Phase I Trial of Motexafin Gadolinium and Chemoradiation in Locally Advanced, Squamous Cell Carcinoma of the Head and Neck
Data Collection
Head and Neck Neoplasms+10
+ Laryngeal Diseases
+ Laryngeal Neoplasms
Treatment Study
Summary
The purpose of this study is to evaluate the safety of adding the investigational drug Motexafin Gadolinium to the standard treatment of radiation therapy and chemotherapy with drugs called 5-FU and cisplatin in patients with advanced head and neck cancer.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.18 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.Over 18 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: * At least 18 years of age * Each patient must sign a study-specific informed consent form * Newly diagnosed, locally advanced, non-metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) arising from a primary site in the oropharynx, hypopharynx, or larynx confirmed by evaluation of fine needle aspiration or biopsy samples and MRI * Eligible for curative intent treatment with hyperfractionated radiation and concurrent 5-FU and cisplatin * Karnofsky Performance Status score of at least 60% * Primary tumor at least 4 cm in diameter Exclusion Criteria: Laboratory Values of: * Serum creatinine \> 1.8 mg/dL; unless 24-hour urine creatinine clearance is ≥ 70 mL/min * Serum total bilirubin \> 1.5 times the upper limit of normal * ALT (formerly SGPT) \> 1.5 times the upper limit of normal * Alkaline phosphatase \> 1.5 times the upper limit of normal * Absolute neutrophil count (ANC) \< 1500/L * Platelet count \< 100,000/L * 3+ or greater proteinuria on urinalysis and * Squamous Cell Carcinoma of the Head and Neck arising from a primary site in the oral cavity or nasopharynx * Distant metastases * Prior history of cancer at any site treated with radiotherapy and/or chemotherapy * History of SCCHN diagnosed within 5 years of current diagnosis
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
University of Texas, San Antonio Health Science Center
San Antonio, United States