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Pegfilgrastim as Support to Pediatric Sarcoma Patients Receiving Chemotherapy

This study is currently recruiting patients.

Sponsored by: Amgen
Information provided by: Amgen

Purpose

Physicians are conducting a clinical trial for patients with 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 patients up through the age of 11 with sarcoma.

Condition Treatment or Intervention Phase
Sarcoma
Neutropenia
 Drug: pegfilgrastim
Phase II

MedlinePlus related topics:  Blood and Blood Disorders;   Soft Tissue Sarcoma

Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Safety/Efficacy Study

Official Title: A Study of Single Dose Per Cycle Filgrastim-SD/01 as an Adjunct to VAdriaC/IE Chemotherapy in Pediatric Sarcoma Patients

Further Study Details: 

Expected Total Enrollment:  84

Study start: May 2003

Eligibility

Ages Eligible for Study:  up to  11 Years,  Genders Eligible for Study:  Both

Criteria


Location and Contact Information

For additional information regarding investigative sites for this trial, contact the Amgen Call Center at      1-866-57AMGEN (1-866-572-6436) 

Arkansas
      Research Center, Little Rock,  Arkansas,  United States; Recruiting

California
      Research Center, Orange,  California,  United States; Recruiting

Tennessee
      Research Center, Memphis,  Tennessee,  United States; Recruiting

More Information

AmgenTrials -- Amgen's clinical trial resource site

Center Watch -- Clinical trial resource site

Study ID Numbers:  990130
Record last reviewed:  April 2004
Record first received:  May 3, 2002
ClinicalTrials.gov Identifier:  NCT00035620
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10
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