Study on Erdafitinib for Treating Children and Young Adults with Advanced Cancers with FGFR Mutations
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT03210714
This clinical trial is testing the effectiveness of erdafitinib, a drug that may help stop the growth of cancer cells with FGFR mutations, in children and young adults with advanced solid tumors, non-Hodgkin lymphoma, or histiocytic disorders that have returned or not responded to treatment.
Patient Parameters
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Program Overview
The purpose of this study is to see how well erdafitinib works in treating children and young adults with advanced cancers that have specific FGFR mutations. These cancers include solid tumors, non-Hodgkin lymphoma, and histiocytic disorders that have spread or come back after treatment. Erdafitinib may help by blocking certain enzymes that cancer cells need to grow. Participants will take erdafitinib daily in cycles of 28 days, for up to 26 cycles, unless the cancer progresses or side effects become too severe. Regular scans and blood tests will be conducted to monitor the treatment's effects.
Description
The main goal of this study is to find out how many children and young adults with advanced cancers respond to treatment with erdafitinib, either by completely or partially shrinking their tumors. The study will also look at how long patients can live without their cancer getting worse and how well they tolerate the drug. Researchers will also study how the drug moves through the body and explore changes in the cancer's genetic makeup over time.
Participants will take erdafitinib by mouth once a day for 28-day cycles, continuing for up to two years if the treatment is effective and side effects are manageable. During the study, participants will undergo various scans and tests, including blood tests and possibly bone marrow tests, to track their progress and health.
After finishing the treatment, participants will have follow-up visits to monitor their health and any long-term effects of the treatment.
Eligibility Criteria
Inclusion Criteria
- Must be enrolled in a related study and have a specific FGFR mutation.
- Aged between 12 months and 21 years.
- Have a body surface area of at least 0.53 m².
- Have measurable cancer that can be seen on scans, or specific types of neuroblastoma.
- Be in good general health, with a performance score of at least 50%.
- Have recovered from previous cancer treatments and meet specific timeframes since last treatment.
- Have adequate blood cell counts and organ function as determined by specific tests.
- Be able to swallow tablets.
- Provide informed consent from themselves or their guardians.
Exclusion Criteria
- Pregnant or breastfeeding individuals.
- Currently taking certain medications, including other investigational drugs or anti-cancer agents.
- Have uncontrolled infections or have had a solid organ transplant.
- Have certain heart conditions or significant eye problems.
- Have a history of severe cardiovascular events or other serious health issues that could interfere with the study.
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 |
| Cedars Sinai Medical Center | 90048 | Los Angeles | California |
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