Romiplostim for Bone Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests romiplostim, a supportive treatment, for individuals newly diagnosed with Ewing sarcoma, a type of bone cancer, who are undergoing intensive chemotherapy. The primary goal is to determine if romiplostim can manage low platelet counts caused by chemotherapy, which can lead to easy bruising or bleeding. The trial also assesses the safety and practicality of including romiplostim in the treatment plan. Suitable candidates are those recently diagnosed with Ewing sarcoma who are not receiving certain other cancer treatments, such as extensive radiation or therapies affecting bone marrow. As an Early Phase 1 trial, this research focuses on understanding how romiplostim works in people, offering participants a chance to contribute to groundbreaking treatment development.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but certain treatments like previous use of romiplostim, eltrombopag, or other platelet-producing agents, and erythropoietin-stimulating agents are not allowed. If you are on these or similar treatments, you may need to stop them to participate.
Is there any evidence suggesting that romiplostim is likely to be safe for humans?
Research has shown that romiplostim has been tested for safety in various situations. In some studies, about 9% of patients experienced serious side effects from the treatment. A small number of patients had changes in their bone marrow, where blood cells are made, but this was uncommon.
Romiplostim has also been used in patients with solid tumors. In these cases, 71% of patients responded well to the treatment, and 79% avoided issues like delayed chemotherapy or needing lower doses. This suggests that many people generally tolerate the treatment well.
Romiplostim is already approved for some other uses, which can be reassuring about its safety. However, discussing any concerns with a healthcare provider before joining a trial is always advisable.12345Why do researchers think this study treatment might be promising?
Romiplostim is unique because it targets platelet production, which is not a typical focus in bone cancer treatment. Most existing therapies for bone cancer, like chemotherapy and radiation, primarily aim to kill cancer cells directly. Romiplostim, however, acts as a thrombopoietin receptor agonist, stimulating the body's production of platelets. This feature can be particularly beneficial for patients undergoing chemotherapy, as it can help manage and prevent low platelet counts, a common side effect. Researchers are excited about Romiplostim because it offers a novel way to support patients' blood health during intensive cancer treatments.
What evidence suggests that romiplostim might be an effective treatment for Ewing sarcoma?
Research has shown that romiplostim can help cancer patients manage low platelet counts caused by chemotherapy. In one study, 71% of patients with solid tumors responded well to romiplostim. Another study found that 93% of patients had their platelet counts return to normal within three weeks. Romiplostim also helped 79% of patients avoid delays or reductions in their chemotherapy doses. In this trial, participants will receive romiplostim alongside chemotherapy cycles, which might help patients with Ewing sarcoma maintain healthier platelet levels during treatment.678910
Who Is on the Research Team?
Brian Turpin, DO
Principal Investigator
Children's Hospital Medical Center, Cincinnati
Are You a Good Fit for This Trial?
This trial is for patients newly diagnosed with Ewing sarcoma, a type of bone cancer, who are about to start chemotherapy and are at risk of developing low platelet counts (thrombocytopenia). Specific eligibility criteria were not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive romiplostim as a supportive care measure alongside interval-compressed chemotherapy for Ewing sarcoma
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Romiplostim
Trial Overview
The study tests romiplostim's effectiveness in preventing low platelet counts caused by chemotherapy in Ewing sarcoma patients. It aims to see if this drug can help maintain safe platelet levels during treatment.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Enrolled patients may start romiplostim, as early as cycle 1 day 1; all patients MUST initiate romiplostim no later than 2 weeks from the start of the 5th cycle of chemotherapy. If plt count \< 200,000/mm3, patients will start romiplostim based on their weight.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Hospital Medical Center, Cincinnati
Lead Sponsor
Citations
1.
journals.lww.com
journals.lww.com/md-journal/fulltext/2025/08080/successful_treatment_of_refractory_cancer.125.aspxSuccessful treatment of refractory cancer therapy-induced...
Romiplostim N01 effectively managed refractory CTIT in this case, showing rapid and sustained platelet recovery. This case demonstrates the ...
A multicenter study of romiplostim for chemotherapy-induced ...
Romiplostim was effective in solid tumor patients: 71% of patients achieved a romiplostim response, 79% avoided chemotherapy dose reductions/treatment delays, ...
real-world effectiveness of romiplostim n01 in cancer ...
The overall treatment efficacy within 3 weeks was 80.8%. Anti-platelet antibody testing in 24 patients showed 50% positivity, with lower ...
4.
ashpublications.org
ashpublications.org/blood/article/134/Supplement_1/389/426153/A-Multicenter-Study-of-Romiplostim-to-TreatA Multicenter Study of Romiplostim to Treat Chemotherapy ...
Both weekly and intracycle dosing were effective and equally safe, but weekly dosing maintained higher Plt overall and higher Plt nadirs with ...
Romiplostim Treatment of Chemotherapy-Induced ...
In the randomization phase, 14 of 15 romiplostim-treated patients (93%) experienced correction of their platelet count within 3 weeks, compared ...
Long-term safety and efficacy of romiplostim for treatment ...
This review focuses on the efficacy data and safety analysis of the pooled data from the clinical trials evaluating romiplostim for treatment of adults with ...
7.
ashpublications.org
ashpublications.org/blood/article/113/10/2161/24354/Safety-and-efficacy-of-long-term-treatment-withSafety and efficacy of long-term treatment with romiplostim in ...
Treatment-related serious adverse events were reported in 13 patients (9%). Bone marrow reticulin was observed in 8 patients; marrows were not routinely ...
NCT07048249 | Single Arm Romiplostim to Prevent CIT
The goal of this clinical trial is to to assess the efficacy of romiplostim as a supportive care measure in patients with a new diagnosis of Ewing sarcoma ...
A multicenter study of romiplostim for chemotherapy ...
Romiplostim was effective in solid tumor patients: 71% of patients achieved a romiplostim response, 79% avoided chemotherapy dose reductions/treatment delays ...
Romiplostim (Nplate) - Medical Clinical Policy Bulletins
The major safety concerns consisted of risks for bone marrow reticulin formation and worsened thrombocytopenia (compared to baseline) following romiplostim ...
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