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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00035620 |
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.
Condition | Intervention | Phase |
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Sarcoma Neutropenia |
Drug: pegfilgrastim Drug: filgrastim |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, 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 |
Enrollment: | 44 |
Study Start Date: | April 2000 |
Study Completion Date: | April 2007 |
Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Filgrastim: Active Comparator
Filgrastim
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Drug: filgrastim
filgrastim
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Pegfilgrastim: Experimental
Pegfilgrastim
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Drug: pegfilgrastim
pegfilgrastim
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Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 990130 |
Study First Received: | May 3, 2002 |
Last Updated: | March 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00035620 |
Health Authority: | United States: Food and Drug Administration |
Bone cancer Sarcoma Neutropenia Chemotherapy |
Neoplasms, Connective and Soft Tissue Neutropenia Bone Neoplasms Hematologic Diseases Malignant mesenchymal tumor Bone neoplasms |
Agranulocytosis Sarcoma Leukocyte Disorders Leukopenia Granulocytopenia Soft tissue sarcomas |
Neoplasms Neoplasms by Histologic Type |