Defining the Role of CD4+CD25+ Immunoregulatory T-cells in the Treatment of Patients With Advanced Ovarian Cancer Who Receive Dendritic Cell Based Vaccine Therapies

NCT00703105 Phase 2 UNKNOWN

The purpose of this study is to determine if a dendritic cell vaccine made with autologous tumor lysate or for patients who are HLA-A2 with peptides of MUC1 and WT1 therapy will produce remissions in patients with advanced ovarian cancer. This research is being done because we want to find new therapies for treatment of relapsed or refractory (resistant to ordinary treatment) ovarian cancer. The use of vaccine therapy is research. A new experimental approach for treating refractory or relapsed ovarian cancer involves using the patients own immune system to kill the cancer cells. These immune cells are called monocytes and are harvested from blood. The process of Leukapheresis collects the monocytes called Dendritic Cells. This is usually a 3 hour process done in the comfort of a hospital bed in the apheresis lab, similar to giving blood for donation. Approximately 300cc's are collected during this process, the equivalent of about 10 ounces of blood. Once these dendritic cells are collected - a special laboratory grows and processes them into a vaccine using a patient's own tumor cells or for those with a specific HLA type (HLA-A2) with tumor peptides. This preparation is then given back to the patient hopefully to stimulate the immune system to kill cancer cells. This type of treatment is considered biological research.

Details

Lead sponsor	Loyola University
Phase	Phase 2
Status	UNKNOWN
Enrolment	36
Start date	2008-10
Completion	2021-07

Conditions

• Ovarian Cancer

Interventions

• DC vaccination

Primary outcomes

• To determine if administration of an autologous tumor lysate or tumor peptide-loaded dendritic cell vaccine enhances the immune response in patients with relapsed/refractory ovarian cancer — days 45 and 62 post vaccine
  response rate

Countries

United States