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
Investigators:

  • Christine Chung

Overview

Study Title

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

Summary

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.

Objective

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.

Inclusion Criteria

  • Pathologically confirmed (histology or cytology) Stage II, III, or IVA squamous cell cancer of the oral cavity (excluding lip)
  • Disease surgically resectable with curative intent
  • Hematological function: hemoglobin >9 g/dL; lymphocyte count >500 x 10^9/mL; neutrophil count >1500 x 10^9/mL; platelet count >100,000 x 10^9/mL
  • Hepatic function: serum albumin >3.0 g/dL; aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) less than 3x the upper limits of normal (ULN); alkaline phosphatase less than 2x the ULN
  • Prothrombin time (PT) and partial thromboplastin time (PTT) less than 1.4x the ULN
  • Calculated creatinine clearance > 50 mL/minute
  • At least 18 years of age
  • Willing and able to give informed consent and adhere to protocol therapy
  • Karnofsky performance status (KPS) >=70%
  • Able and willing to use a medically acceptable form of pregnancy prevention
  • Negative urine/serum pregnancy test, if applicable

  • Exclusion Criteria

  • Prior surgery, radiation therapy, or chemotherapy other than biopsy or emergency procedure required for supportive care of this oral cavity cancer
  • Any medical contraindications or previous therapy that would preclude treatment with either IRX 2 Regimen 1 or 2 or the surgery, reconstruction or adjuvant therapy required to treat the oral tumor appropriately
  • Clinical status of either participant or tumor such that administration of 21 day neoadjuvant IRX-2 Regimen 1 or 2 before surgery would be medically inappropriate
  • Tumor of the oropharynx
  • Other clinical issues that would make participation in this clinical trial inappropriate