NCT00899015

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
Last Updated

March 16, 2012

Status Verified

March 1, 2012

First QC Date

May 9, 2009

Last Update Submit

March 14, 2012

Conditions

LeukemiaLymphoma

Keywords

recurrent childhood acute myeloid leukemiachildhood acute promyelocytic leukemia (M3)recurrent childhood acute lymphoblastic leukemiarecurrent childhood large cell lymphomarecurrent childhood lymphoblastic lymphomarecurrent childhood small noncleaved cell lymphomarecurrent/refractory childhood Hodgkin lymphomachildhood chronic myelogenous leukemiaatypical chronic myeloid leukemia, BCR-ABL1 negative

Outcome Measures

Primary Outcomes (3)

  • Pharmacokinetics (PK)

  • Pharmacodynamics (PD)

  • Correlation of PK and PD with clinical parameters, such as age, gender, and dose

Interventions

pharmacological studyOTHER

Eligibility Criteria

Age2 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

LeukemiaLymphomaPrecursor Cell Lymphoblastic Leukemia-LymphomaDendritic Cell Sarcoma, InterdigitatingBurkitt LymphomaRecurrenceLeukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, LymphoidHistiocytic Disorders, MalignantHistiocytosisEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, MyeloidMyelodysplastic-Myeloproliferative DiseasesBone Marrow DiseasesChronic Disease

Study Officials

  • Elizabeth Fox, MD

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Completion

February 1, 2008

Last Updated

March 16, 2012

Record last verified: 2012-03