Targeted Therapy to Increase RAI Uptake in Metastatic DTC

Launched by CHILDREN'S HOSPITAL OF PHILADELPHIA · Aug 23, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how targeted therapies, which are special medications that focus on specific genetic changes in cancers, can help improve the uptake of radioactive iodine (RAI) in patients with metastatic differentiated thyroid cancer (DTC), including papillary thyroid cancer. RAI is often used to treat thyroid cancer, and the researchers want to see if these new targeted drugs can make RAI work better. The trial is open to patients of all ages who have been diagnosed with differentiated thyroid cancer and have specific genetic changes that can be treated with targeted therapies.

If you or your child are interested in participating, you would need to meet certain criteria, such as having a confirmed diagnosis of DTC and specific genetic alterations identified in a lab. Participants will receive a targeted therapy and then undergo tests, including a whole body thyroid scan about a month later, to see how well the treatment is working. It’s important to note that pregnant or breastfeeding individuals cannot participate due to potential risks, and those who need sedation for the scans are also excluded. This study is currently recruiting participants, and it aims to gather more information about how these new therapies can improve treatment outcomes for thyroid cancer patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria (Prospective Cohort):
• • 1. Patients with a histologic diagnosis of differentiated thyroid cancer
• • 2. 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
• 3. Anatomically evaluable disease on chest Computed tomography (CT) meeting oneo f the following criteria (obtained within 180 days of enrollment):
• • 1. multiple (10 or more) noncalcified solid pulmonary nodules visible on CT and/or
• • 2. enlarging, discrete pulmonary nodules visible on CT of any number consistent with metastatic disease
• 4. 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:
• • 1. Larotrectinib, entrectinib, selitrectinib, and repotrectinib for NTRK fusions
• • 2. Selpercatinib and pralsetinib for RET fusions
• • 3. Crizotinib, lorlatinib, repotrectinib, and alectinib for ALK fusions
• • 4. Dabrafenib and/or trametinib for BRAF V600 mutations
• • 5. Oncogene-specific kinase inhibitors other than those specifically delineated above must be approved by the overall study PI prior to enrollment
• Inclusion Criteria (Data Sharing Cohort):
• • 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.
• Exclusion Criteria (All Cohorts):
• • 1. No prior oncogene-specific targeted therapy allowed. However, patients may enroll within 4 weeks of starting oncogene-specific therapy if a pre-therapy WBS is available. Prior therapy with non-oncogene specific multi-thyrosine kinase inhibitors (such as sorafenib, lenvatinib, and/or cabozantanib) is allowed.
• • 2. Females who are pregnant or breastfeeding are excluded due to the potential risks of the RAI used in the WBS to the fetus/neonate.
• • 3. Patients who require sedation/general anesthesia to complete a WBS are excluded.
• • 4. U.S. Military Personnel are excluded due to the Children's Hospital of Philadelphia (CHOP) Institutional Review Board (IRB) requirements.