Status:
WITHDRAWN
Studying Body Mass Index in Younger Patients Who Are Receiving Treatment for High-Risk Acute Lymphoblastic Leukemia
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Acute Lymphoblastic Leukemia
Untreated Childhood Acute Lymphoblastic Leukemia
Eligibility:
All Genders
10-19 years
Brief 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 ...
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 tha...
Eligibility Criteria
Inclusion
- Patients must be newly diagnosed with acute lymphoblastic leukemia and the intended induction treatment must contain prednisone/prednisolone, vincristine and daunorubicin in the doses and schedule as per the current COG AALL0232 protocol; prior registration onto a COG protocol is not required
- Patients must be able to take either prednisone/prednisolone reliably by mouth on day 1 or 8 of induction (depending on sampling schedule chosen); patients who are being sampled on Induction day 8 and who have received intravenous corticosteroid therapy in the first week of induction must have received a minimum of six oral prednisone/prednisolone doses prior to the morning prednisone/prednisolone dose on induction day 8
Exclusion
- Serum transaminase concentrations \>= 5 X ULN for age
- Total serum bilirubin (conjugated + unconjugated) \>= 1.5 mg/dl (\>= 26 micromol/L)
- Serum creatinine \> 1.5 X ULN for age
- With the exception of prednisone/prednisolone, receipt of medications or food known or with the potential to alter the pharmacokinetics of the drugs under study within 14 days of diagnosis and throughout the period of pharmacokinetic sampling; such agents include but are not limited to: grapefruit, tangelos or the juice of these fruits; St. Johns wort; anticonvulsants: carbamazepine, oxcarbazepine, phenytoin, phenobarbital, primidone; azole antifungal agents: ketoconazole, fluconazole, itraconazole, voriconazole; macrolide antibiotics: erythromycin, clarithromycin; isoniazid; rifampin; verapamil; and diltiazem
- Presence of known malabsorption syndrome
- Females with known pregnancy (pregnancy test must be negative to be eligible)
Key Trial Info
Start Date :
March 24 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00900445
Start Date
March 24 2008
Last Update
August 7 2018
Active Locations (1)
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1
Childrens Oncology Group
Philadelphia, Pennsylvania, United States, 19104