Neoplasms

All Conditions

Rare Diseases

Glioblastoma

Glioma

Astrocytoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Receive additional dose of 18Gy to the subventricular zone

Receive additional dose of 20Gy to the subventricular zone

Receive additional dose of 22Gy to the subventricular zone

Stereotactic radiosurgery dose escalation by either 18, 20, or 22 Gy to the subventricular zone in addition to standard of care

Stereotactic Radiosurgery

Alexis M Demopoulos, MD

Several investigations suggest neural stem cells located in the subventricular region play an active role in promoting or even initiating cortical malignant glioma growth. Although normal appearing on neuroimaging, surgical specimens taken from this region show it contains malignant glioma stem-like cells. Some retrospective analyses found patients who received radiation therapy to this region during standard of care treatments lived longer than patients who did not.

The investigator's study hypothesizes (1) stereotactic radiosurgery of cancer stem-like cells in these regions will be well tolerated during standard of care therapy, (2) focused stereotactic radiosurgery will be more effective in destroying cancer stem cells than conventional radiation therapy, and (3) treatment will improve malignant glioma survival.

Since 2005, standard treatment for malignant gliomas includes surgery as extensive as possible to reduce tumor bulk without causing deficits, followed by temozolomide chemotherapy with radiation therapy to the surgical area plus an additional 1-2 cm margin around this cavity. Despite advances in surgical techniques and radiation delivery, 80% of tumors recur at the margins of the surgery, within the regions that were treated with radiation.

In 2014, different institutions found patients lived longer if part of the brain that looked normal received radiation therapy. This region was called the "subventricular zone" and was known to contain embryonic stem cells that formed the brain. Researchers believed this region contained cancer stem cells promoting tumor survival and growth. Some studies suggested this area might even represent another reservoir of malignant tumor cells.

During participation in this clinical trial, targeted radiation to the subventricular zone is given in addition to standard of care radiation and chemotherapy. The subventricular zone is divided into four regions and one of four regions on the same side as the tumor is treated, not the whole subventricular zone. Only patients scheduled to receive six weeks of standard therapy are eligible for participation. The additional radiation therapy is delivered over the course of one day. The study is not randomized and all patients will receive the experimental treatment. Patients complete regular evaluations over the next two years to monitor toxicity, which is the main concern of this Phase I study.

Study of Stereotactic Radiosurgery to the Subventricular Zone in Malignant Gliomas

Phase I Study of Subventricular Zone Tumor Stem Cell Stereotactic Radiosurgery With Standard of Care Chemoradiation Therapy in Newly Diagnosed Malignant Gliomas (WHO III and WHO IV Astrocytomas)

INCIDENCE OF TREATMENT-EMERGENT ADVERSE EVENTS AS DEFINED BY CTCAE criteria as well as BY steroid requirement

PFS measured by time to recurrence as well as pattern of recurrence

Northwell Health

Symptoms and General Pathology

Nervous System Diseases

Recurrence

Brain Neoplasms

Anti-Infective Agents

All Drugs and Chemicals

Metronidazole

Pathological assessment of tumor cellularity, apoptosis, and quantitative histo-morphometry of residual tumor cells will be performed. Each metric will be statistically compared between groups.

Tumor samples from patients treated with TTFields at initial diagnosis.

Tumor samples from patients treated with TTFields at tumor recurrence.

Medical College of Wisconsin Cancer Center Clinical Trials Office

Peter LaViolette

Peter LaViolette, PhD

This study will assess whole brain samples from glioblastoma patients at autopsy to determine the underlying pathological signatures of tumor treatment fields at autopsy.

RATIONALE:

Optune therapy with tumor treatment fields (TTFields) has recently been FDA approved for the treatment of newly diagnosed glioblastoma due to a recent clinical trial that showed improvement in progression free survival and overall survival compared to standard therapy. (1) TTFields also have a role in the recurrent glioblastoma treatment where it has demonstrated equal efficacy to second-line chemotherapy also has been shown to tumor progression and improve overall survival.(2) Though preclinical studies are ongoing, glioblastoma patients who have undergone TTField therapy have not yet been assessed at autopsy to determine both the pathological signature of TTField treatment, and the pattern of failure. This study will determine how the underlying pathological signatures of tumors treated with TTFields differ from those naïve to TTFields by comparing tumor tissue at autopsy.

STUDY:

All patients undergoing TTField therapy for newly diagnosed and recurrent glioblastoma will be considered for inclusion for this study. The investigators expect to enroll five patients per year for four years, totaling 10 patients treated upfront and 10 patients treated at tumor recurrence. An objective of this study is to determine differences in the pathological pattern of failure when patients are treated with TTFields at initial diagnosis (up-front) compared to those treated at tumor recurrence.

Samples are obtained from regions suspicious for tumor at autopsy.

NovoTTF Treatment Signatures in Glioblastoma Patients at Autopsy

Tissue samples will be obtained at autopsy and stained for KI-67. Slides will then be digitized, and the number of active cells will be counted computationally.

Tissue samples will be obtained at autopsy and stained for KI-67. Slides will then be digitized, and the number of not active cells will be counted computationally.

Number of mitotically active cells divided by the number of not mitotically active cells per patient will be calculated.

Medical College of Wisconsin

Principal Investigator

Antineoplastic Agents

Bevacizumab

Temozolomide

Endothelial Growth Factors

Mitogens

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Bevacizumab + temozolomide + radiotherapy followed by adjuvant bevacizumab + temozolomide

Bevacizumab every 2 weeks 10mg/kg beginning 2 weeks after start of Radiation Therapy

Camilo E Fadul, MD

Blood samples will be obtained from newly diagnosed GBM patients treated with combined radiotherapy (RT), temozolomide (TMZ) and bevacizumab (BEV) at specific time points. The primary outcome is the shift in T reg cell fraction a defined by determining the proportion of CD4 cells that are CD4+ CD25.

Glioblastoma multiforme (GBM) is the most frequent malignant brain tumor and it remains a lethal disease. Approximately 4 weeks post surgery for tumor resection, patients will proceed to standard of care treatment which currently consists of temozolomide (TMZ) with concurrent radiation therapy (RT) for 6 weeks. This study will add bevacizumab (BEV) to the standard of care regimen in newly diagnosed patients. The Bevacizumab will be added 2 weeks post start of RT/TMZ. Administration of bevacizumab will continue concurrently with TMZ every 2 weeks for 12 months. Blood samples will be obtained from these patients at 3 different time points during this study.

Exploratory Study of the Modulation of the Immune System by VEGF Blockade in Patients With Glioblastoma Multiforme (GBM)

DMS 0947 Exploratory Study of the Modulation of the Immune System by Vascular Endothelial Growth Factor (VEGF) Blockade in Patients With Glioblastoma Multiforme (GBM)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Stereotactic Radiosurgery to the Subventricular Zone in Malignant Gliomas	NCT03956706	Glioblastoma Astrocytoma, Gr... Astrocytoma, Gr... Malignant Gliom...	Stereotactic Ra...	18 Years -	Northwell Health
Study of Stereotactic Radiosurgery to the Subventricular Zone in Malignant Gliomas	NCT03956706	Glioblastoma Astrocytoma, Gr... Astrocytoma, Gr... Malignant Gliom...	Stereotactic Ra...	18 Years -	Northwell Health
NovoTTF Treatment Signatures in Glioblastoma Patients at Autopsy	NCT03194971	Glioblastoma	Tumor samples f... Tumor samples f...	18 Years -	Medical College of Wisconsin
Exploratory Study of the Modulation of the Immune System by VEGF Blockade in Patients With Glioblastoma Multiforme (GBM)	NCT01091792	Glioblastoma Mu...	Bevacizumab	18 Years -	Dartmouth-Hitchcock Medical Center
Exploratory Study of the Modulation of the Immune System by VEGF Blockade in Patients With Glioblastoma Multiforme (GBM)	NCT01091792	Glioblastoma Mu...	Bevacizumab	18 Years -	Dartmouth-Hitchcock Medical Center
NovoTTF Treatment Signatures in Glioblastoma Patients at Autopsy	NCT03194971	Glioblastoma	Tumor samples f... Tumor samples f...	18 Years -	Medical College of Wisconsin

Spots Global Cancer Trial Database for grade iv

Every month we try and update this database with for grade iv cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for grade iv

Every month we try and update this database with for grade iv cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for grade iv cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.