Working... Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00108875
Recruitment Status : Unknown
Verified June 2005 by Julius-Maximilians University.
Recruitment status was:  Recruiting
First Posted : April 20, 2005
Last Update Posted : July 28, 2006
Information provided by:
Julius-Maximilians University

Brief Summary:
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 or disease Intervention/treatment Phase
Malignant Melanoma Pancreatic Cancer Colon Cancer Cervical Cancer Biological: Survivin peptide vaccine Phase 1 Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2003

Primary Outcome Measures :
  1. Progression-free survival
  2. Overall survival
  3. Immunological response

Secondary Outcome Measures :
  1. Best response

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   19 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00108875

Layout table for location contacts
Contact: Juergen C Becker, MD, PhD +49-931-201-26396
Contact: Marion B Wobser +49-931-201-26722

Layout table for location information
Julius-Maximilians-University of Wuerzburg, Germany, Department of Dermatology Recruiting
Wuerzburg, Bavaria, Germany, 97080
Contact: Juergen C Becker, MD, PhD    +49-931-201-26396   
Contact: Marion B Wobser    +49-931-201-26722   
Principal Investigator: Juergen C Becker, MD, PhD         
Sponsors and Collaborators
Julius-Maximilians University
Layout table for investigator information
Principal Investigator: Juergen C Becker, MD Department of Dermatology, University of Wuerzburg, Germany


Layout table for additonal information Identifier: NCT00108875     History of Changes
Other Study ID Numbers: SuMo-Sec-01
PEI 0899/01
IRB 07/03
First Posted: April 20, 2005    Key Record Dates
Last Update Posted: July 28, 2006
Last Verified: June 2005

Keywords provided by Julius-Maximilians University:
Peptide vaccine therapy

Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Neoplasms
Uterine Cervical Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Immunologic Factors
Physiological Effects of Drugs