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NCT00035620 Clinical Trial

Pegfilgrastim as Support to Pediatric Sarcoma Patients Receiving Chemotherapy

Sarcoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00035620
Other study ID # 990130
Secondary ID
Status Completed
Phase Phase 2
First received May 3, 2002
Last updated February 25, 2010
Start date April 2000
Est. completion date April 2007

Study information
Verified date February 2010
Source Amgen
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 44
Est. completion date April 2007
Est. primary completion date January 2007
Accepts healthy volunteers No
Gender Both
Age group N/A to 21 Years
Eligibility - Sarcoma * No previous chemotherapy or radiotherapy * Patients who will be receiving chemotherapy consisting of Vincristine, Doxorubicin, Cyclophosphamide, Etoposide, Ifosfamide, and Mesna

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• pegfilgrastim
pegfilgrastim
• filgrastim
filgrastim

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Amgen

Outcome
Type Measure Description Time frame Safety issue
Primary Duration of severe neutropenia in chemotherapy in cycles 1 and 3 cycles 1 and 3 No
Primary Time to ANC recovery to greater than or equal to 0.5 x 10^9/L in cycles 1 and 3 cycles 1 and 3 No
Secondary Pharmacokinetic profile in chemotherapy cycles 1 and 3 cycles 1 and 3 No
Secondary Incidence of adverse events across all cycles of chemotherapy all cycles Yes
Secondary Overall rates of febrile neutropenia all cycles No
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