Allogeneic Tumor Cell Vaccination in Patients With Solid Tumors

Metastatic Solid Tumors Clinical Trial

Official title:

Allogeneic Tumor Cell Vaccination in Patients With Solid Tumors

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00148993
• Other study ID #: 100798-HMO-CTIL
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: September 7, 2005
• Last updated: April 7, 2011
• Start date: July 1998
• Est. completion date: July 2005

Study information

• Verified date: July 2005
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 100
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Metastatic Solid Tumors

Intervention

Biological:
• Tumor Cell Vaccine

Locations

Country	Name	City	State
Israel	The International Center for Cell Therapy & Cancer Immunotherapy (CTCI)	Tel Aviv

Sponsors (2)

Lead Sponsor	Collaborator
Hadassah Medical Organization	The International Center for Cell Therapy & Cancer Immunotherapy (CTCI)

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigate the feasibility of anti-tumor immune response by allogeneic tumor cell vaccine using tumor cells that share MHC determinants with the patient.
Secondary	Investigate the feasibility of immune responses against cancer cells by combining allogeneic TCV with indomethacin, cimetidine, tetanus and rIL-2.