Genetically Modified Neural Stem Cells, Flucytosine, and Leucovorin for Treating Patients With Recurrent High-Grade Gliomas
Status:
Completed
Trial end date:
2017-10-07
Target enrollment:
Participant gender:
Summary
This phase I trial studies the side effects and determines the best dose of genetically
modified neural stem cells and flucytosine when given together with leucovorin for treating
patients with recurrent high-grade gliomas. Neural stem cells can travel to sites of tumor in
the brain. The neural stem cells that are being used in this study were genetically modified
express the enzyme cytosine deaminase (CD), which converts the prodrug flucytosine (5-FC)
into the chemotherapy agent 5-fluorouracil (5-FU). Leucovorin may help 5-FU kill more tumor
cells. The CD-expressing neural stem cells are administered directly into the brain. After
giving the neural stem cells a few days to spread out and migrate to tumor cells, research
participants take a 7 day course of oral 5-FC. (Depending on when a research participant
enters the study, they may also be given leucovorin to take with the 5-FC.) When the 5-FC
crosses into brain, the neural stem cells convert it into 5-FU, which diffuses out of the
neural stem cells to preferentially kill rapidly dividing tumor cells while minimizing
toxicity to healthy tissues. A Rickham catheter, placed at the time of surgery, will be used
to administer additional doses of NSCs every two weeks, followed each time by a 7 day course
of oral 5-FC (and possibly leucovorin). This neural stem cell-based anti-cancer strategy may
be an effective treatment for high-grade gliomas.
Funding Source - FDA OOPD