Study to Compare the Overall Survival of Patients Receiving INGN 201 (Study Drug) With Patients Receiving Methotrexate

Sponsoren

Hauptsponsor: Introgen Therapeutics

Quelle Introgen Therapeutics
Kurze Zusammenfassung

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) will be compared to methotrexate in patients who have failed surgery, radiotherapy and chemotherapy with platinum or taxanes.

Gesamtstatus Unknown status
Phase Phase 3
Studientyp Interventional
Bedingung
Intervention

Interventionsart: Genetic

Interventionsname: INGN 201

Teilnahmeberechtigung

Kriterien:

- 18 years or older

- Not eligible for surgery

- Must have had radiation and chemotherapy treatments

- No prior methotrexate treatments

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: N/A

Gesunde Freiwillige: No

Insgesamt offiziell
Gesamtkontakt

Nachname: Introgen Therapeutics, Inc.

Telefon: 866.631.4646

Email: [email protected]

Ort
Einrichtung: Status: Kontakt: Ermittler:
Unversity of Colorado Cancer Center | Aurora, Colorado, 80045, United States Recruiting Brittney Hines 720-848-0678 [email protected] Madeleine Kane, MD Principal Investigator
Norton Healthcare Pavilion | Louisville, Kentucky, 40202, United States Recruiting Daniela Neamtu 502-629-4679 [email protected] John Hamm, MD Principal Investigator
Cancer 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
Standort Länder

United States

Überprüfungsdatum

March 2008

Schlüsselwörter
Bedingung Durchsuchen
Studiendesign Info

Zuweisung: Randomized

Interventionsmodell: Parallel Assignment

Hauptzweck: Treatment

Maskierung: None (Open Label)

Quelle: ClinicalTrials.gov