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Non-Therapeutic Protocol

CALIPSO: A Phase III Trial of Calfactant for Acute Lung Injury in Pediatric Leukemia and Hematopoietic Stem Cell Transplant Patients

Type of Protocol/Clinical Study

Associated Stem Cell Transplant Studies, Associated Leukemia / Lymphoma Studies : acute respiratory distress (ARDS) / acute lung injury (ALI)

Description

Acute Respiratory Distress Syndrome is a life-threatening lung condition that prevents enough oxygen from getting into the blood. This usually occurs in people who are very ill with another disease or who have major injuries. One reason for the lungs not working properly is because surfactant, a natural chemical in our lungs, is decreased. Our body makes surfactant in our lungs and is vital to normal lung function because it keeps the lungs inflated and protected from infection. When the body does not make enough surfactant, it can be difficult to breathe. In past studies, surfactant treatment has been shown to make the lungs work better and increase the amount of oxygen in the blood of some individuals with ALI/ARDS. This can help reduce the amount of time an individual has to be supported by the breathing machine. It may also help reduce the number of days an individual stays in the Intensive Care Unit

Putting surfactant down the breathing tube is a very effective treatment for premature infants who are born too early for their lungs to make their own surfactant. A type of surfactant that comes from cows called “calfactant” has been approved by the Food and Drug Administration for use in these infants. The study team believes this same surfactant may be helpful in older children with ALI/ARDS because they also appear to have a decreased amount of surfactant in their lungs. Their preliminary studies with calfactant in children who are on the respirator for ALI/ARDS have generally shown improvement in lung function with few side effects.

The purpose of this study is to evaluate the safety and tolerability of calfactant when given to children with leukemia, lymphoma, or who have received a hematopoietic stem cell transplant who have developed ALI/ARDS.


Objectives


Eligibility

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE (1-866-278-5833).

Principal Investigator

R. Ray Morrison, MD

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.