Azeliragon + Radiation for Brain Cancer
(ADORATION Trial)
Recruiting in Palo Alto (17 mi)
Overseen byMinesh Mehta, M.D.
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: Baptist Health South Florida
Must not be taking: CYP 2C8 inhibitors
Disqualifiers: Leptomeningeal disease, MRI inability, others
No Placebo Group
Trial Summary
What is the purpose of this trial?To determine the safety and efficacy of using the drug azeliragon combined with stereotactic radiosurgery. Specifically, to determine if this combination will lead to improved response in the brain (tumor shrinking in size) and overall tumor control (how long tumor remains controlled).
Will I have to stop taking my current medications?
The trial requires that you stop taking corticosteroids at least 5 days before the treatment, unless they are part of this trial's protocol. Additionally, you cannot take Cytochrome P450 (CYP) 2C8 inhibitors during the trial.
What data supports the effectiveness of the treatment Azeliragon + Radiation for Brain Cancer?
Stereotactic radiosurgery (SRS), a component of the treatment, is effective for treating small, well-defined brain tumors and can improve survival in patients with brain metastases when combined with whole-brain radiation therapy. However, its benefit for newly diagnosed malignant gliomas is not established, and it is mainly used for recurrent disease.
12345Is the combination of Azeliragon and radiation therapy safe for humans?
The safety of stereotactic radiosurgery (SRS), including methods like CyberKnife and Gamma Knife, has been evaluated in various studies for different brain conditions, showing it to be generally safe with some potential for side effects. However, specific safety data for the combination of Azeliragon with radiation therapy is not available in the provided research.
46789How is the treatment Azeliragon + Stereotactic Radiosurgery unique for brain cancer?
This treatment combines Azeliragon, a drug that may target specific pathways in brain cancer, with Stereotactic Radiosurgery (SRS), a precise radiation technique that focuses high doses of radiation on small, well-defined areas of the brain, potentially offering a targeted approach with less damage to surrounding healthy tissue compared to traditional methods.
510111213Eligibility Criteria
This trial is for adults with small brain tumors from cancer spread, who are not pregnant or breastfeeding and agree to use contraception. They should have a certain level of physical function, no recent steroids or other clinical trials, and meet specific blood count and chemistry levels.Inclusion Criteria
I am not pregnant or breastfeeding and will use effective birth control during and for 6 months after treatment.
My cancer was confirmed by a doctor within the last 5 years, or I have recent proof it's still active.
I am 18 years old or older.
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Exclusion Criteria
I have a stomach or intestine condition that affects my eating or digestion.
I have cancer that has spread to the lining of my brain and spinal cord.
Patients with concurrent participation in another interventional clinical trial or use of another investigational agent within 7 days of starting azeliragon. Patients who are participating in non-interventional clinical trials (e.g., QOL, imaging, observational, follow-up studies, etc.) are eligible, regardless of the timing of participation
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive azeliragon combined with stereotactic radiosurgery, with potential corticosteroid regimens
4 weeks
Multiple visits for treatment administration and monitoring
Follow-up
Participants are monitored for safety and effectiveness after treatment, including neurocognitive and quality of life assessments
24 months
Extension
Long-term monitoring of neurocognitive outcomes and quality of life changes
24 months
Participant Groups
The study tests the safety and effectiveness of azeliragon in combination with focused radiation therapy (stereotactic radiosurgery) on patients with brain metastases to see if it can shrink tumors and control their growth better.
1Treatment groups
Experimental Treatment
Group I: Azeliragon and Stereotactic Radiosurgery (SRS)Experimental Treatment3 Interventions
In the Phase 1 portion of the study, three treatment regimens will be systematically evaluated:
1. Azeliragon + SRS + loading corticosteroid dose (LD) + corticosteroid taper (CT)
2. Azeliragon + SRS + loading corticosteroid dose (LD)
3. Azeliragon + SRS
The starting cohort will receive Regimen #2, and depending on the tolerability, participants will be allocated to subsequent cohorts as follows: if Regimen #2 is not well tolerated, participants will be allocated to Regimen #1; if #2 is well tolerated, participants will be allocated to Regimen #3.
Once a Regimen has been identified as safe and tolerable, it will be used for the Phase 2 portion of the study.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Miami Cancer Institute at Baptist Health, Inc.Miami, FL
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Who Is Running the Clinical Trial?
Baptist Health South FloridaLead Sponsor
Cantex Pharmaceuticals Inc.Collaborator
Miami Cancer InstituteCollaborator
References
Intracranial Stereotactic Radiation Therapy With a Jawless Ring Gantry Linear Accelerator Equipped With New Dual Layer Multileaf Collimator. [2022]To test the feasibility of a simplified, robust, workflow for intracranial stereotactic radiation therapy (SRT) using a ring gantry linear accelerator (RGLA) equipped with a dual-layer stacked, staggered, and interdigitating multileaf collimator.
Pattern of disease progression following stereotactic radiosurgery in malignant glioma patients. [2020]The clinical benefit of stereotactic radiosurgery (SRS) in the treatment of malignant glioma remains controversial. We analyzed failure patterns of malignant gliomas following SRS to identify the clinical implications of SRS against these malignancies.
Local recurrence patterns after postoperative stereotactic radiation surgery to resected brain metastases: A quantitative analysis to guide target delineation. [2019]In the treatment of resected metastatic brain disease, a recent phase 3 trial by the North Central Cancer Treatment Group (N107C/CEC.3) surprisingly found that the local control rate for whole-brain radiation therapy was better than that of stereotactic radiation surgery (SRS). To optimize target delineation, we performed a quantitative analysis of local failure patterns after postoperative SRS.
Clinical outcomes of benign brain tumors treated with single fraction LINAC-based stereotactic radiosurgery: Experience of a single institute. [2023]Accelerator-based stereotactic radiosurgery (SRS) is a noninvasive and effective treatment modality widely used for benign brain tumors. This study aims to report 20-year treatment outcomes in our institute.
The role of radiosurgery in the management of malignant brain tumors. [2019]Stereotactic radiosurgery (SRS) provides the means for creating lesions in deep-seated areas of the brain inaccessible to invasive surgery, using single high doses of focused ionizing radiation, administered using stereotactic guidance. It is a surgical technique designed to produce a specific radiobiological effect within a sharply defined target region in a single treatment session. Its technical application requires a stereotactic coordinate system, highly accurate patient repositioning (usually fixed), and multiple convergent beams of photon radiation. SRS appears to provide no benefit in the upfront treatment of newly diagnosed malignant gliomas but may be used to effectively palliate small well-demarcated volumes of recurrent disease. For selected patients with brain metastases treated with whole-brain radiation therapy (WBRT), the addition of SRS improves median survival. In selected patients with brain metastases, it is also rational to withhold WBRT in favor of radiosurgery alone, with WBRT reserved for salvage without a decrease in median survival time.
Preliminary results of linac-based radiosurgery in arteriovenous malformations and cerebral tumours in the Oncology Centre in Bydgoszcz. [2021]Efficacy of stereotactic radiosurgery (SRS) in the treatment in cerebral AVM's, mennigiomas, metastases, acoustic neuromas and recurrent anaplastic gliomas is well documented. The object of this work was the analysis of the results of the treatment of AVM and selected cerebral lesions with linear accelerator-based stereotactic radiosurgery.
Efficacy and toxicity of CyberKnife re-irradiation and "dose dense" temozolomide for recurrent gliomas. [2022]Stereotactic radiosurgery (SRS) can be a useful adjunct to the treatment of recurrent glioblastoma multiforme (GBM). Its combination with chemotherapy is attractive for the possible radiosensitization effect and cytotoxicity on tumor cells in distant areas. The aim of this study was to evaluate the efficacy and toxicity of CyberKnife SRS alone and combined with a "dose-dense" administration of temozolomide (TMZ) for recurrent GBM.
Gamma knife radiosurgery for trigeminal schwannomas: A systematic review and meta-analysis. [2022]Gamma knife radiosurgery (GKRS) has been deemed as the gold standard stereotactic radiosurgery (SRS) mode for the treatment of intracranial tumors, cerebrovascular diseases and brain functional diseases. Our study was aimed to systematically evaluate the efficacy, safety, and complications of gamma knife radiosurgery for trigeminal schwannomas.
Risk-adapted robotic stereotactic body radiation therapy for inoperable early-stage non-small-cell lung cancer. [2022]To evaluate efficacy and toxicity of stereotactic body radiation therapy (SBRT) with CyberKnife® (Accuray, Sunnyvale, CA, USA) in a selected cohort of primary, medically inoperable early-stage non-small cell lung cancer (NSCLC) patients.
Predictors of linear accelerator versus Gamma Knife stereotactic radiosurgery use for brain metastases in the United States. [2022]Stereotactic radiosurgery (SRS) for brain metastases is predominantly delivered via single-fraction Gamma Knife SRS (GKRS) or linear accelerator (LINAC) in up to five fractions. Predictors of SRS modality have been sparsely examined on a nationwide level.
Radiotherapy management of brain metastases using conventional linear accelerator. [2019]As treatments for primary cancers continue to improve life expectancy, unfortunately, brain metastases also appear to be constantly increasing and life expectancy for patients with brain metastases is low. Longer survival and improved quality of life may be achieved using localised radiological and surgical approaches in addition to low dose corticosteroids. Stereotactic brain radiotherapy is one rapidly evolving localized radiation treatment. This article describes our experience with stereotactic radiotherapy using a linear accelerator.
[Stereotactic radiotherapy in brain metastases]. [2018]Stereotactic radiotherapy of brain metastases is increasingly proposed after polydisciplinary debates among experts. Its definition and modalities of prescription, indications and clinical interest regarding the balance between efficacy versus toxicity need to be discussed. Stereotactic radiotherapy is a 'high precision' irradiation technique (within 1mm), using different machines (with invasive contention or frameless, photons X or gamma) delivering high doses (4 to 25Gy) in a limited number of fractions (usually 1 to 5, ten maximum) with a high dose gradient. Dose prescription will depend on materials, dose constraints to organs at risk varying with fractionation. Stereotactic radiotherapy may be proposed: (1) in combination with whole brain radiotherapy with the goal of increasing (modestly) overall survival of patients with a good performance status, 1 to 3 brain metastases and a controlled extracranial disease; (2) for recurrence of 1-3 brain metastases after whole brain radiotherapy; (3) after complete resection of a large and/or symptomatic brain metastases; (4) after diagnosis of 3-5 asymptomatic new or progressing brain metastases during systemic therapy, with the aim of delaying whole brain radiotherapy (avoiding its potential neurotoxicity) and maintaining a high focal control rate. Only a strict follow-up with clinical and MRI every 3 months will permit to deliver iterative stereotactic radiotherapies without jeopardizing survival. Simultaneous delivering of stereotactic radiotherapy with targeted medicines should be carefully discussed.
Stereotactically guided radiosurgery using the linear accelerator. [2020]Leksell initiated the concept of stereotactic radiosurgery in 1951. This last decade has seen a rapid proliferation in the development of the methodology which is certainly related in part to the simultaneous growth of high-resolution neuro-imaging techniques. By focusing the beams of 201 hemispherically arrayed cobalt 60 sources, the gamma-knife delivers a high dose of radiation to a small target. Another possibility proposed by several authors is the bragg peak cyclotron-generated irradiation with accelerated protons or helium ions. In Lille, since 1988, we have chosen to develop stereotactic radiosurgery, according to the system of Betti, by the association of Talairach's stereotactic methodology and external single-dose encephalic irradiation with high energy X-rays, delivered by means of a linear accelerator. The major indication for the use of this method is an arteriovenous malformation. Stereotactic radiosurgery may be proposed alone or in combination with surgery and embolisation. It has been shown to be a potentially effective treatment and an attractive alternative in carefully selected patients with intracranial tumours: slow-growing, well limited, deep-seated tumours, such as some gliomas, acoustic neurinomas, skull base meningiomas, pituitary adenomas. This treatment is also used to deliver a focal boost of radiation to previously administered fractionated radiotherapy in patients with small gliomas and solitary brain metastases.