Survivin Peptide Vaccination for Patients With Advanced Melanoma, Pancreatic, Colon and Cervical Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2005 by Julius-Maximilians University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Julius-Maximilians University
ClinicalTrials.gov Identifier:
NCT00108875
First received: April 19, 2005
Last updated: July 27, 2006
Last verified: June 2005
  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 1
Phase 2

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:

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

ClinicalTrials.gov processed this record on October 22, 2014