Studying Body Mass Index in Younger Patients Who Are Receiving Treatment for High-Risk Acute Lymphoblastic Leukemia
RATIONALE: 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.
PURPOSE: This clinical trial is studying body mass index in younger patients receiving prednisone/prednisolone, vincristine, daunorubicin, and pegaspargase for high-risk acute lymphoblastic leukemia.
Drug: daunorubicin hydrochloride
Drug: vincristine sulfate
Other: high performance liquid chromatography
Other: immunoenzyme technique
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Other: liquid chromatography
Other: pharmacological study
|Official Title:||Impact of Obesity on the Pharmacokinetics of Anticancer Therapy in Children With High Risk Acute Lymphoblastic Leukemia (ALL)|
- Activity correlation of pharmacokinetics of prednisone, vincristine, and daunorubicin hydrochloride to BMI [ Designated as safety issue: No ]
- Correlation of BMI and pharmacokinetics with response status to induction therapy [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
- 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 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.
Show 22 Study Locations
|Study Chair:||Lillian Sung, MD, PhD||The Hospital for Sick Children|
|Principal Investigator:||Gregory H. Reaman, MD||Children's Oncology Group - Group Chair Office|