Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Roswell Park Cancer Institute
With
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.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
