Conditions: Squamous Cell Carcinoma of the Head and Neck
Keywords: Head and Neck Cancer Immunotherapy IRX-2 Mouth Cancer Throat Cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 27
Healthy volunteers: no

Brief summary:
This was a Phase 2a trial to investigate the safety and biological activity of the RIX-2 Regimen in patients with untreated, resectable squamous cell cancer of the head and neck (HNSCC).

Detailed description:
IRX-2 is a primary cell-derived biologic that reduces the immune suppression that is often seen in the cancer tumor micro-environment, restores immune function and activates a coordinated immune response against the tumor. IRX-2 is a complex proprietary therapeutic containing numerous active cytokine components, which restores and activates multiple immune cell types including T cells, dendritic cells, and natural killer cells to recognize and destroy tumors.

The present study administered the IRX-2 Regimen to 27 patients as a neoadjuvant (before surgery) therapy, and the main objective of the study was to determine the safety and tolerability of the IRX-2 regimen.

Arms:
arm 1: The IRX-2 regimen is the combination of a 2-week course of IRX-2 itself, an initial dose of cyclophosphamide, and a 3-week course of indomethacin, zinc supplementation, and omeprazole.

Interventions: intervention 1: IRX-2 intervention 2: Cyclophosphamide intervention 3: Indomethacin intervention 4: Zinc intervention 5: Omeprazole
Intervention descriptions: intervention 1: IRX-2 for 10 days (2 s.c. injections of 1 mL each day) into bilateral mastoid insertion regions. intervention 2: Single i.v. injection of low-dose (300 mg/m2) on Day 1 intervention 3: 21 days of oral indomethacin, 25 mg. 3 times daily intervention 4: 21 days of zinc gluconate (65 mg) as part of an oral multivitamin intervention 5: 21 days of 20 mg. orally

Protocol document: