NCT00055718

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2001

Longer than P75 for phase_2

Geographic Reach
2 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 7, 2003

Completed
6.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

December 18, 2013

Status Verified

May 1, 2006

First QC Date

March 6, 2003

Last Update Submit

December 17, 2013

Conditions

Drug/Agent Toxicity by Tissue/OrganLeukemia

Keywords

drug/agent toxicity by tissue/organchildhood acute lymphoblastic leukemia

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

  • 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

Interventions

silymarinDIETARY_SUPPLEMENT

Eligibility Criteria

Age2 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (8)

Miami Children's Hospital

Miami, Florida, 33155, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, 10032, United States

Location

Children's Hospital Medical Center of Akron

Akron, Ohio, 44308-1062, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Hospital and Regional Medical Center - Seattle

Seattle, Washington, 98105-3916, United States

Location

McMaster Children's Hospital at Hamilton Health Sciences

Hamilton, Ontario, L8N 3Z5, Canada

Location

Related Publications (1)

  • 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.

    PMID: 20014183RESULT

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse ReactionsLeukemiaPrecursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Silymarin

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

FlavonolignansFlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Kara Kelly, MD

    Herbert Irving Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 6, 2003

First Posted

March 7, 2003

Study Start

November 1, 2001

Study Completion

January 1, 2010

Last Updated

December 18, 2013

Record last verified: 2006-05

Locations

US(7)CA(1)