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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00899015
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : March 16, 2012
National Cancer Institute (NCI)
Information provided by:
National Institutes of Health Clinical Center (CC)

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.

Condition or disease Intervention/treatment
Leukemia Lymphoma Other: pharmacological study

Detailed Description:


  • 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.

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Study Type : Observational
Estimated Enrollment : 23 participants
Official Title: Sample Analysis for Terminated Protocol 00-C-0070, Pediatric Phase I Trial of Arsenic Trioxide
Actual Study Completion Date : February 2008

Primary Outcome Measures :
  1. Pharmacokinetics (PK)
  2. Pharmacodynamics (PD)
  3. Correlation of PK and PD with clinical parameters, such as age, gender, and dose

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   2 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • See NCI-00-C-0070J


  • See NCI-00-C-0070J

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00899015

Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
National Cancer Institute (NCI)
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Principal Investigator: Elizabeth Fox, MD National Cancer Institute (NCI)
Layout table for additonal information Identifier: NCT00899015    
Other Study ID Numbers: 999907221
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: March 16, 2012
Last Verified: March 2012
Keywords provided by National Institutes of Health Clinical Center (CC):
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
Additional relevant MeSH terms:
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Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases