Study of Fixed vs. Flexible Filgrastim to Accelerate Bone Marrow Recovery After Chemotherapy in Children With Cancer
Condition: Childhood Choroid Plexus Tumor; Childhood Medulloblastoma; Childhood Pineoblastoma; Childhood Soft Tissue Sarcoma; Childhood Supratentorial Primitive Neuroectodermal Tumor; Neuroblastoma; Osteosarcoma; Retinoblastoma; Wilms Tumor and Other Childhood Kidney Tumors; Recurrent/Refractory Childhood Hodgkin Lymphoma; Unspecified Childhood Solid Tumor, Protocol Specific
MeSH terms: Sarcoma; Neuroblastoma; Osteosarcoma; Medulloblastoma; Neuroectodermal Tumors; Neuroectodermal Tumors, Primitive; Wilms Tumor; Retinoblastoma; Choroid Plexus Neoplasms; Pinealoma
Intervention: filgrastim
Intervention description: Given SC once daily starting on day 1 after chemotherapy in Arm I (fixed) and on any day when ANC drops below 1000/mcl in Arm II (flexible)
Intervention MeSH terms: Lenograstim
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 1 Year
Maximum age: 25 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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