Study on Larotrectinib for Treating TRK Fusion Solid Tumors and Relapsed TRK Fusion Leukemia
Sponsor: Children's Oncology Group
ClinicalTrials ID:NCT03834961
This clinical trial is testing the effectiveness and safety of larotrectinib, a drug that may help stop the growth of cancer cells with TRK fusions, in patients with certain solid tumors and leukemia that have not been treated before or have returned.
Patient Parameters
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Program Overview
The purpose of this study is to see how well larotrectinib works in treating patients with TRK fusion solid tumors and TRK fusion acute leukemia that has come back. Larotrectinib may help stop the growth of cancer cells by blocking the TRK enzymes needed for cell growth. The study will also look at the side effects of the drug and how long patients respond to the treatment.
Description
The main goal of this study is to find out how many children with infantile fibrosarcoma (IFS) respond to larotrectinib before surgery. Other goals include understanding how long children with IFS and other TRK fusion solid tumors live without the cancer getting worse, and how long they live overall. The study will also look at the side effects of larotrectinib in children with solid tumors and leukemia. Researchers will check for cancer DNA in the blood at different times during the treatment to see how the cancer responds.
Patients will take larotrectinib by mouth or through a tube twice a day for 28 days. This cycle can be repeated up to 26 times unless the cancer progresses or side effects become too severe. If the tumors shrink enough, patients may have surgery to remove them. After finishing the treatment, patients will have follow-up visits for up to 5 years to monitor their health.
Eligibility Criteria
Inclusion Criteria
- Must be 30 years old or younger.
- For Cohort A: Must have infantile fibrosarcoma with a specific TRK fusion.
- For Cohort B: Must have a solid tumor with a TRK fusion, excluding high-grade gliomas.
- For Cohort C: Must have relapsed or hard-to-treat leukemia with a TRK fusion.
- Must have measurable disease that cannot be completely removed without significant risk.
- Must have a performance status score of 50 or higher, meaning they are able to carry out daily activities.
- For Cohorts A and B: No prior anti-cancer therapy other than surgery.
- For Cohort C: Must have recovered from previous cancer treatments and meet specific timeframes since last treatment.
- Must have adequate blood counts and organ function.
- Must not have received TRK inhibitors before.
- Must be able to swallow medication or have a feeding tube.
- Must have signed informed consent.
Exclusion Criteria
- Pregnant or breastfeeding women cannot participate.
- Cannot be on corticosteroids unless on a stable dose for at least 7 days.
- Cannot be taking other investigational drugs or anti-cancer agents.
- Cannot be on medications to prevent graft-versus-host disease.
- Cannot be taking strong CYP3A4 inducers or inhibitors.
- Cannot have conditions that affect drug absorption.
- Cannot have uncontrolled infections.
- Cannot have had a solid organ transplant.
- Must be able to comply with study requirements.
- Patients with high-grade gliomas are not eligible.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Children's Hospital of Alabama | 35233 | Birmingham | Alabama |
| Arkansas Children's Hospital | 72202-3591 | Little Rock | Arkansas |
| Kaiser Permanente Downey Medical Center | 90242 | Downey | California |
| Children's Hospital Los Angeles | 90027 | Los Angeles | California |
| Kaiser Permanente-Oakland | 94611 | Oakland | California |
| Children's Hospital of Orange County | 92868 | Orange | California |
| UCSF Medical Center-Mission Bay | 94158 | San Francisco | California |
| Children's Hospital Colorado | 80045 | Aurora | Colorado |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center | 80218 | Denver | Colorado |
| Yale University | 06520 | New Haven | Connecticut |
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