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| Study Summary No. GS97-183:.......Lung......Swisher, Stephen G., M.D.......Thoarcic & Cardiovascular |
| Study Summary Title |
| An Efficacy Study Of Adenoviral Vector Expressing Wildtype P53 (AD-P53) Administered Intralesionally As An Adjunct To Radiation Therapy In Patients With Non-Small Cell Lung Cancer | ||||
| Physician | New Patient Referral |
| Name: | Swisher, Stephen G., M.D. | Patients Call: | 800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.) | |
| Dept: | Thoarcic & Cardiovascular | Referring MD Call: | 800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.) | |
| Phone: | 713-792-6933 | |||
| Contact us about clinical trials |
| General Information. |
| Disease Group: | Lung | Sponsor(s): | Rhone-Poulenc Rorer | |
| Phase of Study: | 1&2 | Return Visit: | Daily for 5 weeks during rad therapy, week 6, 3 months, 6 months, then every 6 months | |
| Treatment Agents: | AD-P53 | Home Care: | None | |
| Treatment Loc: | ||||
| Estimated Length of Stay in Houston: | ||||
| Description of Study: |
| Enrollment Eligibility |
| Inclusion Criteria: | Signed informed consent Histologically confirmed non-small cell lung cancer w/ measurable disease clinical stage IB, II or III and in whom XRT is accepted standard of care as the initial therapy Has either an endobronchial tumor accessible by the bronchoscope with some clinical evidence of bronchial obstruction, or advanced local-regional cancer which is unresectable or medically inoperable Has not had XRT to the primary lesion or for any other reason involving the same region Life expectancy of >/= 12 weeks Karnofsky performance status of at least 60% at screening Age 18 and older Negative serum pregnancy test (serum HCG) if female and of child-bearing potential Negative serology for HIV 1 and HIV 2, Hepatitis B surface antigen and Hepatitis C antibody Agrees to use barrier contraception for the duration of the study Adequate bone marrow and hepatic function ANC >/= 2 x 1,000,000,000/L Platelet count of >/= 100 x 1,000,000,000/L Bilirubin </= upper limit of normal institutional range (ULN) AST/SGOT and/or ALT/SGPT </= 1.5 x ULN Stable cardiac condition (NYHC < III) Alkaline phosphatase </= 5 x ULN |
| Exclusion Criteria: | Pregnant or lactating Prior radiation performed to areas of measurable disease Serious concomitant medical conditions including active uncontrolled infection Receipt of systemic anti-cancer therapy for the treatment of primary lung cancer Active upper respiratory infections Prior experimental therapy directly injected into the lesion selected for treatment in this study Concurrent treatment w/ non-topical corticosteroids unless chronic treatment (>/= 6 mths) at low doses (</= 10 mg/day of oral prednisone or equivalent) History of malignancies other than the study malignancy unless curatively treated and disease free for 2 yrs or more Use of any investigational agent w/ in 4 wks of study treatment Prior gene therapy using adenoviral vector(s) Prior autologous or allogeneic organ/tissue transplant or foreseeable contact w/ former tissue/organ transplant recipients & persons known as suffering from severe immunodeficiency disease, w/in 28 days following last dose of Ad5CMV-p53 Psychological, familial, sociological or geographical conditions which do not permit study follow-up and compliance with the study protocol |