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A Pharmacokinetic Study of Valacyclovir in Pediatric Oncology Patients

This study has been completed.
Sponsor:
Collaborator:
Texas Children's Hospital
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00042328
First received: July 26, 2002
Last updated: June 23, 2005
Last verified: May 2005
History of Changes

July 26, 2002
June 23, 2005
August 2001
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Complete list of historical versions of study NCT00042328 on ClinicalTrials.gov 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.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Neoplasms
Drug: Valacyclovir
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
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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.
Both
2 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00042328
H9912, VALACYCLOVIR SINGLE DOSE
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Baylor College of Medicine
Texas Children's Hospital
Principal Investigator: Susan Blaney, MD Texas Children's Hospital
Baylor College of Medicine
May 2005

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