NCT00900445

Studying Body Mass Index in Younger Patients Who Are Receiving Treatment for High-Risk Acute Lymphoblastic Leukemia

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 10 Years – 19 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Acute Lymphoblastic Leukemia
• Untreated Childhood Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	Daunorubicin Hydrochloride	Given IV
OTHER	Pharmacological Study	Correlative studies
DRUG	Prednisolone	Given orally
DRUG	Prednisone	Given orally
DRUG	Vincristine Sulfate	Given IV

Timeline

• Start date: 2008-03-24
• Primary completion: 2009-08-17
• First posted: 2009-05-12
• Last updated: 2018-08-07

Locations

1 site across 1 country: United States