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
+ Cyclophosphamide
+ Indomethacin
Squamous Cell Carcinoma of Head and Neck+5
+ Carcinoma
+ Carcinoma, Squamous Cell
Treatment Study
Summary
Study start date: July 1, 2005
Actual date on which the first participant was enrolled.IRX-2 is a primary cell-derived biologic that reduces the immune suppression that is often seen in the cancer tumor micro-environment, restores immune function and activates a coordinated immune response against the tumor. IRX-2 is a complex proprietary therapeutic containing numerous active cytokine components, which restores and activates multiple immune cell types including T cells, dendritic cells, and natural killer cells to recognize and destroy tumors. The present study administered the IRX-2 Regimen to 27 patients as a neoadjuvant (before surgery) therapy, and the main objective of the study was to determine the safety and tolerability of the IRX-2 regimen.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.27 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives