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.

Condition	Treatment or Intervention	Phase
Drug Toxicity childhood acute lymphoblastic leukemia	Drug: silymarin  Procedure: biologically based therapies  Procedure: cancer prevention intervention  Procedure: chemoprotection  Procedure: complementary and alternative therapy  Procedure: herbal medicine / botanical therapy  Procedure: supportive care/therapy	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  2 Years   -   21 Years,  Genders Eligible for Study:  Both

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

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

Florida
      Miami Children's Hospital, Miami,  Florida,  33155,  United States; Recruiting
New York
      Herbert Irving Comprehensive Cancer Center at Columbia University, New York,  New York,  10032,  United States; Recruiting
      Mount Sinai School of Medicine, New York,  New York,  10029,  United States; Recruiting
      Winthrop University Hospital, Mineola,  New York,  11501,  United States; Recruiting
Ohio
      Children's Hospital Medical Center of Akron, Akron,  Ohio,  44308-1062,  United States; Recruiting
Pennsylvania
      Children's Hospital of Philadelphia, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting
Washington
      Children's Hospital and Regional Medical Center - Seattle, Seattle,  Washington,  98105-3916,  United States; Recruiting
Canada, Ontario
      McMaster Children's Hospital at Hamilton Health Sciences, Hamilton,  Ontario,  L8N 3Z5,  Canada; Recruiting

Study chairs or principal investigators

Kara Kelly, MD,  Study Chair,  Herbert Irving Comprehensive Cancer Center   

Study ID Numbers:  CDR0000270914; CPMC-IRB-14117; NCT00055718
Record last reviewed:  February 2003
Last Updated:  December 6, 2004
Record first received:  March 6, 2003
ClinicalTrials.gov Identifier:  NCT00055718
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08