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Innovative Approaches for Targeted Immunotherapy of Cancer Using Donor Lymphocytes Labelled With In-vitro Bispecific Antibodies.


Phase 2
N/A
N/A
Not Enrolling
Both
Metastatic Solid Tumors

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Trial Information

Innovative Approaches for Targeted Immunotherapy of Cancer Using Donor Lymphocytes Labelled With In-vitro Bispecific Antibodies.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Shimon Slavin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hadassah Medical Organization

Authority:

Israel: Israeli Health Ministry Pharmaceutical Administration

Study ID:

240502-HMO-CTIL

NCT ID:

NCT00149019

Start Date:

May 2002

Completion Date:

September 2005

Related Keywords:

  • Metastatic Solid Tumors

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