Clinical Study for Evaluating the Effectiveness of Haloperidol and Temozolomide Synergism on Adult Recurrence Glioblastoma
The study of investigators indicated that TMZ can up-regulate dopamine D2 receptor (DRD2) expression, and mediates Ferroptosis inhibition and chemoresistance of GBM. The clinical data also proved that the DRD2 expression in recurrent GBM is significantly higher than that in primary GBM. Moreover, the DRD2 antagonist haloperidol can attenuate the above function of DRD2, and increase the sensitivity of GBM to the TMZ by inducing fatal autophagy and ferroptosis. In xenograft mice, the combined usage of haloperidol and Temozolomide (TMZ) can significantly inhibit tumor growth and increase overall survival. The investigators' findings have been published in Clinical cancer research. Haloperidol known as a butylbenzene antipsychotic drug, has been widely used in several kinds of mental illnesses, such as depression, schizophrenia, and Bipolar disorder. And the safe dosage of the haloperidol is clear so far. So in this study, the investigators will recruit the patients who suffered from recurrent GBM, and evaluate the effectiveness of single TMZ chemotherapy or combined with haloperidol.
NCT06218524 — Glioblastoma Multiforme
Status: Not yet recruiting
http://inclinicaltrials.com/glioblastoma-multiforme/NCT06218524/
Hitting the Mark: Introducing State-of-the-art MRI for Precision Radiotherapy of Glioblastoma
The goal of this prospective cohort study is to assess the potential of advanced MRI for improved radiotherapy target delineation in patients diagnosed with glioblastoma. The main questions it aims to answer are: - How does the coverage of the recurrence volume by a radiotherapy plan based on advanced MRI compare to the coverage by the clinical radiotherapy plan? - How does the distribution of the dose to organs at risk by a radiotherapy plan based on advanced MRI compare to the distribution by the clinical radiotherapy plan? Participants will undergo an extended MRI-protocol prior to radiotherapy. This extended MRI-protocol includes the clinical brain tumor imaging protocol plus additional advanced MRI-sequences. Radiation treatment and patient follow-up will occur according to the clinical standard.
NCT06183983 — Glioblastoma
Status: Recruiting
http://inclinicaltrials.com/glioblastoma/NCT06183983/
PH Weighted Chemical Exchange Saturation Transfer Based Surgical Resections of Glioblastoma
Standard of care therapy and all FDA approved adjuvant therapy for glioblastoma continue to provide < 12-month progression free survival (PFS) and < 24-month overall survival (OS). Standard of care therapy continues to be defined by the volume of tumor that enhances with gadolinium on standard magnetic resonance imaging (MRI). The investigators have identified a significant tumor burden in non-enhancing (NE) regions beyond the contrast-enhancing (CE) portion of tumor. Furthermore, the investigators have adapted a pH-sensitive technique called amine chemical exchange saturation transfer (CEST) MRI to identify tumor cells in NE regions with high sensitivity and specificity. This study is a randomized trial of CEST based resections versus standard of care in newly diagnosed glioblastoma with primary endpoint of progression free survival and secondary endpoints of overall survival and quality of life metrics. The hypothesis being tested is whether surgical resection of infiltrating tumor cells visualized by CEST MRI contributes to survival in glioblastoma patients.
NCT06176066 — Glioblastoma
Status: Not yet recruiting
http://inclinicaltrials.com/glioblastoma/NCT06176066/
A Phase II Open Label, Randomized Study Testing the Efficacy of Retifanlimab in Combination With Bevacizumab and Hypofractionated Radiotherapy in Patients With Recurrent GBM
This phase II trial tests how well retifanlimab with bevacizumab and hypofractionated radiotherapy, compared to bevacizumab and hypofractionated radiotherapy alone, works in treating patients with glioblastoma that has come back after a period of improvement (recurrent). A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as retifanlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving retifanlimab with bevacizumab and hypofractionated radiotherapy may work better in treating patients with recurrent glioblastoma than bevacizumab and hypofractionated radiotherapy alone.
NCT06160206 — Recurrent Glioblastoma
Status: Not yet recruiting
http://inclinicaltrials.com/recurrent-glioblastoma/NCT06160206/
Phase I/II Clinical Trial of Allogeneic Cytomegalovirus-specific T Cells in Combination With Pembrolizumab for Recurrent and Newly Diagnosed Glioblastoma Multiforme
The goal of this clinical trial is to test a combined therapy approach (allogeneic cytomegalovirus [CMV]-specific T cells and pembrolizumab) in patients with brain cancer. The type of brain cancer being studied is glioblastoma multiforme/astrocytoma grade 4. The purpose of part 1 of this study is to determine the maximum-tolerated dose and/or recommended dose(s) for future exploration of allogeneic CMV-specific T cells as monotherapy or in combination with pembrolizumab in patients with recurrent GBM/astrocytoma grade 4. Part 2 of the study aims to investigate the anti-tumour activity of allogeneic CMV-specific T cells as monotherapy or in combination with pembrolizumab, assessed by magnetic resonance imaging and survival, in patients with recurrent or newly diagnosed GBM/grade 4 astrocytoma.
NCT06157541 — Glioblastoma Multiforme
Status: Recruiting
http://inclinicaltrials.com/glioblastoma-multiforme/NCT06157541/
Immunotherapy Targeting of Cytomegalovirus Antigens in Glioblastoma (INTERROGATE-GBM)
In Australia, glioblastoma (GBM) has a higher annual fatality rate than a variety of other cancers, such as melanoma, bladder, and kidney tumors. While the 5-year survival rate for other cancers, such as breast and prostate cancer, has increased, there have been no notable advancements in GBM during the past ten years, and the incidence and mortality patterns have barely changed between 1982 and 2011. In particular, GBM poses a challenging therapeutic dilemma for patients and physicians due to its aggressive biology and resistance to available treatments. Recent studies showed that cytomegalovirus (CMV) is expressed in GBM tumors, making it a good target for immunotherapy trials. This phase I trial aims to determine the safety and tolerability of the PEP-CMV vaccine in patients with newly diagnosed MGMT-unmethylated GBM in combination with one cycle of adjuvant temozolomide.
NCT06132438 — Glioblastoma
Status: Not yet recruiting
http://inclinicaltrials.com/glioblastoma/NCT06132438/
Glioblastoma Remote Monitoring and Care - Research Protocol
The purpose of this research is to learn more about how what the Apple watch measures, in terms of walking data, heart rate, breathing rate, and sleep habits, relates to how participants feel. During the course of the treatment, the symptoms participants experience change, and whether the Apple watch can detect these changes. Ultimately, this knowledge is being used to design proactive tools and signatures that can predict complications or symptom changes before they happen.
NCT06129760 — Glioblastoma
Status: Recruiting
http://inclinicaltrials.com/glioblastoma/NCT06129760/
Imaging and Biological Markers for Prediction and Identification of Glioblastoma Pseudoprogression: a Prospective Study.
The goal of this interventional study is the development and validation of imaging markers, MRI and PET, plasma biomarkers, and/or cell markers that could support clinicians and researchers in differentiating pseudoprogression from true tumor progression in routine clinical activities and clinical trials in patients affected by glioblastoma. The endpoints of the study are: - the elaboration of predictive models using imaging advanced biomarkers, PET and MRI, biological serum markers, and cancer cell derived makers to differentiate tumor pseudoprogression or real progression in patients affected by glioblastoma who underwent therapeutical protocol as per treating physicians' indications (Stupp or hypofractionated RT) - to establish an in vivo murine model of pseudoprogression by orthotopic transplantation of glioblastoma stem cells derived from thirty-five patient subjected to subsequent treatment with irradiation and temozolomide administration. Participants will undergo: - baseline MRI and 18F-GE-180 PET imaging, and blood withdrawal - surgery - collection of glioblastoma stem cells (and hematopoietic stem cells from a sub-group of subjects) - standard treatment with radiotherapy and chemotherapy - MRI every 3 months - PET and blood withdrawal in case of MRI evidence of either suspected tumor progression or pseudoprogression - second surgery OR stereotactic biopsy OR clinico-radiological follow-up as for standard of care according to the Institutional Multidisciplinary Brain Tumor Board
NCT06113705 — Glioblastoma
Status: Not yet recruiting
http://inclinicaltrials.com/glioblastoma/NCT06113705/
Exploration Into the Association Between Decorin (DCN) Expression and MR Phenotypes in GBM
This clinical trial uses a type of imaging scan called magnetic resonance imaging (MRI) to study brain tumor biology in patients with glioblastoma that can be removed by surgery (resectable). Malignant gliomas are the second leading cause of cancer mortality in people under the age of 35 in the United States. Glioblastoma is a type of malignant glioma with very poor patient prognosis. There are currently only about 3 drugs approved by the Food and Drug Administration (FDA) for the treatment of glioblastoma, one of them being administration of bevacizumab, which is very expensive. It is the most widely used treatment for glioblastoma with dramatic results. However, previous clinical trials have not demonstrated an overall survival benefit across all patient populations with glioblastoma that has returned after treatment (recurrent). The study aims to identify which patients who will benefit from bevacizumab therapy by observing MRI images and corresponding imaging biomarkers.
NCT06090903 — Glioblastoma
Status: Recruiting
http://inclinicaltrials.com/glioblastoma/NCT06090903/
Open-label Phase 2 Study of N-803 and PD-L1 t-haNK Combined With Bevacizumab in Subjects With Recurrent or Progressive Glioblastoma
This is a phase 2 open-label study to evaluate the safety and efficacy of N-803 and PD-L1 t-haNK when combined with Bevacizumab in subjects with recurrent or progressive GBM. Participants will receive N-803 subcutaneously (SC), PD-L1 t-haNK intravenously (IV), and Bevacizumab IV combination therapy. Treatment for all enrolled participants will consist of repeated cycles of 28 days for a maximum treatment period of 76 weeks (19 cycles). Treatment will be administered on days 1 and day 15 of each cycle. Treatment will be discontinued if the participant reports unacceptable toxicity (not corrected with dose reduction), withdraws consent, if the Investigator feels it is no longer in the participant's best interest to continue treatment, or the participant has confirmed progressive disease by iRANO, unless the participant is potentially deriving benefit per Investigator's assessment. Participants will be followed for collection of survival status every 12 weeks (± 2 weeks) for the first 2 years, then yearly thereafter.
NCT06061809 — Glioblastoma
Status: Not yet recruiting
http://inclinicaltrials.com/glioblastoma/NCT06061809/