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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This study has been withdrawn prior to enrollment.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
  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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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
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 May 21, 2013