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A Phase 2, Open-label Trial of the Safety and Biological Effect of Subcutaneous IRX-2 (With Cyclophosphamide, Indomethacin, and Zinc) in Patients With Resectable Cancer of the Head and Neck

Phase 2
18 Years
80 Years
Not Enrolling
Squamous Cell Carcinoma of the Head and Neck

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Trial Information

A Phase 2, Open-label Trial of the Safety and Biological Effect of Subcutaneous IRX-2 (With Cyclophosphamide, Indomethacin, and Zinc) in Patients With Resectable Cancer of the Head and Neck

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

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. Evaluation of clinical safety included regular clinical
and laboratory evaluations. In the patients treated before surgery, evaluation of tumor
response was undertaken by comparison of tumor size before and after the IRX-2 regimen.
This study provided preliminary evidence of the safety and possible efficacy of IRX-2 in the
pre-surgical, neoadjuvant treatment of HN SCC. The regimen was well tolerated in most
patients, and histological and clinical tumor responses were observed.

The current study utilizes the same IRX-2 regimen evaluated in a more recent 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.

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Adverse Events and Serious Adverse Events

Outcome Description:

The frequency of all Adverse Events (greater than 5%) is reported. All Serious Adverse Events were described. The number of deaths during study and their relatedness (or not) to treatment, as well as changes in laboratory measures, were published (see referenced publication for details: Wolf, 2011).

Outcome Time Frame:

Enrollment through 30 days post-surgery

Safety Issue:


Principal Investigator

Jeffrey S. Moyer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan Hospitals


United States: Food and Drug Administration

Study ID:

IRX-2 2005-A



Start Date:

July 2005

Completion Date:

December 2010

Related Keywords:

  • Squamous Cell Carcinoma of the Head and Neck
  • Head and Neck Cancer
  • Immunotherapy
  • IRX-2
  • Mouth Cancer
  • Throat Cancer
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms



Montefiore Medical Center Bronx, New York  10467-2490
Stanford Cancer Center Stanford, California  94305-5824
University of Alabama at Birmingham Birmingham, Alabama  35294-3300
Hospital of the University of Pennsylvania Philadelphia, Pennsylvania  19104
University of Iowa Hospital & Clinics Iowa City, Iowa  52242
Lahey Clinic Medical Center Burlington, Massachusetts  01805
University of Kentucky Chandler Medical Center Lexington, Kentucky  40536
University of Michigan Hospitals Ann Arbor, Michigan  48109-0312