Doxorubicin Pharmacokinetic (PK) Study | NCT00124956

Studies
Doxorubicin Pharmacokinetic (PK) Study

NCT00124956

Sponsor

Boston Children's Hospital

Status

Withdrawn

Last Update Posted

Sep 11, 2017Actual

Enrollment

0Actual

Phase

Phase 1Phase 2

Conditions

Cancer

Interventions

Doxorubicin

Countries

United States

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

Sep 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2003

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jul 7, 2005

First Submission Date that Met QC Criteria

Jul 28, 2005

First Posted Date

Jul 29, 2005Estimated

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

Sep 7, 2017

Last Update Posted Date

Sep 11, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Steven Dubois, Associate Professor of Pediatrics, Dana-Farber Cancer InstitutePrincipal Investigator

Lead Sponsor

Boston Children's HospitalOTHER

Collaborators

Name	Class
Glaser Pediatric Research Network	NETWORK
Elizabeth Glaser Pediatric AIDS Foundation	OTHER

Description Module

Brief Summary

This protocol is designed to obtain detailed information on the impact of body composition on the pharmacokinetic behavior of doxorubicin after a single intravenous dose in children 21 years of age or younger. There is no efficacy component. Approximately 9 children will be enrolled at Children's Hospital Boston. The information gained from this study could be very important in developing dosing strategies for doxorubicin in the obese patient population.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
Doxorubicin	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the relationship between obesity and doxorubicin pharmacokinetics in children

Secondary Outcomes

Measure	Description	Time Frame
To explore the relationship between PK parameters and the patients' characteristics (age, gender, and ethnicity) and to correlate between PK parameters and DXA data (fat mass, lean tissue mass, and bone mineral content)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Eligible patients will be > 1 and ≤ 21 years old.
All patients must be receiving chemotherapy that includes doxorubicin administered as an infusion of any duration < 24 hours, on either a 1-day or 2-day schedule. This includes bolus and all short infusion schedules.
All patients or their parents/legal guardians will provide informed consent/assent (as required by law) indicating their awareness of the investigational nature and the risks of this study according to the informed consent process.

Exclusion Criteria:

Women who are known to be pregnant or lactating
Patients with significant uncontrolled systemic illness
Serum glutamic oxaloacetic transaminase (SGOT/AST), serum glutamic pyruvate transaminase (SGPT/ALT) > 3 times the upper limit of normal tested within 14 days prior to infusion
Bilirubin > the upper limit of normal tested within 14 days prior to infusion
Patients whose dose of doxorubicin is based on ideal body weight
Patients who weigh < 12 kilograms at time of screening

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

21 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Holcombe Grier, MD	Dana Farber Cancer Insitute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital, Boston		Boston	Massachusetts	02115	United States

ID	Term
D009369	Neoplasms

Intervention Browse Module

MeSH Terms

ID	Term
D004317	Doxorubicin

Ancestor Terms

ID	Term
D003630	Daunorubicin
D018943	Anthracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons

Browse Leaves

Not provided

Browse Branches

Not provided