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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00899015

Enrollment

Registered

2009-05-12

Start date

Unknown

Completion date

2008-02-29

Last updated

2012-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Lymphoma

Keywords

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

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.

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.

Interventions

OTHERpharmacological study

Eligibility

Sex/Gender

ALL

Age

2 Years to 21 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics (PK)	—
Pharmacodynamics (PD)	—
Correlation of PK and PD with clinical parameters, such as age, gender, and dose	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026