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

Metastatic Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00149019
• Other study ID #: 240502-HMO-CTIL
• Status: Withdrawn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• Status: Withdrawn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
• 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

• Metastatic Solid Tumors

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.