Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase III | Treatment | Active | 18 and over | Pharmaceutical / Industry | T302 INTROGEN-T302, UCLA-0312111-01, NCT00041626 |
Summary
There is a need for more treatment options for patients with recurrent squamous cell cancer of the head and neck (SCCHN). These tumors usually have a variety of genetic defects that include disruption of the p53 pathway, a pathway that would ordinarily work to prevent the development of tumors. In this study the transfer of the p53 gene to tumor cells using a modified adenovirus (INGN 201) in combination with chemotherapy (cisplatin and fluorouracil) will be compared to chemotherapy with cisplatin and fluorouracil in patients who have failed surgery and radiotherapy.
Eligibility Criteria
- 18 years or older
- Must have had radiation treatment
- Eligible for chemotherapy
- Not eligible for surgery
Trial Lead Organizations/Sponsors
Introgen Therapeutics, Incorporated
| Kerstin Menander, MD |  | Study Director |
| Julie Sicam | | Study Chair |
| Introgen Therapeutics, Inc. | | Ph: 866.631.4646 |
| Email: clinicaltrials@introgen.com | ||
Trial Sites
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| U.S.A. | |||
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| Arkansas | |||
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| Little Rock | |||
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| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | |||
| Karen Duvall | Ph: 501-526-7129 | ||
| Email: kaduvall@uams.edu | |||
| James Yee Suen | Principal Investigator | ||
| Colorado | |||
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| Aurora | |||
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| University of Colorado Cancer Center at UC Health Sciences Center | |||
| Brittney Hines | Ph: 720-848-0678 | ||
| Email: Brittany.Hines@uchsc.edu | |||
| Madeleine A. Kane | Principal Investigator | ||
| Florida | |||
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| Miami | |||
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| University of Miami Sylvester Comprehensive Cancer Center - Miami | |||
| Andrea Gachupin-Garcia | Ph: 305-243-3379 | ||
| Email: agachupin@med.miami.edu | |||
| Jarrad Goodwin, MD | Principal Investigator | ||
| Kentucky | |||
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| Louisville | |||
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| Louisville Oncology at Norton Cancer Institute - Louisville | |||
| Daniela Neamtu | Ph: 502-629-4679 | ||
| Email: daniela.neamtu@nortonhealthcare.org | |||
| John Turner Hamm | Principal Investigator | ||
| Maryland | |||
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| Baltimore | |||
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| Greater Baltimore Medical Center Cancer Center | |||
| Lauren Titus | Ph: 443-849-3285 | ||
| Email: ltitus@gbmc.org | |||
| Marshall A. Levine | Principal Investigator | ||
| South Carolina | |||
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| Columbia | |||
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| Veterans Affairs Medical Center - Columbia | |||
| Justin Reynolds | Ph: 803-776-4000 Ext.6074 | ||
| Email: Justin.Reynolds@va.gov | |||
| William J. M. Hrushesky | Principal Investigator | ||
| Texas | |||
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| Dallas | |||
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| Mary Crowley Medical Research Center at Sammons Cancer Center | |||
| Arlen Waclawczyk | Ph: 214-658-1985 | ||
| Email: awaclawczyk@mcmrc.com | |||
| John J. Nemunaitis | Principal Investigator | ||
| Houston | |||
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| M. D. Anderson Cancer Center at University of Texas | |||
| Aida Berryman | Ph: 713-745-1428 | ||
| Email: atberryman@mdanderson.org | |||
| Gary L. Clayman | Principal Investigator | ||
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00041626
Information obtained from ClinicalTrials.gov on December 14, 2011
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