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Home > "A" Clinical Trials Conditions > A Pharmacokinetic Study of Valacyclovir in Pediatric Oncology Patients  A Pharmacokinetic Study of Valacyclovir in Pediatric Oncology Patients
A Pharmacokinetic Study of Valacyclovir in Pediatric Oncology Patients
For Condition: Neoplasms
Status: Recruiting
Sponsor(s): Baylor College of Medicine , Texas Children's Hospital
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Minimum Age/Maximum Age: 2 Years/18 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 30
Location and Contact Information:
Overall Study Official:
SusanBlaney, Principal Investigator, Texas Children's Hospital
Texas Children's Hospital *Recruiting*
Houston, Texas,
United States
Recruiting Susan Blaney 832-824-4586
Additional Information:
Study ID Numbers: H9912; VALACYCLOVIR SINGLE DOSE
Study Start Date: August 2001
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00042328
Other Neoplasms Studies:
1. Cord Blood Stem Cell Transplantation Study (COBLT)
2. Safety and Tolerability Study of FPTI in Combination with Docetaxel in Advanced Solid Tumors
3. Study of SS1(dsFv)-PE38 (SS1P) Anti-Mesothelin Immunotoxin in Advanced Malignancies: IV Infusion QOD x Six Doses
4. Safety and Tolerability Study of Farnesyl Protein Transferase Inhibitor in Combination with Gemcitabine and Cisplatin in Advanced Cancer
5. A Phase I, Open Label, Dose Escalation Study of a New Formulation of Calcitriol (DN-101) for Safety, Tolerability, and Pharmacokinetics in Patients with Advanced Malignancies
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A Pharmacokinetic Study of Valacyclovir in Pediatric Oncology Patients
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