Friday, June 30, 2023
DFMO Clinical Trial
Caroline and Mark traveled to Levine Children's Hospital in Charlotte, NC this week to enroll in the only "expanded access" DFMO clinical trial currently available. "Expanded access," also called “compassionate use,” allows patients with serious/life-threatening conditions to gain access to investigational medicine for treatment when no alternative therapy options are available, and they aren't eligible for the drug though any other trials. Although it's been a long, administrative-heavy process to get access to this drug, we believe DFMO will give Caroline the best chance for remaining NED (no evidence of disease).
Caroline enrolled in the DFMO clinical trial at Vanderbilt in April 2019, immediately after completing the treatment protocol for her original diagnosis. She took 6 pills per day for 2 years...remaining cancer-free while taking the drug, and then relapsing within a year of stopping the medication. This time, Caroline will be getting "high-dose DFMO," which requires her to take 22 pills per day for 2 years (that's 16,060 pills!!!). DFMO is only available within clinical research trials, and only for a 2 year period. Unless the FDA approves this drug as a part of standard treatment and/or maintenance post-treatment, Caroline will have to stop taking DFMO in June 2025.
Vanderbilt and Levine have both been amazing through this process, and thankfully are willing to work together to minimize our travel. She will continue to go to Vanderbilt for monthly labs/tests and progress scans every 3 months, but will be required to travel to Levine to visit their clinic periodically to get the clinical trial medication.
Many thanks to Dr. Giselle Sholler, her team, and the Beat Childhood Cancer Foundation for remaining steadfast in their search for a cure to give these kids the best chance at life.
We will continue to post on this blog as there are updates. Thank you for your never-ending support, love and prayers for our family. Cancer sucks.
The Lantz Family
Caroline and Dr. Sholler
3 months of DFMO