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

Part of paid clinical trials in Palo Alto, California.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT04901702
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • 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 Solid Tumor
  • 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

Eligibility Criteria

Sex
ALL
Age
12 Months - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Onivyde — DRUG
    Given intravenous on Days 1 and 8
  • Talazoparib — DRUG
    Given orally twice on Day 1 (daily maximum is 1000mcg/day), then daily on Days 2-6
  • Temozolomide — DRUG
    Given once a day on Days 1-5.

Study Details

The phase I portion of this study is designed for children or adolescents and young adults (AYA) with a diagnosis of a solid tumor that has recurred (come back after treatment) or is refractory (never completely went away). The trial will test 2 combinations of therapy and participants will be randomly assigned to either Arm A or Arm B. The purpose of the phase I study is to determine the highest tolerable doses of the combinations of treatment given in each Arm. In Arm A, children and AYAs with recurrent or refractory solid tumors will receive 2 medications called Onivyde and talazoparib. Onivyde works by damaging the DNA of the cancer cell and talazoparib works by blocking the repair of the DNA once the cancer cell is damaged. By damaging the tumor DNA and blocking the repair, the cancer cells may die. In Arm B, children and AYAs with recurrent or refractory solid tumors will receive 2 medications called Onivyde and temozolomide. Both of these medications work by damaging the DNA of the cancer call which may cause the tumor(s) to die. Once the highest doses are reached in Arm A and Arm B, then "expansion Arms" will open. An expansion arm treats more children and AYAs with recurrent or refractory solid tumors at the highest doses achieved in the phase I study. The goal of the expansion arms is to see if the tumors go away in children and AYAs with recurrent or refractory solid tumors. There will be 3 "expansion Arms". In Arm A1, children and AYAs with recurrent or refractory solid tumors (excluding Ewing sarcoma) will receive Onivyde and talazoparib. In Arm A2, children and AYAs with recurrent or refractory solid tumors, whose tumors have a problem with repairing DNA (identified by their doctor), will receive Onivyde and talazoparib. In Arm B1, children and AYAs with recurrent or refractory solid tumors (excluding Ewing sarcoma) will receive Onivyde and temozolomide. Once the highest doses of medications used in Arm A and Arm B are determined, then a phase II study will open for children or young adults with Ewing sarcoma that has recurred or is refractory following treatment received after the initial diagnosis. The trial will test the same 2 combinations of therapy in Arm A and Arm B. In the phase II, a participant with Ewing sarcoma will be randomly assigned to receive the treatment given on either Arm A or Arm B.

Key Dates

Start date
Jun 9, 2021
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: (Arm A) ONI plus TAL
    The phase I/II study will evaluate a treatment regimen; nanoliposomal irinotecan (nal-IRN, Onivyde) plus talazoparib (TAL)
  • Active Comparator: (Arm B) ONI plus TMZ
    The phase I/II study will evaluate a treatment regimen; Onivyde (ONI) plus temozolomide (TMZ)

Primary Outcome Measure

Phase I:To determine the recommended phase 2 doses (RP2Ds) of Onivyde combined with talazoparib (Arm A) and Onivyde combined with temozolomide (Arm B) administered to children, adolescents and young adults with refractory or recurrent solid malignancies. [ Time Frame: approximately 21 days ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Lucille Packard Children's Hospital StanfordPalo AltoCalifornia94304
Allison Pribnow, MD, MPH
[email protected]
650-723-5535
Allison Pribnow, MD, MPH (PRINCIPAL_INVESTIGATOR)
Children's Hospital ColoradoAuroraColorado80045
Carrye Cost, MD
[email protected]
720-777-6775
Carrye Cost, MD (PRINCIPAL_INVESTIGATOR)
Children's National Medical CenterWashington D.C.District of Columbia20010
AeRang Kim, PhD
[email protected]
202-476-5685
AeRang Kim, PhD (PRINCIPAL_INVESTIGATOR)
Jeffrey Dome, MD,PhD (SUB_INVESTIGATOR)
Children's Healthcare of Atlanta/Emory University School of MedicineAtlantaGeorgia30322
Thomas Cash, MD, MSc
[email protected]
404-785-6288
Thomas Cash, MD, MSc (PRINCIPAL_INVESTIGATOR)
Children's Hospital and Clinics of MinnMinneapolisMinnesota55404
Kris Ann Schultz, MD (PRINCIPAL_INVESTIGATOR)
St. Jude Children's Research HospitalMemphisTennessee38105
Sara M Federico, MD
[email protected]
888-226-4343
Sara M Federico, MD (PRINCIPAL_INVESTIGATOR)
Texas Children's Hospital/ Baylor College of MedicineHoustonTexas77030-

Find similar trials in Palo Alto, CA

By research site
Lucille Packard Children's Hospital Stanford· Palo Alto, CAChildren's Hospital Colorado· Aurora, COChildren's National Medical Center· Washington D.C., DCChildren's Healthcare of Atlanta/Emory University School of Medicine· Atlanta, GAChildren's Hospital and Clinics of Minn· Minneapolis, MNSt. Jude Children's Research Hospital· Memphis, TN

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