Clinical Trials Search
Clinical Trial 18789
Cancer Type: Head & Neck
Interventions:IRX-2; Indomethacin; cyclophosphamide; cytoxan (cyclophosphamide); multivitamin/mineral; omeprazole (Prilosec)
Study Type: Treatment
Phase of Study: Phase II
- Christine Chung
A Randomized Phase 2 Trial of Neoadjuvant and Adjuvant Therapy with the IRX-2 Regimen in Patients with Newly Diagnosed Stage II, III or IVA Squamous Cell Carcinoma of the Oral Cavity
The main purpose of this study is to find out the effects, good and/or bad, the study drugs have on study participants with their type of cancer. The study will also identify any side effects of the study drugs as they are used in this study.
Primary Objective: To determine if the event-free survival (EFS) of subjects treated with Regimen 1 is longer than for subjects treated with Regimen 2. Co-Primary Exploratory Objectives: To determine and compare between the Regimens: 1) changes in tumor size from baseline to surgery measured by CT scans (MRI also acceptable, so long as the same modality is used for baseline and pre-surgery scans). 2) changes from baseline to surgery in functional imaging as measured by PET scan. 3) lymphocyte infiltrates in the pre-treatment tumor biopsy, the surgical specimen and changes between these two samples. When aggregate EFS and overall survival (OS) data are unblinded, these data will be analyzed to seek any baseline characteristics that are correlated with differences in outcome between the Regimens. Secondary Objectives: 1) to determine if OS of subjects treated with Regimen 1 is longer than for subjects treated with Regimen 2. 2) to compare the safety of each Regimen. 3) to compare the feasibility of each Booster Regimen.