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Brain Neoplasms clinical trials

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NCT ID: NCT05868928 Recruiting - Brain Metastases Clinical Trials

Imaging Features for the Risks for Recurrence After Stereotactic Radiosurgery in Brain Metastasis

Start date: December 7, 2023
Phase:
Study type: Observational [Patient Registry]

This trial uses multi-parametric magnetic resonance imaging (MRI) to develop and validate imaging risk score to predict radiation necrosis in participants with brain metastasis treated with radiation therapy. Diagnostic procedures, such as multi-parametric magnetic resonance imaging (MRI), may improve the ability to diagnose radiation necrosis early and help establish treatment strategies.

NCT ID: NCT05866432 Recruiting - Clinical trials for Breast Cancer Stage IV

Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases

TUXEDO-2
Start date: July 1, 2023
Phase: Phase 2
Study type: Interventional

Datopotamab-deruxtecan in triple-negative breast cancer patients with newly diagnosed or progressing brain metastases.

NCT ID: NCT05865990 Recruiting - Clinical trials for Metastatic Breast Cancer

HER3-DXd in Breast Cancer and NSCLC Brain Metastases and Solid Tumor Leptomeningeal Disease

TUXEDO-3
Start date: November 24, 2023
Phase: Phase 2
Study type: Interventional

The goal of this phase II clinical trial] is to analyze the efficacy of patritumab deruxtecan (HER3-DXd) in patients with metastatic breast cancer (MBC) or advanced non-small cell lung cancer (aNSCLC) with active brain metastases (BM) who have received at least one line of systemic therapy in the advanced setting, or patients with active leptomeningeal carcinomatosis/disease (LMD) after radiotherapy from an advanced solid tumor who do not need immediate local treatment, and have not received prior treatment with an anti-HER3 targeted drug]. The main questions it aims to answer are: - The intracranial objective response rate (ORR-IC) per local investigator as judged by best central nervous system (CNS) response according to Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria of HER3-DXd in patients with active BM from MBC (Cohort 1) and aNSCLC (Cohort 2). - The overall survival (OS) rate at 3 months of HER3-DXd in patients with advanced solid tumors with untreated LMD (Cohort 3). Participants will receive HER3-DXd on day (D1) of each 21-day cycle until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason. Researchers will compare historical groups to see if HER3-DXd positively impacts patient outcomes.

NCT ID: NCT05858359 Recruiting - Clinical trials for Cognitive Impairment

Contextualized Neuropsychological Rehabilitation for CNS Cancer Survivors: The ImPACT Program

ImPACT
Start date: June 1, 2023
Phase: N/A
Study type: Interventional

The aim of the present randomized-controlled study is to evaluate the feasibility, acceptability, and preliminary efficacy of a novel, context-sensitive neuropsychological rehabilitation intervention for brain cancer survivors.

NCT ID: NCT05848050 Recruiting - Brain Metastases Clinical Trials

Evaluation of the Humoral and Tumoral Molecular Alteration Profile of Brain Metastases

METALIQ
Start date: June 27, 2023
Phase: N/A
Study type: Interventional

The purpose of the study is to determine in brain metastases and according to feasibility in liquid biopsies: - Molecular alterations including in particular mutations, amplifications, Copy number gene variants and fusion transcripts identified by high-throughput sequencing; - The rate of variation either in gain or in loss of expression of the different messenger Ribonucleic Acids by analysis of the transcriptome; - Epigenetic alterations by methylation of deoxyribonucleic acid clusters by methylome chips.

NCT ID: NCT05844605 Recruiting - Brain Tumor Clinical Trials

Prehabilitation, Rehabilitation and Comprehensive Approach to the Sequelae of Brain Tumors

PREHABILITA
Start date: June 21, 2021
Phase: Phase 1
Study type: Interventional

The goal of the present pilot single-cohort feasibility trial is to investigate the feasibility and understand potential mechanisms of efficacy for Neuromodulation-Induced Cortical Prehabilitation (NICP) in adults with brain tumours and eligible for neurosurgery. The main questions it aims to answer are: - is the intervention feasible, in terms of adherence, retention, safety and patient's satisfaction; - what are the mechanisms of neuroplasticity primed by NICP Participants will undergo a prehabilitation protocol, consisting of daily sessions (total: 10-20 sessions) structured as follows: - Intervention 1: non-invasive neuromodulation (TMS/tDCS). - Intervention 2: motor and/or cognitive training, during or immediately after non-invasive neuromodulation, for about 60 minutes. The timeline is structured as follows: T1: baseline (before NICP) T2-T3: NICP period T4: after NICP T5: surgery T6: after surgery Clinical, neuroimaging and neurophysiology assessments will be performed before NICP (T1), after NICP (T4), and after neurosurgery (T6). Feasibility outcomes will be determined during NICP protocol (T2-T3). The objective of the proposed intervention is to progressively reduce the functional relevance of eloquent areas, which are healthy brain areas close with the tumour and thus exposed to the risk of being lesioned during surgery. In fact, previous studies have shown that temporary inhibition of eloquent areas (by neuromodulation) coupled with intensive motor/cognitive training promoted the activation of alternative brain resources, with a shift of functional activity from eloquent areas to areas functionally related, but anatomically distant from the tumour. By moving the activation of key motor/cognitive functions away from the tumour, the risk of postoperative functional sequelae will be reduced; which in turn will falicitate a more radical tumour excision by the neurosurgeon.

NCT ID: NCT05840770 Recruiting - Clinical trials for Stage IV Lung Cancer AJCC v8

Cemiplimab for the Treatment of Untreated Brain Metastases From PD-L1 >= 50% Non-Small Cell Lung Cancer

Start date: June 1, 2024
Phase: Phase 2
Study type: Interventional

This phase II trial tests how well cemiplimab works in treating patients with PD-L1 >= 50% non-small cell lung cancer (NSCLC) that has spread from where it first started (primary site) to the brain (metastases). Approximately 10% of patients diagnosed with metastatic NSCLC present with brain metastases and another 30% develop brain metastases during the illness. Currently, the management of brain metastases relies on stereotactic radiosurgery (SRS), which has high rates of local control, but in combination with systemic therapy, can cause certain toxicities, including central nervous system (CNS) necrosis or potential cognitive changes or memory deficits. Additionally, in patients with numerous brain metastases, whole brain radiation (WBRT) is recommended, leading to significant neurocognitive deficits. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. However, there is little data on the effectiveness of newer systemic therapies, such as immunotherapy, in penetrating and treating previously untreated brain metastases. Cemiplimab without upfront SRS or WBRT for asymptomatic brain metastases may help delay the need for radiation in patients with untreated brain metastases from PD-L1 >= 50% NSCLC.

NCT ID: NCT05831631 Recruiting - Clinical trials for Brain Tumor, Primary

Characterization of Circulating and Tumor-infiltrating Immune Cells in Malignant Brain Tumors

Start date: August 1, 2022
Phase:
Study type: Observational

The goal of this observational study is to characterize the circulating leukocyte profile and the immune T cells distribution within the tumor in patients with malignant brain tumors and to correlate these findings with the oncological outcome. Participants will be subjected to blood sampling before surgery and for 12 months of follow-up. Additional sampling and analysis will be performed on tumor samples.

NCT ID: NCT05800223 Recruiting - Clinical trials for Non-small Cell Lung Cancer Metastatic

Armatinib Alone or in Combination With SRT for Brain Metastases EGFR-mutated Non-small Cell Lung Cancer

Start date: January 1, 2023
Phase: Phase 3
Study type: Interventional

Objective:Patients with asymptomatic or minimally symptomatic Stage IV EGFR-positive NSCLC with baseline intracranial metastases. Aim: To investigate the timing, efficacy and safety of radiotherapy in patients with EGFR positive brain metastases treated with armatinib alone or combined with stereotactic radiotherapy. Method: Almonertinib: specification 55mg/tablet; The dosage is 110 mg / day (2 tablets / day) orally once a day; SBRT: 3-5 doses of 27-40 Gy

NCT ID: NCT05793489 Recruiting - Clinical trials for Brain Metastases, Adult

Prospective Double Arm Randomized Trial: WBRT Alone and WBRT Plus Silibinin

Start date: March 6, 2023
Phase: N/A
Study type: Interventional

The occurrence of brain metastases (BMs) is increasing given the availability of a more accurate radiological imaging such as MRI for detecting also small brain lesions and the most effective systemic therapy able to control extracranial disease. Although, the new target therapy and immunotherapy has proven to be effective on brain metastasis too, a subgroup of patients shows prove themselves unresponsive to medical treatment. A further subgroup of patients exhibit diffuse brain disease for the presence of multiple brain lesion (>10 BMs) or leptomeningeal carcinomatosis. Among these patients the most treatment employed is represented by whole brain RT. Since the 1950s, whole-brain radiation therapy (WBRT) has been the most widely used treatment for patients with multiple brain metastases, given its effectiveness in palliation, widespread availability, and ease to delivery. However, the median overall survival recorded is restricted to 3 months, on the average. A better understanding of the molecular and cellular mechanisms underlying brain metastasis might be expected to lead to improvements in the overall survival rate for these patients. Recent studies have revealed complex interactions between metastatic cancer cells and their microenvironment in the brain. Priego et al. describe that brain metastatic cells induce and maintain the co-option of a pro-metastatic program driven by signal transducer and activator of transcription 3 (STAT3) in a subpopulation of reactive astrocytes surrounding metastatic lesions. In patients, active STAT3 in reactive astrocytes correlates with reduced survival from diagnosis of intracranial metastases. Blocking STAT3 signaling in reactive astrocytes reduces experimental brain metastasis from different primary tumor sources, even at advanced stages of colonization. Silibinin (or silybin) is a natural polyphenolic flavonoid isolated from seed extracts of the herb milk thistle (Silybum marianum). Silibinin has been shown to impair STAT3 activation. Preclinical studies show that Silibinin has an anticancer effects in vitro and in vivo. Based on this background, the investigators designed a double arm randomized trial evaluating the benefit of Silibinin (in the form of marketed supplement) associated to WBRT respect to WBRT alone.