John W. Hadden

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OBJECTIVES To test the efficacy of a natural cytokine mixture (IRX-2), cyclophosphamide, indomethacin, and zinc to induce immune regression of squamous cell carcinoma (SCC) of the head and neck (H&N) prior to conventional therapy and to characterize the responses. PATIENTS AND DESIGN A phase 2 trial was performed in 15 adults with recently diagnosed,(More)
OBJECTIVE To determine if lymph nodes (LN) of patients receiving IRX-2 immunotherapy reflect changes in histology. SETTING National Cancer Institute, Mexico City, Mexico. PATIENTS Thirty patients with advanced squamous cell carcinoma of the head and neck (H and N SCC) and 10 non-cancer controls. INTERVENTION A 21-day cycle of preoperative(More)
Mouse studies showed a synergy of thymosin alpha1 (Talpha1) and a natural cytokine mixture (IRX-2) in increasing T lymphocyte number and responses. Clinical studies with IRX-2 showed increases of T lymphocytes in lymphocytopenic cancer patients but relatively little effect on irradiated, lymphocytopenic patients. The present phase 1 and 2 study shows that(More)
OBJECTIVES Head and neck squamous cell carcinoma (HNSCC) is associated with profound defects in cellular immunity. IRX-2, a primary cell-derived biologic containing multiple cytokines, has enhanced immune responses and induced tumor rejection in preclinical studies. This phase 1 open label study aimed to determine the clinical and laboratory safety of an(More)
Cellular immunodeficiency is associated with human cancer. Extensive reviews on cancer of the head and neck, lung, esophagus and breast convince the author that for these diseases the immunodeficiency is reasonably well established yet the mechanisms are poorly understood. Evidence indicates that other tumors are similarly associated with cellular immune(More)
A Phase II trial in 42 patients with squamous cell cancer of the head and neck (H and NSCC) was performed using a combination immunotherapy with 10-20 days of perilymphatic injections of a natural cytokine mixture (NCM: IRX-2; 200 units IL-2 equivalence) preceded by low dose cyclophosphamide (CY; 300 mg/m(2)) and followed by daily oral indomethacin (25 mg(More)
Twenty-seven subjects with squamous cell cancer of the head and neck received the neoadjuvant IRX-2 immunotherapy regimen prior to surgery in a Phase 2 trial. Pretreatment tumor biopsies were compared with the primary tumor surgical specimens for lymphocyte infiltration, necrosis and fibrosis, using hematoxylin and eosin stain and immunohistochemistry in 25(More)
OBJECTIVE To induce tumor regression with immunotherapy and to characterize the histology. SETTING National Institute of Cancerology, Mexico City, Mexico. PATIENTS Thirteen patients with advanced squamous cell carcinoma of the head and neck region. INTERVENTION A 21-day cycle of preoperative immunotherapy, including a single intravenous infusion of(More)
The purpose of this paper is to review ways in which the neurohormonal system can interact with the immune system and to outline the main mechanisms which are involved in this interaction. Experimental as well as clinical evidence is presented to support the existence of a close interaction and bi-directional communication between the central nervous and(More)