Clinical Trial: Survivin Peptide Vaccination for Patients with Advanced Melanoma, Pancreatic, Colon and Cervical Cancer

This study is currently recruiting patients.

Sponsored by: Julius-Maximilians University
Information provided by: Julius-Maximilians University

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 Treatment or Intervention Phase
Malignant Melanoma
Pancreatic Cancer
Colon Cancer
Cervical Cancer
 Vaccine: Survivin peptide vaccine
Phase I
Phase II

MedlinePlus related topics:  Cervical Cancer;   Colorectal Cancer;   Melanoma;   Pancreatic Cancer

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

Further Study Details: 
Primary Outcomes: Progression-free survival; Overall survival; Immunological response
Secondary Outcomes: Best response
Expected Total Enrollment:  70

Study start: April 2003;  Expected completion: December 2005
Last follow-up: December 2005;  Data entry closure: December 2005

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 every month. Standard staging examinations are performed every three months. Clinical, laboratory and immunological monitoring is done every month.

Eligibility

Ages Eligible for Study:  19 Years   -   90 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • Advanced melanoma, pancreatic, colon and cervical cancer
  • 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
  • Older than 18 years
  • Informed consent

Exclusion Criteria:

  • Infections
  • Autoimmune disorders
  • Pregnancy, breast feeding

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00108875

Juergen C Becker, MD, PhD      +49-931-201-26396    becker_jc@klinik.uni-wuerzburg.de
Marion B Wobser      +49-931-201-26722    wobser_m@klinik.uni-wuerzburg.de

Germany, Bavaria
      Julius-Maximilians-University of Wuerzburg, Germany, Department of Dermatology, Wuerzburg,  Bavaria,  97080,  Germany; Recruiting
Juergen C Becker, MD, PhD  +49-931-201-26396    becker_jc@klinik.uni-wuerzburg.de 
Marion B Wobser  +49-931-201-26722    wobser_m@klinik.uni-wuerzburg.de 
Juergen C Becker, MD, PhD,  Principal Investigator

More Information

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.

Study ID Numbers:  SuMo-Sec-01; PEI 0899/01; IRB 07/03
Record last reviewed:  April 2005
Last Updated:  April 20, 2005
Record first received:  April 19, 2005
ClinicalTrials.gov Identifier:  NCT00108875
Health Authority: Germany: Paul-Ehrlich-Institut (Awaiting confirmation)
ClinicalTrials.gov processed this record on 2005-05-03


Source: ClinicalTrials.gov
Cache Date: May 4, 2005

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