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Gene Therapy in Treating Patients With Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Gene Therapy in Treating Patients With Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Gene Therapy in Treating Patients With Cancer Clinical research trials and Gene Therapy in Treating Patients With Cancer medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Gene Therapy in Treating Patients With Cancer. Gene Therapy in Treating Patients With Cancer Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Gene Therapy in Treating Patients With Cancer clinical trial. Participants frequently obtain the most expert healthcare available for their Gene Therapy in Treating Patients With Cancer condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "G" Clinical Trials Conditions > Gene Therapy in Treating Patients With Cancer  Gene Therapy in Treating Patients With Cancer
Gene Therapy in Treating Patients With Cancer
For Condition: Head and Neck Cancer,adult primary liver cancer,Lung Cancer,Colon Cancer,Endometrial Cancer,kidney tumor,Vaginal Cancer,Rectal Cancer,Pancreatic Cancer,ovarian epithelial cancer,Prostate Cancer,Renal Cell Cancer,Esophageal Cancer,Cervical Cancer,Gastric Cancer,Salivary Gland Cancer,Colorectal Cancer,Bladder Cancer
Status: Suspended
Sponsor(s): Beth Israel Deaconess Medical Center ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RichardJunghans, Study Chair, Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Additional Information:
Study ID Numbers: CDR0000067388; NEDH-941101148,NCI-V99-1577
Study Start Date: April 1998
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004178
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2. Endoscopic Placement of Metal Stent in Patients With Cancer-Related Bowel Obstruction
3. Chemoprevention with Folic Acid
4. Interleukin-12 in Treating Patients With Cancer in the Abdomen
5. Octreotide as Palliative Therapy for Cancer-Related Bowel Obstruction That Cannot Be Removed by Surgery
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Gene Therapy in Treating Patients With Cancer
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