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

National Institutes of Health Clinical Center (CC)

Status: Completed

Conditions: Lymphoma; Leukemia

Treatments: Other: pharmacological study

Study type: Observational

Funder types: NIH

Identifiers

NCT00899015

999907221

CDR0000570658

07-C-N221

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 estimated patients

Sex: All

Ages: 2 to 21 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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