A Pharmacokinetic Study of Valacyclovir in Pediatric Oncology Patients

Baylor College of Medicine

Status and phase

Completed

Phase 2

Conditions

Neoplasms

Treatments

Drug: Valacyclovir

Study type

Interventional

Funder types

Other

Identifiers

NCT00042328

H9912

VALACYCLOVIR SINGLE DOSE

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

2 to 18 years old

Volunteers

No Healthy Volunteers

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.