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

Sponsor

Hadassah Medical Organization (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00149019

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Solid Tumors	Drug: Cell therapy with bispecific antibodies	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2002

Anticipated Study Completion Date :

Sep 1, 2005

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hadassah Medical Organization	Jerusalem		Israel	91120

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

Principal Investigator: Shimon Slavin, MD, Hadassah Medical Organization

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00149019

Other Study ID Numbers:

240502-HMO-CTIL

First Posted:

Sep 8, 2005

Last Update Posted:

Apr 8, 2011

Last Verified:

Sep 1, 2005

Additional relevant MeSH terms:

Antibodies

Antibodies, Bispecific

Study Results

No Results Posted as of Apr 8, 2011