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This study has been withdrawn prior to enrollment.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
  Purpose

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 Intervention Phase
Metastatic Solid Tumors
Drug: Cell therapy with bispecific antibodies
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Innovative Approaches for Targeted Immunotherapy of Cancer Using Donor Lymphocytes Labelled With In-vitro Bispecific Antibodies.

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

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.

Estimated Enrollment: 12
Study Start Date: May 2002
Estimated Study Completion Date: September 2005
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00149019

Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Shimon Slavin, MD Hadassah Medical Organization
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00149019     History of Changes
Other Study ID Numbers: 240502-HMO-CTIL
Study First Received: September 7, 2005
Last Updated: April 7, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Antibodies
Immunoglobulins
Antibodies, Bispecific
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014