A Pharmacokinetic Study of Valacyclovir in Pediatric Oncology Patients

Neoplasms Clinical Trial

Official title:

A Pharmacokinetic Study of Valacyclovir in Pediatric Oncology Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00042328
• Other study ID #: H9912
• Secondary ID: VALACYCLOVIR SIN
• Status: Completed
• Phase: Phase 2
• First received: July 26, 2002
• Last updated: August 20, 2015
• Start date: August 2001
• Est. completion date: May 2005

Study information

• Verified date: August 2015
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 18 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• Valacyclovir

Locations

Country	Name	City	State
United States	Texas Children's Hospital	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	Texas Children's Hospital

Country where clinical trial is conducted

United States,