Allogeneic Tumor Cell Vaccination in Patients With Solid... | NCT00148993

Studies
Allogeneic Tumor Cell Vaccination in Patients With Solid Tumors

NCT00148993

Sponsor

Hadassah Medical Organization

Status

Withdrawn

Last Update Posted

Apr 8, 2011Estimated

Enrollment

100Estimated

Phase

Phase 1Phase 2

Conditions

Metastatic Solid Tumors

Interventions

Tumor Cell Vaccine

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2005

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI (Prof. Slavin) not longer work at Hadassah

Expanded Access Info

Start Date

Jul 1998

Primary Completion Date

Not provided

Completion Date

Jul 2005Estimated

First Submitted Date

Sep 7, 2005

First Submission Date that Met QC Criteria

Sep 7, 2005

First Posted Date

Sep 8, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 7, 2011

Last Update Posted Date

Apr 8, 2011Estimated

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

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Name	Type	Description	Arm Group Labels	Other Names
Tumor Cell Vaccine	Biological

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
shimon slavin, MD	The International Center for Cell Therapy & Cancer Immunotherapy (CTCI)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The International Center for Cell Therapy & Cancer Immunotherapy (CTCI)		Tel Aviv		64239	Israel

Intervention Browse Module

MeSH Terms

ID	Term
C573235	FANG vaccine

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided