Skip to main content
OpenTrials
Completed

NCT Number: NCT00035620

Pegfilgrastim as Support to Pediatric Sarcoma Patients Receiving Chemotherapy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sarcoma Agranulocytosis Bone Diseases Bone Neoplasms Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Leukocyte Disorders Leukopenia Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Neutropenia

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pegfilgrastim

Drug

pegfilgrastim

Filgrastim

Drug

filgrastim

Primary outcomes

  1. Duration of severe neutropenia in chemotherapy in cycles 1 and 3

    Time frame: cycles 1 and 3

  2. 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

Secondary outcomes

  1. Pharmacokinetic profile in chemotherapy cycles 1 and 3

    Time frame: cycles 1 and 3

  2. Incidence of adverse events across all cycles of chemotherapy

    Time frame: all cycles

  3. Overall rates of febrile neutropenia

    Time frame: all cycles

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2007
Study completion
2007
First posted
May 6, 2002
Registry last updated
Feb 26, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.