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A Prospective Observational Study to Evaluate Acute Kidney Injury Biomarkers In Patients Receiving First Cycle of Cisplatin Chemotherapy for Head and Neck Cancers

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ClinicalTrials.gov Identifier: NCT01936376
Recruitment Status : Unknown
Verified July 2014 by Foundation for the National Institutes of Health.
Recruitment status was:  Recruiting
First Posted : September 6, 2013
Last Update Posted : January 27, 2015
Sponsor:
Collaborators:
University of Southern California
University of Minnesota - Clinical and Translational Science Institute
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 Corp.
Pfizer
Critical Path Institute - Predictive Safety Testing Consortium
Information provided by (Responsible Party):
Foundation for the National Institutes of Health

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.

Condition or disease
Head and Neck Cancer

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.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Prospective Observational Study to Evaluate Acute Kidney Injury Biomarkers In Patients Receiving First Cycle of Cisplatin Chemotherapy for Head and Neck Cancers
Study Start Date : September 2012
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

Group/Cohort
head & neck cancer patients, cisplatin treatment
cancer patients, no cisplatin, no nephrotoxic agent



Primary Outcome Measures :
  1. biomarker change from baseline [ Time Frame: up to 3 weeks ]

Biospecimen Retention:   Samples Without DNA
urine and blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
cancer patients
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01936376


Contacts
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Contact: Stefan Sultana, MD stefan.sultana@novartis.com
Contact: Jessica Ratay, MS (301) 435-4038 jratay@fnih.org

Locations
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United States, Massachusetts
Harvard Medical School - Brigham and Women's Hospital Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Research Coordinator1         
Contact: Research Coordinator2         
Principal Investigator: Sushrut Waikar, MD         
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Research Coordinator1         
Contact: Research Coordinator2         
Principal Investigator: Robert Haddad, MD         
United States, Texas
University of Texas MD Anderson Recruiting
Houston, Texas, United States, 77030
Contact: Research Coordinator1         
Contact: Research Coordinator2         
Principal Investigator: Bonnie Glisson, MD         
Sub-Investigator: Ala Abudayyeh, MD         
Sponsors and Collaborators
Foundation for the National Institutes of Health
University of Southern California
University of Minnesota - Clinical and Translational Science Institute
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 Corp.
Pfizer
Critical Path Institute - Predictive Safety Testing Consortium
Investigators
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Principal Investigator: Abdulla Salahudeen, MD University of Texas MD Anderson
Principal Investigator: Sushrut Waikar, MD Dana-Farber Cancer Institute

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Responsible Party: Foundation for the National Institutes of Health
ClinicalTrials.gov Identifier: NCT01936376     History of Changes
Other Study ID Numbers: Kidney Safety - Cisplatin
First Posted: September 6, 2013    Key Record Dates
Last Update Posted: January 27, 2015
Last Verified: July 2014

Keywords provided by Foundation for the National Institutes of Health:
kidney safety
biomarkers
serum creatinine
BUN
cystic fibrosis
head and neck cancer
renal injury
drug induced acute kidney injury
aminoglycoside
cisplatin
nephrotoxicity
biomarker qualification

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Acute Kidney Injury
Neoplasms by Site
Neoplasms
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Cisplatin
Antineoplastic Agents