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| Sponsor: | Neotropix |
|---|---|
| Information provided by: | Neotropix |
| ClinicalTrials.gov Identifier: | NCT00314925 |
Purpose
The primary purpose of the study is to determine if Seneca Valley Virus may be administered safely to patients with certain types of advanced cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoid Neuroendocrine |
Drug: Seneca Valley Virus (biological agent) |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Phase I Dose-Escalation Study of Seneca Valley Virus (SVV-001), a Replication-Competent Picornavirus, in Patients With Advanced Solid Tumors With Neuroendocrine Features |
| Estimated Enrollment: | 60 |
| Study Start Date: | April 2006 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: Seneca Valley Virus (biological agent)
Dose escalation (starting at 1 × 10^7 vp/kg), IV (in the vein) over 1 hour in a single administration
|
This is the first study in man of Seneca Valley Virus, a virus which seeks and kills certain tumors in non-human model systems. Subjects in this trial will be patients with advanced cancer displaying certain specified neuroendocrine features, pathologically; they will have exhausted standard methods of treatment for their tumor. The primary purpose of the trial is to determine if the virus may be administered safely. Additional purposes are to learn about the distribution of the virus in the body, the elimination of the virus from the body, the immune response to the virus and whether the virus might have some beneficial effects upon the tumors which the patients have. The first patients will be treated with low amounts of virus and subsequent patients may receive higher amounts. At the end of the trial, it is intended to select a dose for further study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate bone marrow, hepatic, and renal function as defined below:
creatinine <= 1.5 x upper limit of normal OR
Exclusion Criteria:
Contacts and Locations| United States, Florida | |
| Cancer Centers of Florida | Recruiting |
| Ocoee, Florida, United States, 34761 | |
| Contact: Lynn Hogue 407-297-6735 lynn.hogue@usoncology.com | |
| Principal Investigator: Carlos A. Alemany, MD | |
| United States, Indiana | |
| Central Indiana Cancer Centers | Recruiting |
| Indianapolis, Indiana, United States, 46219 | |
| Contact: Yvonne LaFary 317-964-5200 yvonne.lafary@usoncology.com | |
| Principal Investigator: David Loesch, MD | |
| United States, Maryland | |
| The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting |
| Baltimore, Maryland, United States, 21231 | |
| Contact: Barbara Coleman 410-502-3474 bcolema1@jhmi.edu | |
| Principal Investigator: Charles Rudin, MD, PhD | |
| United States, New York | |
| New York Oncology Hematology P.C. | Recruiting |
| Albany, New York, United States, 12208 | |
| Contact: Michele Butler 518-489-2607 michele.butler@usoncology.com | |
| Principal Investigator: Lawrence Garbo, MD | |
| United States, Ohio | |
| Dayton Oncology & Hematology, P.A . | Recruiting |
| Kettering, Ohio, United States, 45409 | |
| Contact: Michelle Owens 937-528-0317 michelle.owens@usoncology.com | |
| Principal Investigator: Robert Raju, MD | |
| United States, South Carolina | |
| Cancer Centers of the Carolinas | Recruiting |
| Greenville, South Carolina, United States, 29605 | |
| Contact: Lisa Johnson 864-679-3966 Lisa.Johnson@usoncology.com | |
| Contact: Sebrina Madden 864-679-3966 Sebrina.Madden@USONCOLOGY.COM | |
| Principal Investigator: Joe Stephenson, MD | |
| United States, Texas | |
| Tyler Cancer Center | Recruiting |
| Tyler, Texas, United States, 75702 | |
| Contact: Linda Dunklin 903-579-9867 linda.dunklin@usoncology.com | |
| Principal Investigator: Don Richards, MD | |
| Mary Crowley Research Center | Recruiting |
| Dallas, Texas, United States, 75201 | |
| Contact: Ned Adams, RN 214-370-1815 nadams@marycrowley.org | |
| Principal Investigator: Neil Senzer, MD | |
| United States, Virginia | |
| Virginia Oncology Associates | Recruiting |
| Norfolk, Virginia, United States, 23502 | |
| Contact: Gabrielle Geho 757-213-5637 gabrielle.geho@usoncology.com | |
| Principal Investigator: Paul Conkling, MD | |
| United States, Washington | |
| Northwest Cancer Specialists - Vancouver Cancer Center | Recruiting |
| Vancouver, Washington, United States, 98684 | |
| Contact: Judy Welch 360-449-6522 judith.welch@usoncology.com | |
| Principal Investigator: David Smith, MD | |
| Study Chair: | Rudin Charles, MD, PhD | Sidney Kimmel Comprehensive Cancer Center |
More Information
| Responsible Party: | Theradex, Inc. ( Margaret Valnoski, President ) |
| Study ID Numbers: | N05-10564 |
| Study First Received: | April 13, 2006 |
| Last Updated: | September 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00314925 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
advanced carcinoma carcinoid neuroendocrine features oncolytic virus phase I study dose escalation study rhabdomyosarcoma alveolar rhabdomyosarcoma medulloblastoma |
rhabdoid glioblastoma ewing's sarcoma pediatric oncologies neuroblastoma wilms' tumor retinoblastoma Large cell lung cancer |
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Neuroectodermal Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue |
Carcinoid Tumor Adenocarcinoma Neoplasms, Glandular and Epithelial Carcinoma Neuroendocrine Tumors |