A Phase I Study of WT1-Specific T Cells for the Treatment of Patients with Advanced Ovarian, Primary Peritoneal, and Fallopian Tube Cancers

Protocol
06-155
Full Title
A Phase I Dose Escalation Safety and Feasibility Study of WT1-Specific T Cells for the Treatment of Patients with Advanced Ovarian, Primary Peritoneal, and Fallopian Tube Carcinomas
Purpose

T cells are small white blood cells that play an important part in immune defenses. T cells can be enhanced in the laboratory to recognize a protein called the Wilms’ Tumor gene (WT1), which is present on some tumors. About 80 percent of ovarian cancers have the WT1 protein. Laboratory studies have shown that T cells from ovarian cancer patients that have been taught to recognize the WT1 protein can kill tumor cells.

The purpose of this study is to evaluate the safety of WT1-targeted T cell treatment in patients with recurrent or persistent advanced ovarian, primary peritoneal, or fallopian tube cancers that contain the WT1 protein and to see if patients develop an immune response as a result of the treatment.

Patients in this study will be treated at five different dose levels. The first three groups will receive T cells only. The fourth and fifth groups will receive T cells and chemotherapy with cyclophosphamide and fludarabine.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a confirmed diagnosis of advanced ovarian, primary peritoneal, or fallopian tube cancer that has returned or persisted despite prior platinum-based therapy.
  • Patients’ cancers must contain the WT1 protein.
  • At least 3 weeks must have passed since completion of prior therapy and entry into the study.
  • Patients must be age 18 or older.

For more information and to inquire about eligibility for this study, please contact Dr. Carol Aghajanian at 646-888-4217.

Disease(s)
Ovarian Cancer
Locations
Related Diseases