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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00900445
First received: May 9, 2009
Last updated: November 13, 2010
Last verified: November 2010
History of Changes
  Purpose

RATIONALE: 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.

PURPOSE: This clinical trial is studying body mass index in younger patients receiving prednisone/prednisolone, vincristine, daunorubicin, and pegaspargase for high-risk acute lymphoblastic leukemia.


Condition Intervention
Leukemia
 Drug: daunorubicin hydrochloride
Drug: prednisolone
Drug: prednisone
Drug: vincristine sulfate
Other: high performance liquid chromatography
Other: immunoenzyme technique
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Other: liquid chromatography
Other: pharmacological study

Study Type: Observational
Official Title: Impact of Obesity on the Pharmacokinetics of Anticancer Therapy in Children With High Risk Acute Lymphoblastic Leukemia (ALL)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Activity correlation of pharmacokinetics of prednisone, vincristine, and daunorubicin hydrochloride to BMI [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation of BMI and pharmacokinetics with response status to induction therapy [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2008
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • 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.
  • 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) (≥ 95^th percentile [obese] vs 10^th to 95^th percentile [normal or at risk for overweight] vs ≤ 10^th 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.

  Eligibility

Ages Eligible for Study:   10 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Newly diagnosed acute lymphoblastic leukemia

  • Must be assigned to receive prednisone/prednisolone, vincristine, and daunorubicin during induction treatment in the doses and schedule as per the current COG AALL0232 protocol

    • Prior registration onto a COG protocol is not required

  • Must meet 1 of the following criteria:

    • Obese (defined as a body mass index [BMI] ≥ 95^th percentile)
    • Normal weight or at risk for overweight (defined as BMI between 10^th and 95^th percentile)
    • Underweight (defined as ≤ 10^th percentile)

PATIENT CHARACTERISTICS:

  • Able to take either prednisone or prednisolone by mouth on day 1 or 8 of induction therapy
  • Not pregnant
  • Negative pregnancy test
  • AST/ALT < 5 times upper limit of normal (ULN)
  • Total bilirubin (conjugated + unconjugated) < 1.5 mg/dL
  • Creatinine ≤ 1.5 times ULN
  • No known malabsorption syndrome

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

  • At least 2 weeks since prior and no concurrent medications or food known or with the potential to alter the pharmacokinetics of the drugs under study including any of the following

    • Grapefruit, tangelos, or the juice of these fruits
    • Hypericum perforatum (St. John's wort)
    • Anticonvulsants
    • Carbamazepine
    • Oxcarbazepine
    • Phenytoin
    • Phenobarbital
    • Primidone

    • Azole antifungal agents including:

      • Ketoconazole
      • Fluconazole
      • Itraconazole
      • Voriconazole
    • Macrolide antibiotics
    • Erythromycin
    • Clarithromycin
    • Isoniazid
    • Rifampin
    • Verapamil
    • Diltiazem
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00900445

  Show 22 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Lillian Sung, MD, PhD The Hospital for Sick Children
Principal Investigator: Gregory H. Reaman, MD Children's Oncology Group - Group Chair Office
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00900445     History of Changes
Other Study ID Numbers: CDR0000588173, COG-ACCL0631
Study First Received: May 9, 2009
Last Updated: November 13, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
childhood acute lymphoblastic leukemia in remission
untreated childhood acute lymphoblastic leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Daunorubicin
Prednisolone
Methylprednisolone Hemisuccinate
Prednisone
Vincristine
Methylprednisolone acetate
 Prednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antiemetics

ClinicalTrials.gov processed this record on May 23, 2013