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Allogeneic Tumor Cell Vaccination in Patients With Solid Tumors
This study is currently recruiting participants.
Verified by Hadassah Medical Organization, July 2005
First Received: September 7, 2005   Last Updated: January 17, 2006   History of Changes
Sponsor: Hadassah Medical Organization
Information provided by: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00148993
  Purpose

The goal of this study is to apply allogeneic tumor cell vaccination for immunotherapy in patients with micro-metastatic disease and/or in patients at high risk disease progression. The present study will use allogeneic tumor cell lines for tumor cell vaccines that share MHC determinants with the patient aiming to overcome possible restriction of antigen presentation.


Condition Intervention Phase
Metastatic Solid Tumors
Biological: Tumor Cell Vaccine
Phase I
Phase II

Study Type: Interventional
Study Design: Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Allogeneic Tumor Cell Vaccination in Patients With Solid Tumors

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Investigate the feasibility of anti-tumor immune response by allogeneic tumor cell vaccine using tumor cells that share MHC determinants with the patient.

Secondary Outcome Measures:
  • Investigate the feasibility of immune responses against cancer cells by combining allogeneic TCV with indomethacin, cimetidine, tetanus and rIL-2.

Estimated Enrollment: 100
Study Start Date: July 1998
Estimated Study Completion Date: July 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with measurable metastatic disease or disease resistant to chemotherapy or with minimal residual disease at high risk to relapse.

Exclusion Criteria:

  • Karnofsky less than 60%. Unrelated condition requiring the use of any cytotoxic agents or immunosuppressive agents which may interfere with optimal immune response.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00148993

Contacts
Contact: Shimon Slavin, MD +972-2-6776561 slavin@cc.huji.ac.il
Contact: Reuven Or, MD +972-2-6778352 reuvenor@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Recruiting
Jerusalem, Israel, 911230
Contact: Arik Tzukert, DMD     +972-2-6776095     arik@hadassah.org.il    
Contact: Hadas Lemberg, PhD     +972-2-6777572     lhadas@hadassah.org.il    
Principal Investigator: Shimon Slavin, MD            
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Shimon Slavin, MD Hadassah Medical Organization
  More Information

No publications provided

Study ID Numbers: 100798-HMO-CTIL
Study First Received: September 7, 2005
Last Updated: January 17, 2006
ClinicalTrials.gov Identifier: NCT00148993     History of Changes
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
Tumor cell vaccine

ClinicalTrials.gov processed this record on February 08, 2010