This phase I trial studies the safety and side effects of a personalized vaccine (total tumor messenger ribonucleic acid [mRNA]-pulsed autologous dendritic cells [TTRNA-DCs] & tumor-specific ex vivo expanded autologous lymphocyte transfer [TTRNA-xALT]) in treating patients with World Health Organization grade 2 or 3 oligodendroglioma that has come back after a period of improvement (recurrent) or that is growing, spreading, or getting worse (progressive). The study vaccine consists of two parts: dendritic cells (DC) and T-cells. In this trial, blood and tumor tissue are collected to grow and change these cells for creation of the study vaccine. The first part of the vaccine involves DCs loaded with genetic material (ribonucleic acid) from the tumor to stimulate them. The goal is to activate the immune system to attack the brain tumor cells while leaving normal cells unharmed. The second part, TTRNA-xALT, is also created in the lab using the same genetic material from the tumor. Another type of cells collected during vaccine creation, called peripheral blood stem cells, help bone marrow recover more quickly after chemotherapy and have been shown to enhance immune responses against the tumor. Giving a personalized vaccine may be safe and effective in treating recurrent/progressive WHO grade 2 or 3 oligodendroglioma.
Additional locations may be listed on ClinicalTrials.gov for NCT06254326.
Locations matching your search criteria
United States
Florida
Gainesville
University of Florida Health Science Center - GainesvilleStatus: Active
Contact: Ashley Parham Ghiaseddin
Phone: 352-273-9000
PRIMARY OBJECTIVE:
I. Assess the feasibility and safety of adoptive cellular therapy in patients with refractory oligodendroglioma.
SECONDARY OBJECTIVE:
I. Explore the immunologic response to adoptive cellular therapy in patients with refractory oligodendroglioma.
EXPLORATORY OBJECTIVE:
I. Explore the metabolic signature at the tumor bed location by magnetic resonance (MR) spectroscopy pre and post immunotherapy.
OUTLINE:
LEUKAPHERESIS #1: Patients receive filgrastim intravenously (IV) and undergo leukapheresis for vaccine generation over 2 days.
SALVAGE THERAPY: Beginning 1-2 weeks following leukapheresis, patients receive standard of care (SOC) IDH 1/2 inhibitor orally (PO) daily throughout the trial in the absence of disease progression or unacceptable toxicity.
PRIMING PHASE: After 1-2 cycles of SOC IDH 1/2 inhibitor therapy, patients receive TTRNA DCs intradermally (ID) every 2 weeks (Q2W) for 3 doses in the absence of disease progression or unacceptable toxicity. Patients also receive tetanus and diphtheria toxoids adsorbed (Td) vaccine intramuscularly (IM) 4-24 hours prior to first and third doses of TTRNA DCs.
LEUKAPHERESIS #2: Seven to 14 days following TTRNA DCs dose #3, patients undergo a second leukapheresis procedure without filgrastim over 2 days.
MAINTENANCE PHASE: Patients receive TTRNA DCs ID once monthly for up to 3 months in the absence of disease progression or unacceptable toxicity. Patients also receive Td vaccine IM 4-24 hours prior to 2nd monthly TTRNA DC dose.
ADOPTIVE CELLULAR THERAPY (ACT): Patients receive cyclophosphamide intravenously (IV) over 30-60 minutes once daily (QD) and fludarabine IV over 30 minutes QD on days 1-3, and autologous CD34-positive peripheral blood stem cells IV over 5-10 minutes on day 3 in the absence of disease progression or unacceptable toxicity. Patients then receive TTRNA-xALT IV over 10-30 minutes on day 4. Patients also receive TTRNA DCs ID 1 hour following TTRNA-xALT, followed by Q2W for 2 doses in the absence of disease progression or unacceptable toxicity. In addition, patients receive Td vaccine IM 4-24 hours prior to first and third TTRNA DCs.
Patients also undergo collection of leftover tissue during SOC surgery, echocardiography (ECHO), magnetic resonance (MR) spectroscopy, and X-ray imaging on study, and lumbar puncture for cerebrospinal fluid collection and magnetic resonance imaging (MRI) throughout the trial.
After completion of study treatment, patients are followed up at 6 weeks and then every 6 months thereafter.
Lead OrganizationUniversity of Florida Health Science Center - Gainesville
Principal InvestigatorAshley Parham Ghiaseddin