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

Herbert Irving Comprehensive Cancer Center50 enrolled

Overview

RATIONALE: Silymarin (milk thistle extract) is an herb that may be effective in treating liver disorders caused by cancer therapy. PURPOSE: Randomized phase II trial to study the effectiveness of silymarin in treating patients who have acute lymphoblastic leukemia with chemotherapy-related side effects to the liver.

OBJECTIVES: * Determine the effect of silymarin, in terms of liver function tests, in patients with acute lymphoblastic leukemia receiving hepatotoxic chemotherapy. * Determine the effect of this drug on free and conjugated serum silibinin values in these patients. * Determine the serum antioxidant capacity by Oxygen Radical Absorbance Capacity in patients treated with this drug. * Determine the oxidative damage, as determined by 8-oxodeoxyguanosine adducts, in patients treated with this drug. 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. PROJECTED ACCRUAL: A total of 50 patients (25 per treatment arm) will be accrued for this study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Drug/Agent Toxicity by Tissue/Organ Leukemia

Interventions

silymarinDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 2 YearsMax age: 21 Years

Medical Language ↔ Plain English

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 PATIENT CHARACTERISTICS: Age * 2 to 21 Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * See Disease Characteristics Renal * Not specified PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics Endocrine therapy * See Disease Characteristics Radiotherapy * Not specified Surgery * Not specified

Locations (8)

Miami Children's Hospital

Miami, Florida, United States

Winthrop University Hospital

Mineola, New York, United States

Mount Sinai School of Medicine

New York, New York, United States

Herbert Irving Comprehensive Cancer Center at Columbia University

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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