Gene Therapy in Treating Patients With Cancer
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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I Study of T Cells Modified With Chimeric AntiCEA Immunoglobulin-T Cell Receptors (IgTCR) in Adenocarcinoma|
|Study Start Date:||April 1998|
|Study Completion Date:||December 2001|
|Primary Completion Date:||December 2000 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004178
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Study Chair:||Richard P. Junghans, MD, PhD||Beth Israel Deaconess Medical Center|