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Treatment of Patients with Advanced Epithelial Ovarian Cancer using Anti-CD3 Stimulated Peripheral Blood Lymphocytes Transduced with a Gene Encoding a Chimeric T-Cell Receptor Reactive with Folate Binding Protein Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Treatment of Patients with Advanced Epithelial Ovarian Cancer using Anti-CD3 Stimulated Peripheral Blood Lymphocytes Transduced with a Gene Encoding a Chimeric T-Cell Receptor Reactive with Folate Binding Protein conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Treatment of Patients with Advanced Epithelial Ovarian Cancer using Anti-CD3 Stimulated Peripheral Blood Lymphocytes Transduced with a Gene Encoding a Chimeric T-Cell Receptor Reactive with Folate Binding Protein Clinical research trials and Treatment of Patients with Advanced Epithelial Ovarian Cancer using Anti-CD3 Stimulated Peripheral Blood Lymphocytes Transduced with a Gene Encoding a Chimeric T-Cell Receptor Reactive with Folate Binding Protein health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Treatment of Patients with Advanced Epithelial Ovarian Cancer using Anti-CD3 Stimulated Peripheral Blood Lymphocytes Transduced with a Gene Encoding a Chimeric T-Cell Receptor Reactive with Folate Binding Protein. Treatment of Patients with Advanced Epithelial Ovarian Cancer using Anti-CD3 Stimulated Peripheral Blood Lymphocytes Transduced with a Gene Encoding a Chimeric T-Cell Receptor Reactive with Folate Binding Protein Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Treatment of Patients with Advanced Epithelial Ovarian Cancer using Anti-CD3 Stimulated Peripheral Blood Lymphocytes Transduced with a Gene Encoding a Chimeric T-Cell Receptor Reactive with Folate Binding Protein clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Treatment of Patients with Advanced Epithelial Ovarian Cancer using Anti-CD3 Stimulated Peripheral Blood Lymphocytes Transduced with a Gene Encoding a Chimeric T-Cell Receptor Reactive with Folate Binding Protein condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > Treatment of Patients with Advanced Epithelial Ovarian Cancer using Anti-CD3 Stimulated Peripheral Blood Lymphocytes Transduced with a Gene Encoding a Chimeric T-Cell Receptor Reactive with Folate Binding Protein  Treatment of Patients with Advanced Epithelial Ovarian Cancer using Anti-CD3 Stimulated Peripheral Blood Lymphocytes Transduced with a Gene Encoding a Chimeric T-Cell Receptor Reactive with Folate Binding Protein
Treatment of Patients with Advanced Epithelial Ovarian Cancer using Anti-CD3 Stimulated Peripheral Blood Lymphocytes Transduced with a Gene Encoding a Chimeric T-Cell Receptor Reactive with Folate Binding Protein
For Condition: Ovarian Neoplasm
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: Patients with measurable recurrent disease are treated on Regimen A; those with minimal residual disease are treated on Regimen B. Regimen A: Gene Therapy/Biological Response Modifier Therapy. Peripheral blood lymphocytes (PBL) stimulated with OKT3 (anti-CD3) monoclonal antibody and retrovirally transduced with the anti-ovarian cancer MOv-gamma chimeric receptor gene (MOv-PBL); with Interleukin-2 (Chiron), IL-2, NSC-373364. Intravenous administration. Regimen B: Gene Therapy/Biological Response Modifier Therapy. MOv-PBL; with IL-2. Peritoneal administration.
Details: Patients with recurrent, evaluable ovarian cancer will receive intravenous therapy with autologous peripheral blood lymphocytes that have been genetically modified to recognize an ovarian cancer-associated antigen (MOv-PBL). The duration of survival in the systemic circulation and at the tumor site will be evaluated. Patients will also be evaluated for a clinical response.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry Criteria: INCLUSION CRITERIA Patients must have a biopsy-proven recurrent, resected recurrent, or residual epithelial ovarian cancer that has recurred following standard effective therapy including cisplatin/carboplatin or paclitaxel containing regimens. Age greater than or equal to 18 years. Clinical performance status of ECOG 0 or 1. Serum creatinine less than or equal to 2.0 mg/dl. Prior to infusion of MOv-PBL, more than 2 weeks must have elapsed since any prior therapy, besides surgical debulking. Women of child bearing potential must have a negative pregnancy test. Patients must have tumor that is positive on immunohistochemistry or FACS analysis for MOv18. Hgb greater than 9.0, WBC greater than 3000, and platelets greater than 100,000. Bilirubin 2.0 mg/dl or less and LFTs less than 3 times the upper limit of normal. FEV1 greater than 70% and DLCO greater than 70% predicted. Have an intact immune system, evidenced by a positive reaction to Candida Albicans skin tests, mumps skin test, or tetanus toxoid skin test on a standard anergy panel. EXCLUSION CRITERIA Require steroid therapy Are seropositive for HIV antibody. Are seropositive for hepatitis B antigen. Have active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular or respiratory systems are not eligible.
Total Enrollment: 50
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 960011; 96-C-0011
Study Start Date: November 6, 1995
Record last reviewed: October 1, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001494
Other Ovarian Neoplasm Studies:
1. Microarray Analysis for Human Genetic Disease
2. Experimental Drug SS1(dsFv)-PE38 to Treat Cancer
3. A Phase II Trial of Trastuzumab and Paclitaxel in Patients with HER2 Overexpressing Breast and Ovarian Tumors Who Have Relapsed or Progressive Disease Following Conventional Cytotoxic Chemotherapy Regimens for Metastatic Cancer
4. A Safety and Tolerability Study of Oral TAK-165 Administered to Subjects with Tumors Known to Express HER2
5. A Phase II Trial of Orally Administered CAI for Patients with Persistent or Refractory Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Related Studies:
Other Ovarian Neoplasm Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Treatment of Patients with Advanced Epithelial Ovarian Cancer using Anti-CD3 Stimulated Peripheral Blood Lymphocytes Transduced with a Gene Encoding a Chimeric T-Cell Receptor Reactive with Folate Binding Protein
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