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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
IRX-2 for 10 days (2 s.c. injections of 1 mL each day) into bilateral mastoid insertion regions.
Single i.v. injection of low-dose (300 mg/m2) on Day 1
21 days of oral indomethacin, 25 mg. 3 times daily
Number of Participants With Adverse Events and Serious Adverse Events
The frequency of all Adverse Events (greater than 5%) is reported. All Serious Adverse Events were described.
Time frame: Enrollment through 30 days post-surgery
Clinical and Histological Tumor Responses
Number of participants with the specified percent change in size of target lesion is presented
Time frame: On approximately Day 21 (last day of treatment) prior to undergoing post-treatment surgery
Patient Tolerance of Surgery and Post-operative Adjuvant Therapy;
Patient Tolerance of Surgery and Post-operative Adjuvant Therapy as measured by median days spent in the hospital, intensive care unit, and step down unit.
Time frame: Following surgery and post-operative therapy (up to 39 days post surgery)
Immune Competence as Measured by Skin Test Reactivity
To assess measures of immune competence following administration of the IRX-2 regimen, including skin test reactivity.
Time frame: At approx. 21 days, prior to surgery
Disease-free Survival
Estimate disease-free survival (DFS) (time from surgery to death or clinically apparent, biopsy confirmed recurrent or progressive disease after the completion of initial therapy, assessed up to 3 years; margins of resection positive for tumor will not be considered disease recurrence).
Time frame: Time from surgery to death or clinically apparent, biopsy confirmed recurrent or progressive disease after the completion of initial therapy, assessed up to 3 years; margins of resection positive for tumor will not be considered disease recurrence
Overall Survival
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21 days of zinc gluconate (65 mg) as part of an oral multivitamin
21 days of 20 mg. orally
Estimate overall survival (OS) in patients receiving the IRX-2 regimen. IRX-2 is currently being studied in an on-going Phase 2b clinical trial in patients with newly diagnosed Stage II, III, and IVA squamous cell carcinoma of the oral cavity (INSPIRE)
Time frame: Time from surgery to death or confirmed recurrent or progressive disease, assessed up to 3 years
Number of Participants With High Lymphocyte Infiltration (LI) According to the Visual Analog Scale (VAS)
Immunologic response features were extracted and quantified using a VAS of 0-100 mm to provide for a more continuous variable than the 0-4+ scale that is often used to assess histological responses. The scoring was such that 100 represented the maximum for any sample and 0 represented the lack of any parameter of interest. See publication of Berinstein, et al., 2012 for complete details.
Time frame: On approximately Day 21 (last day of treatment) prior to undergoing post-treatment surgery
Relationship Between Overall Survival (OS) and Immune Competence (Lymphocyte Infiltration, LI) in Participants With High LI and Low LI
After participants completed the IRX-2 regimen and the tumor resection was performed, tumor pathology was evaluated from tissue specimens obtained at tumor resection. Formalin-fixed, paraffin-embedded blocks, or unstained slides from the primary tumor were submitted to an independent pathology laboratory for hematoxylin and eosin staining, and evaluation of lymphocyte infiltration (LI). Participants were grouped into a "low LI" and "high LI" group based on the change in lymphocyte infiltration from the pretreatment tumor biopsy to the post-treatment tumor surgical resection. 5-year overall survival probabilities were then estimated (Kaplan-Meier) between the "low LI" and "high LI" groups
Time frame: At time of surgery, after treatment with IRX-2 Regimen, assessed up to 5 years