Phase II Randomized Pilot Study of Silymarin (Milk Thistle Extract) in Patients With Acute Lymphoblastic Leukemia Receiving Hepatotoxic Chemotherapy. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. cannot verify the accuracy of the information.

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Alternate Title

Silymarin (Milk Thistle Extract) in Treating Patients With Acute Lymphoblastic Leukemia Who Are Receiving Chemotherapy. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. cannot verify the accuracy of the information.

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IISupportive careClosed2 to 21NCICPMC-IRB-14117

Special Category: NCI Web site featured trial


  1. Determine the effect of silymarin, in terms of liver function tests, in patients with acute lymphoblastic leukemia receiving hepatotoxic chemotherapy.
  2. Determine the effect of this drug on free and conjugated serum silibinin values in these patients.
  3. Determine the serum antioxidant capacity by Oxygen Radical Absorbance Capacity in patients treated with this drug.
  4. Determine the oxidative damage, as determined by 8-oxodeoxyguanosine adducts, in patients treated with this drug.

Entry Criteria

Disease Characteristics:

  • Diagnosis of acute lymphoblastic leukemia (ALL)
  • Currently receiving maintenance or continuation phase chemotherapy for ALL
    • Regimen comprising intrathecal and oral methotrexate; vincristine IV; oral prednisone or dexamethasone; and oral mercaptopurine
  • Elevated liver function tests, evidenced by 1 of the following criteria:
    • Bilirubin greater than 1.5 times upper limit of normal (ULN)
    • AST greater than 2.5 times ULN
    • ALT greater than 2.5 times ULN

Prior/Concurrent Therapy:

    Biologic therapy

  • Not specified


  • See Disease Characteristics

    Endocrine therapy

  • See Disease Characteristics


  • Not specified


  • Not specified

Patient Characteristics:


  • 2 to 21

    Performance status

  • Not specified

    Life expectancy

  • Not specified


  • Not specified


  • See Disease Characteristics


  • Not specified

Expected Enrollment


A total of 50 patients (25 per treatment arm) will be accrued for this study.


Primary Outcome(s)

Effect of silymarin on elevated liver function tests (AST, ALT, total bilirubin, and direct bilirubin) at baseline, day 28, and day 56

Secondary Outcome(s)

Serum antioxidant capacity as measured by the Oxygen Radical Absorbance Capacity (ORAC) at baseline, day 28, and day 56
Oxidative damage as measured by 8-oxodeoxyguanosine adducts at baseline, day 28, and day 56


This is a randomized, double-blind, placebo-controlled study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral silymarin daily for 28 days.
  • Arm II: Patients receive oral placebo as in arm I.

Patients are followed at day 56.

Published Results

Ladas EJ, Kroll DJ, Oberlies NH, et al.: A randomized, controlled, double-blind, pilot study of milk thistle for the treatment of hepatotoxicity in childhood acute lymphoblastic leukemia (ALL). Cancer 116 (2): 506-13, 2010.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

Kara Kelly, MD, Protocol chair
Ph: 212-305-5808

Related Information

Featured trial article

Registry Information

Official TitleA Pilot Study of Silymarin During Maintenance Therapy in Children with Acute Lymphoblastic Leukemia (ALL)
Trial Start Date2001-11-01
Registered in ClinicalTrials.govNCT00055718
Date Submitted to PDQ2002-01-13
Information Last Verified2006-05-08
NCI Grant/Contract NumberCA13696

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.