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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00899015
First received: May 9, 2009
Last updated: March 14, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Leukemia
Lymphoma
Other: pharmacological study

Study Type: Observational
Official Title: Sample Analysis for Terminated Protocol 00-C-0070, Pediatric Phase I Trial of Arsenic Trioxide

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Pharmacokinetics (PK) [ Designated as safety issue: No ]
  • Pharmacodynamics (PD) [ Designated as safety issue: No ]
  • Correlation of PK and PD with clinical parameters, such as age, gender, and dose [ Designated as safety issue: No ]

Estimated Enrollment: 23
Study Completion Date: February 2008
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.

  Eligibility

Ages Eligible for Study:   2 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00899015

Sponsors and Collaborators
Investigators
Principal Investigator: Elizabeth Fox, MD National Cancer Institute (NCI)
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00899015     History of Changes
Other Study ID Numbers: 999907221, 07-C-N221, CDR0000570658
Study First Received: May 9, 2009
Last Updated: March 14, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
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

Additional relevant MeSH terms:
Leukemia
Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Arsenic trioxide
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014