PEEL-224, Vincristine and Temozolomide in Pediatric Solid Tumors

Part of paid clinical trials in Los Angeles, California.

Sponsor
Theodore Laetsch
Study ID
NCT06721689
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Refractory Neuroblastoma
  • Refractory Rhabdomyosarcoma
  • Refractory Solid Tumors
  • Relapsed Neuroblastoma
  • Relapsed Rhabdomyosarcoma
  • Relapsed Solid Tumors

Eligibility Criteria

Sex
ALL
Age
1 Year - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • PEEL-224 — DRUG
    PEEL-224 (PEG-\[SN22\]4) is a novel topoisomerase I inhibitor
  • Vincristine — DRUG
    Vincristine is an inhibitor of microtubular formation which is approved by the Food and Drug Administration (FDA) and is commercially available.
  • Temozolomide (TMZ) — DRUG
    Temozolomide is an alkylating agent which is approved by the FDA and is commercially available.

Study Details

The phase 1 primary objective is to determine the pediatric recommended phase 2 dose (RP2D) of PEEL-224 as a single agent (phase 1A) and in combination with vincristine and temozolomide (phase 1B). The phase 2 primary objective is to estimate the objective response rate (ORR) in children with refractory, progressive and relapsed NBL and rhabdomyosarcoma (RMS) treated with the RP2D of PEEL-224 in combination with vincristine and temozolomide.

Key Dates

Start date
Mar 23, 2025
Status verified
Apr 2026
Primary completion
Apr 30, 2030
Completion
Apr 30, 2031

Study Design

Enrollment
59 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: PEEL-224
    Phase 1A will test the safety, tolerability and PK profile of PEEL-224 as a single agent in pediatric patients with refractory, progressive and relapsed solid tumors.
  • Experimental: PEEL-224, Vincristine, and Temozolomide
    Phase 1B will test the safety, tolerability and pharmacokinetic profile of PEEL-224 in combination with vincristine and temozolomide in pediatric subjects with refractory, progressive and relapsed solid tumors. Phase 2 will preliminary evaluate the activity profile of PEEL-224 in combination with vincristine and temozolomide in pediatric patients with refractory, progressive and relapsed NBL and RMS.

Primary Outcome Measure

Phase 1A and Phase 1B: Number of participants who experience a dose limiting toxicity (DLT) [ Time Frame: 1 month ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Leo Mascarhenhas, MD (PRINCIPAL_INVESTIGATOR)
University of California, San FranciscoSan FranciscoCalifornia94143
Jennifer Michlitsch, MD (PRINCIPAL_INVESTIGATOR)
Boston Children's HospitalBostonMassachusetts02115
David Shulman, MD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
David Shulman, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Meghan Donnelly, MPH
[email protected]
267-426-9343
Jacquelyn Crane, MD (PRINCIPAL_INVESTIGATOR)
Texas Children's HospitalHoustonTexas77030
Jennifer Foster, MD (PRINCIPAL_INVESTIGATOR)
University of Utah HospitalSalt Lake CityUtah84132
Matthew Dietz, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By condition
Neuroblastoma
By specialty
OncologyPediatric oncology
By research site
Cedars-Sinai Medical Center· Los Angeles, CAUniversity of California, San Francisco· San Francisco, CABoston Children's Hospital· Boston, MADana-Farber Cancer Institute· Boston, MAChildren's Hospital of Philadelphia· Philadelphia, PATexas Children's Hospital· Houston, TX

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