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


Phase 2
2 Years
21 Years
Open (Enrolling)
Both
Drug/Agent Toxicity by Tissue/Organ, Leukemia

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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 PhiladelphiaPhiladelphia, Pennsylvania  19104
Mount Sinai School of MedicineNew York, New York  10029
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105
Miami Children's HospitalMiami, Florida  33155-4069
Children's Hospital Medical Center of AkronAkron, Ohio  44308
Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032
Winthrop University HospitalMineola, New York  11501