Clinical Trial Details
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NCT01987596 : Study of Fixed vs. Flexible Filgrastim to Accelerate Bone Marrow Recovery After Chemotherapy in Children With Cancer
PhasePhase 3
AgesMin: 1 Year Max: 25 Years
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 >

- 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
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