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 II

Further Study Details: 

Primary Outcomes: The purpose will be to evaluate safety using donor lymphocytes labelled in-vitro with bispecific antibodies for metastatic cancer patients.
Secondary Outcomes: To evaluate primary efficacy using donor lymphocytes labelled in-vitro with bispecific antibodies for metastatic cancer patients.
Expected Total Enrollment:  12

Genders Eligible for Study:  Both

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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00149019

Shimon Slavin, MD      +972-2-6776561    slavin@hadassah.org.il

Israel
      Hadassah Medical Organization, Jerusalem,  91120,  Israel; Recruiting

Study chairs or principal investigators

Shimon Slavin, MD,  Principal Investigator,  Hadassah Medical Organization   

Study ID Numbers:  31-24-05-02
Last Updated:  September 7, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00149019
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration
ClinicalTrials.gov processed this record on 2005-09-13