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

Primary Purpose

Drug/Agent Toxicity by Tissue/Organ, Leukemia

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

silymarin

About this trial

This is an interventional supportive care trial for Drug/Agent Toxicity by Tissue/Organ focused on measuring drug/agent toxicity by tissue/organ, childhood acute lymphoblastic leukemia

Eligibility Criteria

2 Years - 21 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

Miami Children's Hospital
Winthrop University Hospital
Mount Sinai School of Medicine
Herbert Irving Comprehensive Cancer Center at Columbia University
Children's Hospital Medical Center of Akron
Children's Hospital of Philadelphia
Children's Hospital and Regional Medical Center - Seattle
McMaster Children's Hospital at Hamilton Health Sciences

Outcomes

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

Full Information

NCT ID

NCT00055718

First Posted

March 6, 2003

Last Updated

December 17, 2013

Sponsor

Herbert Irving Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00055718

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2006

Overall Recruitment Status

Completed

Study Start Date

November 2001 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Herbert Irving Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Drug/Agent Toxicity by Tissue/Organ, Leukemia

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Masking

Double

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Dietary Supplement

Intervention Name(s)

silymarin

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Serum antioxidant capacity as measured by the Oxygen Radical Absorbance Capacity (ORAC) at baseline, day 28, and day 56

Title

Oxidative damage as measured by 8-oxodeoxyguanosine adducts at baseline, day 28, and day 56

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kara Kelly, MD

Organizational Affiliation

Herbert Irving Comprehensive Cancer Center

Official's Role

Study Chair

Facility Information:

Facility Name

Miami Children's Hospital

City

Miami

State/Province

Florida

ZIP/Postal Code

33155

Country

United States

Facility Name

Winthrop University Hospital

City

Mineola

State/Province

New York

ZIP/Postal Code

11501

Country

United States

Facility Name

Mount Sinai School of Medicine

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Herbert Irving Comprehensive Cancer Center at Columbia University

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Children's Hospital Medical Center of Akron

City

Akron

State/Province

Ohio

ZIP/Postal Code

44308-1062

Country

United States

Facility Name

Children's Hospital of Philadelphia

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Children's Hospital and Regional Medical Center - Seattle

City

Seattle

State/Province

Washington

ZIP/Postal Code

98105-3916

Country

United States

Facility Name

McMaster Children's Hospital at Hamilton Health Sciences

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 3Z5

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

20014183

Citation

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.

Results Reference

result

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

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