NCT00148993

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 1998

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1998

Completed
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
Last Updated

April 8, 2011

Status Verified

July 1, 2005

First QC Date

September 7, 2005

Last Update Submit

April 7, 2011

Conditions

Metastatic Solid Tumors

Keywords

Tumor cell vaccine

Outcome Measures

Primary Outcomes (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 Outcomes (1)

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

Interventions

Tumor Cell VaccineBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Karnofsky less than 60%. Unrelated condition requiring the use of any cytotoxic agents or immunosuppressive agents which may interfere with optimal immune response.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Tel Aviv, 64239, Israel

Location

MeSH Terms

Interventions

FANG vaccine

Study Officials

  • shimon slavin, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 8, 2005

Study Start

July 1, 1998

Study Completion

July 1, 2005

Last Updated

April 8, 2011

Record last verified: 2005-07

Locations

IL(1)