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Topoisomerase I inhibitor

Onivyde + Talazoparib/Temozolomide for Ewing Sarcoma

Phase 1 & 2
Recruiting
Led By Sara Federico, MD
Research Sponsored by St. Jude Children's Research Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients should have received first line therapy and developed either refractory or recurrent disease (first relapse)
Patients must be > 12 months and < 30 years at the time of enrollment on study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at time of randomization until evaluation of respective endpoints, up to 2 years after enrollment of last participant
Awards & highlights

Study Summary

This trial is testing 2 combinations of therapy in children and young adults with recurrent or refractory solid tumors. The first part of the trial will determine the highest doses of the medications that can be given safely. The second part of the trial will test to see if the tumors go away in children and young adults with Ewing sarcoma.

Who is the study for?
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.Check my eligibility
What is being tested?
The study tests Onivyde combined with either talazoparib or temozolomide in two separate arms (A & B) to find the highest tolerable doses against solid tumors. It includes expansion arms for different tumor types at these doses. Phase II focuses on Ewing sarcoma patients testing the same combinations.See study design
What are the potential side effects?
Potential side effects may include damage to DNA of cancer cells which could lead to their death; however specific side effects are not listed but generally can range from nausea, fatigue, blood count changes to more serious complications depending on individual patient response.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer came back or didn't respond after my first treatment.
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I am between 1 year and 30 years old.
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I have been treated with irinotecan or temozolomide before.
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My cancer is Ewing sarcoma with a specific genetic change.
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My Ewing sarcoma has come back or didn't respond to first treatment.
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I am mostly independent in my daily activities.
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My cancer cannot be cured and has come back or did not respond to treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the end of treatment (up to 24 months after enrollment of last participant)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of treatment (up to 24 months after enrollment of last participant) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Temozolomide
Phase II:To estimate the progression-free survival (PFS) of Onivyde plus talazoparib and Onivyde plus temozolomide in patients with refractory or recurrent Ewing sarcoma.
Secondary outcome measures
Phase I:To characterize the safety profile of the treatment regimens, Onivyde plus talazoparib (Arm A) and Onivyde plus temozolomide (Arm B)
Phase II: To describe the toxicity of the treatment regimens.
To characterize the plasma pharmacokinetics Onivyde and talazoparib in children, adolescents and young adults with refractory or recurrent Ewing sarcoma
+4 more

Trial Design

2Treatment groups
Active Control
Group I: (Arm A) ONI plus TALActive Control2 Interventions
The phase I/II study will evaluate a treatment regimen; nanoliposomal irinotecan (nal-IRN, Onivyde) plus talazoparib (TAL)
Group II: (Arm B) ONI plus TMZActive Control2 Interventions
The phase I/II study will evaluate a treatment regimen; Onivyde (ONI) plus temozolomide (TMZ)

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor
428 Previous Clinical Trials
5,306,453 Total Patients Enrolled
4 Trials studying Ewing Sarcoma
755 Patients Enrolled for Ewing Sarcoma
PfizerIndustry Sponsor
4,570 Previous Clinical Trials
10,915,851 Total Patients Enrolled
2 Trials studying Ewing Sarcoma
241 Patients Enrolled for Ewing Sarcoma
IpsenIndustry Sponsor
345 Previous Clinical Trials
73,068 Total Patients Enrolled
1 Trials studying Ewing Sarcoma
119 Patients Enrolled for Ewing Sarcoma

Media Library

Onivyde (Topoisomerase I inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04901702 — Phase 1 & 2
Ewing Sarcoma Research Study Groups: (Arm A) ONI plus TAL, (Arm B) ONI plus TMZ
Ewing Sarcoma Clinical Trial 2023: Onivyde Highlights & Side Effects. Trial Name: NCT04901702 — Phase 1 & 2
Onivyde (Topoisomerase I inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04901702 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there other scientific investigations that have looked at the effects of (Arm A) ONI plus TAL?

"(Arm A) The combination therapy of ONI plus TAL was first researched in 2002 at Mayo Clinic, Rochester. So far, 795 clinical trials have completed with this intervention. As of now, 518 studies are actively recruiting patients; a majority of these trial sites are based in Toronto, Canada."

Answered by AI

How many individuals are being given the opportunity to participate in this research project?

"Yes, this is an ongoing trial that is still recruiting patients according to the latest update on clinicaltrials.gov from September 8th, 2022. The study was first posted on June 9th, 2021 and 160 participants are needed at 9 locations."

Answered by AI

What is the primary purpose of (Arm A) ONI plus TAL?

"The (Arm A) ONI plus TAL treatment plan is typically used to manage progression and disease. However, it has also been successful in treating patients with other conditions like ovarian cancer and colorectal carcinoma."

Answered by AI

What are the requirements to be a part of this experiment?

"This trial is looking for 160 participants aged 12 months to 30 years old who currently have neuroectodermal tumors. The ideal candidate also meets the following criteria: -Prior therapy, with refractory or recurrent Ewing sarcoma ( during or after completion of first line treatment) -Disease status that includes non-CNS solid tumors not amenable to curative treatment -A performance level of Karnofsky > 50% for patients > 16 years of age and Lansky> 50% for patients < 16 years of age."

Answered by AI

Does this experiment only include test subjects who are 30 years old or younger?

"For this particular study, only those aged 12 months to 30 years old may apply. There are 784 other clinical trials for children under 18 and 4004 for senior citizens above 65."

Answered by AI

Are there any current vacancies for participants in this experiment?

"Yes, this trial is still looking for patients according to the information available on clinicaltrials.gov. This study was originally posted on June 9th, 2021 and has been updated September 8th, 2022."

Answered by AI

What primary objectives does this research hope to elucidate?

"The purpose of this medical trial, which will take approximately 21 days, is to compare the progression-free survival rates of two different treatments for Ewing sarcoma. Additionally, the team hopes to collect data on overall survival rates, safety and tolerability profiles, and antitumor activity."

Answered by AI

Who else is applying?

What site did they apply to?
Children's National Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Study of Onivyde With Talazoparib or Temozolomide in Children With Recurrent Solid Tumors and Ewing Sarcoma
2021. "Study of Onivyde With Talazoparib or Temozolomide in Children With Recurrent Solid Tumors and Ewing Sarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04901702.
All > Osteosarcoma > Rhabdomyosarcoma
~59 spots leftby Dec 2025
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