Reactivating Tumor Suppressor Genes
Name of the Trial
Why This Trial Is Important
Preclinical studies have shown, however, that FdCyd is rapidly broken down in the body, and the breakdown products do not block methylation. Another drug called tetrahydrouridine (THU) may help prevent FdCyd breakdown when administered with it. THU may allow FdCyd to remain intact long enough to reduce the hypermethylation of tumor suppressor genes and possibly allow them to be reactivated.
This is the first clinical trial to test the combination of FdCyd and THU in humans. Researchers are interested in establishing the maximum tolerated dose and determining how this regimen affects the methylation of certain genes. They will also determine the toxicity of this treatment, and examine its effects on levels of proteins that are important for the progression of cancer.
"FdCyd/THU is being developed collaboratively by researchers at the City of Hope Comprehensive Cancer Center and the NCI," said Dr. Doroshow. "So far, patients in the trial have tolerated the combination well, and we have seen some clinical responses.
"Our hope is to develop the regimen as an orally available combination that will safely and effectively deliver repetitive doses of these tumor-suppressor gene-activating agents to patients."
Who Can Join This Trial
Study Sites and Contact Information
An archive of "Featured Clinical Trial" columns is available at http://cancer.gov/clinicaltrials/ft-all-featured-trials.