Allogeneic Tumor Cell Vaccination in Patients With Solid Tumors

This study has been withdrawn prior to enrollment.

(PI (Prof. Slavin) not longer work at Hadassah)

Sponsor:

Collaborator:

The International Center for Cell Therapy & Cancer Immunotherapy (CTCI)

Information provided by:

Hadassah Medical Organization

ClinicalTrials.gov Identifier:

NCT00148993

First received: September 7, 2005

Last updated: April 7, 2011

Last verified: July 2005

History of Changes

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 1 Phase 2


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label)
Official Title:	Allogeneic Tumor Cell Vaccination in Patients With Solid Tumors

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 (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

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: 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


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
Study First Received:	September 7, 2005
Last Updated:	April 7, 2011

Keywords provided by Hadassah Medical Organization:


Tumor cell vaccine

Additional relevant MeSH terms:


Vaccines Immunologic Factors Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 21, 2017

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