Neoplasms

All Conditions

Nervous System Diseases

Rare Diseases

Glioblastoma

Brain Neoplasms

Astrocytoma

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

Autologous DCs derived from PBMC loaded with RNA encoding the human CMV matrix protein pp65-flLAMP plus GM-CSF

Ashley Ghiaseddin, MD

In prior trials of CMV RNA-pulsed dendritic cell vaccines, there has been a narrow window between surgery and initiation of chemoradiation to enroll patients and perform leukapheresis (to obtain cells needed to generate investigational vaccine). Patients who had started chemoradiation were not eligible to participate.

In this study, the investigators propose to conduct a pilot study to evaluate the ability to generate pp65 full-length LAMP RNA-pulsed DCs in patients who have completed standard external beam radiation and concomitant temozolomide who are receiving adjuvant temozolomide chemotherapy at the time of enrollment.

This pilot study will enroll adult patients with newly diagnosed WHO Grade IV glioma (GBM) who have completed standard of care chemoradiation and are receiving adjuvant temozolomide chemotherapy. Patients will undergo leukapheresis and resume their adjuvant chemotherapy cycles following their treatment plan for 1 to 2 cycles while CMV pp65 RNA-pulsed DCs are generated.

After QA/QC release, study Vaccine #1 will be given at day 22-24 of the TMZ cycle. All patients will receive Td booster (5 Lf) with Vaccine #1 regardless of booster history. Vaccine #2 and #3 will occur at 2-week intervals.

The following TMZ cycle will start about 2 weeks after Vaccine #3. Patients may complete up to 6 to 12 adjuvant cycles every 5 weeks with pp65 full-length RNA-pulsed DCs administered at day 22-24 of each cycle until all available vaccines are exhausted with a maximum of 10 study vaccines or until disease progression (whichever comes first).

RENEW: Feasibility of CMV RNA-Pulsed Dendritic Cells Vaccines for the Treatment of Newly Diagnosed Glioblastoma Patients.

RENEW: Pilot Study of Feasibility of CMV RNA-Pulsed Dendritic Cells Vaccines for the Treatment of Newly Diagnosed Glioblastoma Patients.

Proportion of patients who are able to generate at least 3 CMV pp65 RNA-pulsed DCs vaccines

Immunomic Therapeutics, Inc.

University of Florida

Symptoms and General Pathology

Body Weight

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

peritumoral glial cell infiltration

Betty JEAN

This study will examine the use of a variation of standard magnetic resonance imaging (MRI) called diffusion tensor MRI (DT-MRI), in order to evaluate the peripheral white matter infiltration of high grade brain tumors. Organized architecture is destroyed once brain tumor cells are infiltrating surrounding tissue. The infiltrated tissue is then isotropic (or less anisotropic). DT-MRI can assess anisotropy after datasets post treatment. Primary outcome is to find if a correlation exists between GA (generalized anisotropy) and the infiltration percentage of stereotactic peritumoral biopsies.

Patients with high grade brain tumor undergo a usual brain tumor MRI protocol as well as a 20 or 60 directions DT-MRI sequence upon patient collaboration. Images are acquired using a 3 Tesla MRI scanner (GE MR750 Discovery).

The usual brain tumor MRI protocol contains the following sequences: 3DT1, Axial T2, Flair, T2 EG, diffusion (b0-b1000), 3DT1CE.

They will then undergo stereotactic tumor biopsies with Leksell frame mounted.

Biopsy targets will be surgically planned. The coordinates of this first biopsy will be recorded for later coregistration with DT-MRI datasets.

Histopathologic analysis of the biopsies will be done using usual procedure. various immunologic markers such as MAP2, Ki67 will be used on the first biopsy sample in order to estimate the percentage of infiltration (ratio of tumor cells number over total cells number).

Analysis of DT-MRI datasets will be done using home-made software for high order tensor resolution and GA estimation at the exact coordinates of the biopsy sites.

Finally a statistical analysis (Pearson or Spearman) will be done to correlate GA and the infiltration percentage.

Histopathologic Evaluation of High Grade Brain Tumors by High Order Diffusion Tensor Imaging

Histopathologic Evaluation of High Grade Brain Tumors by High Order Diffusion Tensor Imaging: Peritumoral Glial Cell Infiltration Quantitative Method

University Hospital, Clermont-Ferrand

Recurrence

Ependymoma

Antineoplastic Agents

Bevacizumab

Temozolomide

Recurrent high-grade glioma and ependamoma patients will receive treatment with the Optune NovoTTF-200A system as monotherapy.

Interventions: Device: Optune NovoTTF-200A System Optune NovoTTF-200A System receive treatment with 200kHz for a minimum of 18 hours per day in 28 day cycles combined with Temozolomide and Bevacizumab.

Optune NovoTTF-200A System receive treatment with 200kHz for a minimum of 18 hours per day in 28 day cycles combined with Temozolomide and Bevacizumab.

Optune NovoTTF-200A System

Derek Hanson, MD

The purpose of this study is to determine if the Optune NovoTTF-200A device can be safely used in combination with chemotherapy in pediatric patients with recurrent high-grade glioma and ependemoma.

This phase I trial will utilize a standard 3+3 design to determine the safety and tolerability of the Optune NovoTTF-200A System in pediatric patients with recurrent high-grade glioma end ependemomas.

Patients will receive treatment with the Optune NovoTTF-200A System along with Temozolomide and Bevacizumab and will consist of children with recurrent high-grade gliomas and Ependamomas. Patients enrolled will receive treatment with the Optune NovoTTF-200A with 200kHz for a minimum of 18 hours per day in 28 day cycles as monotherapy. Phase I safety evaluation will take place over the initial two cycles (56 days) of treatment. Following the completion of the safety evaluation period, patients will continue to receive treatment in 28 day cycles, which may be repeated continuously without therapy interruption for 12 cycles or until clinical criteria for discontinuation are met. Patients how appear to benefit from this treatment may be allowed to continue treatment beyond 12 cycles if approved by the study Principle Investigator.

HUMC 1612: Optune NovoTTF-200A System

HUMC 1612: A Phase I Trial of the Optune NovoTTF-200A System With Concomitant Temozolomide and Bevacizumab in Pediatric Patients With High-grade Glioma

Number of participants receiving treatment with the Optune NovoTTF-200A System with treatment-related adverse events as assessed by CTCAE v4.0.

Number of participants receiving treatment with the Optune NovoTTF-200A System with who return tolerability questionaire

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
RENEW: Feasibility of CMV RNA-Pulsed Dendritic Cells Vaccines for the Treatment of Newly Diagnosed Glioblastoma Patients.	NCT04963413	Glioblastoma	Autologous DCs ...	18 Years - 90 Years	University of Florida
Histopathologic Evaluation of High Grade Brain Tumors by High Order Diffusion Tensor Imaging	NCT01699269	High Grade Brai...	peritumoral gli...	18 Years - 85 Years	University Hospital, Clermont-Ferrand
HUMC 1612: Optune NovoTTF-200A System	NCT03128047	High Grade Glio... Ependymoma	Optune NovoTTF-...	5 Years - 21 Years	Hackensack Meridian Health
RENEW: Feasibility of CMV RNA-Pulsed Dendritic Cells Vaccines for the Treatment of Newly Diagnosed Glioblastoma Patients.	NCT04963413	Glioblastoma	Autologous DCs ...	18 Years - 90 Years	University of Florida
Histopathologic Evaluation of High Grade Brain Tumors by High Order Diffusion Tensor Imaging	NCT01699269	High Grade Brai...	peritumoral gli...	18 Years - 85 Years	University Hospital, Clermont-Ferrand
Histopathologic Evaluation of High Grade Brain Tumors by High Order Diffusion Tensor Imaging	NCT01699269	High Grade Brai...	peritumoral gli...	18 Years - 85 Years	University Hospital, Clermont-Ferrand

Spots Global Cancer Trial Database for high grade brain tumor