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Clinical Trial: Gene Therapy in Treating Patients With Cancer
This study has been suspended.
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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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Lung Cancer Pancreatic Cancer Gastric Cancer Salivary Gland Cancer Renal Cell Cancer Endometrial Cancer Esophageal Cancer Head and Neck Cancer Colorectal Cancer adult primary liver cancer ovarian epithelial cancer Bladder Cancer Colon Cancer Prostate Cancer Cervical Cancer Rectal Cancer Vaginal Cancer kidney tumor | Gene Transfer: T cells modified with chimeric anti-CEA immunoglobulin T cell receptors | Phase I |
MedlinePlus related topics: Bladder Cancer; Cancer; Cervical Cancer; Colorectal Cancer; Esophageal Cancer; Head and Neck Cancer; Kidney Cancer; Liver Cancer; Lung Cancer; Oral Cancer; Ovarian Cancer; Pancreatic Cancer; Prostate Cancer; Salivary Gland Disorders; Stomach Cancer; Uterine Cancer; Vaginal Cancer
Genetics Home Reference related topics: bladder cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Study of T Cells Activated In Vitro and Modified with Chimeric Anti-CEA Immunoglobulin T Cell Receptors (Ig TCR) and Reinfused in Patients with CEA Expressing Adenocarcinomas
Study start: April 1998
OBJECTIVES: I. 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. II. Determine the pharmacokinetics of this regimen by the persistence of modified T cells in the blood of these patients. III. Evaluate the immunogenicity of murine sequences in chimeric anti-CEA Ig TCR. IV. Assess immunologic parameters which correlate with the efficacy of this regimen in these patients. V. Evaluate, in a preliminary manner, the efficacy of this regimen in patients with CEA bearing tumors.
PROTOCOL 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.
Eligibility
Ages Eligible for Study: 18 Years and above
Criteria
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Histologically proven CEA expressing adenocarcinoma; Serum CEA levels greater than 10 ng/mL; Failed standard therapy
- Measurable disease
--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
--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
Location Information
Massachusetts
Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States
Richard P. Junghans, Study Chair, Beth Israel Deaconess Medical Center
More Information
Record last reviewed: April 2004
Last Updated: October 13, 2004
Record first received: January 21, 2000
ClinicalTrials.gov Identifier: NCT00004178
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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