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

July 27, 2006 updated by: Julius-Maximilians University

Vaccination of Patients With Advanced Melanoma, Pancreatic, Colon and Cervical Cancer With HLA-A1, -A2 and -B35 Restricted Survivin Peptides

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

70

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Wuerzburg, Bavaria, Germany, 97080
        • Recruiting
        • Julius-Maximilians-University of Wuerzburg, Germany, Department of Dermatology
        • Contact:
        • Contact:
        • Principal Investigator:
          • Juergen C Becker, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Progression-free survival
Overall survival
Immunological response

Secondary Outcome Measures

Outcome Measure
Best response

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Julius-Maximilians University

Investigators

  • Principal Investigator: Juergen C Becker, MD, Department of Dermatology, University of Wuerzburg, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Study Registration Dates

First Submitted

April 19, 2005

First Submitted That Met QC Criteria

April 19, 2005

First Posted (Estimate)

April 20, 2005

Study Record Updates

Last Update Posted (Estimate)

July 28, 2006

Last Update Submitted That Met QC Criteria

July 27, 2006

Last Verified

June 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SuMo-Sec-01
  • PEI 0899/01
  • IRB 07/03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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