A Study of Romiplostim to Prevent Low Platelet Counts in Children and Young Adults Receiving Chemotherapy for Solid Tumors

  • STATUS
    Recruiting
  • End date
    Dec 10, 2022
  • participants needed
    30
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 25 March 2022

Summary

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.

Details
Condition Solid Tumor, Solid Tumor, Childhood, Solid Carcinoma
Treatment romiplostim
Clinical Study IdentifierNCT04671901
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Patients with history of hematologic malignancies or allogenic/autogenic stem cell
transplant
Aplastic anemia
Patients with a currently known predisposition to a myeloid stem cell disorder
Ataxia telangiectasia
myeloid leukemia, and/or bone marrow failure syndrome including, but not limited to
Bloom syndrome
Congenital amegakaryocytic thrombocytopenia
Cyclic neutropenia
Diamond Blackfan anemia
Dyskeratosis congenita
Fanconi anemia
Familial AML/MDS syndromes (including ANKRD26, CEBPA, DDX41, ETV6, GATA2, RUNX1
Kostmann disease
Li-Fraumeni syndrome
SRP72)
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 receiving other investigational agents are not eligible for study entry
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
Pregnant women/lactating mothers
receptor agonist, or any investigational platelet producing agent
Patients unwilling to use effective contraception method, which includes abstinence
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
Patients with an inability to return for follow-up visits or obtain follow-up studies
required to assess toxicity to therapy
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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