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

NCT ID: NCT00149019

Last Updated: 2011-04-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-05-31
• Study Completion Date: 2005-09-30

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.

Conditions

Metastatic Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Cell therapy with bispecific antibodies

Intervention Type: DRUG

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Principal Investigators

Shimon Slavin, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

Hadassah Medical Organization

Jerusalem, , Israel

Countries

Israel

Other Identifiers

240502-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id