Know Cancer

forgot password

Impact of Obesity on the Pharmacokinetics of Anticancer Therapy in Children With High Risk Acute Lymphoblastic Leukemia (ALL)

10 Years
19 Years
Not Enrolling

Thank you

Trial Information

Impact of Obesity on the Pharmacokinetics of Anticancer Therapy in Children With High Risk Acute Lymphoblastic Leukemia (ALL)


- To compare the pharmacokinetics of prednisone/prednisolone, vincristine, and
daunorubicin hydrochloride among obese, middle-weight, and underweight children aged 10
to less than 20 years of age undergoing induction therapy for high-risk acute
lymphoblastic leukemia.

- To examine the relationship between the above parameters and response status as defined
by early response and induction failure.

OUTLINE: This is a multicenter study. Patients are stratified according to body mass index
(BMI) (≥ 95^th percentile [obese] vs 10^th to 95^th percentile [normal or at risk for
overweight] vs ≤ 10^th percentile [underweight]).

Patients receive anticancer therapy as prescribed by their treating clinicians. Patients
receive prednisone/prednisolone orally twice on either day 1 or day 8. Patients also receive
daunorubicin hydrochloride IV over 30 minutes and vincristine IV once on the same day.

Blood samples are obtained on either day 1 or day 8** of induction therapy for
pharmacokinetic analysis of prednisone, daunorubicin hydrochloride, and vincristine activity

Blood samples are analyzed via high-performance liquid chromatography (HPLC),
ultrafiltration, a Nessler reaction, ELISA, and liquid chromatography using reverse-phase
chromatography, fluorescent detection, and solid-phase extraction.

Demographic information, including ethnicity, is also collected. Weight and height is
recorded at diagnosis and on the day pharmacokinetic assessment of vincristine, prednisone,
and daunorubicin hydrochloride begins.

NOTE: **Patients who are being sampled on day 8 of induction therapy and who have received
intravenous corticosteroid therapy in the first week of induction must have received at
least six oral prednisone/prednisolone doses prior to the morning prednisone/prednisolone
dose on day 8.

Inclusion Criteria


- Newly diagnosed acute lymphoblastic leukemia

- Must be assigned to receive prednisone/prednisolone, vincristine, and daunorubicin
during induction treatment in the doses and schedule as per the current COG AALL0232

- Prior registration onto a COG protocol is not required

- Must meet 1 of the following criteria:

- Obese (defined as a body mass index [BMI] ≥ 95^th percentile)

- Normal weight or at risk for overweight (defined as BMI between 10^th and 95^th

- Underweight (defined as ≤ 10^th percentile)


- Able to take either prednisone or prednisolone by mouth on day 1 or 8 of induction

- Not pregnant

- Negative pregnancy test

- AST/ALT < 5 times upper limit of normal (ULN)

- Total bilirubin (conjugated + unconjugated) < 1.5 mg/dL

- Creatinine ≤ 1.5 times ULN

- No known malabsorption syndrome


- See Disease Characteristics

- At least 2 weeks since prior and no concurrent medications or food known or with the
potential to alter the pharmacokinetics of the drugs under study including any of the

- Grapefruit, tangelos, or the juice of these fruits

- Hypericum perforatum (St. John's wort)

- Anticonvulsants

- Carbamazepine

- Oxcarbazepine

- Phenytoin

- Phenobarbital

- Primidone

- Azole antifungal agents including:

- Ketoconazole

- Fluconazole

- Itraconazole

- Voriconazole

- Macrolide antibiotics

- Erythromycin

- Clarithromycin

- Isoniazid

- Rifampin

- Verapamil

- Diltiazem

Type of Study:


Study Design:

Time Perspective: Prospective

Outcome Measure:

Pharmacokinetic parameters of prednisone/prednisolone

Outcome Description:

Two multiple comparisons (normal weight versus obese and normal weight versus underweight groups) will be conducted with a priori planned contrasts using the Bonferroni adjustment method.

Outcome Time Frame:

Pre-dose, 0.5, 1, 1.5, 2, 4, 6 to 8, 10 and 12 hours

Safety Issue:


Principal Investigator

Lillian Sung, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

The Hospital for Sick Children


United States: Federal Government

Study ID:




Start Date:

June 2008

Completion Date:

August 2009

Related Keywords:

  • Leukemia
  • childhood acute lymphoblastic leukemia in remission
  • untreated childhood acute lymphoblastic leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma



Cancer Research Center of Hawaii Honolulu, Hawaii  96813
Children's Hospital of Pittsburgh Pittsburgh, Pennsylvania  15213
Nemours Children's Clinic Jacksonville, Florida  32207
St. Christopher's Hospital for Children Philadelphia, Pennsylvania  19134-1095
Driscoll Children's Hospital Corpus Christi, Texas  78466
East Tennessee Children's Hospital Knoxville, Tennessee  37901
Overlook Hospital Summit, New Jersey  07902-0220
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital Long Beach, California  90801
Nemours Children's Clinic - Orlando Orlando, Florida  32806
Sacred Heart Cancer Center at Sacred Heart Hospital Pensacola, Florida  32504
St. Joseph's Cancer Institute at St. Joseph's Hospital Tampa, Florida  33607
Kaplan Cancer Center at St. Mary's Medical Center West Palm Beach, Florida  33407
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital Baltimore, Maryland  21215
Wake Forest University Comprehensive Cancer Center Winston-Salem, North Carolina  27157-1096
Methodist Children's Hospital of South Texas San Antonio, Texas  78229-3993
Alfred I. duPont Hospital for Children Wilmington, Delaware  19803
Lucille P. Markey Cancer Center at University of Kentucky Lexington, Kentucky  40536-0093
Akron Children's Hospital Akron, Ohio  44308-1062
Oklahoma University Cancer Institute Oklahoma City, Oklahoma  73104
Greenville Hospital Cancer Center Greenville, South Carolina  29605