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Recruiting

PEPN22P1: Vincristine Dosing in Infants and Young Children

About this study

In this study, researchers will test a new way to give the chemotherapy medicine vincristine to infants and young children with cancer. Vincristine slows or stops the growth of cancer cells. It has been used for many years to treat cancer. The dose of most cancer drugs is based on a patient’s height and weight. But that method cannot be used for infants and young children because they vary in size as they grow. Their bodies also process and use drugs differently. So, infants and young children may get more side effects at the same dose than older children.

Researchers want to find out if giving vincristine based on a new dosing method for infants and children works as well as the standard method used for older children. What we learn will help us find the right dose of vincristine to treat a young child’s cancer and reduce side effects.

The vincristine dose for patients in this study may change over time. Staff will take small blood samples to measure each patient’s vincristine levels. We will compare these levels to those of older children treated with standard dosing. This will show how the new way of dosing affects blood levels of vincristine in infants and young children.

We will also do genetic tests on the blood samples to look for changes in a child’s genes (DNA). Some of these changes may affect how their body uses vincristine.

Eligibility overview

  • Up to 12 years old
  • Newly diagnosed or relapsed cancer treated with vincristine
  • Have a central venous catheter (PICC, port, Broviac)

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.

Overview

Full title:

PEPN22P1, A Pharmacokinetic Study of Vincristine in Infants Dosed According to BSA-Banded Infant Dosing Tables and Older Children Dosed by Traditional BSA Methods

Study goal:

To find out how a new vincristine dosing method affects drug levels in the blood in infants and young children as compared to older children; to learn if genetics influences vincristine drug levels in the blood

Diagnosis:

Newly diagnosed or relapsed cancer

Age:

Up to 12 years old

Clinical trials categories:

Childhood Cancer

For physicians and researchers

Patients accepted to St. Jude must be referred by a physician or other qualified medical professional. Learn how St. Jude can partner with you to care for your patient.

 

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