Cisplatin Plus Temozolomide Compared With Temozolomide in Patients With Newly Diagnosed MGMT Promotor Unmethylated Glioblastoma
Temozolomide provided significant and clinically meaningful benefit in MGMT gene promoter methylation glioblastoma. However, in unmethylated patients, the effect of Temozolomide is limited. The aim of this study is to compare the effect of Cisplatin plus Temozolomide and Temozolomide in patients with MGMT gene promoter unmethylation glioblastoma
NCT06186440 — Glioblastoma Multiforme of Brain
Status: Not yet recruiting
http://inclinicaltrials.com/glioblastoma-multiforme-of-brain/NCT06186440/
Phase Ib Dose Finding Study Assessing Safety and Activity of [177Lu]Lu-NeoB in Combination With Radiotherapy and Temozolomide in Subjects With Newly Diagnosed Glioblastoma and as a Single Agent in Recurrent Glioblastoma
This study will investigate different doses of [177Lu]Lu-NeoB in combination with RT and TMZ in participants with newly diagnosed glioblastoma, with methylated or unmethylated promoter, to assess the safety and efficacy of [177Lu]Lu-NeoB in combination with the SoC and in recurrent glioblastoma as single agent, to identify the recommended dose and to also explore the safety of the PET imaging agent [68Ga]Ga-NeoB and characterize its uptake in the tumor area.
NCT05739942 — Newly Diagnosed and Recurrent Glioblastoma
Status: Recruiting
http://inclinicaltrials.com/newly-diagnosed-and-recurrent-glioblastoma/NCT05739942/
Application of MET-PET in Fusion With MRI in the Surgical Treatment and Postoperative Radiotherapy of Glioblastoma Multiforme - a Randomized, Blinded, Prospective Study
Glioblastoma multiforme (GBM IV WHO) is the most common, primary neoplasm of brain in the adults. Simultanously it is the most agressive one of all primary brain tumors. Despite the treatment the outcome in that group of patients is poor. In case of the optimal therapy the estimated median of survival ranges between 12 and 16 months. The present standard of treatment embraces the gross total resection with the preserved neurological functions and the posoperative management according to the Stupp's protocol (fractionated radiotherapy of 60 Gy dose and the chemotherapy with Temozolamide). Annually the incidence rate of GBM is 5/100.000 of population. According to the National Tumor Registry 2494 people went down to the malignant neoplasmatic disease of brain classified as C71 (ICD-10) in 2020. The evaluation indicates that it is 600 new patients with the diagnosis of GBM. The disease becomes the 9th cause of death among males and the 13th one among females. The peak of incidence appears in the 5th decade of life and concerns the most productive population. Routinely the management embraces the planning of the resection surgery based on the preoperative magnetic resonance investigation (MRI) with contrast. The common image of the tumor allows to put the preliminary diagnosis with the high probability rate. The GBM occurs as the enhanced tumor with the central necrosis and the circumferential brain edema visible in T2 and Flair sequences of MRI. Commonly the border of tumor becomes the line of contrast enhancement. The enhances area is the aim of surgical treatment. The lack of the preoperative enhanced area in the postoperative MRI is assumed as the gross total resection (GTR). It has been proved that the range of the resection translates into the overall survival (OS) and the progression free survival (PFS). Despite the resection classified as GTR the relapse in the operated area often occurs. It can be explained by the presence of the glioma stem cells in the surrounding neuronal tissue. They are responsible for the early relapse of GBM. Notably, it is evident that the MRI with contrast becomes the method which does not reveal the proper range of resection with the relevant sensitivity so as to extend PFS and OS. The positron emission tomography (PET) is one of the diagnostic methods having been clinically evaluated. PET assesses the metabolic demand of the neoplasm for the biochemical substrates. That methodology is commonly used in case of severity of the solid tumors. The fluorodeoxyglucose (18-FDG) is the most frequently used. However the high metabolism of glucose within the brain, particularly in the grey matter, 18-FDG has the limitation in the process of planning of the tumor resection. The higher specificity and sensitivity are elicited among the markers including aminoacids, praticularly 11-C methionine (11C-MET). Within the gliomas the higher uptake is observed than in the healthy brain. The range of the contrast enhancement in the MRI covers only 58% of the higher 11C-MET metabolism. Comparing these results with a tumor resection beyond the enhancement area, indicates the necessity of the precise assessment of the proposed method in the routine planning of the glioma resection. Current body of literature lacks in high quality research concerning that issue. The articles regarding the glioma resection beyond the GTR may be found instead. The surgery is limited to the resection of brain area with the incorrect signal in the FLAIR sequence, suspected of the presence of glioma stem cells. The described technique allows to extend PFS by for about 2 months. In that case the resection is based mainly on the FLAIR sequence which does not determine the presence of the neoplasm therein. The fusion of the MRI and the MET-PET images would allow to plan the resection so as to cover the area of incorrectly increased marker uptake.
NCT06466031 — Glioblastoma Multiforme
Status: Not yet recruiting
http://inclinicaltrials.com/glioblastoma-multiforme/NCT06466031/
Magnetic Resonance Fingerprinting Guided Extended Resection in Glioblastomas
Magnetic resonance imaging, MRI, is a procedure that uses radio waves, a powerful magnet, and a computer to make a series of detailed pictures of areas inside the body. The goal of this study is to determine if MR fingerprinting, new way of acquiring MRI images, can help identify the extent of tumor spread in the brain, better than routine MRI images.
NCT06455189 — Glioblastoma
Status: Not yet recruiting
http://inclinicaltrials.com/glioblastoma/NCT06455189/
FET-PET/MRI Based Treatment Planning for Glioblastoma Multiforme in Post-Surgical Patients (FET-TREAT)
GBM represent the most common primary brain malignancy and prognosis remains poor. The most common subtype is glioblastoma which has a 5-year survival rate of approximately 5%. Despite advances in MRI techniques, accurately determining total extent of tumor remains a challenge. The result is incomplete treatment resulting in reduced survival or overtreatment resulting in avoidable treatment related morbidity. A more accurate means of assessing tumor extent is needed to guide management to improve patient survival and quality of life.
NCT06451042 — Glioblastoma Multiforme
Status: Recruiting
http://inclinicaltrials.com/glioblastoma-multiforme/NCT06451042/
PH Weighted Chemical Exchange Saturation Transfer Based Surgical Resections of Glioblastoma
This phase III trial compares pH weighted chemical exchange saturation transfer (CEST) magnetic resonance imaging (MRI)-based surgical resections to standard of care surgical resections for the treatment of patients with glioblastoma. Standard of care therapy for glioblastoma is surgery to remove tumor tissue that enhances on standard MRI imaging, however, it has been shown that significant tumor burden exists in the region around the tumor tissue that does not enhance with standard MRI. MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. These pictures can show the difference between normal and tumor tissue. CEST MRI is a technique that uses differences in the tissue environment, like protein concentration or intracellular pH, to generate contrast differences. CEST MRI may identify tumor tissue that does not enhance with standard of care MRI. PH weighted CEST MRI based surgical resection may be more effective compared to standard of care surgical resection in treating patients with glioblastoma.
NCT06448286 — Glioblastoma
Status: Not yet recruiting
http://inclinicaltrials.com/glioblastoma/NCT06448286/
Study of Metabolic, Genomic and Proteomic Modifications in Relapsed Glioblastoma. Identification or Prognostic Markers in Patients Undergoing Surgery for Relapsed Glioblastoma.
Glioblastomas are the most frequent and aggressive malignant tumors of the CNS in adults, with almost systematic relapse despite treatment with surgery followed by radio-chemotherapy (STUPP protocol). The aim of this study is to better characterize transcriptomic, proteomic and metabolic changes in relapsed glioblastoma compared to the initial tumor, in order to identify new prognostic markers and potential new therapeutic targets.
NCT06430424 — Relapsed Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/relapsed-cancer/NCT06430424/
Phase III Trial of Temozolomide/Lomustine (TMZ/LOM) Combination Therapy vs. Standard TMZ Therapy for Newly Diagnosed MGMT Promoter Methylated Glioblastoma (IDHwt) Patients +/- Tumor Treating Fields (Optune)
Background: Glioblastoma (GBM) is notoriously difficult to treat, with current therapies often extending life by only a few months. The standard treatment involves surgery followed by radiation and chemotherapy with Temozolomide (TMZ). The efficacy of TMZ, however, is significantly enhanced when the tumor's o6-methylguanine-DNA-methyltransferase (MGMT) gene is methylated. Recent studies, such as the NOA-09 trial, have suggested that adding Lomustine (LOM) to TMZ could improve outcomes for patients with this specific tumor profile. Hypothesis: The investigators hypothesize that the addition of LOM to the TMZ regimen will lead to significantly improved survival rates among patients with newly diagnosed glioblastoma who have a methylated MGMT promoter compared to those receiving only TMZ. Treatment Plans: The study will randomly assign participants to two groups: - Control Group: Standard treatment with TMZ during and after radiation therapy. - Experimental Group: TMZ combined with LOM, starting on the first day of radiation therapy. Outcome Measures: The primary outcome measure will be survival. Other outcomes will include progression-free survival (time from randomization until tumor progression or death), safety profiles (adverse effects of the treatments), and quality of life measures as well as neurocognitive outcomes.
NCT06419946 — Glioblastoma, IDH-wildtype
Status: Not yet recruiting
http://inclinicaltrials.com/glioblastoma-idh-wildtype/NCT06419946/
Neoadjuvant Radio-chemotherapy Safety Pilot Study in Patients With Glioblastoma
The goal of this clinical trial is to evaluate the safety and efficacy of neoadjuvant radiochemotherapy in the surgical resection of glioblastoma (GBM). The main questions it aims to answer are: - What is the safety profile of neoadjuvant radiochemotherapy in terms of neurological deficit, radionecrosis, edema, headache, wound dehiscence, infection, and cerebrospinal fluid fistula? - What is the efficacy of neoadjuvant radiochemotherapy in terms of progression-free survival, overall survival, cognitive function, and quality of life? Participants will undergo the following tasks and treatments: - Stereotactic biopsy and diagnosis confirmation. - Conformal hypofractionated stereotactic radiotherapy with concurrent temozolomide. - Supramarginal resection guided by 5-ALA under intraoperative neurophysiological monitoring. - Maintenance temozolomide administration for 6 months. Researchers will compare the group receiving neoadjuvant radiochemotherapy to the control group following the standard Stupp protocol to assess safety and efficacy outcomes.
NCT06418113 — Glioblastoma
Status: Recruiting
http://inclinicaltrials.com/glioblastoma/NCT06418113/
A Phase 1 Adaptive Dose Escalation With Dose Expansion Study of Triapine in Combination With Temozolomide (TMZ) for Patients With Recurrent Glioblastoma
This phase I trial tests the safety, side effects, and best dose of triapine in combination with temozolomide in treating patients with glioblastoma that has come back after a period of improvement (recurrent). Triapine inhibits an enzyme responsible for producing molecules required for the production of deoxyribonucleic acid (DNA), which may inhibit tumor cell growth. Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill tumor cells and slow down or stop tumor growth. Giving triapine in combination with temozolomide may be safe, tolerable, and/or effective in treating patients with recurrent glioblastoma.
NCT06410248 — Recurrent WHO Grade 2 Glioma
Status: Not yet recruiting
http://inclinicaltrials.com/recurrent-who-grade-2-glioma/NCT06410248/