Immunotherapy of Cancer Using Donor Lymphocytes Labelled With In-vitro Bispecific Antibodies.

This study has been withdrawn prior to enrollment.

(the PI is no longer work at Hadassah)

Sponsor:

Information provided by:

Hadassah Medical Organization

ClinicalTrials.gov Identifier:

NCT00149019

First received: September 7, 2005

Last updated: April 7, 2011

Last verified: September 2005

History of Changes

Tracking Information

First Received Date ^ICMJE

September 7, 2005

Last Updated Date

April 7, 2011

Start Date ^ICMJE

May 2002

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

The purpose will be to evaluate safety using donor lymphocytes labelled in-vitro with bispecific antibodies for metastatic cancer patients.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00149019 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To evaluate primary efficacy using donor lymphocytes labelled in-vitro with bispecific antibodies for metastatic cancer patients.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Immunotherapy of Cancer Using Donor Lymphocytes Labelled With In-vitro Bispecific Antibodies.

Official Title ^ICMJE

Innovative Approaches for Targeted Immunotherapy of Cancer Using Donor Lymphocytes Labelled With In-vitro Bispecific Antibodies.

Brief Summary

Patients with resistant metastatic solid tumors failing all conventional modalities who are eligible for immunotherapy by bispecific antibodies.

First step: NST Second step: Patients with tumor cells expressing positive Her-2Neu and/or EpCAM with residual or recurrent disease following NST will be candidates for donor lymphocytes immunotherapy using bispecific antibodies.

Patients with no matched donor available, expressing positive Her-2Neu and/or EpCAM tumor cells, will be eligible for donor mismatched lymphocytes using in-vitro rIL-2 activated allogeneic lymphocytes targeted to the tumor by bispecific antibodies, Her-2Neu and/or EpCAM.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Metastatic Solid Tumors

Intervention ^ICMJE

Drug: Cell therapy with bispecific antibodies

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients with metastatic solid tumors expressing Her-2/Neu or EpCAM, with available match donor for NST.
Patients with metastatic solid tumors not expected to be cured failing available conventional modalities, age >18, with no upper age limit.
Patients with metastatic breast cancer failing treatment with Herceptin.
Patients with metastatic cancer cells expressing Her-2/Neu or EpCAM.
Patients with evidence of disease following allogeneic stem cell transplantation with tumor cells expressing Her-2/Neu or EpCAM.
Karnofsky performance status >60%
Life expectancy > 3 months, to be able to assess response.

Exclusion Criteria:

Patients not fulfilling any of the above.
Patients with active or ongoing infection that may endanger their life, whenever immunosuppression may be counter-indicated.
Pregnant or lactating women.
Patients positive for HIV.

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Israel

Administrative Information

NCT Number ^ICMJE

NCT00149019

Other Study ID Numbers ^ICMJE

240502-HMO-CTIL

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Hadassah Medical Organization

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Shimon Slavin, MD

Hadassah Medical Organization

Information Provided By

Hadassah Medical Organization

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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