Actively Recruiting
Randomized Phase I/II Study of Talazoparib or Temozolomide with Onivyde in Children and Young Adults with Recurrent Solid Tumors and Ewing Sarcoma
Led by St. Jude Children's Research Hospital · Updated on 2026-05-19
90
Participants Needed
10
Research Sites
N/A
Total Duration
On this page
Sponsors
S
St. Jude Children's Research Hospital
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate two treatment combinations in children, adolescents, and young adults with solid tumors or Ewing sarcoma that have returned or are resistant to previous treatments. The trial includes a phase I dose-finding portion and a phase II study focused on Ewing sarcoma, assessing the highest tolerable doses and comparing progression-free survival between the two treatment arms. The study is sponsored by St. Jude Children's Research Hospital and involves patients aged 1 to 30 years with refractory or recurrent solid tumors or Ewing sarcoma. In phase I, participants are randomly assigned to one of two treatment arms. Arm A receives intravenous Onivyde on Days 1 and 8 plus oral talazoparib twice on Day 1 and daily on Days 2 to 6. Arm B receives intravenous Onivyde on Days 1 and 8 plus oral temozolomide daily on Days 1 to 5. After establishing the highest tolerable doses, expansion cohorts will enroll more patients to assess tumor response. Phase II will then randomize patients with recurrent or refractory Ewing sarcoma to receive the same two regimens. Participants will undergo tumor assessments at the start and after cycles 2, 4, 6, and every 4 cycles afterward. Pharmacokinetic testing occurs during the first cycle. Treatment may continue for up to 24 months unless disease progression or significant toxicities occur. Safety and tolerability are monitored throughout. The primary outcomes include determining recommended doses in phase I and progression-free survival in phase II. Secondary measures include safety, tumor response, and drug pharmacokinetics, with follow-up lasting up to five years after randomization in phase II.
CONDITIONS
Brief Title
Study of Onivyde With Talazoparib or Temozolomide in Children With Recurrent Solid Tumors and Ewing Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged over 12 months and under 30 years at enrollment
- Histologic verification of refractory or recurrent non-central nervous system solid tumors or Ewing sarcoma
- Measurable or evaluable disease as defined by imaging or other criteria
- Karnofsky performance status above 50% for patients over 16 years old or Lansky above 50% for younger patients
- Prior therapy with irinotecan-based or temozolomide-based regimens allowed; prior PARP inhibitors other than talazoparib allowed
- Adequate organ function including blood counts, kidney, liver, and lung function
- Full recovery from prior chemotherapy, immunotherapy, surgery, or radiotherapy according to defined time periods
- Female patients who are post-menarchal must have a negative pregnancy test and agree to ongoing testing
- Male and female participants of reproductive potential must agree to use effective contraception during and after the study
You will not qualify if you...
- Pregnant or breastfeeding women
- Patients unwilling or unable to use two forms of effective contraception if of reproductive potential
- Patients who do not meet organ function or performance status requirements
- Patients with unresolved toxic effects from prior therapies
- Patients who donate sperm or eggs during and shortly after the study treatment period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 24 months
Participants receive intravenous Onivyde on Days 1 and 8 combined with either oral talazoparib or oral temozolomide on specified days in repeating 21-day cycles. Therapy may continue for up to 24 months unless there is disease progression or intolerable toxicity.
Repeated visits on Days 1 and 8 each cycle, with oral medication taken daily on specified days of each 21-day cycle; tumor assessments at baseline and after cycles 2, 4, 6 and then every 4 cycles
Duration - Up to 5 years
Participants will be monitored for progression-free survival and long-term outcomes for up to five years following the last patient randomization.
Periodic visits for assessments following treatment completion
Trial Site Locations
Total: 10 locations
1
Lucille Packard Children's Hospital Stanford
Palo Alto, California, United States, 94304
Actively Recruiting
2
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
3
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
4
Children's Healthcare of Atlanta/Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Actively Recruiting
5
Children's Hospital and Clinics of Minn
Minneapolis, Minnesota, United States, 55404
Actively Recruiting
6
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
7
Texas Children's Hospital/ Baylor College of Medicine
Houston, Texas, United States, 77030
Active, Not Recruiting
8
The Hospital for Sick Children
Toronto, Ontario, Canada
Actively Recruiting
9
CHU Sainte-Justine
Montreal, Canada
Actively Recruiting
10
BC Children's Hospital Research Institute
Vancouver, Canada
Not Yet Recruiting
Research Team
S
Sara Federico, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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