Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Children's Oncology Group

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Biological: filgrastim

Phase:

Phase 3

Eligibility


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

Ages Eligible for Study

N/A - 21 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting