Study on Vaccination for Ovarian Cancer Patients Using Dendritic Cell/Tumor Fusions with GM-CSF and Imiquimod

Sponsor: Beth Israel Deaconess Medical Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT00799110

This clinical trial is testing a new vaccine made from a combination of a patient's own cancer cells and immune cells, along with two other agents, to see how it affects the immune system and the cancer itself in patients with ovarian cancer.

Patient Parameters

Program Overview

This study is exploring a new vaccine that combines a patient's own cancer cells with special immune cells called dendritic cells, along with two agents, GM-CSF and imiquimod. The goal is to see how this vaccine affects the immune system and the cancer in patients with ovarian cancer. Researchers also want to find out what side effects might occur. Dendritic cells are important because they help the immune system recognize and fight off foreign substances, like cancer cells.

Description

Participants in this study must have had surgery to remove as much of their cancer as possible and have stored tissue samples from that surgery. They will be divided into two groups for the study. Both groups will undergo a procedure called leukapheresis, where white blood cells are collected from their blood to obtain dendritic cells. Before this procedure, participants may receive injections of GM-CSF to boost their white blood cell count.

If enough cells are collected, the cancer cells and dendritic cells will be combined in the lab to create the vaccine. Participants in Group 1 will receive the vaccine through an injection under the skin. They will also receive GM-CSF injections at the injection site on the day of the vaccine and for three days after. They will get the vaccine every three weeks for a total of three doses.

Participants in Group 2 will receive the same vaccine and GM-CSF injections as Group 1. Additionally, they will apply a cream called imiquimod to the skin at the injection site two hours before getting the vaccine and continue applying it for three days after each injection. They will also receive the vaccine every three weeks for a total of three doses.

Eligibility Criteria

Exclusion Criteria

  • Patients whose cancer worsened during initial chemotherapy with platinum/taxane drugs cannot participate.
  • Patients with significant autoimmune diseases requiring treatment with immunosuppressants are not eligible.
  • Patients with HIV, due to weakened immune systems, are excluded.
  • Patients with serious illnesses like infections needing IV antibiotics or major heart problems are not eligible.
  • Pregnant or breastfeeding women cannot participate. Women of childbearing age must use effective birth control during the study.
  • Patients with a history of significant blood clots are excluded.
  • Patients with another active cancer, except for certain skin cancers, are not eligible.

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