Gene Therapy in Treating Patients With Cancer

Phase 1

Completed

• Conditions: Cancer

• Registration Number: NCT00004178
• Lead Sponsor: Roger Williams Medical Center

Brief Summary

RATIONALE: Inserting a gene that has been created in the laboratory into a person's white blood cells may make the body build an immune response to kill cancer cells.

PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients who have cancer that has not responded to previous therapy.

Detailed Description

OBJECTIVES:

* Determine the safety and maximum tolerated dose of T cells activated in vitro and modified with chimeric anti-CEA immunoglobulin T cell receptors (Ig TCR) in patients with CEA expressing adenocarcinoma.

* Determine the pharmacokinetics of this regimen by the persistence of modified T cells in the blood of these patients.

* Evaluate the immunogenicity of murine sequences in chimeric anti-CEA Ig TCR.

* Assess immunologic parameters which correlate with the efficacy of this regimen in these patients.

* Evaluate, in a preliminary manner, the efficacy of this regimen in patients with CEA bearing tumors.

OUTLINE: This is a dose escalation study.

Peripheral blood lymphocytes (PBL) are harvested. PBL are activated in vitro and then modified with recombinant chimeric anti-CEA immunoglobulin T cell receptors (Ig TCR). Ig TCR modified T cells are reinfused over 30-60 minutes.

The estimated maximum tolerated dose (MTD) is defined as the dose at which 2 of 6 patients experience unacceptable toxicity. If the MTD is not reached within the first cohort, a second cohort of 3 patients then receives 4 doses of modified T cells at a higher dose.

Patients are followed every 2 weeks for 2 months.

PROJECTED ACCRUAL: A total of 6-9 patients will be accrued for this study.

Study Timeline

• Study Start: 1998-04
• Study First Submitted: 2000-01-21
• Primary Completion: 2000-12
• Study Completion: 2001-12
• Study First Submitted QC: 2004-04-16
• Study First Posted: 2004-04-19
• Status Verified: 2006-05
• Last Update Submitted: 2011-06-09
• Last Update Posted: 2011-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States