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

Herbert Irving Comprehensive Cancer Center

Status and phase: Completed; Phase 2

Conditions: Leukemia; Drug/Agent Toxicity by Tissue/Organ

Treatments: Dietary Supplement: silymarin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00055718

CDR0000270914

CPMC-IRB-14117

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 2 to 21 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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