Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT03735589

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

A Phase I/IIa Safety and Immunologic Efficacy Trial of Intraperitoneal Induction of CTLs Combined With Alpha-Dendritic Cell Vaccine for Primary Ovarian Cancer

Status
Withdrawn
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Roswell Park Cancer Institute · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

PRIMARY OBJECTIVES I. To evaluate the safety, tolerability, and feasibility of intraperitoneal (i.p.) administration of autologous tumor loaded DC vaccines (alpha-type-1 polarized dendritic cell \[alphaDC1\]) combined with intradermally administered aDC1 .(Safety \[Phase I aspect\]) II. To measure the intraperitoneal induction and persistence of aDCI induced sensitized cytotoxic T Cells (CTLs), which express natural killer (NK) cell-like features (nCTLs) and total CTLs following intraperitoneal administration of aDC1. (Local Immunologic Efficacy \[Phase II aspect\]) SECONDARY OBJECTIVES I. To study the T cell populations generated that correlates with higher anti-tumor responses. EXPLORATORY OBJECTIVES 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 nCTLs, followed by a phase IIa study. Patients receive the alpha-type-1 polarized dendritic cell vaccine intradermally (ID) 2 weeks before day 0, on day 0, and on day 28. Patients also receive nCTLs intraperitoneally (IP) over 15-30 minutes 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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALAlpha-type-1 Polarized Dendritic CellsGiven ID
BIOLOGICALAutologous Natural Killer Cell-like CTLsGiven IP

Timeline

Start date
2023-12-15
Primary completion
2025-12-01
Completion
2025-12-01
First posted
2018-11-08
Last updated
2023-11-22

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03735589. Inclusion in this directory is not an endorsement.