A Phase 2, Open-label Trial of the Safety and Biological Effect of Subcutaneous IRX-2 (With Cyclophosphamide, Indomethacin, and Zinc) in Patients With Resectable Cancer of the Head and Neck
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 27
- Primary Endpoint
- Number of Participants With Adverse Events and Serious Adverse Events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Open Label
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Pathologically confirmed (histology) Squamous Cell Carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx.
- •No prior surgery, radiation therapy or chemotherapy of this tumor other than biopsy or emergency procedure required for supportive care.
- •Clinically staged Stage II, III, or IVA cancer, assessed to be surgically resectable with curative intent.
- •Life Expectancy of greater than 6 months
Exclusion Criteria
- •Stage IVB Squamous Cell Carcinoma
- •Use of any investigational agent within the previous 30 days
- •Uncontrolled cardiovascular disease
- •Myocardial infarction within the last 3 months
- •Abnormal hemoglobin, neutrophil, lymphocyte or platelet counts
- •Positive for hepatitis B or C or HIV
- •Evidence of distant metastases
- •Clinical gastritis or peptic ulcer within the last 6 months
- •Stroke within the last six months
Arms & Interventions
IRX-2 Regimen
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.
Intervention: IRX-2 (Biological)
IRX-2 Regimen
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.
Intervention: Cyclophosphamide (Drug)
IRX-2 Regimen
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.
Intervention: Indomethacin (Drug)
IRX-2 Regimen
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.
Intervention: Zinc (Drug)
IRX-2 Regimen
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.
Intervention: Omeprazole (Drug)
Outcomes
Primary Outcomes
Number of Participants With Adverse Events and Serious Adverse Events
Time Frame: Enrollment through 30 days post-surgery
The frequency of all Adverse Events (greater than 5%) is reported. All Serious Adverse Events were described.
Secondary Outcomes
- Overall Survival(Time from surgery to death or confirmed recurrent or progressive disease, assessed up to 3 years)
- Patient Tolerance of Surgery and Post-operative Adjuvant Therapy;(Following surgery and post-operative therapy (up to 39 days post surgery))
- Immune Competence as Measured by Skin Test Reactivity(At approx. 21 days, prior to surgery)
- Relationship Between Overall Survival (OS) and Immune Competence (Lymphocyte Infiltration, LI) in Participants With High LI and Low LI(At time of surgery, after treatment with IRX-2 Regimen, assessed up to 5 years)
- Clinical and Histological Tumor Responses(On approximately Day 21 (last day of treatment) prior to undergoing post-treatment surgery)
- Disease-free Survival(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)
- Number of Participants With High Lymphocyte Infiltration (LI) According to the Visual Analog Scale (VAS)(On approximately Day 21 (last day of treatment) prior to undergoing post-treatment surgery)