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

This study is currently recruiting patients.

Sponsors and Collaborators: Herbert Irving Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

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

MedlinePlus related topics:  Leukemia, Adult Acute;   Leukemia, Adult Chronic;   Leukemia, Childhood;   Poisoning

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Randomized Pilot Study of Silymarin (Milk Thistle Extract) in Patients With Acute Lymphoblastic Leukemia Receiving Hepatotoxic Chemotherapy

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.

Eligibility

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

Location and Contact Information


Florida
      Miami Children's Hospital, Miami,  Florida,  33155,  United States; Recruiting
Teresa Reyersbach  305-662-8374 

New York
      Herbert Irving Comprehensive Cancer Center at Columbia University, New York,  New York,  10032,  United States; Recruiting
Kara Kelly, MD  212-305-5808    kk291@columbia.edu 

      Mount Sinai School of Medicine, New York,  New York,  10029,  United States; Recruiting
William L. Carroll, MD  212-241-4142    bill.carroll@mssm.edu 

      Winthrop University Hospital, Mineola,  New York,  11501,  United States; Recruiting
Linda S. Kelly  516-663-2699 

Ohio
      Children's Hospital Medical Center of Akron, Akron,  Ohio,  44308-1062,  United States; Recruiting
Sarah Friebert, MD  330-543-8580    sfriebert@chmca.org 

Pennsylvania
      Children's Hospital of Philadelphia, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting
Susan Rheingold, MD  215-590-1300    rheingold@email.chop.edu 

Washington
      Children's Hospital and Regional Medical Center - Seattle, Seattle,  Washington,  98105-3916,  United States; Recruiting
Debra Friedman, MD  206-987-1613    debra.friedman@seattlechildrens.org 

Canada, Ontario
      McMaster Children's Hospital at Hamilton Health Sciences, Hamilton,  Ontario,  L8N 3Z5,  Canada; Recruiting
Ronald D. Barr, MD  905-521-2100    rbarr@mcmaster.ca 

Study chairs or principal investigators

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

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

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


Source: ClinicalTrials.gov
Cache Date: April 9, 2005