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This study has been withdrawn prior to enrollment.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:
Hadassah Medical Organization
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
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label |
| 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
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
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
No publications provided
| 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 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Keywords provided by Hadassah Medical Organization:
|
Tumor cell vaccine |
ClinicalTrials.gov processed this record on March 03, 2015