Targeted Therapy to Increase RAI Uptake in Patients With Metastatic DifferentiatedThyroid Cancer

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Procedure
Study Type: Observational
SUMMARY

Papillary thyroid cancer (PTC) is a common type of differentiated thyroid cancer (DTC) in children and represents the second most common cancer in adolescent females. Recently targeted drugs that block many of the genetic drivers of DTC have become available. While Investigators know that these drugs shrink DTC tumors in many cases, the impact on radioactive iodine (RAI) avidity has not been systematically studied.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Patients with a histologic diagnosis of differentiated thyroid cancer

• Presence of an neurotrophic tyrosine kinase receptors (NTRK)-fusion, RET-fusion, anaplastic lymphoma kinase (ALK)-fusion, BRAF V600 mutation, BRAF-fusion or other targetable alteration identified in a Clinical Laboratory Improvement Amendments/College of American Pathologists (CLIA/CAP) laboratory

• Anatomically evaluable disease on chest Computed tomography (CT) meeting oneo f the following criteria (obtained within 180 days of enrollment):

‣ multiple (10 or more) noncalcified solid pulmonary nodules visible on CT and/or

⁃ enlarging, discrete pulmonary nodules visible on CT of any number consistent with metastatic disease

• Patients for whom systemic therapy with an oncogene-specific kinase inhibitor is planned from commercial supply or as part of a separate therapeutic clinical trial (that does not include data sharing with this protocol)/compassionate access protocol/single patient investigational new drug (IND). Such agents include, but are not limited to:

‣ Larotrectinib, entrectinib, selitrectinib, and repotrectinib for NTRK fusions

⁃ Selpercatinib and pralsetinib for RET fusions

⁃ Crizotinib, lorlatinib, repotrectinib, and alectinib for ALK fusions

⁃ Dabrafenib and/or trametinib for BRAF V600 mutations

⁃ Oncogene-specific kinase inhibitors other than those specifically delineated above must be approved by the overall study PI prior to enrollment

∙ 1\. Patients enrolled on other oncogene-specific targeted therapy trials who undergo whole body thyroid scan approximately 28 days after beginning targeted therapy and agree to data sharing as part of the consent process for that trial.

Locations
United States
California
University of California San Francisco
RECRUITING
San Francisco
Georgia
Emory University School of Medicine
RECRUITING
Atlanta
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Pennsylvania
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Tennessee
St. Jude Children's Research Hospital
RECRUITING
Memphis
Texas
MD Anderson Cancer Center
RECRUITING
Houston
Texas Children's Hospital
RECRUITING
Houston
Washington
Seattle Children's Hospital
RECRUITING
Seattle
Other Locations
Australia
Children's Hospital Westmead
RECRUITING
Sydney
Contact Information
Primary
Meghan T Donnelly
donnellymt@chop.edu
2674269343
Backup
James Robinson
robinsonj9@chop.edu
215-590-2053
Time Frame
Start Date: 2021-07-16
Estimated Completion Date: 2033-02-01
Participants
Target number of participants: 32
Treatments
Prospective Cohort
Patients with differentiated thyroid cancer for whom oncogene-specific targeted therapy is planned from commercial supply or as part of a separate therapeutic trial
Data Sharing Cohort
Patients with differentiated thyroid cancer enrolled on other oncogene-specific targeted therapy trials who undergo whole body thyroid scan approximately 28 days after beginning targeted therapy and agree to data sharing
Sponsors
Leads: Children's Hospital of Philadelphia
Collaborators: United States Department of Defense

This content was sourced from clinicaltrials.gov