Recurrent Ovarian Carcinoma Clinical Trial
Official title:
A Phase I Clinical Trial of mTOR Inhibition With Sirolimus for Enhancing NY-ESO-1 Protein With MIS416 Vaccine Induced Anti-Tumor Immunity in Ovarian, Fallopian Tube and Primary Peritoneal Cancer
This phase I clinical trial studies the side effects of sirolimus and NY-ESO-1 protein with MIS416 in treating patients stage II-IV ovarian, fallopian tube, or primary peritoneal cancer. Sirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Vaccine therapy, like Y-ESO-1 protein with MIS416, may strengthen the immune system to find and kill tumor cells. Biological therapies, such as sirolimus, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop tumor cells from growing. Giving sirolimus and vaccine therapy may work betting in treating patients with ovarian, fallopian tube or primary peritoneal cancer.
PRIMARY OBJECTIVE:
I. Determine the safety and feasibility of NY-ESO-1 protein with MIS416 in combination with
mammalian target of rapamycin (mTOR) inhibitor sirolimus.
SECONDARY OBJECTIVES:
I. To determine the effectiveness of these combinatorial therapies by assessing NY-ESO-1
specific cellular and humoral immunity: peripheral blood NY-ESO-1 specific cluster of
differentiation (CD)8+ and CD4+ T-cells; peripheral blood NY-ESO-1 specific antibodies;
peripheral blood frequency of CD4+ CD25+ forkhead box P3 (FOXP3)+ regulatory T-cells; explore
time to disease progression.
OUTLINE:
COHORT I (C1): Patients receive NY-ESO-1 protein with MIS416 vaccine subcutaneously (SC) on
days 1, 15, 29, 57, 85, and 113 in the absence of disease progression or toxicity.
COHORT II (C2): Patients receive NY-ESO-1 protein with MIS416 vaccine as in Cohort I.
Patients also receive sirolimus orally (PO) daily for 2 weeks followed by 2 weeks off
starting on days 1, 29, 57, and 85.
After completion of study treatment, patients are followed up at 30 days and then at 12
months.
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