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Sponsored by: |
IRX Therapeutics |
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Information provided by: | IRX Therapeutics |
ClinicalTrials.gov Identifier: | NCT00210470 |
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.
Condition | Intervention | Phase |
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Squamous Cell Carcinoma of the Head and Neck |
Drug: IRX-2 Drug: Cyclophosphamide Drug: Indomethacin Drug: Zinc Drug: Omeprazole |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 27 |
Study Start Date: | July 2005 |
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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, California | |
Stanford Cancer Center | |
Stanford, California, United States, 94305-5826 | |
United States, Iowa | |
University of Iowa Hospital & Clinics | |
Iowa City, Iowa, United States, 52242 | |
United States, Kentucky | |
University of Kentucky Chandler Medical Center | |
Lexington, Kentucky, United States, 40536 | |
United States, Massachusetts | |
Lahey Clinic Medical Center | |
Burlington, Massachusetts, United States, 01805 | |
United States, Michigan | |
University of Michigan Hospitals | |
Ann Arbor, Michigan, United States, 48109-0312 | |
United States, New York | |
Montefiore Medical Center | |
Bronx, New York, United States, 10467 | |
St. Vincent's Hospital and Medical Center | |
New York, New York, United States, 10011 | |
United States, Pennsylvania | |
Hospital of the University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Jeffrey S. Moyer, MD | University of Michigan Hospitals |
Study ID Numbers: | IRX-2 2005-A |
Study First Received: | September 13, 2005 |
Last Updated: | November 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00210470 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Head and Neck Cancer Immunotherapy IRX-2 Mouth Cancer Throat Cancer |
Anti-Inflammatory Agents Immunologic Factors Omeprazole Cyclophosphamide Squamous Cell Carcinoma Mouth Neoplasms Indomethacin Zinc Anti-Inflammatory Agents, Non-Steroidal Neoplasms, Squamous Cell Analgesics Alkylating Agents Cyclooxygenase Inhibitors |
Carcinoma, Squamous Cell of Head and Neck Cardiovascular Agents Immunosuppressive Agents Oral Cancer Carcinoma Analgesics, Non-Narcotic Head and Neck Neoplasms Epidermoid Carcinoma Antineoplastic Agents, Alkylating Peripheral Nervous System Agents Carcinoma, Squamous Cell Antirheumatic Agents Neoplasms, Glandular and Epithelial |
Anti-Inflammatory Agents Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Omeprazole Cyclophosphamide Reproductive Control Agents Gout Suppressants Neoplasms by Site Tocolytic Agents Sensory System Agents Therapeutic Uses Anti-Ulcer Agents Indomethacin |
Anti-Inflammatory Agents, Non-Steroidal Analgesics Neoplasms, Squamous Cell Alkylating Agents Neoplasms by Histologic Type Cyclooxygenase Inhibitors Gastrointestinal Agents Enzyme Inhibitors Cardiovascular Agents Immunosuppressive Agents Pharmacologic Actions Carcinoma Neoplasms Analgesics, Non-Narcotic Head and Neck Neoplasms |