This phase II trial studies how well vaccine therapy and sargramostim with or without imiquimod work in treating patients with ovarian, primary peritoneal, or fallopian tube cancer that is stage III-IV or has come back. Vaccines made from dendritic cells mixed with tumor cells may help the body build an effective immune response to kill tumor cells. Sargramostim increases white blood cells and may stimulate them to kill tumor cells. Imiquimod stimulates the immune system and may stop tumor cells from growing. It is not yet known whether vaccine therapy and sargramostim are more effective with or without imiquimod in treating patients with ovarian, primary peritoneal, or fallopian tube cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT00799110.
PRIMARY OBJECTIVES:
I. To determine if cellular immunity is induced by serial vaccination with dendritic cell (DC)/tumor fusion cells, when given with GM-CSF (sargramostim) alone, or the combination of GM-CSF and imiquimod in patients with advanced epithelial ovarian cancer, primary peritoneal serous carcinoma, and fallopian tube cancer have undergone debulking surgery and chemotherapy.
SECONDARY OBJECTIVES:
I. To assess the toxicity associated with vaccination with DC/tumor fusion when given with GM-CSF and imiquimod.
II. To assess clinical response to vaccination with DC/tumor fusion when given with GM-CSF and imiquimod.
III. To correlate immunologic response following vaccination with measures of patient cellular immune function and phenotypic characteristics of the vaccine preparation.
OUTLINE: Patients are assigned to 1 of 2 treatment groups.
GROUP I: Patients receive autologous dendritic cells/autologous tumor cell vaccine subcutaneously (SC) on day 0 and sargramostim SC on days 0-3.
GROUP II: Patients receive autologous dendritic cells/autologous tumor cell vaccine SC on day 0 and sargramostim SC on days 0-3. Patients also receive imiquimod topically 2 hours before vaccination and on days 1-4.
In both groups, treatment may repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically for 6 months.
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorDavid E. Avigan