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Antibiotic Therapy With or Without G-CSF in Treating Children With Neutropenia and Fever Caused by Chemotherapy

NCT00003739 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2014-02-14

No results posted yet for this study

Summary

RATIONALE: Antibiotics may decrease the side effects of neutropenia and fever caused by chemotherapy. Colony-stimulating factors such as G-CSF may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. It is not yet known whether antibiotic therapy plus G-CSF is more effective than antibiotic therapy alone for treating side effects caused by chemotherapy.

PURPOSE: Randomized phase III trial to compare the effectiveness of antibiotic therapy with or without G-CSF in treating children who have neutropenia and fever that are caused by chemotherapy.

Conditions

  • Fever, Sweats, and Hot Flashes
  • Neutropenia
  • Unspecified Childhood Solid Tumor, Protocol Specific

Interventions

BIOLOGICAL

filgrastim

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Children's Oncology Group

    lead NETWORK

Principal Investigators

  • M. F. Ozkaynak, MD · New York Medical College

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-03-31
Primary Completion
2002-12-31
Completion
2006-09-30

Countries

  • United States
  • Australia
  • Canada
  • Netherlands
  • New Zealand
  • Puerto Rico
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00003739 on ClinicalTrials.gov