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

This study has been withdrawn prior to enrollment.
(Poor accrual)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00900445
First received: May 9, 2009
Last updated: May 30, 2013
Last verified: May 2013
  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: pharmacological study

Study Type: Observational
Study Design: Time Perspective: Prospective
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:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Pharmacokinetic parameters of prednisone/prednisolone [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6 to 8, 10 and 12 hours ] [ Designated as safety issue: No ]
    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.

  • Pharmacokinetic parameters of vincristine sulfate [ Time Frame: Pre-dose, 0.5, 1, 2, 4, 8, 24 to 36 hours, and 48 to 72 hours ] [ Designated as safety issue: No ]
    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.

  • Pharmacokinetic parameters of daunorubicin hydrochloride [ Time Frame: Pre-dose, 0.5, 0.75, 1, 2, 4, 8, 12, 24 to 36 hours, and 48 to 72 hours ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • RER and SER status [ Time Frame: Up to 1.5 years ] [ Designated as safety issue: No ]
    To examine the relationship between pharmacokinetic parameters and RER versus SER status, univariate and multiple logistic regressions will be performed.


Enrollment: 0
Study Start Date: June 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Obese

Pts are stratified according to body mass index (BMI) (≥ 95th percentile [obese]. Pts receive anticancer therapy and prednisone/prednisolone orally 2x on either day 1 or day 8. Pts receive daunorubicin hydrochloride IV over 30 minutes and vincristine sulfate 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 the pharmacological study of vincristine sulfate, prednisone, and daunorubicin hydrochloride begins.

Drug: daunorubicin hydrochloride
Given IV
Other Names:
  • Daunomycin
  • rubidomycin
  • Cerubidine
  • NSC #82151
Drug: prednisolone
Given orally
Other Names:
  • Deltasolone
  • deltahydrocortisone
Drug: prednisone
Given orally
Other Names:
  • Orasone
  • Predicor
  • Sterapred
Drug: vincristine sulfate
Given IV
Other Names:
  • Oncovin
  • VCR
  • LCR
  • NSC #67574
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Normal

Pts are stratified according to body mass index (BMI) 10th to 95th percentile [normal or at risk for overweight].

Blood samples are obtained on either day 1 or day 8 of induction therapy for pharmacokinetic analysis of prednisone, daunorubicin hydrochloride, and vincristine sulfate 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 the pharmacological study of vincristine sulfate, prednisone, and daunorubicin hydrochloride begins

Drug: daunorubicin hydrochloride
Given IV
Other Names:
  • Daunomycin
  • rubidomycin
  • Cerubidine
  • NSC #82151
Drug: prednisolone
Given orally
Other Names:
  • Deltasolone
  • deltahydrocortisone
Drug: prednisone
Given orally
Other Names:
  • Orasone
  • Predicor
  • Sterapred
Drug: vincristine sulfate
Given IV
Other Names:
  • Oncovin
  • VCR
  • LCR
  • NSC #67574
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Underweight

Patients are stratified according to body mass index (BMI) ≤ 10th percentile [underweight]).

Blood samples are obtained on either day 1 or day 8 of induction therapy for pharmacokinetic analysis of prednisone, daunorubicin hydrochloride, and vincristine sulfate 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 the pharmacological study of vincristine sulfate, prednisone, and daunorubicin hydrochloride begins

Drug: daunorubicin hydrochloride
Given IV
Other Names:
  • Daunomycin
  • rubidomycin
  • Cerubidine
  • NSC #82151
Drug: prednisolone
Given orally
Other Names:
  • Deltasolone
  • deltahydrocortisone
Drug: prednisone
Given orally
Other Names:
  • Orasone
  • Predicor
  • Sterapred
Drug: vincristine sulfate
Given IV
Other Names:
  • Oncovin
  • VCR
  • LCR
  • NSC #67574
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies

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
Sampling Method:   Non-Probability Sample
Study Population

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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00900445

  Show 22 Study Locations
Sponsors and Collaborators
Children's Oncology Group
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

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00900445     History of Changes
Other Study ID Numbers: ACCL0631, COG-ACCL0631, CDR0000588173
Study First Received: May 9, 2009
Last Updated: May 30, 2013
Health Authority: United States: Federal Government

Keywords provided by Children's Oncology Group:
childhood acute lymphoblastic leukemia in remission
untreated childhood acute lymphoblastic leukemia

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

ClinicalTrials.gov processed this record on September 18, 2014