Silymarin (Milk Thistle Extract) in Treating Patients Wit... | NCT00055718

ID	Type	Description	Link
CPMC-IRB-14117

Status Module

Record Verification Date

May 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2001

Primary Completion Date

Not provided

Completion Date

Jan 2010Actual

First Submitted Date

Mar 6, 2003

First Submission Date that Met QC Criteria

Mar 6, 2003

First Posted Date

Mar 7, 2003Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2013

Last Update Posted Date

Dec 18, 2013Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Name	Type	Description	Arm Group Labels	Other Names
silymarin	Dietary Supplement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effect of silymarin on elevated liver function tests (AST, ALT, total bilirubin, and direct bilirubin) at baseline, day 28, and day 56

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

21 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Kara Kelly, MD	Herbert Irving Comprehensive Cancer Center	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Miami Children's Hospital		Miami	Florida	33155	United States
Winthrop University Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20014183	Result	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.

ID	Term
D064420	Drug-Related Side Effects and Adverse Reactions
D007938	Leukemia
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma

ID	Term
D064419	Chemically-Induced Disorders
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D007945	Leukemia, Lymphoid
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases

ID	Term
D044947	Flavonolignans
D005419	Flavonoids
D002867	Chromones
D001578	Benzopyrans
D011714	Pyrans
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring