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A Pharmacokinetic Study of Valacyclovir in Pediatric Oncology Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00042328
First Posted: August 1, 2002
Last Update Posted: August 24, 2015
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.
Collaborator:
Texas Children's Hospital
Information provided by (Responsible Party):
Susan Blaney, Baylor College of Medicine
  Purpose
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: None (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.

  Eligibility

Information from the National Library of Medicine

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

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.
  Contacts and Locations
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): NCT00042328


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

Responsible Party: Susan Blaney, Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00042328     History of Changes
Other Study ID Numbers: H9912
VALACYCLOVIR SINGLE DOSE
First Submitted: July 26, 2002
First Posted: August 1, 2002
Last Update Posted: August 24, 2015
Last Verified: August 2015

Keywords provided by Susan Blaney, Baylor College of Medicine:
Cancer

Additional relevant MeSH terms:
Valacyclovir
Acyclovir
Antiviral Agents
Anti-Infective Agents