Assessing Arsenic Trioxide in Young Patients With Leukemi... | NCT00899015

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

NCT00899015

Sponsor

National Institutes of Health Clinical Center (CC)

Status

Completed

Last Update Posted

Mar 16, 2012Estimated

Enrollment

23Estimated

Phase

Not provided

Conditions

Leukemia
Lymphoma

Interventions

pharmacological study

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Feb 2008Actual

First Submitted Date

May 9, 2009

First Submission Date that Met QC Criteria

May 9, 2009

First Posted Date

May 12, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2012

Last Update Posted Date

Mar 16, 2012Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

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.

Conditions Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

23Estimated

Name	Type	Description	Arm Group Labels	Other Names
pharmacological study	Other

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

21 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Elizabeth Fox, MD	National Cancer Institute (NCI)	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D007938	Leukemia
D008223	Lymphoma
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma
D054739	Dendritic Cell Sarcoma, Interdigitating
D002051	Burkitt Lymphoma
D012008	Recurrence
D054438	Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
07-C-N221
CDR0000570658