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Radiopharmaceutical

Larotrectinib monotherapy with 131I therapy for Pediatric Cancer

Phase 2
Recruiting
Led By Theodore Laetsch, MD
Research Sponsored by Theodore Laetsch
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

Study Summary

This trial is looking at a new treatment option for patients with advanced papillary thyroid cancer after surgery. The current treatment, radioactive iodine therapy, is not always effective and has potential risks such as lung

Who is the study for?
This trial is for people of any age over 1 year with a specific type of thyroid cancer, who've had surgery and possibly other treatments for neck metastases. They must have certain lung nodules seen on CT scans and an NTRK gene fusion without resistance mutations. Good performance status and organ function are required, including specific blood cell counts and creatinine levels.Check my eligibility
What is being tested?
The study tests Larotrectinib's ability to improve the effectiveness of radioactive iodine (RAI) therapy in treating advanced differentiated thyroid cancer after surgery. It aims to see if this drug can help those who don't fully respond to RAI, which has risks like pulmonary fibrosis and secondary cancers.See study design
What are the potential side effects?
While not explicitly listed here, common side effects from Larotrectinib may include fatigue, dizziness, nausea; RAI therapy could lead to dry mouth/throat issues or more serious concerns such as lung scarring or second cancers.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of patients with complete pulmonary structural response

Trial Design

1Treatment groups
Experimental Treatment
Group I: Larotrectinib monotherapy with 131I therapyExperimental Treatment2 Interventions
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.

Find a Location

Who is running the clinical trial?

Theodore LaetschLead Sponsor
2 Previous Clinical Trials
4 Total Patients Enrolled
Children's Hospital of PhiladelphiaLead Sponsor
708 Previous Clinical Trials
8,583,007 Total Patients Enrolled
BayerIndustry Sponsor
2,240 Previous Clinical Trials
25,332,764 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of participants enrolled in this research study?

"Indeed, information from clinicaltrials.gov shows that this investigation is currently open to enrollment. This trial was initially listed on February 14th, 2024 and last modified on February 15th, 2024. The study aims to recruit a total of 13 participants across one site."

Answered by AI

Is Larotrectinib monotherapy combined with 131I therapy considered safe for individuals?

"The safety assessment for Larotrectinib monotherapy combined with 131I therapy is rated at 2 by our team, denoting a Phase II trial status. At this stage, there exists preliminary data regarding safety aspects but not yet on efficacy outcomes."

Answered by AI

Is it possible for me to participate in this research study?

"The trial seeks 13 participants aged between 2 and 99 with thyroid cancer. Eligible candidates must meet the subsequent requirements: age ≥ 1 year, confirmed histologic diagnosis of differentiated thyroid cancer, post-thyroidectomy status along with sufficient local therapy for neck metastatic disease per treating investigator’s judgment either showing multiple (>10) noncalcified solid pulmonary nodules on CT or displaying enlarging discrete pulmonary nodules consistent with metastatic ailment; presence of neurotrophic tyrosine receptor kinase (NTRK) gene fusion validated in a CLIA/CAP accredited laboratory without known resistance mutation within the kinase domain; performance"

Answered by AI

Are individuals who are older than 80 years of age eligible to participate in this trial?

"Eligible participants for this research endeavor range from 2 to 99 years old. Specifically, there are 130 ongoing clinical trials catering to individuals under the age of 18 and another 685 dedicated to those above the age of 65."

Answered by AI

Are there ongoing efforts to actively enroll participants for this medical study?

"Indeed, the details on clinicaltrials.gov reveal that this trial is actively pursuing volunteers. Initially shared on February 14th, 2024, and last revised on February 15th, 2024, the study aims to enroll 13 participants at a single site."

Answered by AI
~9 spots leftby Oct 2024