A Study of Romiplostim to Prevent Low Platelet Counts in Children and Young Adults Receiving Chemotherapy for Solid Tumors
Stopped early · Phase 2
Conditions studied: Solid Tumor, Solid Tumor, Childhood, Solid Carcinoma
In brief
The purpose of this study is to find out whether romiplostim can help prevent low platelet counts caused by N8 or EFT chemotherapy, reduce the number of platelet transfusions required during chemotherapy, and prevent treatment delays due to low platelet counts.
Key facts
- Study ID
- NCT04671901
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 2
- Starts
- 2020-12-10
- Expected to finish
- 2023-03-29
- Last updated by the study team
- 2025-05-28
Who can join
Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Documented diagnosis of a primary solid tumor. Patients must have histological verification of malignancy at 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, D9803 at the time of study enrollment.
- Patients undergoing treatment with MAP chemotherapy w ho 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 ALT/AST ≤ 3 times institutional ULN for age.
- Normal cardiac function:
- 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 ECG with corrected QT (QTc) interval of < 470 msec.
- Timing of cardiac assessment: We will utilize the most recent EKG/ECHO when assessing cardiac function. See section 9.0 for additional details.
- Adequate renal function, defined as an estimated Creatinine Clearance or GFR >40ml/min or an normal creatine for age (see below)
- Serum Creatinine by age:
- Age (years) <6: Maximum Serum Creatinine (mg/dL), Male 0.8, Female 0.8 Age (years) 6 to <10: Maximum Serum Creatinine (mg/dL), Male 1, Female 1 Age (years) 10 to <13: Maximum Serum Creatinine (mg/dL), Male 1.2, Female 1.2 Age (years) 13 to <16: Maximum Serum Creatinine (mg/dL), Male 1.5, Female 1.4 Age (years) >16: Maximum Serum Creatinine (mg/dL), Male 1.7, Female 1.4
- These threshold creatine values were derived from the Scwartz formula estimating GFR, utilizing child length and statured published by the CDC.
You may not qualify if…
- 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 AML/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
Where it is running
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey, United States
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States
- Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities) — Commack, New York, United States
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York, United States
Full record on ClinicalTrials.gov
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