Glioblastoma Clinical Trial
Official title:
A Phase I Clinical Trial of mTOR Inhibition With Rapamycin for Enhancing Intranodal Dendritic Cell Vaccine Induced Anti-tumor Immunity in Patients With NY-ESO-1 Expressing Solid Tumors
This phase I trial studies the side effects and best schedule of vaccine therapy with or without sirolimus in treating patients with cancer-testis antigen (NY-ESO-1) expressing solid tumors. Biological therapies, such as sirolimus, may stimulate the immune system in different ways and stop tumor cells from growing. Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells that express NY-ESO-1. Infusing the vaccine directly into a lymph node may cause a stronger immune response and kill more tumor cells. It is not yet known whether vaccine therapy works better when given with or without sirolimus in treating solid tumors.
PRIMARY OBJECTIVES:
I. Determine the safety of DC205-NY-ESO-1 vaccine (DEC-205/NY-ESO-1 fusion protein CDX-1401)
with and without sirolimus. Toxicity as defined by the National Cancer Institute (NCI)
Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
SECONDARY OBJECTIVES:
I. Assess the 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.
TERTIARY OBJECTIVES:
I. Explore time to disease progression.
OUTLINE:
Patients undergo standard collection of peripheral white blood cells via leukapheresis over
90-240 minutes for vaccine preparation. Patients are assigned sequentially to Cohorts 1a-1d.
COHORT 1a: Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401 intranodally on days 1,
29, 57, and 113.
COHORT 1b: Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401 as in Cohort 1a and
sirolimus orally (PO) on days 1-14, 29-42, and 57-70.
COHORT 1c: Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401 as in Cohort 1a and
sirolimus PO or percutaneous endoscopic gastrostomy (PEG) tube on days 15-28, 43-56, and
71-84.
COHORT 1d: Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401 as in Cohort 1a and
sirolimus PO or PEG on days 1-84.
COHORT 2: Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401 as in the Cohort (1a-1d)
that is determined to be safe and produces optimal immunological effects and sirolimus PO on
days 1-14 as in Cohort 1b dose.
After completion of study treatment, patients are followed up at 6 weeks, 6 months and 12
months.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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