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

Children's Oncology Group

Status and phase: Completed; Phase 3

Conditions: Neutropenia; Unspecified Childhood Solid Tumor, Protocol Specific; Fever, Sweats, and Hot Flashes

Treatments: Biological: filgrastim

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00003739

COG-AS973 (Other Identifier)

COG-973 (Other Identifier)

COG-S9703 (Other Identifier)

CCG-S9703 (Other Identifier)

NCI-P99-0140

AS973

CDR0000066854 (Other Identifier)

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

• Determine whether filgrastim (G-CSF) used in addition to standard antibiotic therapy accelerates time to resolution of febrile neutropenia in children receiving chemotherapy.

OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.

• Arm I: Patients receive standard antibiotic therapy.
• Arm II: Patients receive treatment as in arm I. Patients also receive filgrastim (G-CSF) subcutaneously or IV once a day until at least 2 consecutive afebrile days have passed and absolute neutrophil count is at least 500/mm3.

Patients are followed for 3 days.

PROJECTED ACCRUAL: A total of 200 patients (100 per treatment arm) will be accrued for this study.

Enrollment: 67 patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically diagnosed cancer with fever and chemotherapy-induced neutropenia (absolute neutrophil count no greater than 500/mm3)

  • Acute onset of fever of at least 38.8 degrees Celsius that is not related to the administration of blood products or pyrogenic substances

• No acute myelogenous leukemia

• No myelodysplastic syndrome

• No solid tumor with bone marrow involvement

PATIENT CHARACTERISTICS:

Age:

• 21 and under

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• See Disease Characteristics

Hepatic:

• Creatinine less than 1.5 times upper limit of normal

Renal:

• Not specified

Other:

• No patients in septic shock
• No prolonged fever of unknown origin

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
• See Chemotherapy

Chemotherapy:

• No prior or concurrent myeloablative chemoradiotherapy with bone marrow or peripheral stem cell rescue

Endocrine therapy:

• Not specified

Radiotherapy:

• See Chemotherapy
• No prior radiotherapy to marrow reserves (i.e., craniospinal and/or pelvic irradiation)

Surgery:

• Not specified

Other:

• At least 7 days since prior IV antibiotics