Trials / Completed
CompletedNCT00004178
Gene Therapy in Treating Patients With Cancer
Phase I Study of T Cells Modified With Chimeric AntiCEA Immunoglobulin-T Cell Receptors (IgTCR) in Adenocarcinoma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Roger Williams Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | therapeutic autologous lymphocytes |
Timeline
- Start date
- 1998-04-01
- Primary completion
- 2000-12-01
- Completion
- 2001-12-01
- First posted
- 2004-04-19
- Last updated
- 2011-06-10
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00004178. Inclusion in this directory is not an endorsement.