Targeted Therapy to Increase RAI Uptake in Metastatic DTC

Pediatric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05024929
• Other study ID #: 21-018612
• Status: Recruiting
• Start date: July 16, 2021
• Est. completion date: February 1, 2033

Study information

• Verified date: January 2024
• Source: Children's Hospital of Philadelphia
• Contact: Supriya Behl
• Phone: 267-426-9293
• Email: behls[@]chop.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This is an observational cohort study that will enroll patients with DTC metastatic to the lungs who will receive oncogene-specific targeted therapy as part of routine clinical care or a separate therapeutic clinical trial. After approximately 4 weeks of therapy, patients will have a whole body scan to determine the change in RAI-avidity of their tumor from baseline. Subsequent therapy will be at the discretion of the treating physician or according to the therapeutic trial on which the patient is enrolled.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: February 1, 2033
• Est. primary completion date: February 1, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Differentiated Thyroid Cancer
• Papillary Thyroid Cancer
• Pediatric Cancer
• Thyroid Cancer, Papillary
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Procedure:
• Whole body scan
Patients will receive oncogene-specific molecularly targeted therapy independently of this protocol either via commercial supply of an FDA approved agent, or as part of a separate therapeutic clinical trial/compassionate use protocol/single patient investigational new drug (IND). During screening, patients will undergo a baseline RAI-whole body scan (WBS) to assess RAI-avidity of their tumor per standard of care. Following approximately 28 days of targeted therapy, the WBS will be repeated to determine whether this therapy is associated with an increase in RAI-avidity of their tumor.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts
United States	MD Anderson Cancer Center	Houston	Texas
United States	Texas Children's Hospital	Houston	Texas
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with increased tumor RAI-avidity after receiving oncogene-specific, targeted therapy	The primary outcome measure is to determine the proportion of patients with differentiated thyroid cancer metastatic to the lungs for whom oncogene-specific, targeted therapy increases tumor RAI-avidity.	up to 5 years