Prospective and Randomized Study of Fixed Versus Flexible Prophylactic Administration of Granulocyte Colony-Stimulating Factor (G-CSF) in Children With Cancer
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Enrollment
- 23
- Locations
- 2
- Primary Endpoint
- Days to ANC Greater Than or Equal to 1,000/uL From the Start of Chemotherapy
Study Overview
Brief Summary
This randomized phase III trial studies flexible administration of filgrastim after combination chemotherapy to see how well it works compared to fixed administration of filgrastim in decreasing side effects of chemotherapy in younger patients with cancer. Cancer chemotherapy frequently results in neutropenia (low blood counts) when patients are susceptible to severe infections. A medicine called G-CSF (filgrastim) stimulates bone marrow and daily filgrastim shots are commonly used to shorten neutropenic periods and decrease infections after chemotherapy. Since filgrastim is customarily used on a fixed schedule starting early after chemotherapy and there are data that early doses may not be needed, this study tests new flexible schedule of filgrastim to optimize its use by reducing the number of painful shots, cost of treatment, and filgrastim side effects in children with cancer receiving chemotherapy.
Detailed Description
PRIMARY OBJECTIVES:
I. To compare the effect of flexible vs. fixed administration of G-CSF (filgrastim) on the parameters of hematological recovery including duration of absolute neutrophil count (ANC) < 500/uL; time to ANC recovery >= 1,000/uL and time to platelet recovery >= 75,000/uL in children receiving myelotoxic chemotherapy.
SECONDARY OBJECTIVES:
I. To compare the effect of flexible vs. fixed administration of G-CSF on the incidence of febrile neutropenia and number of hospital days on antibiotics following myelotoxic chemotherapy.
II. To evaluate the number of days of platelet transfusion events after chemotherapy cycles with flexible vs. fixed administration of G-CSF.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 1 Year to 25 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects must have or have had at initial diagnosis, histologic proof of their malignancy; young children with primary embryonal brain tumor treated according to Head Start protocol are eligible; subjects with bone marrow involvement are NOT eligible for study
- •Patients will receive repeated cycles of identical chemotherapy that will likely result in grades III-IV hematological toxicity; patients will be treated outside of Children's Oncology Group (COG) protocols with specific requirements for schedule of G-CSF administration; the following categories of patients treated at Children's Hospital of Michigan are eligible for this study:
- •Patients with brain tumors treated according to Head Start II protocol with vincristine, etoposide, cyclophosphamide, and cisplatin (OPEC) chemotherapy;
- •Patients with recurrent Hodgkin lymphoma treated with ICE (ifosfamide, carboplatin, etoposide) chemotherapy;
- •Patients with recurrent solid tumors including sarcomas, Wilms' tumor, neuroblastomas, or brain tumors treated with high dose ICE or ICT (ifosfamide, carboplatin, topotecan) chemotherapy
- •Patients with UH Wilms' tumor treated with CE (cyclophosphamide, etoposide); patients with neuroblastoma treated with CE (carboplatin, etoposide);
- •Patients with soft tissue sarcomas treated with IA (ifosfamide, doxorubicin);
- •Patients with osteosarcoma treated with high dose ifosfamide
- •Subjects must have fully recovered from the toxic effects of any prior therapy; at least 3 weeks should have elapsed since the last dose of chemotherapy (6 weeks in the case of nitrosourea containing therapy); subjects must have recovered from previous colony-stimulating factor therapy and have been off colony-stimulating factors (G-CSF, granulocyte macrophage colony-stimulating factor [GM-CSF], interleukin [IL]-11) for more than 10 days and off erythropoietin for 30 days
- •ANC > 1000/uL
- •Platelet count > 100,000/uL
- •Creatinine clearance or glomerular filtration rate (GFR) which is greater than or equal to 70 ml/min/1.73 m^2
- •Bilirubin less than 1.5 x normal limit (NL)
- •Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) less than 2.5 x NL for age
- •Subjects should have a normal ejection fraction (per institutional limits), no evidence of cardiac arrhythmias requiring therapy, and a fractional shortening of > 28%
- •All subjects must have a life expectancy of 12 weeks or more
- •Diagnostic categories
- •Sarcoma (soft tissue and bone)
- •Kidney tumors
- •Brain tumors
- •Other solid tumors (gonadal and germ cell tumors, retinoblastoma, neuroblastoma, and miscellaneous tumors)
- •Hodgkin lymphoma
- •Performance status must be > 60 from Lansky (age 1 to 16) or Karnofsky (age > 16)
Exclusion Criteria
- •Subjects with any of the following will NOT be eligible for study:
- •Bone marrow involvement
- •Active myelogenous leukemia, or history of myelogenous leukemia
- •Pregnancy
Outcomes
Primary Outcomes
Days to ANC Greater Than or Equal to 1,000/uL From the Start of Chemotherapy
Time Frame: From the start of the course until the first date the ANC reaches >= 1,000/uL post nadir, assessed up to 1 year
Time in days until absolute neutrophil count (ANC) recovery to greater than or equal to 1,000/uL from the start of chemotherapy
Secondary Outcomes
- Incidence of Febrile Neutropenia(Up to 1 year)
- Days to First G-CSF Dose(time to ANC 1000)
- Cumulative GCSF Dose(up until engraftment)
Investigators
Maxim Yankelevich
Principal Investigator
Barbara Ann Karmanos Cancer Institute