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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Correlative studies
Given recombinant NY-ESO-1 protein SC
Given PO
Roswell Park Cancer Institute
Buffalo, New York, United States
Incidence of adverse events defined by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
The toxicity rate for each adverse event will be estimated using a two-sided, 95%, exact binomial confidence interval (Clopper-Pearson).
Time frame: Up to 30 days
NY-ESO-1 specific CD4+ and CD8+ T-cells cellular immunity assessed in peripheral blood by enzyme-linked immunosorbent spot (ELISPOT) and intracellular cytokine staining (ICS)
Assessed iin peripheral blood by enzyme-linked immunosorbent spot (ELISPOT) and intracellular cytokine staining (ICS)
Time frame: Up to 12 months
NY-ESO-1 specific humoral immunity
assessed in peripheral blood by ELISA
Time frame: Up to 12 months
Time to disease progression as documented by Response Evaluation Criteria in Solid Tumors version 1.1
Time frame: Up to 12 months
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