Head and Neck Cancer
Conditions
Keywords
kidney safety, biomarkers, serum creatinine, BUN, cystic fibrosis, head and neck cancer, renal injury, drug induced acute kidney injury, aminoglycoside, cisplatin, nephrotoxicity, biomarker qualification
Brief summary
The project is designed to test new biomarkers that are more sensitive than the current standard in detecting injury to the proximal kidney tubule and will establish better criteria for when kidney safety concerns may halt further testing of a drug in humans.
Detailed description
The study will be conducted at four major medical centers, including the University of Southern California, the University of Minnesota, the Dana Farber Cancer Institute, and the MD Anderson Cancer Center. Blood and urine samples will be collected from patients undergoing treatment with either cisplatin or aminoglycosides, which are two different drugs known to cause injuries to the proximal tubule of the kidney. Cisplatin is a common chemotherapy drug taken by patients with head and neck cancer. Aminoglycosides are a common antibiotic drug taken by patients with cystic fibrosis.
Interventions
None listed
Sponsors
University of Southern California
University of Minnesota
M.D. Anderson Cancer Center
Brigham and Women's Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Amgen
AstraZeneca
Eli Lilly and Company
Johnson & Johnson
Merck Sharp & Dohme LLC
Pfizer
Critical Path Institute - Predictive Safety Testing Consortium
Foundation for the National Institutes of Health
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(Cisplatin Treatment Group): 1. Males and females ≥ 18 years of age 2. Diagnosis of head & neck cancer and confirmation that patient is due to receive a 1st cycle of cisplatin (75-100 mg/m2/cycle) chemotherapy either: * as single agent chemotherapy in conjunction with local radiotherapy course, or * as part of the TPF combination (docetaxel, cisplatin, and fluorouracil) 3. Willingness and ability to comply with study procedures and study restrictions 4. Ability to provide written informed consent Inclusion Criteria (Control Group): 1. Males and females ≥ 18 years of age 2. Diagnosis of head & neck cancer or similar condition such as an upper body, localised malignancy. These control patients will be scheduled to receive a non-nephrotoxic treatment modality (e.g. local radiotherapy alone) 3. Willingness and ability to comply with study procedures and study restrictions 4. Ability to provide written informed consent
Exclusion criteria
(All Subjects): 1. Chronic kidney disease defined by eGFR \<60 mL/min/1.73m2. Patients with normal eGFR but persistent dipstick proteinuria require urinary albumin measurement: those with microalbuminuria (\>30 mcg/mg creatinine) will be excluded 2. Patients currently receiving other potentially nephrotoxic agents (i.e. chronic use of high dose NSAIDs, intravenous aminoglycosides, intravenous colistin, intravenous vancomycin, or ACEi) 3. Any major surgery (i.e. high risk of acute kidney injury) in the previous month 4. Patients currently receiving trimethoprim or cimetidine or other medications known to alter the tubular secretion of creatinine 5. Use of creatine supplements within 7 days prior to hospitalization 6. Solid organ transplant recipients 7. Abnormal liver function (serum ALT, AST or total bilirubin \>2xULN) 8. Significant anemia (Hemoglobin \< 10 g/dL) 9. Pregnancy 10. Institutionalized individuals
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| biomarker change from baseline | up to 3 weeks |
Countries
United States
Contacts
Primary ContactStefan Sultana, MD
Backup ContactJessica Ratay, MS
Outcome results
None listed