Not Signed In -
Sarcoma |
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Clinical Trial: Pegfilgrastim as Support to Pediatric Sarcoma Patients Receiving Chemotherapy
This study is currently recruiting patients.
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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
Expected Total Enrollment: 84
Study start: May 2003
Eligibility
Ages Eligible for Study: up to 11 Years, Genders Eligible for Study: Both
Criteria
- Sarcoma
- No previous chemotherapy or radiotherapy
- Patients who will be receiving chemotherapy consisting of Vincristine, Doxorubicin, Cyclophosphamide, Etoposide, Ifosfamide, and Mesna
Location and Contact Information
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
Record last reviewed: April 2004
Last Updated: October 13, 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 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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