Glioblastoma Clinical Trial
Official title:
Pilot Study of Spectroscopic MRI-Guided, Dose-Escalated Radiation Therapy for Newly-Diagnosed Glioblastoma
Verified date | February 2024 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This pilot clinical trial studies the side effects of spectroscopic magnetic resonance imaging (MRI)-guided radiation therapy and how well it works in treating patients with newly-diagnosed glioblastoma or gliosarcoma. Spectroscopic MRI can show doctors where the extent of tumor is in the brain beyond current clinical MRI scans by mapping areas of high tumor metabolism. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Spectroscopic MRI-guided radiation therapy may work better in treating patients with glioblastoma or gliosarcoma.
Status | Active, not recruiting |
Enrollment | 34 |
Est. completion date | January 4, 2025 |
Est. primary completion date | January 4, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients must have a newly-diagnosed glioblastoma or gliosarcoma that has been confirmed pathologically by a board-certified neuropathologist - Patients must be able to have MRI scans - Patients must have the following lab values = 14 days prior to registration: - White blood cell (WBC) = 3,000/µL - Absolute neutrophil count (ANC) = 1,500/µL - Platelet count of = 75,000/µL - Hemoglobin = 9.0 gm/dL (transfusion is allowed to reach minimum level) - Serum glutamic-oxaloacetic transaminase (SGOT) = 2.0 x upper limit of normal (ULN) - Bilirubin = 2 x ULN - Creatinine = 1.5 mg/dL - Patients must have a life expectancy of = 12 weeks - Patients must have a Karnofsky performance status (KPS) = 60 - Patients who are women of childbearing potential must have a negative pregnancy test documented = 14 days prior to registration; this is not specific to dose escalation and is mandatory for standard care for patients being treated with radiation therapy; the cost of this test will be covered by standard of care - Patients must be able to understand and provide written informed consent - Members of all races and ethnic groups are eligible for this trial; subjects will be approximately representative of the demographics of the referral base for the participating institutions - Patient must be able to swallow capsules - Patients must be willing to forego other cytotoxic and non-cytotoxic therapies against the tumor while being treated on this protocol Exclusion Criteria: - Patients with pacemakers, aneurysm clips, neurostimulators, cochlear implants, metal in ocular structures, history of being a steel worker, or other incompatible implants which makes MRI safety an issue are excluded - Patients that have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy are excluded - Patients with a history of any other invasive cancer (except non-melanoma skin cancer and excluding carcinoma in-situ), unless in complete remission and off of all therapy for that disease for = 3 years, are ineligible - Patients with an active infection or serious intercurrent medical illness are ineligible - Patients receiving any other investigational agents are excluded - Patients who have received prior cytotoxic, non-cytotoxic or experimental drug therapies for brain tumor are excluded - Patients with a history of prior cranial radiation are ineligible - Patients may not be enrolled on any other therapeutic trial for which they are receiving an anti-tumor therapy - Patients with GBMs located in the following anatomical regions known to have magnetic susceptibility or poor signal will be excluded: mesial temporal lobe, orbitofrontal cortex, prefrontal cortex, medial frontal gyrus, brainstem, and cerebellum - The maximum radiation target volume for gross tumor volume 3 (GTV3) is 65 cc (per NRG Oncology guide); patient may be excluded after the first sMRI scan if the GTV3 volume is greater than 65 cc (we anticipate that contrast-enhancing tumor volume [residual tumor volume following tumor resection] would be less than 20 cc) |
Country | Name | City | State |
---|---|---|---|
United States | Emory University/Winship Cancer Institute | Atlanta | Georgia |
United States | Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland |
United States | University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
Emory University | Johns Hopkins University, National Cancer Institute (NCI), National Institutes of Health (NIH), University of Miami |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Early evidence of GBM progression assessed by sMRI | Changes in sMRI parameters over time will be assessed to determine whether they will be able to predict development of recurrence. | At 2 weeks after start of therapy | |
Other | Neurocognitive performance: Hopkins Verbal Learning Test | Neurocognitive performance will be assessed by the Hopkins Verbal Learning Test - Revised. | Up to 2 years after completion of therapy | |
Other | Neurocognitive performance: Controlled Oral Word Association Test | Neurocognitive performance will be assessed by the Controlled Oral Word Association Test (COWAT) from the Multilingual Aphasia Examination. | Up to 2 years after completion of therapy | |
Other | Overall survival (OS) | The OS actuarial curve and 1-year OS rate will be assessed and compared to historical controls. | From the time of surgical resection to the time of death, assessed up to 1 year | |
Other | Quality of life (QOL): European Organization for Research and Treatment of Cancer | QOL will be assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30/Brain Cancer Module-20. | Up to 2 years after completion of therapy | |
Other | Quality of life (QOL): MD Anderson | QOL will be assessed by the MD Anderson Symptom Inventory Brain Tumor Module. | Up to 2 years after completion of therapy | |
Primary | Feasibility as assessed by successful co-registration of sMRI-based treatment volumes with clinical images into the radiation treatment execution platform | Feasibility of this approach will be determined by whether treatment volumes based on sMRI can be co-registered with clinical images and transferred into the radiation treatment execution platform in a seamless manner, so that sMRI information can be efficiently applied to the patient treatment. | Up to 2 years after completion of therapy | |
Primary | Incidence of adverse event assessed by Common Terminology Criteria for Adverse Events version 4.0 | The safety of sMRI to guide dose-escalated RT will be confirmed by assessing toxicity potentially attributable to the RT. | Up to 2 years after completion of therapy | |
Secondary | Progression free survival (PFS) | PFS actuarial curves will be assessed and compared to historical controls, and will particularly interested in comparing the 1-year PFS rate which, based on the control arm (receiving standard dose RT with TMZ) of recent GBM trials, is approximately 30% in historical cohorts. | From the time of surgical resection to the time of either radiographic progression or death, whichever occurs first, assessed at 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05664243 -
A Phase 1b / 2 Drug Resistant Immunotherapy With Activated, Gene Modified Allogeneic or Autologous γδ T Cells (DeltEx) in Combination With Maintenance Temozolomide in Subjects With Recurrent or Newly Diagnosed Glioblastoma
|
Phase 1/Phase 2 | |
Completed |
NCT02768389 -
Feasibility Trial of the Modified Atkins Diet and Bevacizumab for Recurrent Glioblastoma
|
Early Phase 1 | |
Recruiting |
NCT05635734 -
Azeliragon and Chemoradiotherapy in Newly Diagnosed Glioblastoma
|
Phase 1/Phase 2 | |
Completed |
NCT03679754 -
Evaluation of Ad-RTS-hIL-12 + Veledimex in Subjects With Recurrent or Progressive Glioblastoma, a Substudy to ATI001-102
|
Phase 1 | |
Completed |
NCT01250470 -
Vaccine Therapy and Sargramostim in Treating Patients With Malignant Glioma
|
Phase 1 | |
Terminated |
NCT03927222 -
Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly-Diagnosed WHO Grade IV Unmethylated Glioma
|
Phase 2 | |
Recruiting |
NCT03897491 -
PD L 506 for Stereotactic Interstitial Photodynamic Therapy of Newly Diagnosed Supratentorial IDH Wild-type Glioblastoma
|
Phase 2 | |
Active, not recruiting |
NCT03587038 -
OKN-007 in Combination With Adjuvant Temozolomide Chemoradiotherapy for Newly Diagnosed Glioblastoma
|
Phase 1 | |
Completed |
NCT01922076 -
Adavosertib and Local Radiation Therapy in Treating Children With Newly Diagnosed Diffuse Intrinsic Pontine Gliomas
|
Phase 1 | |
Recruiting |
NCT04391062 -
Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma
|
Phase 2 | |
Active, not recruiting |
NCT03661723 -
Pembrolizumab and Reirradiation in Bevacizumab Naïve and Bevacizumab Resistant Recurrent Glioblastoma
|
Phase 2 | |
Active, not recruiting |
NCT02655601 -
Trial of Newly Diagnosed High Grade Glioma Treated With Concurrent Radiation Therapy, Temozolomide and BMX-001
|
Phase 2 | |
Completed |
NCT02206230 -
Trial of Hypofractionated Radiation Therapy for Glioblastoma
|
Phase 2 | |
Completed |
NCT03493932 -
Cytokine Microdialysis for Real-Time Immune Monitoring in Glioblastoma Patients Undergoing Checkpoint Blockade
|
Phase 1 | |
Terminated |
NCT02709889 -
Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06058988 -
Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer
|
Phase 2 | |
Completed |
NCT03018288 -
Radiation Therapy Plus Temozolomide and Pembrolizumab With and Without HSPPC-96 in Newly Diagnosed Glioblastoma (GBM)
|
Phase 2 | |
Withdrawn |
NCT03980249 -
Anti-Cancer Effects of Carvedilol With Standard Treatment in Glioblastoma and Response of Peripheral Glioma Circulating Tumor Cells
|
Early Phase 1 | |
Not yet recruiting |
NCT04552977 -
A Trail of Fluzoparil in Combination With Temozolomide in Patients With Recurrent Glioblastoma
|
Phase 2 | |
Withdrawn |
NCT02876003 -
Efficacy and Safety of G-202 in PSMA-Positive Glioblastoma
|
Phase 2 |