Pegfilgrastim as Support to Pediatric Sarcoma Patients Re... | NCT00035620

Studies
Pegfilgrastim as Support to Pediatric Sarcoma Patients Receiving Chemotherapy

NCT00035620

Sponsor

Amgen

Status

Completed

Last Update Posted

Feb 26, 2010Estimated

Enrollment

44Actual

Phase

Phase 2

Conditions

Sarcoma
Neutropenia

Interventions

pegfilgrastim
filgrastim

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

Feb 2010

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

Apr 2000

Primary Completion Date

Jan 2007Actual

Completion Date

Apr 2007Actual

First Submitted Date

May 3, 2002

First Submission Date that Met QC Criteria

May 3, 2002

First Posted Date

May 6, 2002Estimated

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

Feb 25, 2010

Last Update Posted Date

Feb 26, 2010Estimated

Description Module

Brief Summary

Physicians are conducting a clinical trial for patients with pediatric sarcoma. Sarcoma is a type of bone cancer that can be treated with chemotherapy which can affect the bone marrow, where blood cells are produced. Neutrophils are a type of white blood cells that fight infection and are produced in the bone marrow. If the neutrophil count becomes too low due to chemotherapy, a potentially serious condition called neutropenia occurs. Neutropenia is serious because it can affect the body's ability to protect against many types of infections. Pegfilgrastim is an investigational drug being evaluated for its potential ability to increase the number of neutrophils. The purpose of this study is to determine the safety and effectiveness of pegfilgrastim in preventing neutropenia following chemotherapy in pediatric patients up through the age of 21 with sarcoma.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Filgrastim	Active Comparator	Filgrastim	Drug: filgrastim
Pegfilgrastim	Experimental	Pegfilgrastim	Drug: pegfilgrastim

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pegfilgrastim	Drug	pegfilgrastim	Pegfilgrastim
filgrastim

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Duration of severe neutropenia in chemotherapy in cycles 1 and 3		cycles 1 and 3
Time to ANC recovery to greater than or equal to 0.5 x 10^9/L in cycles 1 and 3		cycles 1 and 3

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetic profile in chemotherapy cycles 1 and 3		cycles 1 and 3
Incidence of adverse events across all cycles of chemotherapy		all cycles
Overall rates of febrile neutropenia

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Sarcoma * No previous chemotherapy or radiotherapy * Patients who will be receiving chemotherapy consisting of Vincristine, Doxorubicin, Cyclophosphamide, Etoposide, Ifosfamide, and Mesna

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

21 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
MD	Amgen	Study Director

References Module

Citations

Not provided

Label	URL
AmgenTrials clinical trials website	View source
FDA-approved Drug Labeling	View source

ID	Term
D012509	Sarcoma
D009503	Neutropenia
D001859	Bone Neoplasms

ID	Term
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D000380	Agranulocytosis

ID	Term
D016179	Granulocyte Colony-Stimulating Factor
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates