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A Pharmacokinetic Study of Valacyclovir in Pediatric Oncology Patients

This study has been completed.
Texas Children's Hospital
Information provided by (Responsible Party):
Susan Blaney, Baylor College of Medicine Identifier:
First received: July 26, 2002
Last updated: August 20, 2015
Last verified: August 2015
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.

Condition Intervention Phase
Neoplasms Drug: Valacyclovir Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pharmacokinetic Study of Valacyclovir in Pediatric Oncology Patients

Resource links provided by NLM:

Further study details as provided by Susan Blaney, Baylor College of Medicine:

Estimated Enrollment: 30
Study Start Date: August 2001
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Detailed Description:

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.


Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00042328

United States, Texas
Texas Children's Hospital
Houston, Texas, United States
Sponsors and Collaborators
Baylor College of Medicine
Texas Children's Hospital
Principal Investigator: Susan Blaney, MD Texas Children's Hospital
  More Information

Responsible Party: Susan Blaney, Professor, Baylor College of Medicine Identifier: NCT00042328     History of Changes
Other Study ID Numbers: H9912
Study First Received: July 26, 2002
Last Updated: August 20, 2015

Keywords provided by Susan Blaney, Baylor College of Medicine:

Additional relevant MeSH terms:
Antiviral Agents
Anti-Infective Agents processed this record on June 23, 2017