A Phase I Clinical Trial of mTOR Inhibition With Sirolimus for Enhancing ALVAC(2)-NY-ESO-1(M)/TRICOM Vaccine Induced Anti-Tumor Immunity in Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
PRIMARY OBJECTIVES:
I. Determine the safety of ALVAC(2)-NY-ESO-1 (M)/TRICOM vaccine with sirolimus at varying
dose and schedule.
SECONDARY OBJECTIVES:
I. To determine the effectiveness of sirolimus on enhancing vaccine efficacy 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.
II. Explore time to disease progression.
OUTLINE: This is a dose-escalation study of sirolimus.
Patients receive ALVAC(2)-NY-ESO-1 (M)/TRICOM vaccine subcutaneously (SC) on day 1 and
sargramostim (GM-CSF) SC on days 1-4. Patients also receive sirolimus orally (PO) once daily
(QD) on days 1-14 OR 15-28 OR 1-28. Treatment repeats every 28 days for up to 4 courses in
the absence of disease progression or unacceptable toxicity. Patients then receive an
additional course of ALVAC(2)-NY-ESO-1 (M)/TRICOM vaccine only followed by ALVAC(2)-NY-ESO-I
(M)/TRICOM vaccine SC 8 weeks after completion of course 4.
After completion of study treatment, patients are followed up at 30 days, and 6 and 12
months.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety of ALVAC(2)-NY-ESO-1 (M)/TRICOM vaccine in combination with varying dose levels and schedules of sirolimus, assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4
The toxicity rate will be estimated using a one-sided, 95%, exact binomial confidence interval (Clopper-Pearson). The lower one sided limit will be used.
Up to 30 days after completion of study treatment
Yes
Kunle Odunsi
Principal Investigator
Roswell Park Cancer Institute
United States: Food and Drug Administration
I 199911
NCT01536054
August 2012
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |