Kidney Cancer Clinical Trial
A Prospective Observational Study to Evaluate Acute Kidney Injury Biomarkers In Patients Receiving First Cycle of Cisplatin Chemotherapy for Head and Neck Cancers
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.
Full 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.
Eligibility Criteria
Inclusion Criteria (Cisplatin Treatment Group):
Males and females ≥ 18 years of age
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)
Willingness and ability to comply with study procedures and study restrictions
Ability to provide written informed consent
Inclusion Criteria (Control Group):
Males and females ≥ 18 years of age
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)
Willingness and ability to comply with study procedures and study restrictions
Ability to provide written informed consent
Exclusion Criteria (All Subjects):
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
Patients currently receiving other potentially nephrotoxic agents (i.e. chronic use of high dose NSAIDs, intravenous aminoglycosides, intravenous colistin, intravenous vancomycin, or ACEi)
Any major surgery (i.e. high risk of acute kidney injury) in the previous month
Patients currently receiving trimethoprim or cimetidine or other medications known to alter the tubular secretion of creatinine
Use of creatine supplements within 7 days prior to hospitalization
Solid organ transplant recipients
Abnormal liver function (serum ALT, AST or total bilirubin >2xULN)
Significant anemia (Hemoglobin < 10 g/dL)
Pregnancy
Institutionalized individuals
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There are 3 Locations for this study
Boston Massachusetts, 02115, United States More Info
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Principal Investigator
Boston Massachusetts, 02215, United States More Info
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Principal Investigator
Houston Texas, 77030, United States More Info
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Principal Investigator
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