Actively Recruiting
Treatment of Radiation and Cisplatin Induced Toxicities with Tempol
Led by Matrix Biomed, Inc. · Updated on 2024-11-20
120
Participants Needed
9
Research Sites
342 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A 10 week trial to assess the ability of Tempol to prevent and/or reduce toxicities associated with cisplatin and radiation treatment in head and neck cancer patients. Over the course of the 10 week trial, mucositis, nephrotoxicity, and ototoxicity will be monitored and assessed.
CONDITIONS
Official Title
Treatment of Radiation and Cisplatin Induced Toxicities with Tempol
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 18 years of age or older with medically diagnosed squamous cell cancer of the head and neck
- Scheduled to receive curative radiotherapy or proton therapy
- Use effective birth control if female and of childbearing potential
- Use adequate contraception if male and of childbearing potential; no sperm donation for 90 days after study
- Receiving cisplatin chemotherapy
- Provide informed consent and comply with study procedures
- Have an ECOG performance status score of 2 or less
- Life expectancy of at least 6 months
- Adequate baseline organ function as defined by hematology, liver, renal, nutritional, and metabolic criteria
- Absolute neutrophil count (ANC) of at least 1.5
- Hemoglobin level of at least 10 g/dL
- Platelet count of at least 100,000 per microliter of blood
- Total bilirubin less than or equal to 2 times the upper limit of normal
- Alanine amino transferase (ALT) and Aspartate aminotransferase (AST) less than or equal to 5 times upper limit of normal
- Serum creatinine at or below upper limit of normal or creatinine clearance at least 60 mL/min if serum creatinine is elevated
- Urine albumin less than 3.0 mg/dL
You will not qualify if you...
- Prior radiotherapy of the head and neck
- Clinically significant infection requiring therapy within 14 days before starting treatment
- Use of non-approved therapies for oral mucositis during or within 14 days before treatment
- Use of mugard during or within 14 days before treatment
- Use of prostaglandins, pentoxifylline, or leucovorin during or within 14 days before treatment
- Use of certain mouthwashes (allopurinol, hydrogen peroxide, sucralfate, chlorhexidine) during or within 14 days before treatment
- Recent serious non-malignant medical complications
- Use of investigational drugs within 28 days before starting treatment
- History of positive blood test for HIV
- Significant active medical illness preventing study completion
- Treatment plan including chemoradiation followed by further chemotherapy
- Body weight less than 35 kg (77 lbs)
- Pregnancy or breastfeeding
- Known intolerance to platinum drugs
- History of insulin-dependent diabetes mellitus
- Hepatitis B or C infection
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 9 locations
1
UCSD
La Jolla, California, United States, 92093
Actively Recruiting
2
Mercy Medical Center
Merced, California, United States, 95340
Actively Recruiting
3
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94158
Active, Not Recruiting
4
Central Coast Medical Oncology
Santa Maria, California, United States, 93454
Actively Recruiting
5
Mission Hope Health Center
Santa Maria, California, United States, 93454
Actively Recruiting
6
Montefiore Medical Center-Einstein Campus
The Bronx, New York, United States, 10461
Actively Recruiting
7
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
8
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98195
Actively Recruiting
9
University of Washington Medical Center
Seattle, Washington, United States, 98195
Actively Recruiting
Research Team
B
Benji Crane
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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