Recurrent Ovarian Epithelial Cancer Clinical Trial
Official title:
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
This phase I trial studies the side effects and best dose and schedule of sirolimus when given together with vaccine therapy in treating patients with stage II-IV ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer. Sirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy together with sirolimus may be an effective treatment for ovarian, fallopian tube, or 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.
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