Clinical trialPhase 1Completed
Gene Therapy in Treating Patients With Cancer
Phase I Study of T Cells Modified With Chimeric AntiCEA Immunoglobulin-T Cell Receptors (IgTCR) in Adenocarcinoma
- Outcome
- Finished, no results posted
- Cell product
- CAR-T cells
Phase I Study of T Cells Modified With Chimeric AntiCEA Immunoglobulin-T Cell Receptors (IgTCR) in Adenocarcinoma
- Target antigen
- CEA
Phase I Study of T Cells Modified With Chimeric AntiCEA Immunoglobulin-T Cell Receptors (IgTCR) in Adenocarcinoma
- Cell source
- Autologous
Biological: therapeutic autologous lymphocytes
- Phase
- Phase 1
- Status
- Completed
- Study type
- Interventional
- Start
- April 1998
- Ended
- December 2001
- Sites
- 1
- Sponsor type
- Academic / other
- Results posted
- No
- Last update
- 10 June 2011
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Source text
Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.
Intervention public domain (ClinicalTrials.gov)
Biological: therapeutic autologous lymphocytes.
Eligibility public domain (ClinicalTrials.gov)
DISEASE CHARACTERISTICS: * Histologically proven CEA expressing adenocarcinoma * Serum CEA levels greater than 10 ng/mL * Failed standard therapy * Measurable disease PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * 0-2 Life expectancy: * Greater than 2 months Hematopoietic: * Not specified Hepatic: * No significant hepatic disease * Bilirubin no greater than 3 mg/dL * No active clinical disease caused by hepatitis B Renal: * No significant renal disease * Creatinine no greater than 3 mg/dL Cardiovascular: * No significant cardiovascular disease Pulmonary: * No significant pulmonary disease Other: * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception * No significant endocrine, rheumatologic, or allergic disease * No active clinical disease caused by cytomegalovirus or tuberculosis * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 4 weeks since prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since prior radiotherapy Surgery: * Not specified