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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pilot Study of Silymarin During Maintenance Therapy in Children With Acute Lymphoblastic Leukemia (ALL)

Conditions
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Drug/Agent Toxicity by Tissue/Organ, Leukemia

Intervention / Treatment
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* Dietary Supplement: silymarin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: silymarin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of silymarin on elevated liver function tests (AST, ALT, total bilirubin, and direct bilirubin) at baseline, day 28, and day 56 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug/agent toxicity by tissue/organ, childhood acute lymphoblastic leukemia