A Pharmacokinetic Study of Valacyclovir in Pediatric Oncology Patients - Full Text View

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 II

MedlinePlus related topics:

Cancer

Drug Information available for:

Valaciclovir Valacyclovir hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study

Official Title:	A Pharmacokinetic Study of Valacyclovir in Pediatric Oncology Patients

Further study details as provided by Baylor College of Medicine:

Estimated Enrollment:	30
Study Start Date:	August 2001

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

Ages Eligible for Study:	2 Years to 18 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

Study ID Numbers:	H9912, VALACYCLOVIR SINGLE DOSE
First Received:	July 26, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00042328
Health Authority:	United States: Food and Drug Administration

Keywords provided by Baylor College of Medicine:

Cancer

Study placed in the following topic categories:

Valacyclovir

Additional relevant MeSH terms:

Anti-Infective Agents

Neoplasms

Therapeutic Uses

Antiviral Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008

Sponsors and Collaborators:	Baylor College of Medicine Texas Children's Hospital
Information provided by:	Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT00042328