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Study of Onivyde With Talazoparib or Temozolomide in Children With Recurrent Solid Tumors and Ewing Sarcoma

Testing Onivyde with Talazoparib or Temozolomide for children's recurrent tumors.

Recruiting
12-30 years
All
Phase 1/2

This study is for kids and young adults with tumors that have come back or haven't responded to treatment. In this trial, participants will be divided into two groups, called Arm A and Arm B. Arm A will receive two medicines: Onivyde and talazoparib. Onivyde damages the cancer's DNA, while talazoparib stops the DNA from fixing itself, leading to cancer cell death. Arm B will use Onivyde and another medicine called temozolomide, both aiming to damage cancer DNA.

Once the right doses are found for each group, more kids will join to see if the treatments help their tumors disappear. If successful, a second phase will start, focusing on a specific cancer type called Ewing sarcoma. This study helps find the best dose and checks if the treatment works without causing too many side effects.

  • The study involves multiple visits and treatments over up to 24 months.
  • This study is for kids and young adults aged 12 months to 30 years.
  • Participants are randomly assigned to receive different medicine combinations.
Study details
    Recurrent Solid Tumor
    Recurrent Ewing Sarcoma
    Recurrent Hepatoblastoma
    Recurrent Malignant Germ Cell Tumor
    Recurrent Malignant Solid Neoplasm
    Recurrent Neuroblastoma
    Recurrent Osteosarcoma
    Recurrent Peripheral Primitive Neuroectodermal Tumor
    Recurrent Rhabdoid Tumor
    Recurrent Rhabdomyosarcoma
    Recurrent Soft Tissue Sarcoma
    Recurrent Wilms Tumor
    Refractory Ewing Sarcoma
    Refractory Hepatoblastoma
    Refractory Malignant Germ Cell Tumor
    Refractory Malignant Solid Neoplasm
    Refractory Neuroblastoma
    Refractory Osteosarcoma
    Refractory Peripheral Primitive Neuroectodermal Tumor
    Refractory Rhabdoid Tumor
    Refractory Rhabdomyosarcoma
    Refractory Soft Tissue Sarcoma

NCT04901702

St. Jude Children's Research Hospital

31 July 2026

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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