A Pharmacokinetic Study of Valacyclovir in Pediatric Oncology Patients

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor College of Medicine
• Collaborator: Texas Children's Hospital
• Treatments: Acyclovir; Valacyclovir

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.