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

NCT00149019 | Withdrawn Phase 2

• 1 other identifier: 240502-HMO-CTIL
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• To evaluate primary efficacy using donor lymphocytes labelled in-vitro with bispecific antibodies for metastatic cancer patients.

Interventions

Cell therapy with bispecific antibodies DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

MeSH Terms

Interventions

Cell- and Tissue-Based Therapy; Antibodies, Bispecific

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Shimon Slavin, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 8, 2005
• Study Start: May 1, 2002
• Study Completion: September 1, 2005
• Last Updated: April 8, 2011

Record last verified: 2005-09

Locations

IL (1)