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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-24

Brief Summary

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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

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Detailed Description

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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

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Acute Lymphoblastic Leukemia Untreated Childhood Acute Lymphoblastic Leukemia

Study Groups

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Basic science (pharmacokinetics)

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.

Daunorubicin Hydrochloride

Intervention Type DRUG

Given IV

Pharmacological Study

Intervention Type OTHER

Correlative studies

Prednisolone

Intervention Type DRUG

Given orally

Prednisone

Intervention Type DRUG

Given orally

Vincristine Sulfate

Intervention Type DRUG

Given IV

Interventions

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Daunorubicin Hydrochloride

Given IV

Intervention Type DRUG

Pharmacological Study

Correlative studies

Intervention Type OTHER

Prednisolone

Given orally

Intervention Type DRUG

Prednisone

Given orally

Intervention Type DRUG

Vincristine Sulfate

Given IV

Intervention Type DRUG

Other Intervention Names

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Cerubidin Cerubidine Cloridrato de Daunorubicina Daunoblastin Daunoblastina Daunoblastine Daunomycin Hydrochloride Daunomycin, hydrochloride Daunorubicin.HCl Daunorubicini Hydrochloridum FI-6339 Ondena RP-13057 Rubidomycin Hydrochloride Rubilem (11beta)-11,17,21-Trihydroxypregna-1,4-diene-3,20-dione .delta.1-Hydrocortisone Adnisolone Aprednislon Capsoid Cortalone Cortisolone Dacortin H Decaprednil Decortin H Delta(1)Hydrocortisone Delta- Cortef Delta-Cortef Delta-Diona Delta-F Delta-Phoricol Delta1-dehydro-hydrocortisone Deltacortril Deltahydrocortisone Deltasolone Deltidrosol Dhasolone Di-Adreson-F Dontisolon D Estilsona Fisopred Frisolona Gupisone Hostacortin H Hydeltra Hydeltrasol Klismacort Kuhlprednon Lenisolone Lepi-Cortinolo Linola-H N Linola-H-Fett N Longiprednil Metacortandralone Meti Derm Meticortelone Opredsone Panafcortelone Precortisyl Pred-Clysma Predeltilone Predni-Coelin Predni-Helvacort Prednicortelone Prednisolonum Prelone Prenilone Sterane .delta.1-Cortisone 1, 2-Dehydrocortisone Adasone Cortancyl Dacortin DeCortin Decortisyl Decorton Delta 1-Cortisone Delta-Dome Deltacortene Deltacortisone Deltadehydrocortisone Deltasone Deltison Deltra Econosone Lisacort Meprosona-F Metacortandracin Meticorten Ofisolona Orasone Panafcort Panasol-S Paracort PRED Predicor Predicorten Prednicen-M Prednicort Prednidib Prednilonga Predniment Prednisonum Prednitone Promifen Servisone SK-Prednisone Kyocristine Leurocristine sulfate Leurocristine, sulfate Oncovin Vincasar Vincosid Vincrex Vincristine, sulfate

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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)

Minimum Eligible Age

10 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No