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

IRX-2 is designed to activate your own body's immune system so that it can better fight the invasion of head and neck cancer. In pre-clinical studies, IRX-2 has been shown to activate a number of different cells of the immune system.

IRX-2 was previously tested in a study of 13 patients with advanced head and neck cancer who had been previously treated and failed chemotherapy and/or radiation therapy. The trials were specifically designed to test the safety of IRX-2. Researchers found that IRX-2 did not appear to have major side effects. Also, the researchers believed that further study in less advanced head and neck cancer patients could be useful in obtaining more data on the safety of IRX-2 as well as data on possible effects on tumors and on patient survival.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

IRX Therapeutics

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