Study on Selpercatinib for Treating Advanced Cancers with RET Gene Changes in Children and Young Adults
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT04320888
This clinical trial is testing how well the drug selpercatinib works in treating children and young adults with advanced solid tumors, lymphomas, or histiocytic disorders that have specific genetic changes in the RET gene. The study aims to see if selpercatinib can help shrink tumors by blocking cancer cell growth.
Patient Parameters
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Program Overview
This study is exploring the effectiveness of selpercatinib in treating advanced cancers in children and young adults. These cancers include solid tumors, lymphomas, or histiocytic disorders that have specific changes in the RET gene, which can affect cancer growth. Selpercatinib may help reduce tumor size by targeting these genetic changes. Participants will take selpercatinib orally twice a day in 28-day cycles, for up to 2 years, as long as the cancer does not progress and side effects are manageable. Various imaging tests will be used throughout the trial to monitor the cancer's response to treatment.
Description
The main goal of this study is to determine how well selpercatinib works in shrinking tumors in children and young adults with advanced cancers that have specific RET gene changes. Researchers will also look at how long patients can live without the cancer getting worse and how well patients tolerate the drug. Additionally, the study will explore changes in the cancer's genetic makeup over time by analyzing DNA from the tumor.
Participants will take selpercatinib by mouth twice daily for 28 days, repeating this cycle for up to 26 cycles (2 years) unless the cancer progresses or side effects become too severe. During the study, participants may undergo various imaging tests like PET, CT, MRI, and X-rays to track the cancer's response to the treatment. After finishing the treatment, participants will be monitored for 30 days and then periodically to check their health and any long-term effects.
Eligibility Criteria
Inclusion Criteria
- Must be enrolled in a related study and assigned to this trial based on specific genetic changes.
- Aged between 12 months and 21 years.
- Must have measurable cancer that can be seen on scans. For neuroblastoma, certain scan results are acceptable.
- Must be in relatively good health, with a performance score of 50% or higher.
- Must have recovered from previous cancer treatments and meet specific timeframes since last treatment.
- Must not have received selpercatinib or similar drugs before.
- Must have adequate blood counts and organ function as determined by specific tests.
- Must provide informed consent and agree to follow study procedures.
Exclusion Criteria
- Pregnant or breastfeeding individuals cannot participate.
- Must not be taking certain medications that could interfere with the study drug.
- Must not have had major surgery within 14 days before starting the study.
- Must not have conditions that affect drug absorption or have allergies to the study drug.
- Must not have uncontrolled high blood pressure, thyroid issues, calcium imbalances, or infections.
- Must not have had a solid organ transplant.
- Must be able to comply with study requirements according to the investigator's judgment.
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 |
| Phoenix Childrens Hospital | 85016 | Phoenix | 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 |
| City of Hope Comprehensive Cancer Center | 91010 | Duarte | California |
| Loma Linda University Medical Center | 92354 | Loma Linda | California |
| Miller Children's and Women's Hospital Long Beach | 90806 | Long Beach | California |
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