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Sponsored by: |
Beth Israel Deaconess Medical Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004178 |
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 | Intervention | Phase |
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Cancer |
Biological: therapeutic autologous lymphocytes |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Study of T Cells Modified With Chimeric AntiCEA Immunoglobulin-T Cell Receptors (IgTCR) in Adenocarcinoma |
Study Start Date: | April 1998 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven CEA expressing adenocarcinoma
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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 |
Study ID Numbers: | CDR0000067388, BIDMC-941101148, NEDH-941101148, NCI-V99-1577 |
Study First Received: | January 21, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00004178 History of Changes |
Health Authority: | United States: Federal Government |
stage III colon cancer stage IV colon cancer stage III gastric cancer stage IV gastric cancer recurrent gastric cancer recurrent non-small cell lung cancer stage II pancreatic cancer stage III pancreatic cancer recurrent pancreatic cancer stage III rectal cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer stage II esophageal cancer stage III esophageal cancer |
stage IV esophageal cancer recurrent esophageal cancer stage III cervical cancer recurrent cervical cancer stage IVB cervical cancer stage IVA cervical cancer adenocarcinoma of the prostate stage III renal cell cancer stage IV renal cell cancer recurrent renal cell cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer recurrent ovarian epithelial cancer adenocarcinoma of the stomach extensive stage small cell lung cancer |
Cystadenocarcinoma, Serous Rectal Neoplasms Pancreatic Neoplasms Esophageal Neoplasms Vaginal Cancer Endometrial Cancer Bile Duct Cancer, Extrahepatic Pancrelipase Carcinoma, Endometrioid Liver Neoplasms Renal Cancer Adenocarcinoma, Clear Cell Lung Neoplasms Stomach Neoplasms Metaplasia |
Bladder Neoplasm Salivary Gland Diseases Immunoglobulins Vaginal Neoplasms Kidney Cancer Rectal Neoplasm Urinary Bladder Neoplasms Esophageal Cancer Ovarian Epithelial Cancer Recurrence Carcinoma Carcinoma, Small Cell Gall Bladder Cancer Antibodies Rectal Cancer |
Neoplasms Neoplasms by Histologic Type Adenocarcinoma Neoplasms, Glandular and Epithelial Carcinoma |