Expired Study
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Boston, Massachusetts 02215


Purpose:

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 summary:

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.


Criteria:

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


NCT ID:

NCT00004178


Primary Contact:

Study Chair
Richard P. Junghans, MD, PhD
Beth Israel Deaconess Medical Center


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02215
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 19, 2017

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