Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Houston, Texas


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.

Study summary:

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.


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.



Primary Contact:

Principal Investigator
Susan Blaney, MD
Texas Children's Hospital

Backup Contact:


Location Contact:

Houston, Texas
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.