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Pegfilgrastim as Support to Pediatric Sarcoma Patients Receiving Chemotherapy

NCT ID: NCT00035620

Last Updated: 2010-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-04-30

Study Completion Date

2007-04-30

Brief Summary

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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

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Conditions

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Sarcoma Neutropenia

Keywords

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Bone cancer Sarcoma Neutropenia Chemotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Filgrastim

Filgrastim

Group Type ACTIVE_COMPARATOR

filgrastim

Intervention Type DRUG

filgrastim

Pegfilgrastim

Pegfilgrastim

Group Type EXPERIMENTAL

pegfilgrastim

Intervention Type DRUG

pegfilgrastim

Interventions

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pegfilgrastim

pegfilgrastim

Intervention Type DRUG

filgrastim

filgrastim

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Amgen Inc.

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Countries

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Australia United States

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf

Notice regarding posted summaries of trial results

http://download.veritasmedicine.com/REGFILES/amgen/08D_FDAMA_113_Posting_Summary_11_GCSFSD01_990130.pdf

To access clinical trial results information click on this link

http://www.neulasta.com/

FDA-approved Drug Labeling

Other Identifiers

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990130

Identifier Type: -

Identifier Source: org_study_id