Trial Search Results

A Phase 2 Clinical Trial of the Safety and Effects of IRX-2 in Treating Patients With Operable Head and Neck Cancer

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).

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Brooklyn ImmunoTherapeutics, LLC

Intervention(s):

  • Biological: IRX-2
  • Drug: Cyclophosphamide
  • Drug: Indomethacin
  • Drug: Zinc
  • Drug: Omeprazole

Phase:

Phase 2

Eligibility


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

Ages Eligible for Study

18 Years - 80 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting