Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Silymarin (Milk Thistle Extract) in Treating Patients With Acute Lymphoblastic Leukemia Who Are Receiving Chemotherapy

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Supportive care	Closed	2 to 21	NCI	CPMC-IRB-14117 NCT00055718

Special Category: NCI Web site featured trial

Objectives

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

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• See Disease Characteristics

Radiotherapy

• Not specified

Surgery

• Not specified

Patient Characteristics:

Age

• 2 to 21

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• See Disease Characteristics

Renal

• Not specified

Expected Enrollment

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

Outcomes

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

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

Outline

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.

Trial Contact Information

Trial Lead Organizations

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

Kara Kelly, MD, Protocol chair		Ph: 212-305-3374 Email: kk291@columbia.edu

Related Information

Featured trial article

Registry Information
Official Title		A Pilot Study of Silymarin During Maintenance Therapy in Children with Acute Lymphoblastic Leukemia (ALL)
Trial Start Date		2001-11-01
Registered in ClinicalTrials.gov		NCT00055718
Date Submitted to PDQ		2002-01-13
Information Last Verified		2006-05-08
NCI Grant/Contract Number		CA13696

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