CompletedPhase 3

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

United States, Australia, Canada67 participantsStarted 1999-03

Plain-language 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.

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time to Resolution of Febrile Neutropenia

Trial details

NCT IDNCT00003739

SponsorChildren's Oncology Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2002-12

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