavaria | |
Julius-Maximilians-University of Wuerzburg, Germany, Department of Dermatology | Recruiting |
Wuerzburg, Bavaria, Germany, 97080 | |
Contact: Juergen C Becker, MD, PhD +49-931-201-26396 becker_jc@klinik.uni-wuerzburg.de | |
Contact: Marion B Wobser +49-931-201-26722 wobser_m@klinik.uni-wuerzburg.de | |
Principal Investigator: Juergen C Becker, MD, PhD |
Principal Investigator: | Juergen C Becker, MD | Department of Dermatology, University of Wuerzburg, Germany |
Study ID Numbers: | SuMo-Sec-01, PEI 0899/01, IRB 07/03 |
Study First Received: | April 19, 2005 |
Last Updated: | July 27, 2006 |
ClinicalTrials.gov Identifier: | NCT00108875 |
Health Authority: | Germany: Paul-Ehrlich-Institut |
Peptide vaccine therapy Survivin |
Digestive System Neoplasms Gastrointestinal Diseases Pancreatic Neoplasms Colonic Diseases Endocrine System Diseases Intestinal Diseases Intestinal Neoplasms Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Digestive System Diseases |
Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma Pancreatic Diseases Gastrointestinal Neoplasms Endocrinopathy Nevus Colonic Neoplasms Colorectal Neoplasms Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Nerve Tissue Nevi and Melanomas |