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Sponsored by: |
SynerGene Therapeutics, Inc. |
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Information provided by: | SynerGene Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT00470613 |
The purpose of this study is to evaluate the safety of a single course of SGT-53 and determine the recommended dose for evaluation in subsequent clinical studies for the treatment of solid phase tumors.
Condition | Intervention | Phase |
---|---|---|
Neoplasm |
Genetic: SGT53-01 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study |
Official Title: | A Phase I Open-Label Safety and Pharmacokinetic Study of Escalating Doses of SGT-53 for Infusion in Subjects With Advanced Solid Tumors |
Estimated Enrollment: | 10 |
Study Start Date: | February 2008 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
The p53 gene is a vital tumor suppressor gene in humans. Numerous human tumors possess a loss or mutation of wild type p53 (wtp53). In addition to playing a crucial role in cell cycle control, the p53 gene is a critical component in two of the pathways involved in regulating tumor cell growth: cell death (apoptosis) and the regulation of angiogenesis. The loss of such critical tumor suppressor activity is believed to be responsible for p53's involvement in such a broad array of human tumors and resistance to chemo/radiotherapy. SGT-53 is a complex composed of a wild type p53 gene (plasmid DNA) encapsulated in a liposome that is targeted to tumor cells by means of an anti-transferrin receptor single-chain antibody fragment (TfRscFv) attached to the outside of the liposome. This phase 1 dose escalation clinical study is designed to evaluate the safety and maximum tolerated dose (MTD) of SGT-53. In addition, pharmacokinetics of escalating doses of SGT-53 will be measured and correlated with tumor response and toxicity.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Laboratory values meeting the following criteria:
Exclusion Criteria:
Had within six months prior to enrollment any of the following:
Contact: Alyssa Roth | 972-566-3061 | aroth@marycrowley.org |
Contact: Beth Asilo | 214-370-1877 | basilo@marycrowley.org |
United States, Texas | |
Mary Crowley Medical Research Center | Recruiting |
Dallas, Texas, United States, 75201 | |
Contact: John J. Nemunaitis, MD 214-370-1870 jnemunaitis@marycrowley.org | |
Contact: Cynthia Bedell, MSN RN ANP-C 214-370-1870 cbedell@marycrowley.org | |
Principal Investigator: John J. Nemunaitis, MD | |
Sub-Investigator: Neil N. Senzer, MD | |
Sub-Investigator: Gerald Edelman, MD, PhD | |
Sub-Investigator: Carolyn M. Matthews, MD | |
Sub-Investigator: Shrinivas M. Diggikar, MD | |
Sub-Investigator: Jairo R. Olivares, MD | |
Sub-Investigator: Cynthia H. Bedell, MSN RN ANP-C | |
Sub-Investigator: Cara East, MD | |
Sub-Investigator: Jay G. Courtright, MD | |
Sub-Investigator: Charles S. White, III, MD | |
Sub-Investigator: Kartik Konduri, MD | |
Sub-Investigator: Joseph A. Kuhn, MD, FACS |
Principal Investigator: | John J. Nemunaitis, MD | Mary Crowley Medical Research Center |
Responsible Party: | SynerGene Therapeutics, Inc. ( Leanne S. Sleer, Ph.D. ) |
Study ID Numbers: | SGT53-01 |
Study First Received: | May 4, 2007 |
Last Updated: | May 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00470613 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Neoplasm |
Neoplasms |