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

Sponsors and Collaborators:	Herbert Irving Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00055718

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	Intervention	Phase
Cancer-Related Problem/Condition Leukemia	Drug: silymarin	Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for: Silymarin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double-Blind, Placebo Control
Official Title:	A Pilot Study of Silymarin During Maintenance Therapy in Children With Acute Lymphoblastic Leukemia (ALL)

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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:

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

Estimated Enrollment:	50
Study Start Date:	November 2001

Detailed Description:

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 to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00055718

Locations

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

Sponsors and Collaborators

Herbert Irving Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Kara Kelly, MD

Herbert Irving Comprehensive Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Featured trial article This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000270914, CPMC-IRB-14117
Study First Received:	March 6, 2003
Last Updated:	October 18, 2008
ClinicalTrials.gov Identifier:	NCT00055718
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

drug/agent toxicity by tissue/organ
childhood acute lymphoblastic leukemia

Study placed in the following topic categories:

Lymphatic Diseases
Leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders

Precursor Cell Lymphoblastic Leukemia-Lymphoma
Silymarin
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:

Neoplasms
Antioxidants
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action

Immune System Diseases
Physiological Effects of Drugs
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009