A Pilot Study of Silymarin During Maintenance Therapy in Children With Acute Lymphoblastic Leukemia (ALL)
2 Years
21 Years
Both
Drug/Agent Toxicity by Tissue/Organ, Leukemia
Trial Information
A Pilot Study of Silymarin During Maintenance Therapy in Children With Acute Lymphoblastic Leukemia (ALL)
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Outcome Measure:
Effect of silymarin on elevated liver function tests (AST, ALT, total bilirubin, and direct bilirubin) at baseline, day 28, and day 56
Principal Investigator
Kara Kelly, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Herbert Irving Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000270914
NCT ID:
NCT00055718
Start Date:
November 2001
Completion Date:
Related Keywords:
- Drug/Agent Toxicity by Tissue/Organ
- Leukemia
- drug/agent toxicity by tissue/organ
- childhood acute lymphoblastic leukemia
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
Name | Location |
|---|---|
| Children's Hospital of Philadelphia | Philadelphia, Pennsylvania 19104 |
| Mount Sinai School of Medicine | New York, New York 10029 |
| Children's Hospital and Regional Medical Center - Seattle | Seattle, Washington 98105 |
| Miami Children's Hospital | Miami, Florida 33155-4069 |
| Children's Hospital Medical Center of Akron | Akron, Ohio 44308 |
| Herbert Irving Comprehensive Cancer Center at Columbia University | New York, New York 10032 |
| Winthrop University Hospital | Mineola, New York 11501 |
