NCT00042328

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2001

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2002

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 1, 2002

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
Last Updated

August 24, 2015

Status Verified

August 1, 2015

Enrollment Period

3.8 years

First QC Date

July 26, 2002

Last Update Submit

August 20, 2015

Conditions

Neoplasms

Keywords

Cancer

Interventions

ValacyclovirDRUG

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Children's Hospital

Houston, Texas, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Valacyclovir

Intervention Hierarchy (Ancestors)

AcyclovirGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Susan Blaney, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 26, 2002

First Posted

August 1, 2002

Study Start

August 1, 2001

Primary Completion

May 1, 2005

Study Completion

May 1, 2005

Last Updated

August 24, 2015

Record last verified: 2015-08

Locations

US(1)