A Pharmacokinetic Study of Valacyclovir in Pediatric Oncology Patients

Completed · Phase 2

Conditions studied: Neoplasms

In brief

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.

Key facts

Study ID

NCT00042328

Run by

Baylor College of Medicine

People needed

30

Starts

2001-08-01

Expected to finish

2005-05-01

Last updated by the study team

2015-08-24

Who can join

Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Texas Children's Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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