A Prospective Observational Study to Evaluate Acute Kidney Injury Biomarkers In Patients Receiving First Cycle of Cisplatin Chemotherapy for Head and Neck Cancers
Conditions
Head and Neck Cancer
Conditions: official terms
Acute Kidney Injury - Head and Neck Neoplasms
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
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Case Control, Time Perspective: Prospective
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Locations
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Status: Recruiting
Contact: Research Coordinator1
Harvard Medical School - Brigham and Women's Hospital
Boston, Massachusetts, United States
Status: Not yet recruiting
Contact: Research Coordinator1
University of Texas MD Anderson
Houston, Texas, United States
Status: Recruiting
Contact: Research Coordinator1
Start Date
September 2012
Completion Date
June 2015
Sponsors
Foundation for the National Institutes of Health
Source
Foundation for the National Institutes of Health
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page