Larotrectinib to Enhance RAI Avidity in Differentiated Thyroid Cancer

Part of paid clinical trials in San Francisco, California.

Sponsor
Children's Hospital of Philadelphia
Study ID
NCT05783323
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
2 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Larotrectinib monotherapy — DRUG
    Patients will receive larotrectinib monotherapy for 6 months at the FDA-approved dose.
  • 131I therapy — RADIATION
    Patients will receive 131I therapy after 6 months of larotrectinib.

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
Feb 14, 2024
Status verified
Nov 2025
Primary completion
Oct 1, 2026
Completion
Oct 1, 2027

Study Design

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

Arms

  • Experimental: Larotrectinib monotherapy with 131I therapy
    Patients will receive larotrectinib monotherapy for 6 months at the FDA-approved dose. Patients will receive 131I therapy after 6 months of larotrectinib. Larotrectinib 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 larotrectinib will proceed to 131I therapy and discontinue larotrectinib.

Primary Outcome Measure

Number of patients with complete pulmonary structural response [ Time Frame: 18 months ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94115
Arun Rangaswami, MD
[email protected]
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Meghan Donnelly
[email protected]
267-426-9343
Theodore Laetsch, MD (PRINCIPAL_INVESTIGATOR)
St. Jude Children's Research HospitalMemphisTennessee19807
Sara Helmig, MD
[email protected]
901-593-3300
MD Anderson Cancer CenterHoustonTexas77030
Luz Castellanos, MD
[email protected]
713-792-2841
Seattle Children's HospitalSeattleWashington98105
Tyler Ketterl, MD, MS

Find similar trials in San Francisco, CA

By research site
University of California, San Francisco· San Francisco, CAChildren'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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