Gene Therapy in Treating Patients With Cancer
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|ClinicalTrials.gov Identifier: NCT00004178|
Recruitment Status : Completed
First Posted : April 19, 2004
Last Update Posted : June 10, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Biological: therapeutic autologous lymphocytes||Phase 1|
- 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 Type :||Interventional (Clinical Trial)|
|Official Title:||Phase I Study of T Cells Modified With Chimeric AntiCEA Immunoglobulin-T Cell Receptors (IgTCR) in Adenocarcinoma|
|Study Start Date :||April 1998|
|Primary Completion Date :||December 2000|
|Study Completion Date :||December 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|