Official Title: “A Phase 2, Open-Label Trial of the Safety and Biological Effect of Pre-Operative Peri-Lymphatic Ultralow Dose IRX-2 (With Cyclophosphamide, Indomethacin, and Zinc) in Patients With Resectable Cancer of the Head and Neck”

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. Researchers hope that IRX-2 will help your immune system to mount a more effective attack on the cancer.

IRX-2 has been tested in two clinical studies involving over 50 patients with head and neck cancer. 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. In both trials, the researchers found evidence of tumor shrinkage. This may suggest that the immune system was attacking the cancer.

Keep in mind that these are only considered to be preliminary results that provide scientists with enough evidence to continue studying IRX-2. They need to conduct more trials to prove that IRX-2 works and can be made publicly available.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

IRX-2 is a biologic product that contains multiple cytokines produced under pharmaceutical standards from phytohemagglutinin (PHA) stimulated mononuclear cells obtained from normal donors. The IRX-2 regimen to be studied is the combination of a 2-week course of IRX-2 itself, an initial dose of cyclophosphamide and a 3-week course of indomethacin and zinc supplementation.

The present study is based in large part on observations made during an exploratory Phase 1-2 study of the safety and efficacy of the IRX-2 regimen performed at the Instituto Nacional de Cancerologia (INCAN), Mexico's National Cancer Institute. Patients with head and neck (HN) squamous cell carcinoma (SCC) were treated with the IRX-2 regimen, some as neoadjuvant therapy prior to surgery and some for advanced disease. Three different doses and dose schedules were studied. In the patients treated preoperatively, evaluation of tumor response was undertaken by comparison of tumor size before and after the IRX-2 regimen. Histological specimens were also graded by percent increase in lymphocyte infiltration and by tumor cell reduction or fragmentation. Evaluation of clinical safety included regular clinical and laboratory evaluations.

This study provided preliminary evidence of the safety and likely efficacy of IRX-2 in the pre-surgical, neoadjuvant treatment of HN SCC. The regimen was well tolerated in most patients, histological and clinical tumor responses were observed and overall survival appeared to be improved compared to similar patients treated at INCAN.

The current study utilizes the same IRX-2 regimen recently evaluated in a Phase 1 trial in patients with recurrent, refractory HN SCC performed at INCAN and the University of Kentucky, where the safety of the IRX-2 regimen was studied and some evidence of clinical activity was observed in 2 of 10 refractory patients.

The current study in patients with newly diagnosed, resectable HN SCC is being conducted to confirm the safety and biological effect of the IRX-2 regimen in a multi-institutional study in the same population to be studied in a planned randomized Phase 3 trial. The primary focus will be on observations made from the start of treatment through the planned surgical resection of the primary tumor.

Intervention(s) in this Clinical Trial

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

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: IRX Therapeutics

Overall Clinical Trial Officials and Contacts

Jeffrey S. Moyer, MD Principal Investigator University of Michigan Hospitals  

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00210470

Study ID Number: IRX-2 2005-A

ClinicalTrials.gov Identifier: NCT00210470

Health Authority: United States: Food and Drug Administration

IRX Therapeutics website