Survivin Peptide Vaccination for Patients With Advanced Melanoma, Pancreatic, Colon and Cervical Cancer - Full Text View

Sponsor:	Julius-Maximilians University
Information provided by:	Julius-Maximilians University
ClinicalTrials.gov 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.

Condition	Intervention	Phase
Malignant Melanoma Pancreatic Cancer Colon Cancer Cervical Cancer	Biological: Survivin peptide vaccine	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Vaccination of Patients With Advanced Melanoma, Pancreatic, Colon and Cervical Cancer With HLA-A1, -A2 and -B35 Restricted Survivin Peptides

Resource links provided by NLM:

MedlinePlus related topics: Cancer Cervical Cancer Melanoma Pancreatic Cancer

U.S. FDA Resources

Further study details as provided by Julius-Maximilians University:

Primary Outcome Measures:

Progression-free survival
Overall survival
Immunological response

Secondary Outcome Measures:

Best response

Estimated Enrollment:	70
Study Start Date:	April 2003

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	19 Years to 90 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00108875

Contacts

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

Locations

Germany
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

Sponsors and Collaborators

Julius-Maximilians University

Investigators

Principal Investigator:

Juergen C Becker, MD

Department of Dermatology, University of Wuerzburg, Germany

More Information

Additional Information:

Homepage of the University Hospital of Wuerzburg, Germany This link exits the ClinicalTrials.gov site

Publications:

Blanc-Brude OP, Mesri M, Wall NR, Plescia J, Dohi T, Altieri DC. Therapeutic targeting of the survivin pathway in cancer: initiation of mitochondrial apoptosis and suppression of tumor-associated angiogenesis. Clin Cancer Res. 2003 Jul;9(7):2683-92.

Otto K, Andersen MH, Eggert A, Keikavoussi P, Pedersen LO, Rath JC, Bock M, Brocker EB, Straten PT, Kampgen E, Becker JC. Lack of toxicity of therapy-induced T cell responses against the universal tumour antigen survivin. Vaccine. 2005 Jan 4;23(7):884-9.

Andersen MH, Pedersen LO, Capeller B, Brocker EB, Becker JC, thor Straten P. Spontaneous cytotoxic T-cell responses against survivin-derived MHC class I-restricted T-cell epitopes in situ as well as ex vivo in cancer patients. Cancer Res. 2001 Aug 15;61(16):5964-8.

Andersen MH, Pedersen LO, Becker JC, Straten PT. Identification of a cytotoxic T lymphocyte response to the apoptosis inhibitor protein survivin in cancer patients. Cancer Res. 2001 Feb 1;61(3):869-72.

Kim HS, Shiraki K, Park SH. Expression of survivin in CIN and invasive squamous cell carcinoma of uterine cervix. Anticancer Res. 2002 Mar-Apr;22(2A):805-8.

Reker S, Becker JC, Svane IM, Ralfkiaer E, Straten PT, Andersen MH. HLA-B35-restricted immune responses against survivin in cancer patients. Int J Cancer. 2004 Mar 1;108(6):937-41.

Reker S, Meier A, Holten-Andersen L, Svane IM, Becker JC, thor Straten P, Andersen MH. Identification of novel survivin-derived CTL epitopes. Cancer Biol Ther. 2004 Feb;3(2):173-9. Epub 2004 Feb 1.

ClinicalTrials.gov Identifier:	NCT00108875 History of Changes
Other Study ID Numbers:	SuMo-Sec-01, PEI 0899/01, IRB 07/03
Study First Received:	April 19, 2005
Last Updated:	July 27, 2006
Health Authority:	Germany: Paul-Ehrlich-Institut

Keywords provided by Julius-Maximilians University:

Peptide vaccine therapy
Survivin

Additional relevant MeSH terms:

Colonic Neoplasms
Uterine Cervical Neoplasms
Melanoma
Pancreatic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Uterine Neoplasms

Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on February 09, 2012