Phase I Study of T Cells Modified With Chimeric AntiCEA Immunoglobulin-T Cell Receptors (IgTCR) in Adenocarcinoma
therapeutic autologous lymphocytes
Urogenital Diseases+78
+ Genital Diseases
+ Adenocarcinoma
Treatment Study
Summary
Study start date: April 1, 1998
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Beth Israel Deaconess Medical Center
Boston, United StatesOpen Beth Israel Deaconess Medical Center in Google Maps