MDACC Study Summary COGABTR06C1 (Archived)

Study Summary
No. COGABTR06C1:.......Leukemia......Cesar Nunez......Pediatrics

Study Summary Title



Study Summary Number:	COGABTR06C1

Study Title:	Pharmacokinetics of Daunomycin in Children

Physician

New Patient Referral



Name:	Cesar Nunez	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Pediatrics	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-6620 Contact us about clinical trials

General Information



Disease Group:	Leukemia	Supported By:	Children's Oncology Group

Phase of Study:	N/A	Return Visit:	The length of the study will be about 2-3 weeks. Within that time they will have blood samples obtained over a 72 - hour period and a DXA scan performed within seven days before or after the blood sample collection.

Treatment Agents:	Daunorubicin	Home Care:	NA

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	Depending on what time of day the patient receives the dose of daunomycin, they might stay in the hospital overnight.


Description/ Intervention:	The goal of this clinical research study is to learn how your body handles the drug, daunomycin, related to your weight and body fat. To study this, researchers will perform a body-fat scan and pharmacokinetic (PK) blood tests. PK testing measures the amount of study drug in the body at different time points.

Study Objectives / Outcomes

The primary aim of this study is to determine the pharmacokinetics of daunomycin in children.

The secondary aims are to : 1) evaluate the relationship between body composition (percent body fat) and daunomycin pharmacokinetics in children. 2) determine whether daunomycin pharmacokinetics are correlated with gender, age, or ethnic background in children. 3) explore in a preliminary fashion possible relationships between pharmacokinetic results and toxicity. 4) explore in a preliminary fashion possible relationships between pharmacokinetic results and ranal and hepatic function and complete blood count (CBC).

Study Status Information



Study Activation / Registration Date:	04/25/2007

IRB Review and Approval Date:	04/25/2007

Study Type:	Laboratory

Recruitment Status:	Terminated

Projected Accrual:	100

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Prior to patient enrollment, all patients must have been registered via the eRDE system into the COG Cancer Registry.

2) Patient may be enrolled on the study once all eligibility requirements for the study have been met.

3) All studies to determine eligibility and pre-study evaluations must be performed within 14 days prior to enrollment.

4) Must be </= 21 yrs of age at the time of study entry.

5) All patients must be receiving chemotherapy that includes daunomycin administered as an infusion of any duration < 24 hours on either a 1- or a 2-day schedule.

6) Patients with any diagnosis of a malignancy are eligible.

Exclusion Criteria:

1) Women who are pregnant or breast-feeding.

2) Patients with significant uncontrolled systemic illness.

Links

Registration Number: NCT00673257
Study Information on Clinical Trials Registry (clinicaltrials.gov)