Radiotherapy, Cetuximab, and Injections of TNFerade™ Biologic for Elderly or Frail Patients With Head and Neck Cancer
This study is looking at the safety and tolerability of TNFeradeä Biologic combined with conventional once daily radiation therapy in elderly or frail patients with new onset locally advanced head and neck tumors.
Head and Neck Cancer
Head and Neck Neoplasms
Drug: TNFerade biologic
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.