Assessing Arsenic Trioxide in Young Patients With Leukemia or Lymphoma Who Were Treated on Clinical Trial NCI-00-C-0070J
|ClinicalTrials.gov Identifier: NCT00899015|
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : March 16, 2012
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|
- 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.
|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|
- Pharmacokinetics (PK)
- Pharmacodynamics (PD)
- Correlation of PK and PD with clinical parameters, such as age, gender, and dose
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00899015
|Principal Investigator:||Elizabeth Fox, MD||National Cancer Institute (NCI)|