Onivyde + Talazoparib/Temozolomide for Ewing Sarcoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores new treatment combinations for children and young adults with solid tumors that have returned or not fully responded to previous treatments. It tests two drug combinations: Onivyde (a chemotherapy drug) with talazoparib (a PARP inhibitor), and Onivyde with temozolomide (an oral chemotherapy drug). The goal is to determine the best dose for each combination and assess their effectiveness against the tumors. This study may suit those with a solid tumor that persists or recurs after initial treatment. As a Phase 1/Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking cancer treatment advancements.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, there are specific requirements about the time that must pass after certain treatments before joining the study, such as chemotherapy or radiotherapy. It's best to discuss your current medications with the trial team to get a clear answer.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that using Onivyde and talazoparib together aims to damage the DNA of cancer cells and prevent repair. This method remains experimental for children and young adults with solid tumors, as it is being tested for safety and effectiveness. Onivyde is also being tested with temozolomide, which similarly targets cancer cell DNA.
In earlier studies, Onivyde combined with talazoparib or temozolomide aimed to stop or shrink tumors. The safety of these combinations is still under evaluation, especially in young people. So far, no specific safety issues have emerged, but as this is a Phase 1 and Phase 2 trial, the primary goal is to determine the safest dose levels. This indicates the treatment is in early testing stages, and researchers are closely monitoring participants' responses.
While these drugs are being tested in this trial, Onivyde is already used in other adult treatments, suggesting some known safety information. However, its use in children and young adults is still under careful study. Participants in the trial will be closely monitored to ensure the treatment's safety.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they offer a fresh approach to tackling Ewing sarcoma, a rare and aggressive cancer. Unlike the standard chemotherapy options typically used, Onivyde is a nanoliposomal formulation of irinotecan, which allows for better delivery and absorption by the cancer cells, potentially enhancing effectiveness. Additionally, Talazoparib is a PARP inhibitor that disrupts cancer cell DNA repair mechanisms, a novel approach in this context. Meanwhile, Temozolomide, when combined with Onivyde, could enhance the cancer-killing effect due to its ability to damage cancer cell DNA. These innovative combinations aim to improve outcomes for patients with limited options.
What evidence suggests that this trial's treatments could be effective for Ewing sarcoma?
Research has shown that combining Onivyde and talazoparib, which participants in this trial may receive in Arm A, might help stop or shrink solid tumors, such as Ewing sarcoma. Onivyde damages the DNA of cancer cells, while talazoparib prevents the repair of this damage, potentially leading to cancer cell death. Another approach in this trial, Arm B, uses Onivyde with temozolomide, both of which damage cancer cell DNA and may shrink tumors. These combinations remain experimental for children and young adults with Ewing sarcoma, but early studies have shown promise in other cases. It is important to note that these treatments are being tested to determine the best doses and assess their effectiveness for Ewing sarcoma.12346
Who Is on the Research Team?
Sara M Federico, MD
Principal Investigator
St. Jude Children's Research Hospital
Are You a Good Fit for This Trial?
This trial is for children and young adults aged between 1 and 30 with recurrent or refractory solid tumors, including Ewing sarcoma. Participants must have measurable disease, be in a certain health condition (Karnofsky >50% or Lansky >50%), have adequate organ function, not be pregnant or breastfeeding, agree to use contraception, and have recovered from previous treatments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase I Treatment
Participants receive Onivyde plus talazoparib or Onivyde plus temozolomide to determine the recommended phase 2 doses (RP2Ds)
Phase II Treatment
Participants with Ewing sarcoma receive Onivyde plus talazoparib or Onivyde plus temozolomide to evaluate progression-free survival
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Onivyde
- Talazoparib
- Temozolomide
Find a Clinic Near You
Who Is Running the Clinical Trial?
St. Jude Children's Research Hospital
Lead Sponsor
Pfizer
Industry Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University
Ipsen
Industry Sponsor
David Loew
Ipsen
Chief Executive Officer since 2020
BA in Business Administration and MBA from the University of St. Gallen, Switzerland
Sandra Silvestri
Ipsen
Chief Medical Officer since 2023
MD, PhD