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Glioblastoma clinical trials

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NCT ID: NCT04528680 Recruiting - Glioblastoma Clinical Trials

Ultrasound-based Blood-brain Barrier Opening and Albumin-bound Paclitaxel and Carboplatin for Recurrent Glioblastoma

SC9/ABX
Start date: October 29, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Paclitaxel is among the most active agents against glioblastoma in preclinical models. However, its clinical use has been hampered by the blood-brain barrier (BBB). In this trial we will implant a novel device with 9 ultrasound emitters allowing to temporarily and reversibly open the BBB immediately prior to chemotherapy infusion with albumin-bound paclitaxel. In the phase 1 component, increasing doses of chemotherapy will be delivered as long deemed safe based on the prior patient not experiencing severe toxicity. Once the the recommended dosing has been established, carboplatin will be added to the regimen and additional patients will be treated in order to better evaluate the antitumor efficacy of this novel treatment. The device will be implanted at the time of surgical resection of the recurrent tumor. During that procedure and when feasible, a first test dose of the chemotherapy will be administered in the operating room after sonication (procedure of activating ultrasound and opening the BBB) and tissue concentrations in different parts of the resected tumor will be measured. In select patients, the sonication procedure may occur immediately after the test dose of chemotherapy is administered. The objectives of this trial are to establish a safe and effective dose of albumin-bound paclitaxel, to demonstrate that the opening of the BBB increases chemotherapy concentration in the tumor, and to estimate how effective this treatment is in reducing the tumor burden and prolonging life.

NCT ID: NCT04523688 Recruiting - Glioblastoma Clinical Trials

Vaccination With Autologous Dendritic Cells Loaded With Autologous Tumour Homogenate in Glioblastoma

Combi G-Vax
Start date: March 25, 2021
Phase: Phase 2
Study type: Interventional

Single arm, monocentric trial to assess the safety and the progression-free survival related to the combined treatment of dendritic cell vaccine loaded with autologous tumor homogenate and temozolomide in patients operated for glioblastoma and then treated with standard radiochemotherapy (according to Stupp regimen).

NCT ID: NCT04492163 Recruiting - Clinical trials for Glioblastoma Multiforme

Open-Label Pilot Study of OPTUNE® With High Density Transducer Arrays for the Treatment of Recurrent GBM

Start date: July 14, 2020
Phase: Phase 2
Study type: Interventional

This is a prospective, open-label, single arm, historical control pilot study aimed to test the effectiveness and safety of TTFields delivered through high intensity arrays in recurrent glioblastoma. The Optune® System is an investigational , portable, battery operated medical device in this study delivering 200 kHz TTFields to the brain using high intensity transducer arrays for the treatment of patients at the age of 18 years or older with first or second recurrence of Glioblastoma Multiforme (GBM)

NCT ID: NCT04488783 Recruiting - Clinical trials for Newly Diagnosed Glioblastoma Who Underwent at Least Partial Resection of the Tumor Surgically

Potentiation of Chemotherapy in Brain Tumors by Zinc

Start date: July 30, 2020
Phase: N/A
Study type: Interventional

Glioblastoma (GB) is the most common and aggressive type of primary malignant brain tumor in adults. Despite advances in surgical resection, radiotherapy and chemotherapy, prognosis remains very poor. Temozolomide (TMZ) as an alkylating agent has become part of GBM management but it has contributed only marginally to prolongation of life in GBM patients. Our aim is to evaluate the therapeutic potential of the trace element zinc to facilitate temozolomide tumor cell toxicity in GBM. P53 gene is inactive/mutant in most of these patients which may affect the resistance to apoptosis of tumor cells by chemotherapy. Zinc (Zn) has a crucial role in the biology of p53, in that p53 binds to DNA through a structurally complex domain stabilized by zinc atom. We have shown that the cytotoxic activity of TMZ is substantially increased with the addition of zinc in vitro with GBM cell lines as well as in vivo, with intracranial GBM xenografts. Numerous studies of zinc in animal models and in human subjects support its use in the treatment and possibly the prevention of cancer. Zinc has been consumed by the public as an essential mineral (and thus is category A drug) in concentrations which allows this effect with Temozolomide. Vitamin C could add to this by priming the immune system for lymphocyte- linked cancer killing. The vitamin c increases the number of tumor infiltrating lymphocytes and enhances the activation of the immune system.We propose a single arm phase II clinical trial in 30 newly diagnosed GBM patients who will be treated with the standard chemo-radiotherapy with the addition of zinc and vitamin C.

NCT ID: NCT04479696 Recruiting - Glioblastoma Clinical Trials

Customized Neuro-Imaging Referenced Symptom Video for the Reduction of Patient and Caregiver Anxiety Around Radiation Treatment for Brain Tumors

Start date: June 5, 2019
Phase: N/A
Study type: Interventional

This trial studies whether a customized video intervention can help to reduce anxiety in brain cancer patients undergoing radiation treatment and their caregivers. A customized neuro-imaging referenced symptom video that describes symptoms and side effects specific to the patients' tumor may result in an early and sustained reduction in anxiety and distress during and after radiation treatment, thereby improving quality of life.

NCT ID: NCT04478279 Recruiting - Breast Cancer Clinical Trials

A Phase 1-2 Study of ST101 in Patients With Advanced Solid Tumors

Start date: July 1, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label, two-part, phase 1-2 dose-finding study designed to determine the safety, tolerability, PK, PD, and proof-of-concept efficacy of ST101 administered IV in patients with advanced solid tumors. The study consists of two phases: a phase 1 dose escalation/regimen exploration phase and a phase 2 expansion phase.

NCT ID: NCT04477200 Recruiting - Clinical trials for Recurrent Glioblastoma

Mycophenolate Mofetil Combined With Radiation Therapy in Glioblastoma

Start date: August 5, 2020
Phase: Phase 1
Study type: Interventional

This is a phase 0/1 dose-escalation trial to determine the maximum tolerated dose of Mycophenolate Mofetil (MMF) when administered with radiation, in patients with glioblastoma or gliosarcoma.

NCT ID: NCT04469699 Recruiting - Clinical trials for Glioblastoma Multiforme, Adult

Stereotactical Photodynamic Therapy With 5-aminolevulinic Acid (Gliolan®) in Recurrent Glioblastoma

NOA11
Start date: April 12, 2021
Phase: Phase 2
Study type: Interventional

In this multicenter, randomized, non-blinded trial the efficacy and safety of stereotactical photodynamic therapy with 5-aminolevulinic acid will be investigated in 106 patients with recurrent glioblastoma.

NCT ID: NCT04469075 Recruiting - Glioblastoma Clinical Trials

Clindamycin and Triamcinolone in People With Glioblastoma to Prevent Skin-Related Side Effects of Tumor Treating Fields

Start date: July 9, 2020
Phase: Phase 2
Study type: Interventional

The participants are being treated with Tumor Treating Fields (TTFields) for malignant glioma, and this type of treatment may cause skin-related side effects. This study will test whether using clindamycin and triamcinolone topical lotions can prevent skin-related side effects of TTFields.

NCT ID: NCT04443010 Recruiting - Glioblastoma Clinical Trials

Safety and Efficacy of L19TNF Plus Temozolomide Chemoradiotherapy in Patients With Newly Diagnosed Glioblastoma

GLIOSUN
Start date: January 20, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to explore the safety profile and establish a recommended dose (RD) for phase II of the antibody-cytokine fusion protein L19TNF plus standard TMZ chemoradiotherapy in patients with newly diagnosed glioblastoma. The study will be conducted in three consecutive parts: a dose finding part to determine the RD of L19TNF in combination with chemoradiotherapy, followed by a signal seeking part that investigates first signs of activity and then an activity evaluation part that studies the efficacy of L19TNF in combination with chemoradiotherapy against chemoradiotherapy alone.