Acute Lymphoblastic Leukemia Clinical Trial
Official title:
Impact of Obesity on the Pharmacokinetics of Anticancer Therapy in Children With High Risk Acute Lymphoblastic Leukemia (ALL)
This clinical trial is studying body mass index in younger patients receiving prednisone/prednisolone, vincristine, daunorubicin, and pegaspargase for high-risk acute lymphoblastic leukemia. Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about the affect of body mass index on the way anticancer drugs work in the body. It may also help doctors predict how patients will respond to treatment
PRIMARY OBJECTIVES:
I. 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.
II. 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) (greater than or equal to 95th percentile [obese] vs 10th to 95th percentile [normal or
at risk for overweight] vs less than or equal to 10th 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
levels.
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.
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