Silymarin (Milk Thistle Extract) in Treating Patients With Acute Lymphoblastic Leukemia Who Are Receiving Chemotherapy
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2006 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Herbert Irving Comprehensive Cancer Center
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00055718
First received: March 6, 2003
Last updated: February 25, 2010
Last verified: May 2006
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Drug/Agent Toxicity by Tissue/Organ Leukemia |
Dietary Supplement: silymarin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Supportive Care |
| Official Title: | A Pilot Study of Silymarin During Maintenance Therapy in Children With Acute Lymphoblastic Leukemia (ALL) |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
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
| Estimated Enrollment: | 50 |
| Study Start Date: | November 2001 |
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.
Eligibility| Ages Eligible for Study: | 2 Years to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00055718
Locations
| United States, Florida | |
| Miami Children's Hospital | |
| Miami, Florida, United States, 33155 | |
| United States, New York | |
| Winthrop University Hospital | |
| Mineola, New York, United States, 11501 | |
| Herbert Irving Comprehensive Cancer Center at Columbia University | |
| New York, New York, United States, 10032 | |
| Mount Sinai School of Medicine | |
| New York, New York, United States, 10029 | |
| United States, Ohio | |
| Children's Hospital Medical Center of Akron | |
| Akron, Ohio, United States, 44308-1062 | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Washington | |
| Children's Hospital and Regional Medical Center - Seattle | |
| Seattle, Washington, United States, 98105-3916 | |
| Canada, Ontario | |
| McMaster Children's Hospital at Hamilton Health Sciences | |
| Hamilton, Ontario, Canada, L8N 3Z5 | |
Sponsors and Collaborators
Herbert Irving Comprehensive Cancer Center
Investigators
| Study Chair: | Kara Kelly, MD | Herbert Irving Comprehensive Cancer Center |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00055718 History of Changes |
| Other Study ID Numbers: | CDR0000270914, CPMC-IRB-14117 |
| Study First Received: | March 6, 2003 |
| Last Updated: | February 25, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
drug/agent toxicity by tissue/organ childhood acute lymphoblastic leukemia |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Silymarin Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013