drugset / Trial / NCT01673217

Decitabine, Vaccine Therapy, and Pegylated Liposomal Doxorubicin Hydrochloride in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer

NCT01673217

Phase 1 Completed 18 enrolled Roswell Park Cancer Institute Eisai Inc. · collab
NaSingle-groupOpen-labelTreatment

Summary

This phase I trial is studying the side effects and best dose of decitabine when given together with pegylated liposomal doxorubicin hydrochloride and vaccine therapy in treating patients with recurrent ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer. Drugs used in chemotherapy, such as decitabine and pegylated liposomal doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vaccines made from a peptide or antigen may help the body build an effective immune response to kill tumor cells. Giving combination chemotherapy together with vaccine therapy may kill more tumor cells

Timeline

Start
2009-04
Primary completion
2011-10
Completion
2013-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Decitabine Small molecule Intravenous
Subject NY-ESO-1 peptide vaccine Vaccine Subcutaneous
Background Doxorubicin Other / unclassified Intravenous
Background incomplete Freund's adjuvant Other / unclassified Subcutaneous
Background sargramostim Protein / enzyme biologic Subcutaneous