Genetically Modified T Cells and Decitabine in Treating Patients With Recurrent or Refractory Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
A Phase I Open Label Clinical Trial Evaluating the Safety and Efficacy of Adoptive Transfer of NY-ESO-1 TCR Engineered Autologous T Cells in Combination With Decitabine in Patients With Recurrent or Treatment Refractory Ovarian Cancer
Doctors at Roswell Park Cancer Institute seek patients with Ovarian, Primary Peritoneal, or Fallopian Tube cancers that express NY-ESO-1 antigen to trial a therapeutic gene therapy. This therapy utilizes the patient’s own (autologous) stem cells, drawn from bone marrow and blood, which will be gene-modified in the lab to impart a gene for the NY-ESO-1 immune receptor that targets cancer cells. After chemotherapy to reduce the existing immune system, these modified cells are re-infused, intended to replace the immune system with new immune cells that have been redirected to attack and kill the cancer cells. Proleukin drugs also are given to help the cells grow.
Researchers hope this will improve immune system function against cancer. Follow up, including lab and imaging assessments, may continue for up to 15 years.
- Be 18 years of age or older
- Have recurrent or refractory epithelial or non-epithelial ovarian, primary peritoneal or fallopian tube carcinoma who have received platinum containing chemotherapy and either has platinum refractory or resistant disease, or if platinum sensitive disease, have received >= 2 lines of chemotherapy. Subjects may have received PARP inhibitors, bevacizumab or immunotherapy. Non-epithelial tumors of the ovary include sarcomas, granulosa cell tumors and malignant germ cell tumors including choriocarcinoma
- Have life expectancy more than 4 months
THE STUDY INVOLVES:
- Screening to confirm acceptance to the study.
- Leukapheresis to collect the patient’s own stem cells, which will be gene-modified in the lab (no treatment during that period) to target cancer cells.
- Admission to the study center and a course of chemotherapy.
- Infusion of the gene-modified stem cells, followed by aldesleukin/proleukin to promote their growth.
- Follow up, including lab and imaging assessments, may continue for up to 15 years.
LOCATIONS & CONTACTS:
The study site is at the Roswell Park Cancer Institute in Buffalo, New York, Map.