Specialized Immune Cells (nCTLs) and a Vaccine (Alpha-type-1 Polarized Dendritic Cells) in Treating Patients With Stage II-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
NCT03735589 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL
Last updated 2023-11-22
Summary
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.
Conditions
- Stage II Fallopian Tube Cancer AJCC v8
- Stage II Ovarian Cancer AJCC v8
- Stage II Primary Peritoneal Cancer AJCC v8
- Stage IIA Fallopian Tube Cancer AJCC v8
- Stage IIA Ovarian Cancer AJCC v8
- Stage IIA Primary Peritoneal Cancer AJCC v8
- Stage IIB Fallopian Tube Cancer AJCC v8
- Stage IIB Ovarian Cancer AJCC v8
- Stage IIB Primary Peritoneal Cancer AJCC v8
- Stage III Fallopian Tube Cancer AJCC v8
- Stage III Ovarian Cancer AJCC v8
- Stage III Primary Peritoneal Cancer AJCC v8
- Stage IIIA Fallopian Tube Cancer AJCC v8
- Stage IIIA Ovarian Cancer AJCC v8
- Stage IIIA Primary Peritoneal Cancer AJCC v8
- Stage IIIA1 Fallopian Tube Cancer AJCC v8
- Stage IIIA1 Ovarian Cancer AJCC v8
- Stage IIIA2 Fallopian Tube Cancer AJCC v8
- Stage IIIA2 Ovarian Cancer AJCC v8
- Stage IIIB Fallopian Tube Cancer AJCC v8
- Stage IIIB Ovarian Cancer AJCC v8
- Stage IIIB Primary Peritoneal Cancer AJCC v8
- Stage IIIC Fallopian Tube Cancer AJCC v8
- Stage IIIC Ovarian Cancer AJCC v8
- Stage IIIC Primary Peritoneal Cancer AJCC v8
- Stage IV Fallopian Tube Cancer AJCC v8
- Stage IV Ovarian Cancer AJCC v8
- Stage IV Primary Peritoneal Cancer AJCC v8
- Stage IVA Fallopian Tube Cancer AJCC v8
- Stage IVA Ovarian Cancer AJCC v8
- Stage IVA Primary Peritoneal Cancer AJCC v8
- Stage IVB Fallopian Tube Cancer AJCC v8
- Stage IVB Ovarian Cancer AJCC v8
- Stage IVB Primary Peritoneal Cancer AJCC v8
Interventions
- BIOLOGICAL
-
Alpha-type-1 Polarized Dendritic Cells
Given ID
- BIOLOGICAL
-
Autologous Natural Killer Cell-like CTLs
Given IP
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Roswell Park Cancer Institute
lead OTHER
Principal Investigators
-
Emese Zsiros, MD, PhD · Roswell Park Cancer Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-12-15
- Primary Completion
- 2025-12-01
- Completion
- 2025-12-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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