- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00899015
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.
Study Overview
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.
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Pharmacokinetics (PK)
|
Pharmacodynamics (PD)
|
Correlation of PK and PD with clinical parameters, such as age, gender, and dose
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Elizabeth Fox, MD, National Cancer Institute (NCI)
Study record dates
Study Major Dates
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- recurrent childhood small noncleaved cell lymphoma
- recurrent childhood large cell lymphoma
- childhood chronic myelogenous leukemia
- recurrent/refractory childhood Hodgkin lymphoma
- recurrent childhood acute lymphoblastic leukemia
- recurrent childhood acute myeloid leukemia
- recurrent childhood lymphoblastic lymphoma
- atypical chronic myeloid leukemia, BCR-ABL1 negative
- childhood acute promyelocytic leukemia (M3)
Additional Relevant MeSH Terms
Other Study ID Numbers
- 999907221
- 07-C-N221
- CDR0000570658
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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