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

3 augusti 2018 uppdaterad av: Children's Oncology Group

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

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

Studieöversikt

Status

Indragen

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Pennsylvania
      • Philadelphia, Pennsylvania, Förenta staterna, 19104
        • Childrens Oncology Group

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

10 år till 19 år (Barn, Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Beskrivning

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)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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.
Övrig: Farmakologisk studie
Korrelativa studier
Läkemedel: Daunorubicinhydroklorid
Givet IV
Andra namn:
  • Cerubidin
  • Cloridrato de Daunorubicina
  • Daunoblastin
  • Daunoblastina
  • Daunomycinhydroklorid
  • Daunomycin, hydroklorid
  • Daunorubicin.HCl
  • Daunorubicini Hydrochloridum
  • FI-6339
  • Ondena
  • RP-13057
  • Rubidomycinhydroklorid
  • Rubilem
Läkemedel: Vinkristinsulfat
Givet IV
Andra namn:
  • Oncovin
  • Kyocristine
  • Leurocristine, sulfat
  • Vincasar
  • Vincosid
  • Vincrex
  • Vinkristin, sulfat
  • Leurocristinsulfat
Läkemedel: Prednison
Ges oralt
Andra namn:
  • Deltasone
  • Orasone
  • 61-kortison
  • 1,2-dehydrokortison
  • Adasone
  • Cortancyl
  • Dacortin
  • DeCortin
  • Decortisyl
  • Decorton
  • Delta 1-kortison
  • Delta-Dome
  • Deltacortene
  • Deltakortison
  • Deltadehydrokortison
  • Deltison
  • Delta
  • Econosone
  • Lisacort
  • Meprosona-F
  • Metakortandracin
  • Meticorten
  • Ofisolona
  • Panafcort
  • Panasol-S
  • Paracort
  • PRED
  • Predicor
  • Predicorten
  • Prednicen-M
  • Prednicort
  • Prednidib
  • Prednilonga
  • Prediment
  • Prednisonum
  • Predniton
  • Promifen
  • Servisone
  • SK-Prednison
Läkemedel: Prednisolone
Given orally
Andra namn:
  • (11beta)-11,17,21-trihydroxipregna-1,4-dien-3,20-dion
  • 61-hydrokortison
  • Adnisolon
  • Aprednislon
  • Kapsoid
  • Cortalone
  • Kortisolon
  • Dacortin H
  • Decaprednil
  • Decortin H
  • Delta(1)Hydrokortison
  • Delta- Cortef
  • Delta-Cortef
  • Delta-Diona
  • Delta-F
  • Delta-Phoricol
  • Delta1-dehydro-hydrokortison
  • Deltacortril
  • Deltahydrokortison
  • Deltasolone
  • Deltidrosol
  • Dhasolone
  • Di-Adreson-F
  • Dontisolon D
  • Estilsona
  • Fisopred
  • Frisolona
  • Gupisone
  • Hostacortin H
  • Hydeltra
  • Hydeltrasol
  • Klismacort
  • Kuhlprednon
  • Lenisolon
  • Lepi-Cortinolo
  • Linola-H N
  • Linola-H-Fett N
  • Longiprednil
  • Metakortandralon
  • Meti Derm
  • Meticortelone
  • Opredsone
  • Panafkortelon
  • Prekortisyl
  • Pred-Clysma
  • Predeltilone
  • Predni-Coelin
  • Predni-Helvacort
  • Prednikortelon
  • Prednisolum
  • Prelone
  • Prenilon
  • Sterane

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Pharmacokinetic parameters of prednisone/prednisolone
Tidsram: Pre-dose, 0.5, 1, 1.5, 2, 4, 6 to 8, 10 and 12 hours
Two multiple comparisons (normal weight versus obese and normal weight versus underweight groups) will be conducted with a priori planned contrasts using the Bonferroni adjustment method.
Pre-dose, 0.5, 1, 1.5, 2, 4, 6 to 8, 10 and 12 hours
Pharmacokinetic parameters of daunorubicin hydrochloride
Tidsram: Pre-dose, 0.5, 0.75, 1, 2, 4, 8, 12, 24 to 36 hours, and 48 to 72 hours
Two multiple comparisons (normal weight versus obese and normal weight versus underweight groups) will be conducted with a priori planned contrasts using the Bonferroni adjustment method.
Pre-dose, 0.5, 0.75, 1, 2, 4, 8, 12, 24 to 36 hours, and 48 to 72 hours
Pharmacokinetic parameters of vincristine sulfate
Tidsram: Pre-dose, 0.5, 1, 2, 4, 8, 24 to 36 hours, and 48 to 72 hours
Two multiple comparisons (normal weight versus obese and normal weight versus underweight groups) will be conducted with a priori planned contrasts using the Bonferroni adjustment method.
Pre-dose, 0.5, 1, 2, 4, 8, 24 to 36 hours, and 48 to 72 hours

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
RER and SER status
Tidsram: Up to 1.5 years
To examine the relationship between pharmacokinetic parameters and RER versus SER status, univariate and multiple logistic regressions will be performed.
Up to 1.5 years

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Children's Oncology Group

Samarbetspartners

National Cancer Institute (NCI)

Utredare

  • Huvudutredare: Ian Pollack, Children's Oncology Group

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

24 mars 2008

Primärt slutförande (Faktisk)

17 augusti 2009

Studieregistreringsdatum

Först inskickad

9 maj 2009

Först inskickad som uppfyllde QC-kriterierna

9 maj 2009

Första postat (Uppskatta)

12 maj 2009

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

7 augusti 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 augusti 2018

Senast verifierad

1 mars 2013

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • ACCL0631 (Annan identifierare: CTEP)
  • U10CA095861 (U.S.S. NIH-anslag/kontrakt)
  • NCI-2011-02151 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
  • CDR0000588173
  • COG-ACCL0631 (Annan identifierare: DCP)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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