A Pharmacokinetic Study of Valacyclovir in Pediatric Oncology Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00042328
Recruitment Status : Completed
First Posted : August 1, 2002
Last Update Posted : August 24, 2015
Texas Children's Hospital
Information provided by (Responsible Party):
Susan Blaney, Baylor College of Medicine

July 26, 2002
August 1, 2002
August 24, 2015
August 2001
May 2005   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00042328 on Archive Site
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A Pharmacokinetic Study of Valacyclovir in Pediatric Oncology Patients
A Pharmacokinetic Study of Valacyclovir in Pediatric Oncology Patients
The purpose of this research is to study the pharmacology (how the body handles this drug) of valacyclovir in children receiving treatment for cancer. This study will last approximately 7 days.

In this study, patients will receive a single dose of oral valacyclovir. Blood samples will be drawn to evaluate the pharmacology (how the body handles the drug). Blood samples (less than one teaspoon each) will be obtained before receiving the drug and at 0.5, 1, 1.5, 2, 5, 6, and 8 hours after receiving the drug. The total amount of blood drawn from patients for all blood work including routine blood tests as well as pharmacokinetics will not be greater than 5% of the total blood volume.

We will also have all urine output collected for 8 hours starting at the time patients receive the dose of valacyclovir. A 5cc sample of urine will be collected and analyzed to determine how the body handles the drug at hours 2, 4, 6, and 8.

Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Drug: Valacyclovir
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
May 2005
May 2005   (Final data collection date for primary outcome measure)

Inclusion criteria:

  • Age: Patients must be > / = 2 and < / = 18 years old.
  • Life Expectancy: Patients must have a life expectancy of > 8 weeks
  • Subjects must have a diagnosed malignancy, and must currently be receiving consolidation or maintenance chemotherapy
  • Hepatic/Renal Function: Patients must have adequate hepatic function (bilirubin < / = 1.5 mg/dl: SGPT < 3x normal) and adequate renal function (creatinine < / = 1 mg/dl: BUN < 20 )
  • Medication Tolerance: Patients must be able to swallow pills or tolerate a suspension of the medication
  • Fluid Tolerance: Children must be able to retain liquids at the time of enrollment
  • Informed Consent: Written informed consent will be obtained from all patients and/or their parents prior to enrollment
  • Pregnancy: Women of childbearing age must have a negative serum pregnancy test at the time of study entry

Exclusion criteria:

  • More than one prior chemotherapy regimen.
  • Patients with uncontrolled infections.
  • Subjects with known history of adverse reaction to acyclovir in the past.
  • Patients with concurrent infections requiring treatment with valacyclovir or acyclovir.
Sexes Eligible for Study: All
2 Years to 18 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Susan Blaney, Baylor College of Medicine
Baylor College of Medicine
Texas Children's Hospital
Principal Investigator: Susan Blaney, MD Texas Children's Hospital
Baylor College of Medicine
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP