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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00899015
First received: May 9, 2009
Last updated: March 14, 2012
Last verified: March 2012

May 9, 2009
March 14, 2012
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  • Pharmacokinetics (PK) [ Designated as safety issue: No ]
  • Pharmacodynamics (PD) [ Designated as safety issue: No ]
  • Correlation of PK and PD with clinical parameters, such as age, gender, and dose [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00899015 on ClinicalTrials.gov Archive Site
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Assessing Arsenic Trioxide in Young Patients With Leukemia or Lymphoma Who Were Treated on Clinical Trial NCI-00-C-0070J
Sample Analysis for Terminated Protocol 00-C-0070, Pediatric Phase I Trial of Arsenic Trioxide

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.

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.

Observational
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  • Leukemia
  • Lymphoma
Other: pharmacological study
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
February 2008
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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
Both
2 Years to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00899015
999907221, 07-C-N221, CDR0000570658
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National Institutes of Health Clinical Center (CC)
National Cancer Institute (NCI)
Principal Investigator: Elizabeth Fox, MD National Cancer Institute (NCI)
National Institutes of Health Clinical Center (CC)
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP