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Gene Therapy in Treating Patients With Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Gene Therapy in Treating Patients With Cancer conditions. Clinical Trials Search.org is a website devoted 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 healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Gene Therapy in Treating Patients With Cancer. Gene Therapy in Treating Patients With Cancer Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Gene Therapy in Treating Patients With Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their Gene Therapy in Treating Patients With Cancer condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid 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
Other Renal Cell Cancer Studies:
1. Gene Therapy in Treating Patients With Cancer
2. Phase I/II Open Label Multi-Center Study of CpG 7909 in Patients with Stage IV Renal Cell Cancer
3. Indium In 111 Pentetreotide in Treating Patients With Refractory Cancer
4. Avastin With or Without Erlotinib for Treatment of Metastatic Renal Cell Carcinoma
5. Phase I Study of SU006668 in Patients With Advanced Solid Tumors
Related Studies:
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Other Boston Clinical Trials
Gene Therapy in Treating Patients With Cancer
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