Radiotherapy, Cetuximab, and Injections of TNFerade™ Biologic for Elderly or Frail Patients With Head and Neck Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00496236|
Recruitment Status : Completed
First Posted : July 4, 2007
Last Update Posted : February 23, 2012
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer Head and Neck Neoplasms||Drug: TNFerade biologic||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Safety, Tolerability and "Proof of Concept" Study of Radiotherapy, Cetuximab, and Intratumoral Injections of TNFerade™ Biologic (AdGVEGR.TNF.11D) for Elderly or Frail Patients or Intermediate Stage Patients With Head and Neck Cancer|
- The maximum tolerated dose established in the Phase I (dose-finding) portion of the study will be used to assess the investigational drug's ability to enhance clinical outcome. The primary endpoint being locoregional control rate at 24 months.
- Locoregional control at 3,6, and 12 months, objective response rate, progression-free survival at 3,6,12, and 24 months, and the rate of distal metastases at 3,6, 12 and 24 months will also be assessed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00496236
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Everett Vokes,, MD||University of Chicago|