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

Sponsor

Herbert Irving Comprehensive Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00055718

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Duration (Months)

6.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Drug/Agent Toxicity by Tissue/Organ Leukemia	Dietary Supplement: silymarin	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Masking:

Double

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Nov 1, 2001

Actual Study Completion Date :

Jan 1, 2010

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Miami Children's Hospital	Miami	Florida	United States	33155
2	Winthrop University Hospital	Mineola	New York	United States	11501
3	Mount Sinai School of Medicine	New York	New York	United States	10029
4	Herbert Irving Comprehensive Cancer Center at Columbia University	New York	New York	United States	10032
5	Children's Hospital Medical Center of Akron	Akron	Ohio	United States	44308-1062
6	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104
7	Children's Hospital and Regional Medical Center - Seattle	Seattle	Washington	United States	98105-3916
8	McMaster Children's Hospital at Hamilton Health Sciences	Hamilton	Ontario	Canada	L8N 3Z5