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

NCT ID: NCT00899015

Last Updated: 2012-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Completion Date

2008-02-29

Brief Summary

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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

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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.

Conditions

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Leukemia Lymphoma

Interventions

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pharmacological study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

National Institutes of Health Clinical Center (CC)

NIH

Sponsor Role lead

Principal Investigators

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Elizabeth Fox, MD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Other Identifiers

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07-C-N221

Identifier Type: -

Identifier Source: secondary_id

CDR0000570658

Identifier Type: -

Identifier Source: secondary_id

999907221

Identifier Type: -

Identifier Source: org_study_id

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