Symptoms and General Pathology

All Conditions

Neoplasms

Nervous System Diseases

Rare Diseases

Recurrence

Brain Neoplasms

Oligodendroglioma

Disease Attributes

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

All Drugs and Chemicals

Vaccines

Immunomodulating Agents

Immunologic Factors

All participants will receive 9 intradermal DC vaccines (three -bi-weekly (q2 weeks) for priming, monthly for additional 2-3 cycles during T cell expansion, and three bi-weekly during T cell engraftment), a single i.v. infusion of ex vivo expanded tumor-reactive T cells, and a i.v. single infusion of autologous HSCs.

Participants will receive up to 9 intradermal DC vaccines (three -bi-weekly (q2 weeks) for priming, monthly for additional 2-3 cycles during T cell expansion, and three bi-weekly during T cell engraftment

TTRNA-DC vaccines with GM-CSF

Participants will receive a single infusion of autologous CD34+ HSCs

Autologous Hematopoietic Stem cells (HSCs)

Participants will receive a single infusion of ex vivo expanded tumor-reactive T cells

TTRNA-xALT

All patients will receive a full Td booster IM vaccine 4-24 hours prior to Vaccine #1 and vaccine site pretreatment with a one-fifth dose of Td intradermally, at the site of planned vaccine, 4-24 hours prior to vaccines #3, #5, #7 and #9.

Td vaccine

Phuong Deleyrolle, RN

Duane Mitchell, MD, PhD

Ashley Ghiaseddin, MD

This study will enroll 6 DLT evaluable subjects (up to 12 patients total) where we will evaluate feasibility and safety of adoptive cellular therapy in patients with recurrent or progressive oligodendroglioma WHO grade 2 and WHO grade 3.

After screening consent, subjects will undergo standard of care resection or biopsy for confirmatory diagnosis of disease progression and aseptic collection of tumor material for DNA and RNA extraction and sequencing, amplification, and loading of autologous DCs. Following biopsy and confirmatory pathologic diagnosis, eligible patients will be enrolled in treatment.

After surgery, patients will undergo a G-CSF mobilized pheresis to collect PBMCs for DC generation and CD34+ HSCs. Amplified tumor RNA obtained from surgically resected or biopsied specimens will be used to generate total tumor RNA-pulsed DCs (TTRNA-DCs) manufactured while patients initiate salvage chemotherapy regimen after surgery.

Salvage chemotherapy with IDH1/2 inhibitor will initiate 1-2 weeks after G-CSF mobilized leukapheresis for 1-3 cycles after which, treatment cycles will be paused, and the patients will receive 3 priming TTRNA-DCs vaccines every 2 weeks and undergo a non-mobilized leukapheresis to collect vaccine-boosted lymphocytes for ex vivo T cell expansion and generation of additional TTRNA-DC vaccines. Treatment with IDH1/2 inhibitor will resume with monthly TTRNA-DC vaccines for an additional 1-3 cycles until ex vivo expanded T cells are manufactured.

For ACT, patients will undergo non-myeloablative conditioning with cyclophosphamide /fludarabine. The total immunotherapy regimen will consist of up to 9 intradermal DC vaccines (three -bi-weekly (q2 weeks) for priming, monthly for additional 2-3 cycles during T cell expansion, and three bi-weekly during T cell engraftment), a single i.v. infusion of ex vivo expanded tumor-reactive T cells, and a i.v. single infusion of autologous HSCs.

The duration of treatment from enrollment to completion of DLT window is anticipated to be 7 to 9 months.

ADAGiO: Adoptive Cellular Therapy for the TreAtment of Recurrent OliGodendrogliOma (OG) Adult Patients

Feasibility will be measured by the number of patients who receive autologous dendritic cells, T cells and hematopoietic stem cells that meet the FDA IND defined quality assurance and quality control release criteria. A minimum of 66.7% of enrolled subject must achieve this criterion for feasibility endpoint.

Safety will be defined as \< 1 DLT out of six enrolled and treated subjects during the defined period of administration of ex vivo expanded TTRNA T cells through 6 weeks post infusion. Investigational treatment related CTCAE V5.0 adverse events 1) Grade III or greater non-neurologic toxicity; 2) Grade III neurologic toxicity that does not improve to Grade II or better within 5 days; or 3) Grade IV neurologic toxicity will be recorded toward DLT.

Oligo Nation, Inc

University of Florida

Glioblastoma

Astrocytoma

Antineoplastic Agents

Niraparib

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Patients will be treated with individualized starting dose of Niraparib.

The starting dose will be 300 mg niraparib (or modified according patient weight and platelet count), taken orally once a day for each cycle of 28 days.

James Battiste, MD

The purpose of this study is to determine what effects (good and bad) niraparib has on patients with recurrent brain cancer.

Patients will have tests and exams to see if they are eligible for the clinical trial. If found eligible, the patient will receive treatment with niraparib in the form of capsules taken every day for the first 28 days. If this dose is tolerated well, the patients will continue to take the capsules and more patients will be enrolled on the study.

Patients will continue treatment with niraparib while on the study unless there is evidence of tumor growth or they experience unacceptable side effects.

Patients will be monitored during treatment with tests and exams and after treatment completion for up to four years from the time they enrolled on the study.

PARP Inhibition for Gliomas (PI-4G or π4g)

Phase II Trial of Niraparib in Patients With Recurrent Glioma

Number of patients who experience toxicities with individualized starting dose (ISD) of niraparib using CTCAE v5.0

Percentage of patients who respond to niraparib monitored by disease control rate (stable disease and better) using RANO from start of treatment for up to 12 months.

Proportion of patients who have progression-free survival from date of study entry until the first documented date of progression or date of death, whichever comes first.

Proportion of patients with overall survival on the study defined as time from date of study entry to death by any cause.

Duration of response in patients treated with niraparib defined as time from date of first response (stable disease or better) to the first date of non-response post treatment on the study.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ADAGiO: Adoptive Cellular Therapy for the TreAtment of Recurrent OliGodendrogliOma (OG) Adult Patients	NCT06254326	Recurrent Oligo... Progressive Oli...	TTRNA-DC vaccin... Autologous Hema... TTRNA-xALT Td vaccine	18 Years - 89 Years	University of Florida
PARP Inhibition for Gliomas (PI-4G or π4g)	NCT05297864	Recurrent Gliob... Recurrent Astro... Recurrent Oligo... Recurrent Gliom...	Niraparib	18 Years -	University of Oklahoma
ADAGiO: Adoptive Cellular Therapy for the TreAtment of Recurrent OliGodendrogliOma (OG) Adult Patients	NCT06254326	Recurrent Oligo... Progressive Oli...	TTRNA-DC vaccin... Autologous Hema... TTRNA-xALT Td vaccine	18 Years - 89 Years	University of Florida
PARP Inhibition for Gliomas (PI-4G or π4g)	NCT05297864	Recurrent Gliob... Recurrent Astro... Recurrent Oligo... Recurrent Gliom...	Niraparib	18 Years -	University of Oklahoma

Spots Global Cancer Trial Database for recurrent oligodendroglioma