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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT00149019
First Posted: September 8, 2005
Last Update Posted: April 8, 2011
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.
Information provided by:
Hadassah Medical Organization
September 7, 2005
September 8, 2005
April 8, 2011
May 2002
Not Provided
The purpose will be to evaluate safety using donor lymphocytes labelled in-vitro with bispecific antibodies for metastatic cancer patients.
Same as current
Complete list of historical versions of study NCT00149019 on ClinicalTrials.gov Archive Site
To evaluate primary efficacy using donor lymphocytes labelled in-vitro with bispecific antibodies for metastatic cancer patients.
Same as current
Not Provided
Not Provided
 
Immunotherapy of Cancer Using Donor Lymphocytes Labelled With In-vitro Bispecific Antibodies.
Innovative Approaches for Targeted Immunotherapy of Cancer Using Donor Lymphocytes Labelled With In-vitro Bispecific Antibodies.

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Metastatic Solid Tumors
Drug: Cell therapy with bispecific antibodies
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
12
September 2005
Not Provided

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.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT00149019
240502-HMO-CTIL
Not Provided
Not Provided
Not Provided
Not Provided
Hadassah Medical Organization
Not Provided
Principal Investigator: Shimon Slavin, MD Hadassah Medical Organization
Hadassah Medical Organization
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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