Effectiveness and Safety of INGN 201 in Combination With Chemotherapy Versus Chemotherapy Alone

Sponsors

Lead sponsor: Introgen Therapeutics

Source Introgen Therapeutics
Brief 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.

Overall Status Unknown status
Phase Phase 3
Study Type Interventional
Condition
Intervention

Intervention type: Genetic

Intervention name: INGN 201

Eligibility

Criteria:

- 18 years or older

- Must have had radiation treatment

- Eligible for chemotherapy

- Not eligible for surgery

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Overall Contact

Last name: Introgen Therapeutics, Inc.

Phone: 866.631.4646

Email: [email protected]

Location
facility status contact investigator
University of Arkansas | Little Rock, Arkansas, 72205, United States Recruiting Karen Duvall 501-526-7129 [email protected] James Suen, MD Principal Investigator
Unversity of Colorado Cancer Center | Aurora, Colorado, 80045, United States Recruiting Brittney Hines 720-848-0678 [email protected] Madeleine Kane, MD Principal Investigator
University of Miami Hospital and Sylvester Comprehensive Cancer Center | Miami, Florida, 33136, United States Recruiting Andrea Gachupin-Garcia 305-243-3379 [email protected] Jarrad Goodwin, MD Principal Investigator
Norton Healthcare Pavilion | Louisville, Kentucky, 40202, United States Recruiting Daniela Neamtu 502-629-4679 [email protected] John Hamm, MD Principal Investigator
Center Center of GBMC | Baltimore, Maryland, 21204, United States Recruiting Lauren Titus 443-849-3285 [email protected] Marshall Levine, MD Principal Investigator
WJB Dorn VA Medical Center | Columbia, South Carolina, 29209, United States Recruiting Justin Reynolds 803-776-4000 6074 [email protected] William Hrushesky, MD Principal Investigator
Mary Crowley Medical Research Center | Dallas, Texas, 75201, United States Recruiting Arlen Waclawczyk 214-658-1985 [email protected] John Nemunaitis, MD Principal Investigator
University of Texas, MD Andersen Cancer Center | Houston, Texas, 77030, United States Recruiting Aida Berryman 713-745-1428 [email protected] Gary Clayman, MD Principal Investigator
Location Countries

United States

Verification Date

September 2007

Keywords
Condition Browse
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov