Study on Larotrectinib for Treating Children and Young Adults with Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders with NTRK Fusions
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT03213704
This clinical trial is testing how well the drug larotrectinib works in children and young adults with advanced solid tumors, non-Hodgkin lymphoma, or histiocytic disorders that have a specific genetic change called NTRK fusion. The study aims to see if larotrectinib can stop cancer growth by blocking certain enzymes needed for cell growth.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This study is part of the Pediatric MATCH trial and focuses on children and young adults with advanced cancers that have a specific genetic change known as NTRK fusion. The trial is testing the effectiveness of larotrectinib, a drug that may help stop cancer cells from growing by blocking certain enzymes. The study includes patients whose cancer has returned after treatment or has not responded to previous treatments.
Description
The main goal of this study is to find out how well larotrectinib works in treating children and young adults with advanced solid tumors, non-Hodgkin lymphoma, or histiocytic disorders that have NTRK fusions. Researchers will look at how many patients experience a reduction in their cancer (complete or partial response) after treatment.
Secondary goals include estimating how long patients remain free from cancer progression and gathering more information about the drug's safety and how it behaves in the body. The study will also explore changes in the genetic makeup of tumors over time.
Participants will take larotrectinib by mouth or through a feeding tube twice a day in 28-day cycles, continuing for up to two years unless the cancer progresses or side effects become unacceptable. During the study, participants will undergo various scans and tests to monitor their cancer and overall health. After completing the treatment, follow-up visits will occur at 30 days and periodically thereafter.
Eligibility Criteria
Inclusion Criteria
- Must be enrolled in the Pediatric MATCH trial and assigned to this study based on having an NTRK fusion.
- Age between 12 months and 21 years at the time of joining the study.
- Must have cancer that can be measured by scans; certain conditions apply for neuroblastoma and CNS tumors.
- Must have a performance status score of at least 50%.
- Must have recovered from previous cancer treatments and meet specific time frames since last treatment.
- Must have adequate blood counts and organ function as determined by specific tests.
- Must not have received prior treatment with NTRK inhibitors.
- Must provide informed consent and assent if applicable.
Exclusion Criteria
- Pregnant or breastfeeding individuals cannot participate.
- Cannot be on certain medications or treatments that interfere with the study drug.
- Cannot have uncontrolled infections or have had a solid organ transplant.
- Must not have received prior treatment with specific TRK inhibitors.
- Must not be on medications that strongly affect the liver enzyme CYP3A4, unless stable for CNS conditions.
- Must be able to comply with study requirements and safety monitoring.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Children's Hospital of Alabama | 35233 | Birmingham | Alabama |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| Banner Children's at Desert | 85202 | Mesa | Arizona |
| Banner University Medical Center - Tucson | 85719 | Tucson | Arizona |
| Arkansas Children's Hospital | 72202-3591 | Little Rock | Arkansas |
| Kaiser Permanente Downey Medical Center | 90242 | Downey | California |
| Loma Linda University Medical Center | 92354 | Loma Linda | California |
| Miller Children's and Women's Hospital Long Beach | 90806 | Long Beach | California |
| Children's Hospital Los Angeles | 90027 | Los Angeles | California |
| Valley Children's Hospital | 93636 | Madera | California |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.