Pegfilgrastim as Support to Pediatric Sarcoma Patients Receiving Chemotherapy

Sponsor

Amgen (Industry)

Overall Status

Completed

CT.gov ID

NCT00035620

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Sarcoma Neutropenia	Drug: pegfilgrastim Drug: filgrastim	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Apr 1, 2000

Actual Primary Completion Date :

Jan 1, 2007

Actual Study Completion Date :

Apr 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Filgrastim Filgrastim	Drug: filgrastim filgrastim
Experimental: Pegfilgrastim Pegfilgrastim	Drug: pegfilgrastim pegfilgrastim

Arm

Intervention/Treatment

Active Comparator: Filgrastim

Filgrastim

Drug: filgrastim

filgrastim

Experimental: Pegfilgrastim

Pegfilgrastim

Drug: pegfilgrastim

pegfilgrastim

Outcome Measures

Primary Outcome Measures

Duration of severe neutropenia in chemotherapy in cycles 1 and 3 [cycles 1 and 3]
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]

Secondary Outcome Measures

Pharmacokinetic profile in chemotherapy cycles 1 and 3 [cycles 1 and 3]
Incidence of adverse events across all cycles of chemotherapy [all cycles]
Overall rates of febrile neutropenia [all cycles]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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