This phase I/IIa trial studies the side effects and best dose of a type of specialized immune cell (natural killer cell-like cytotoxic T-lymphocytes (CTLs) (nCTLs) and how well they work when given with a vaccine (alpha-type-1 polarized dendritic cells) in treating patients with stage II-IV ovarian, fallopian tube, or primary peritoneal cancer. nCTLs are immune cells that are isolated from each patient’s blood and "taught" in the laboratory how to recognize and eliminate tumor cells. These "educated" immune cells are then given back to the patient. An alpha-type-1 polarized dendritic cell vaccine is another population of "educated" immune cells that work to support the infused nCTLs. Giving nCTLS with a dendritic cell vaccine may work better in treating patients with ovarian, fallopian tube, or primary peritoneal cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03735589.
PRIMARY OBJECTIVES:
I. To evaluate the safety, tolerability, and feasibility of intraperitoneal (i.p.) administration of alpha-type-1 polarized dendritic cells (autologous tumor loaded dendritic cell [DC] vaccines [alphaDC1]), combined with intradermal (i.d.) alphaDC1. (Safety [Phase I aspect])
II. To measure the intraperitoneal induction and persistence of alphaDC1 induced sensitized cytotoxic T cells (CTLs), which express natural killer (NK) cell-like features (nCTLs) and total CTLs following intraperitoneal administration of alphaDC1. (Local Immunologic Efficacy [Phase II aspect])
SECONDARY OBJECTIVE:
I. To study the T cell populations generated that correlates with higher anti-tumor responses.
EXPLORATORY OBJECTIVE:
I. To evaluate the progression-free survival and overall survival of patients treated with this regimen.
OUTLINE: This is a phase I, dose-escalation study of alphaDC1 followed by a phase IIa study.
Patients receive alphaDC1 intradermally (ID) 2 weeks before day 0, on day 0, and on day 28. Patients also receive local alphaDC1 intraperitoneally (IP) over 3-10 seconds on day 0. In the absence of unacceptable side effects, patients may receive the alpha-type-1 polarized dendritic cell vaccine every 1-3 months at the discretion of the physician.
After completion of study treatment, patients are followed up at 14 days, then at 6 and 12 months.
Lead OrganizationRoswell Park Cancer Institute
Principal InvestigatorEmese Zsiros