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Assessing Arsenic Trioxide in Young Patients With Leukemia or Lymphoma Who Were Treated on Clinical Trial NCI-00-C-0070J

Primary Purpose

Leukemia, Lymphoma

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
pharmacological study
Sponsored by
National Institutes of Health Clinical Center (CC)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Leukemia focused on measuring recurrent childhood acute myeloid leukemia, childhood acute promyelocytic leukemia (M3), recurrent childhood acute lymphoblastic leukemia, recurrent childhood large cell lymphoma, recurrent childhood lymphoblastic lymphoma, recurrent childhood small noncleaved cell lymphoma, recurrent/refractory childhood Hodgkin lymphoma, childhood chronic myelogenous leukemia, atypical chronic myeloid leukemia, BCR-ABL1 negative

Eligibility Criteria

2 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Histologically confirmed leukemia or lymphoma refractory to standard curative treatment regimens

    • No meningeal leukemia or lymphoma
    • No HIV-related lymphoma
    • No lymphoproliferative diseases
  • Received treatment on protocol NCI-00-C-0070J
  • Bone marrow or peripheral blood and serum samples collected during treatment on NCI-00-C-0070J are available

PATIENT CHARACTERISTICS:

  • See NCI-00-C-0070J

PRIOR CONCURRENT THERAPY:

  • See NCI-00-C-0070J

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Pharmacokinetics (PK)
    Pharmacodynamics (PD)
    Correlation of PK and PD with clinical parameters, such as age, gender, and dose

    Secondary Outcome Measures

    Full Information

    First Posted
    May 9, 2009
    Last Updated
    March 14, 2012
    Sponsor
    National Institutes of Health Clinical Center (CC)
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00899015
    Brief Title
    Assessing Arsenic Trioxide in Young Patients With Leukemia or Lymphoma Who Were Treated on Clinical Trial NCI-00-C-0070J
    Official Title
    Sample Analysis for Terminated Protocol 00-C-0070, Pediatric Phase I Trial of Arsenic Trioxide
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    March 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    February 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Institutes of Health Clinical Center (CC)
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    5. Study Description

    Brief Summary
    RATIONALE: Studying bone marrow and blood samples from patients with leukemia or lymphoma treated with arsenic trioxide may help doctors learn more about cancer. PURPOSE: This research study is assessing arsenic trioxide in young patients with recurrent or refractory leukemia or lymphoma who were treated on clinical trial NCI-00-C-0070J.
    Detailed Description
    OBJECTIVES: To assess the pharmacokinetic and pharmacodynamic profiles of arsenic trioxide in pediatric patients treated on protocol NCI-00-C-0070J. OUTLINE: Bone marrow or peripheral blood mononuclear cells collected during treatment on NCI-00-C-0070J are assessed for pharmacodynamics studies. Plasma cells collected during treatment are assessed for pharmacokinetics studies. Total arsenic (As), inorganic As forms (AsIII and AsV), and methylated metabolites of As are assessed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Leukemia, Lymphoma
    Keywords
    recurrent childhood acute myeloid leukemia, childhood acute promyelocytic leukemia (M3), recurrent childhood acute lymphoblastic leukemia, recurrent childhood large cell lymphoma, recurrent childhood lymphoblastic lymphoma, recurrent childhood small noncleaved cell lymphoma, recurrent/refractory childhood Hodgkin lymphoma, childhood chronic myelogenous leukemia, atypical chronic myeloid leukemia, BCR-ABL1 negative

    7. Study Design

    Enrollment
    23 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Other
    Intervention Name(s)
    pharmacological study
    Primary Outcome Measure Information:
    Title
    Pharmacokinetics (PK)
    Title
    Pharmacodynamics (PD)
    Title
    Correlation of PK and PD with clinical parameters, such as age, gender, and dose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    DISEASE CHARACTERISTICS: Histologically confirmed leukemia or lymphoma refractory to standard curative treatment regimens No meningeal leukemia or lymphoma No HIV-related lymphoma No lymphoproliferative diseases Received treatment on protocol NCI-00-C-0070J Bone marrow or peripheral blood and serum samples collected during treatment on NCI-00-C-0070J are available PATIENT CHARACTERISTICS: See NCI-00-C-0070J PRIOR CONCURRENT THERAPY: See NCI-00-C-0070J
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Elizabeth Fox, MD
    Organizational Affiliation
    National Cancer Institute (NCI)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Assessing Arsenic Trioxide in Young Patients With Leukemia or Lymphoma Who Were Treated on Clinical Trial NCI-00-C-0070J

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