Phase 2
Completed N=27
A Phase 2 Clinical Trial of the Safety and Effects of IRX-2 in Treating Patients With Operable Head and Neck Cancer
Source: ClinicalTrials.gov NCT00210470 ↗Enrolled (actual)
27
Serious AEs
25.9%
Results posted
Feb 2012
Primary outcomePrimary: Number of Participants With Adverse Events and Serious Adverse Events — 6; 8; 6; 4 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events and Serious Adverse Events |
6; 8; 6; 4; 4; 3 | — |
| SECONDARY Clinical and Histological Tumor Responses |
4; 7; 9; 1; 0; 2 | <0.10 |
| SECONDARY Patient Tolerance of Surgery and Post-operative Adjuvant Therapy; |
8.5; 0.5; 0.5 | — |
| SECONDARY Immune Competence as Measured by Skin Test Reactivity |
12; 6; 6; 2; 3 | — |
| SECONDARY Disease-free Survival |
0.721; 0.641; 0.620 | — |
| SECONDARY Overall Survival |
92; 73; 69 | — |
| SECONDARY Number of Participants With High Lymphocyte Infiltration (LI) According to the Visual Analog Scale (VAS) |
18 | — |
| SECONDARY Relationship Between Overall Survival (OS) and Immune Competence (Lymphocyte Infiltration, LI) in Participants With High LI and Low LI |
0.80; 0.50 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00210470). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.