Selpercatinib Pre-RAI in Patients With RET Fusion Thyroid Cancer (RAISE)

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Children's Hospital of Philadelphia
Study ID
NCT06458036
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cancer
  • Cancer, Thyroid
  • Differentiated Thyroid Cancer
  • Pediatric Cancer

Eligibility Criteria

Sex
ALL
Age
2 Years - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Selpercatinib Monotherapy — DRUG
    Patients will receive selpercatinib monotherapy for 6 months at the FDA-approved dose.
  • 131I Therapy — RADIATION
    Patients will receive 131I therapy after 6 months of selpercatinib.

Study Details

Papillary thyroid cancer (PTC) is the most common form of differentiated thyroid cancer (DTC). The traditional first line treatment for patients with advanced DTC after surgical resection is radioactive iodine (RAI) therapy. However, less than a quarter of patients with lung metastases will achieve a complete response to RAI therapy, and this therapy carries the risk of pulmonary fibrosis and an increasingly recognized risk of secondary malignancies.

Key Dates

Start date
Jul 29, 2024
Status verified
Apr 2026
Primary completion
Nov 1, 2030
Completion
Nov 1, 2031

Study Design

Enrollment
13 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: Selpercatinib Monotherapy with 131I Therapy
    Patients will receive selpercatinib monotherapy for 6 months at the FDA-approved dose. Patients will receive 131I therapy after 6 months of selpercatinib. Selpercatinib will be continued for 5 days after RAI therapy and then patients will enter a wait and see period off treatment. Patients who experience disease progression at any point while on selpercatinib will proceed to 131I therapy and discontinue selpercatinib.

Primary Outcome Measure

Number of patients with complete overall, pulmonary, structural, and biochemical response. [ Time Frame: 18 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Theodore Laetsch, MD
[email protected]
267-425-2187
St. Jude Children's Research HospitalMemphisTennessee38105
Sara Helmig, MD (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77030
Luz Castellanos, MD (PRINCIPAL_INVESTIGATOR)
Seattle Children's HospitalSeattleWashington98105
Priya Mahajan, MD (PRINCIPAL_INVESTIGATOR)

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Children's Hospital of Philadelphia· Philadelphia, PASt. Jude Children's Research Hospital· Memphis, TNMD Anderson Cancer Center· Houston, TXSeattle Children's Hospital· Seattle, WA

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