Trial Information
Sample Analysis for Terminated Protocol 00-C-0070, Pediatric Phase I Trial of Arsenic Trioxide
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.
Inclusion 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
Type of Study:
Observational
Study Design:
N/A
Outcome Measure:
Pharmacokinetics (PK)
Safety Issue:
No
Principal Investigator
Elizabeth Fox, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
National Cancer Institute (NCI)
Authority:
United States: Federal Government
Study ID:
999907221
NCT ID:
NCT00899015
Start Date:
Completion Date:
February 2008
Related Keywords:
- Leukemia
- Lymphoma
- 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
- Leukemia
- Lymphoma