Status:
COMPLETED
A Phase 2 Clinical Trial of the Safety and Effects of IRX-2 in Treating Patients With Operable Head and Neck Cancer
Lead Sponsor:
Brooklyn ImmunoTherapeutics, LLC
Conditions:
Squamous Cell Carcinoma of the Head and Neck
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 respo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00210470
Start Date
July 1 2005
End Date
March 1 2012
Last Update
December 11 2020
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