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

Phase 2

Withdrawn

• Conditions: Metastatic Solid Tumors

• Registration Number: NCT00149019
• Lead Sponsor: Hadassah Medical Organization

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 available

Study Timeline

• Study Start: 2002-05
• Status Verified: 2005-09
• Study Completion: 2005-09
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-08
• Last Update Submitted: 2011-04-07
• Last Update Posted: 2011-04-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel