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Brain Neoplasms clinical trials

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NCT ID: NCT05356507 Withdrawn - Brain Tumor Clinical Trials

The Effects of Spiritual Needs on Spiritual Well-Being in Patients With Brain Tumors: A Structural Equation Modeling Approach

Start date: August 29, 2022
Phase:
Study type: Observational

The aim of this study is to describe a patient's Spiritual Needs and related factors that contribute to a patient's Spiritual Well-Being in the context of perioperative care. The primary objective of this study is to examine the fit of the Structural Equation Model (SEM) of the theory on Spiritual Well-Being (SWB) and explain how SWB is affected by Symptom Burden (SB), Psychological Distress (PsD), and Spiritual Needs (SN) reported by the patients with brain tumors before having surgery.

NCT ID: NCT05255666 Withdrawn - Clinical trials for Triple Negative Breast Cancer

Combination Liposomal Irinotecan and Pembrolizumab For Triple-Negative Breast Cancer (TNBC) With Brain Metastases (BM)

Start date: July 31, 2023
Phase: Phase 2
Study type: Interventional

The study is a phase II with safety lead in, single arm, study using Nal-IRI in combination with pembrolizumab. Nal-IRI will be given IV every 2 weeks starting at 50mg/m2. Pembrolizumab will be given 400mg IV every 6 weeks. Treatment will continue until progression, intolerable side effects or patient/doctor decision to discontinue treatment.

NCT ID: NCT05247749 Withdrawn - Brain Tumor Clinical Trials

CONVIVO System to Discriminate Healthy Tissues vs Tumor Tissues During Brain Tumor Resection

Start date: May 2021
Phase: N/A
Study type: Interventional

The purpose of the study is to do a direct comparison of the CONVIVO system (camera imaging device) with our normal Stanford pathology process. CONVIVO system is being tested to see if the device creates the images very quickly by touching a special camera to the surgical wound.

NCT ID: NCT05180422 Withdrawn - Clinical trials for Non Small Cell Lung Cancer

A Phase I/II Study of AMG 510 in Combination With MVASI in Patients With Advanced, Unresectable or Metastatic KRAS G12C Mutant NSCLC With Asymptomatic Brain Metastasis

Start date: June 15, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multicenter, non-randomized, open-label, phase I/II study to evaluate the safety and tolerability of AMG 510 plus MVASI in subjects with advanced KRAS p.G12C mutant non-small cell lung cancer (NSCLC) with small, untreated brain metastases.

NCT ID: NCT05120960 Withdrawn - Brain Tumor Clinical Trials

A Phase 1a/1b Study to Determine the Recommended Phase 2 Dose, of Tepotinib in Participants With MET Alterations and Brain Tumors

Start date: February 27, 2023
Phase: Phase 1
Study type: Interventional

This is a single center, multi-arm, biomarker-driven phase 1 study to assess the RP2D, PK/PD, safety, and activity of tepotinib in participants with MET alterations and brain tumors. Eligible patients include those with brain metastases or glioblastoma, including patients who are surgical candidates. In patients with EGFR+ NSCLC with EGFR-TKI resistance and MET amplification, tepotinib will be given in combination with osimertinib. This phase 1 study will be conducted in 2 parts, Phase 1a (dose exploration) and Phase 1b (dose expansion). Phase 1a will include a surgical resection window of opportunity component. Phase 1b (dose expansion) can open once the relevant RP2D has been estimated in Phase 1a (dose exploration). Phase 1a (Dose Exploration): Patients will be assigned to dose levels within a Group as outlined in the Statistical Analysis Plan. Group A will be comprised of patients who are surgical resection candidates with newly-diagnosed or recurrent brain metastases and MET alteration. Group B will be comprised of patients who are surgical resection candidates with recurrent glioblastoma and MET alteration. Group C will be comprised of patients with newly-diagnosed or recurrent brain metastases and epidermal growth factor receptor mutated (EGFR+) non-small cell lung cancer (NSCLC). Phase 1b (Dose Expansion): Upon completion of the Phase 1a (dose exploration) component and estimation of a RP2D, dose expansion may proceed within Group A (consisting of patients with brain metastasis and MET alteration) and Group C (EGFR+ NSCLC brain metastasis, TKI resistance, and MET amplification). Dose expansion in these 2 groups may be done concurrently, but enrollment in each group does not require completion of the entire Phase 1a component of the study. There will not be a Group B (glioblastoma) in Phase 1b. Patients in Phase 1b will not undergo surgical resection.

NCT ID: NCT05054400 Withdrawn - Cancer Clinical Trials

Study of Laser Interstitial Thermal Therapy (LITT) Treatment Response Assessment With Fluciclovine PET MR

Start date: February 5, 2020
Phase: Early Phase 1
Study type: Interventional

The purpose of this study is to assess the relationship between brain malignancy volume as defined by post-contrast T1 weighted and F18 Fluciclovine before and following LITT. We hypothesize that imaging with F18 Fluciclovine will be superior to anatomic MR imaging in lesion volume assessment before treatment and that residual F18 Fluciclovine defined tumor will predict local post-LITT disease recurrence.

NCT ID: NCT04856475 Withdrawn - Breast Cancer Clinical Trials

Evaluation of Neratinib for Treatment and Prevention of Subsequent CNS Event(s) in Patients With Brain Metastasis of Advanced HER2 Positive Breast Cancer

NeraBrain
Start date: November 24, 2021
Phase: Phase 2
Study type: Interventional

This is an open-label, non-randomised, phase II study to evaluate the efficacy of neratinib in combination with SOC systemic therapy on CNS metastasis both as for secondary prevention (cohort 1), primary treatment (cohort 2) and for the treatment of LM disease (cohort 3) in subjects with HER2 positive metastatic BC. Subjects with metastatic HER2 positive breast cancer will be eligible for the trial and will be enrolled in one of the following cohorts: Cohort 1: Eligible subjects include HER2 positive metastatic breast cancer subjects treated with at least one line of systemic anti HER2 therapy and pre-treated with local approaches at least for the previous CNS event and currently progressive but locally treated CNS metastasis. Local therapy includes: stereotactic radiosurgery (SRS) or/and WBRT or/and surgery. The study will measure the effect of the drug combination on the time to next CNS event(s). Cohort 2: Eligible subjects include HER2 positive metastatic breast cancer subjects treated with at least one line of systemic anti HER2 therapy or progressing less than 12 months after end of adjuvant therapy with a first diagnosis of brain metastases. The study will measure the objective CNS response in each subject. Cohort 3: Eligible subjects include HER2 positive metastatic breast cancer subjects treated with at least one line of systemic anti HER2 therapy with confirmed LM defined as the presence of malignant cells in the cerebrospinal fluid (CSF) or combination of typical symptoms and MRI. The study will measure the effect of the drug combination on the time to CNS progression including LM progression. As per investigator's choice, eligible subjects in all cohort will receive neratinib in combination with capecitabine or with T-DM1 or with paclitaxel or with vinorelbine as per investigator's choice. Trastuzumab can be added as per investigator's choice to those regimens except for T-DM1. At screening and during the study treatment period (every 9 weeks), brain MRI for cohort 1 and cohort 2 or contrast-enhanced neuraxis brain and spine MRI for cohort 3 and tumour assessment by thoracic and abdomino-pelvic CT scan for all cohorts should be performed. For cohort 3 only, CSF cytological assessment should also be performed. Additionally, at screening and at each cycle during the study treatment period, subjects must fill quality of life questionnaires: EORTC core questionnaire (QLQ-C30) and brain module (QLQ-BN20).

NCT ID: NCT04776980 Withdrawn - Clinical trials for Glioblastoma Multiforme

Multimodality MRI and Liquid Biopsy in GBM

Start date: June 2022
Phase: Early Phase 1
Study type: Interventional

Patients with a new diagnosis of high-grade glioma based on MRI, who are considered surgical candidates determined by neurosurgeons or patients with recurrent glioblastoma with the initial diagnosis of glioblastoma (histologic or molecular proof) and recommended for clinically surgical resection may be eligible for this study. Subjects may participate in this study if they are at least 18 years of age. Ferumoxytol-enhanced MRI will be used to quantify tumor-associated macrophages. This is a non-therapeutic trial in that imaging will not be used to direct treatment decisions. The blood draw is being completed to evaluate cell-free circulating tumor DNA (cfDNA) and cell-free tumor DNA (ctDNA).

NCT ID: NCT04650490 Withdrawn - Clinical trials for Non Small Cell Lung Cancer

SRS Timing With Immune Checkpoint Inhibition in Patients With Untreated Brain Metastases From Non-small Cell Lung Cancer

STICk-IM-NSCLC
Start date: March 2023
Phase: Phase 2
Study type: Interventional

This trial is a randomized, 2-arm, phase II study to determine the effect, if any, of the timing of stereotactic radiosurgery (SRS) relative to immune checkpoint inhibitor (IO) therapy in patients with non-small cell lung cancer (NSCLC) that has spread (metastasized) to the brain.

NCT ID: NCT04585724 Withdrawn - Clinical trials for Metastatic Malignant Neoplasm in the Brain

Stereotactic Radiosurgery With Abemaciclib, Ribociclib, or Palbociclib in Treating Patients With Hormone Receptor Positive Breast Cancer With Brain Metastases

Start date: June 12, 2020
Phase: Phase 1
Study type: Interventional

This phase I trial studies the side effects of stereotactic radiosurgery with abemaciclib, ribociclib, or palbociclib in treating patients with hormone receptor positive breast cancer that has spread to the brain (brain metasteses). Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Abemaciclib, ribociclib, and palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving abemaciclib, ribociclib, or palbociclib concurrently with stereotactic radiosurgery may reduce the side effects and/or increase the response to each of the therapies.