Name of the Trial
Phase II Randomized Pilot Study of Silymarin (Milk Thistle Extract) in Patients with Acute Lymphoblastic Leukemia Receiving Hepatotoxic Chemotherapy (CPMC-IRB-14117). See the protocol summary at http://cancer.gov/clinicaltrials/CPMC-IRB-14117.

Principal Investigator
Dr. Kara Kelly, Herbert Irving Comprehensive Cancer Center at Columbia University and the Children's Oncology Group

Why Is This Trial Important?
Acute lymphoblastic leukemia (ALL) is the most common form of cancer in children. Treatment of childhood ALL is usually done in three phases: an induction phase to bring about a major remission of the cancer, a consolidation phase to kill any remaining cancer cells, and a maintenance phase to kill any cancer cells that may regrow.

Although necessary, many chemotherapy drugs used to treat ALL cause harmful side effects, including liver damage. Consequently, treatment doses must often be reduced or withheld.

In this trial, researchers are testing the ability of a nutritional supplement called silymarin to treat liver damage caused by chemotherapy for ALL. Silymarin is an extract of the milk thistle plant and has been shown in laboratory and animal studies to protect the liver from certain toxic chemicals.

"We observed that some parents of children undergoing treatment for ALL were using milk thistle supplements to lessen the effects of liver toxicity, in some cases with noticeable improvement," said Dr. Kelly. "With this trial, we are trying to verify milk thistle's efficacy in reducing chemotherapy-related liver toxicity.

"Additionally, we are exploring the interaction between milk thistle supplements and the chemotherapy drugs used to treat ALL, and so far we have found no evidence of an adverse interaction."

Who Can Join This Trial?
Researchers seek to enroll 50 patients aged 2 to 21 with ALL who are receiving maintenance phase chemotherapy. See the list of eligibility criteria at http://www.cancer.gov/clinicaltrials/CPMC-IRB-14117.

Where Is This Trial Taking Place?
Multiple study sites in the United States are recruiting patients for this trial. See the list of study sites at http://www.cancer.gov/clinicaltrials/CPMC-IRB-14117.

Contact Information
See the list of study contacts at http://www.cancer.gov/clinicaltrials/CPMC-IRB-14117 or call NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The call is toll free and completely confidential.