We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00149019
Recruitment Status : Withdrawn (the PI is no longer work at Hadassah)
First Posted : September 8, 2005
Last Update Posted : April 8, 2011
Sponsor:
Information provided by:

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  (Clinical Trial)
Estimated 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 2002
Estimated Study Completion Date : September 2005
Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. The purpose will be to evaluate safety using donor lymphocytes labelled in-vitro with bispecific antibodies for metastatic cancer patients.

Secondary Outcome Measures :
  1. To evaluate primary efficacy using donor lymphocytes labelled in-vitro with bispecific antibodies for metastatic cancer patients.

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00149019     History of Changes
Other Study ID Numbers: 240502-HMO-CTIL
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: April 8, 2011
Last Verified: September 2005

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