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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00149019
Other study ID # 240502-HMO-CTIL
Secondary ID
Status Withdrawn
Phase Phase 2
First received September 7, 2005
Last updated April 7, 2011
Start date May 2002
Est. completion date September 2005

Study information

Verified date September 2005
Source Hadassah Medical Organization
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 12
Est. completion date September 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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.

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Cell therapy with bispecific antibodies


Locations

Country Name City State
Israel Hadassah Medical Organization Jerusalem

Sponsors (1)

Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary The purpose will be to evaluate safety using donor lymphocytes labelled in-vitro with bispecific antibodies for metastatic cancer patients.
Secondary To evaluate primary efficacy using donor lymphocytes labelled in-vitro with bispecific antibodies for metastatic cancer patients.
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