This randomized phase III trial studies combination chemotherapy and fixed administration of filgrastim to see how well it works compared to combination chemotherapy and flexible administration of filgrastim in treating younger patients with cancer. Drugs used in chemotherapy, such as etoposide, ifosfamide, carboplatin, vincristine sulfate, cyclophosphamide, and cisplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as filgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. It is not yet known whether combination chemotherapy and fixed administration of filgrastim is more effective than combination chemotherapy and flexible administration of filgrastim in treating cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01987596.
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.
III. To evaluate on the incidence and duration of G-CSF-related side effects including extremities/back pain and headaches after chemotherapy courses followed by flexible vs. fixed administration of G-CSF.
IV. To evaluate the peripheral blood progenitor responses and subsets of progenitor cells (cluster of differentiation [CD]34/41/61/117/10/19/11b/33) to chemotherapy followed by flexible vs. fixed administration of G-CSF.
OUTLINE:
CHEMOTHERAPY: Patients are assigned to 1 of 3 chemotherapy regimens.
ICE: Patients receive etoposide intravenously (IV) over 1 hour on days 1-3, ifosfamide IV over 3 hours on days 1-3, and carboplatin IV over 1 hour on day 4. Patients with recurrent Hodgkin lymphoma receive etoposide and ifosfamide on days 1-3 and carboplatin on day 3.
ICT: Patients receive topotecan hydrochloride IV over 30 minutes on days 1-3, and ifosfamide and carboplatin as in ICE.
OPEC: Patients receive vincristine sulfate on days 1, 8, and 15; etoposide IV over 1 hour on days 1-3; cyclophosphamide IV over 1 hour on days 1-2; and cisplatin IV over 6 hours on day 4.
For all chemotherapy regimens, treatment repeats every 14 days for 2 courses. Patients are then randomized to 1 of 2 treatment arms.
ARM I (fixed filgrastim): Patients receive filgrastim subcutaneously (SC) once daily (QD) started at 24 hours after completion of chemotherapy and stopped when ANC reaches at least 2,000/uL post nadir.
ARM II (flexible filgrastim): Patients receive filgrastim SC QD started on the first day after chemotherapy when ANC falls below 1,000/uL and stopped when ANC reaches at least 1,000/uL post nadir.
After completion of the first filgrastim treatment, patients repeat 2 courses of chemotherapy as before and then cross-over to the other filgrastim arm. After completion of the second filgrastim treatment, chemotherapy treatment may continue for up to 5 (OPEC) or 6 (ICE, ICT) courses in the absence of disease progression or unacceptable toxicity.
Trial PhasePhase III
Trial Typesupportive care
Lead OrganizationWayne State University/Karmanos Cancer Institute
Principal InvestigatorMaxim Yankelevich
