Romiplostim for the Prevention of Low Platelet Counts in Children and Young Adults Receiving Chemotherapy for Solid Tumors

Inclusion Criteria

• Documented diagnosis of a primary solid tumor. Patients must have histological verification of malignancy at Memorial Sloan-Kettering Cancer Center (MSKCC)
• Male and female patients aged 1-21 years with a primary solid tumor undergoing treatment with the pre-defined chemotherapy regimens of EFT, MAP, D9803. Prior to enrollment patient could have been undergoing induction therapy with a similarly myelosuppressive regimen as long as they will be continuing with EFT, MAP, D8903 at the time of study enrollment
• Patients undergoing treatment with MAP chemotherapy who have had >= 1 platelet transfusion during induction stage of treatment
• Total bilirubin (sum of conjugated + unconjugated) =< 3 times institutional upper limit of normal (ULN) for age and
• Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =< 3 times institutional ULN for age
• Shortening fraction greater than or equal to 28% by echocardiogram OR left ventricular ejection fraction (LVEF) greater than or equal to 50% on technetium- 99m pertechnetate radionuclide cineangiography (MUGA) or echocardiogram
• Screening electrocardiogram (ECG) with corrected QT (QTc) interval of < 470 msec
• Timing of cardiac assessment: We will utilize the most recent electrocardiogram (EKG)/echocardiography (ECHO) when assessing cardiac function
• Adequate renal function, defined as an estimated creatinine clearance or glomerular filtration rate (GFR) > 40 ml/min or an normal creatinine for age Age: < 6; Maximum serum creatinine (mg/dL): 0.8 (male); 0.8 (female) Age: 6 to < 10; Maximum serum creatinine (mg/dL): 1 (male); 1 (female) Age: 10 to < 13; Maximum serum creatinine (mg/dL): 1.2 (male); 1.2 (female) Age: 13 to < 16; Maximum serum creatinine (mg/dL): 1.5 (male); 1.4 (female) Age: > 16; Maximum serum creatinine (mg/dL): 1.7 (male); 1.4 (female)

Exclusion Criteria

• Patients with history of hematologic malignancies or allogenic/autogenic stem cell transplant
• Patients with a currently known predisposition to a myeloid stem cell disorder, myeloid leukemia, and/or bone marrow failure syndrome including, but not limited to: * Aplastic anemia * Ataxia telangiectasia * Bloom syndrome * Congenital amegakaryocytic thrombocytopenia * Cyclic neutropenia * Diamond Blackfan anemia * Dyskeratosis congenita * Familial acute myeloid leukemia (AML)/myelodysplastic syndrome (MDS) syndromes (including ANKRD26, CEBPA, DDX41, ETV6, GATA2, RUNX1, SRP72) * Fanconi anemia * Kostmann disease * Li-Fraumeni syndrome * Neurofibromatosis * Nijmegen breakage syndrome * Noonan syndrome * Paroxysmal nocturnal hemoglobinuria * Pearson syndrome * Poland syndrome * Rothmund-Thomson syndrome * Severe congenital neutropenia * Thrombocytopenia absent radii syndrome * Trisomy 8 * Trisomy 21 * WHIM syndrome * Wiskott Aldrich syndrome * Xeroderma pigmentosa
• Secondary malignancy in the past 5 years
• Patients who have previously undergone up-front chemotherapy and have relapsed or progressed through therapy
• Patients who have received 4 or more cycles of induction chemotherapy for their current malignancy prior to time of enrollment
• Previous use of romiplostim, eltrombopag, recombinant human TPO, or any other TPO receptor agonist, or any investigational platelet producing agent
• Patients receiving other investigational agents are not eligible for study entry
• History of uncontrolled arrhythmias, clinically significant electrocardiogram (ECG) abnormalities, active heart failure or pericardial disease
• Patients with current or prior venous thrombotic event or arterial thrombotic event at time of enrollment will be ineligible for this study
• Pregnant women/lactating mothers
• Patients unwilling to use effective contraception method, which includes abstinence
• Patients with an inability to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy