A Study to Evaluate 5 μg/kg Tbo-filgrastim in Infants, Children and Adolescents With Solid Tumors Without Bone Marrow Involvement

You may be eligible if

• Inclusion:
• 1. Male or female infants, children and adolescents aged 1 month to \<16 years.
• 2. Patients with solid tumors without bone marrow involvement, who are scheduled to receive myelosuppressive CTX.
• 3. Body weight ≥5 kg.
• 4. Patients must have an initial diagnosis and histologic proof of their malignancy. All enrolled subjects should have signed consent for a CTX regimen that is known to be myelotoxic, with counts expected to drop below the absolute neutrophil count (ANC) of 0.5 × 109/L for at least 3 days. These regimens would include at least one of the following:
• * Etoposide
• * doxorubicin
• * ifosfamide
• * cyclophosphamide
• 5. ANC and platelet count: Patients must have an ANC \>1 × 109/L and a platelet count \>100 × 109/L to be eligible for therapy at the start of CTX.
• 6. Normal cardiac, renal, and hepatic function.
• 7. All subjects must have a life expectancy of 12 weeks or more.
• 8. Performance Status: Lansky performance score \>60 (age 1 to \<16 years).
• * More criteria may apply, please contact the investigator for more information.
• Exclusion:
• 1. Bone marrow involvement.
• 2. Active myelogenous leukemia or history of myelogenous leukemia.
• 3. Previous treatment with colony-stimulating factors (granulocyte colony-stimulating factor \[G-CSF\], granulocyte-macrophage colony-stimulating factor, interleukin 11 \[IL-11\]) less than 6 weeks prior to study entry.
• 4. History of congenital neutropenia or cyclic neutropenia.
• 5. Pregnant or nursing female patients.
• 6. Fertile patients who do not agree to use highly reliable contraceptive measures Prior bone marrow or stem cell transplant, or prior radiation to ≥25% of bone marrow within the 4 weeks prior to the first tbo-filgrastim dose.
• 7. Ongoing active infection or history of infectious disease within 2 weeks prior to the screening visit.
• 8. Treatment with lithium at screening or planned during the study
• * More criteria may apply, please contact the investigator for more information.