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Allogeneic Tumor Cell Vaccination in Patients With Solid Tumors

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ClinicalTrials.gov Identifier: NCT00148993
Recruitment Status : Withdrawn (PI (Prof. Slavin) not longer work at Hadassah)
First Posted : September 8, 2005
Last Update Posted : April 8, 2011
Sponsor:
Collaborator:
The International Center for Cell Therapy & Cancer Immunotherapy (CTCI)
Information provided by:
Hadassah Medical Organization

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Metastatic Solid Tumors Biological: Tumor Cell Vaccine Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Allogeneic Tumor Cell Vaccination in Patients With Solid Tumors
Study Start Date : July 1998
Estimated Study Completion Date : July 2005
Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 :
  1. Investigate the feasibility of immune responses against cancer cells by combining allogeneic TCV with indomethacin, cimetidine, tetanus and rIL-2.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT00148993


Locations
Israel
The International Center for Cell Therapy & Cancer Immunotherapy (CTCI)
Tel Aviv, Israel, 64239
Sponsors and Collaborators
Hadassah Medical Organization
The International Center for Cell Therapy & Cancer Immunotherapy (CTCI)
Investigators
Principal Investigator: shimon slavin, MD The International Center for Cell Therapy & Cancer Immunotherapy (CTCI)
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Shimon Slavin MD, The International Center for Cell Therapy & Cancer Immunotherapy (CTCI)
ClinicalTrials.gov Identifier: NCT00148993     History of Changes
Other Study ID Numbers: 100798-HMO-CTIL
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: April 8, 2011
Last Verified: July 2005

Keywords provided by Hadassah Medical Organization:
Tumor cell vaccine

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs