Silymarin (Milk Thistle Extract) in Treating Patients With Acute Lymphoblastic Leukemia Who Are Receiving Chemotherapy
NCT ID: NCT00055718
Last Updated: 2013-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2001-11-30
2010-01-31
Brief Summary
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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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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SUPPORTIVE_CARE
DOUBLE
Interventions
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silymarin
Eligibility Criteria
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Inclusion Criteria
* 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
2 Years
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Herbert Irving Comprehensive Cancer Center
OTHER
Principal Investigators
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Kara Kelly, MD
Role: STUDY_CHAIR
Herbert Irving Comprehensive Cancer Center
Locations
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Miami Children's Hospital
Miami, Florida, United States
Winthrop University Hospital
Mineola, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada
Countries
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References
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Ladas EJ, Kroll DJ, Oberlies NH, Cheng B, Ndao DH, Rheingold SR, Kelly KM. A randomized, controlled, double-blind, pilot study of milk thistle for the treatment of hepatotoxicity in childhood acute lymphoblastic leukemia (ALL). Cancer. 2010 Jan 15;116(2):506-13. doi: 10.1002/cncr.24723.
Other Identifiers
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CPMC-IRB-14117
Identifier Type: -
Identifier Source: secondary_id
CDR0000270914
Identifier Type: -
Identifier Source: org_study_id