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Topoisomerase I inhibitor

Onivyde + Talazoparib/Temozolomide for Ewing Sarcoma

Phase 1 & 2

Waitlist Available

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

Must not have

Males or females of reproductive potential may not participate unless they have agreed to use two methods of birth control

Females considered not of childbearing potential include those who are surgically sterile (bilateral salpingectomy, bilateral oophorectomy, or hysterectomy)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the end of cycle 1 (approximately 21 days after last participant enrollment)

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am using two forms of birth control.

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I am a woman who cannot become pregnant due to surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the end of cycle 1 (approximately 21 days after last participant enrollment)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the end of cycle 1 (approximately 21 days after last participant enrollment)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of cycle 1 (approximately 21 days after last participant enrollment) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

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