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

January 23, 2015 updated by: Foundation for the National Institutes of Health
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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jessica Ratay, MS
  • Phone Number: (301) 435-4038
  • Email: jratay@fnih.org

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute
        • Contact:
          • Research Coordinator1
        • Contact:
          • Research Coordinator2
        • Principal Investigator:
          • Robert Haddad, MD
      • Boston, Massachusetts, United States, 02115
        • Not yet recruiting
        • Harvard Medical School - Brigham and Women's Hospital
        • Contact:
          • Research Coordinator1
        • Contact:
          • Research Coordinator2
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas MD Anderson
        • Contact:
          • Research Coordinator1
        • Contact:
          • Research Coordinator2
        • Principal Investigator:
          • Bonnie Glisson, MD
        • Sub-Investigator:
          • Ala Abudayyeh, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

cancer patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
biomarker change from baseline
Time Frame: up to 3 weeks
up to 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Foundation for the National Institutes of Health

Collaborators

M.D. Anderson Cancer Center
Eli Lilly and Company
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Merck Sharp & Dohme LLC
Pfizer
AstraZeneca
Johnson & Johnson
University of Southern California
Brigham and Women's Hospital
University of Minnesota
Amgen
Critical Path Institute - Predictive Safety Testing Consortium

Investigators

  • Principal Investigator: Abdulla Salahudeen, MD, University of Texas MD Anderson
  • Principal Investigator: Sushrut Waikar, MD, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

June 1, 2015

Study Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

August 29, 2013

First Submitted That Met QC Criteria

September 3, 2013

First Posted (Estimate)

September 6, 2013

Study Record Updates

Last Update Posted (Estimate)

January 27, 2015

Last Update Submitted That Met QC Criteria

January 23, 2015

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kidney Safety - Cisplatin

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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