Pegfilgrastim as Support to Pediatric Sarcoma Patients Receiving Chemotherapy

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00035620
First received: May 3, 2002
Last updated: February 25, 2010
Last verified: February 2010
  Purpose

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
Sarcoma
Neutropenia
Drug: pegfilgrastim
Drug: filgrastim
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Study of Single Dose Per Cycle Filgrastim-SD/01 as an Adjunct to VAdriaC/IE Chemotherapy in Pediatric Sarcoma Patients

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Duration of severe neutropenia in chemotherapy in cycles 1 and 3 [ Time Frame: cycles 1 and 3 ] [ Designated as safety issue: No ]
  • Time to ANC recovery to greater than or equal to 0.5 x 10^9/L in cycles 1 and 3 [ Time Frame: cycles 1 and 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetic profile in chemotherapy cycles 1 and 3 [ Time Frame: cycles 1 and 3 ] [ Designated as safety issue: No ]
  • Incidence of adverse events across all cycles of chemotherapy [ Time Frame: all cycles ] [ Designated as safety issue: Yes ]
  • Overall rates of febrile neutropenia [ Time Frame: all cycles ] [ Designated as safety issue: No ]

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
Active Comparator: Filgrastim
Filgrastim
Drug: filgrastim
filgrastim
Other Name: filgrastim
Experimental: Pegfilgrastim
Pegfilgrastim
Drug: pegfilgrastim
pegfilgrastim

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • Sarcoma * No previous chemotherapy or radiotherapy * Patients who will be receiving chemotherapy consisting of Vincristine, Doxorubicin, Cyclophosphamide, Etoposide, Ifosfamide, and Mesna
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035620

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00035620     History of Changes
Other Study ID Numbers: 990130
Study First Received: May 3, 2002
Last Updated: February 25, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Bone cancer
Sarcoma
Neutropenia
Chemotherapy

Additional relevant MeSH terms:
Neutropenia
Sarcoma
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014