A Phase 1 Study of ZSP1602 in Participants With Advanced Solid Tumors
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics, and determine the maximum tolerated dose of ZSP1602 in participants with basal cell carcinoma, adenocarcinoma of esophagogastric junction, small cell lung cancer, neuroendocrine neoplasm and other advanced solid tumors.
A Phase 1 Trial of CBL0137 in Patients With Metastatic or Unresectable Advanced Solid Neoplasm
The primary objective of the study is to determine the maximally tolerated dose and recommended Phase 2 dose of CBL0137 when administered intravenously (IV) to patients with metastatic or unresectable advanced solid malignancies.
A Phase 2 Trial of High-Dose Ascorbate in Glioblastoma Multiforme
This clinical trial evaluates adding high-dose ascorbate (vitamin C) to standard of care treatment of glioblastoma multiforme (a type of brain tumor) in adults. All subjects will receive high-dose ascorbate in addition to the standard treatment.
A Phase I/IIa Study Evaluating Temferon in Patients With Glioblastoma & Unmethylated MGMT
This is a non-randomized, open label, phase I/IIa, dose-escalation study, involving a single injection of Temferon, an investigational advanced therapy consisting of autologous CD34+-enriched hematopoietic stem and progenitor cells exposed to transduction with a lentiviral vector driving myeloid specific interferon-alpha2 expression, which will be administered to up to 21 patients affected by GBM who have an unmethylated MGMT promoter. Part A will evaluate the safety and tolerability of 3 escalating doses of Temferon in up to 9 patients, following first line treatment. In Part B, a further 12 patients will receive a single dose of Temferon,...
A Phase I/IIa Study of Cerebraca Wafer Plus Adjuvant Temozolomide (TMZ) in Patients With Recurrent High Grade Glioma
A Phase I/IIa Study to Determine the Maximum Tolerated Dose (MTD) and to Evaluate the Safety and Efficacy Profile of Cerebraca Wafer Plus Adjuvant Temozolomide (TMZ) in Patients With Recurrent High Grade Glioma. High grade gliomas, glioblastoma multiforme (grade IV) and anaplastic anaplastic astrocytoma (Grade III), are the most comment malignant brain tumor. The cause of gliomas remains unknown. Despite of several researches on environmental hazards and genetic alterations, no direct causes were found. Patient suffering from glioma usually develops symptoms such as headaches, seizures, memory loss and changes in behavior in its...
A Phase II/III Study of High-dose, Intermittent Sunitinib in Patients With Recurrent Glioblastoma Multiforme
In this study the investigators will evaluate the effect of high-dose, intermittent sunitinib versus treatment with lomustine in patients with recurrent glioblastoma multiforme. The investigators hypothesize that sunitinib, when given in a high-dose, intermittent schedule, will achieve adequate concentration levels in the tumor and will, besides its anti-angiogenic properties, inhibit gliomagenesis by inhibition of multiple kinases.
A Phase III Trial of With Marizomib in Patients With Newly Diagnosed Glioblastoma
The standard of care for newly diagnosed glioblastoma includes surgery, involved-field radiotherapy, and concomitant and six cycles of maintenance temozolomide chemotherapy, however the prognosis remains dismal. Marizomib has been tested in patients with newly diagnosed and recurrent glioblastoma in phase I and phase II studies. In patients with recurrent glioblastoma, marizomib was administered as a single agent or in combination with bevacizumab (NCT02330562). Based on encouraging observations, a phase I/II trial of marizomib in combination with TMZ/RT -->TMZ in newly diagnosed glioblastoma has been launched (NCT02903069) which explores...
A Phase III Trial on Adjuvant Temozolomide With or Without Interferon-alpha in Newly Diagnosed High-grade Gliomas
This study is being conducted to help determine whether the addition of Interferon-alpha(α-IFN),which were determined sensitized the activity of Temozolomide(TMZ) in vivo and vitro, when given along with temozolomide during the monthly cycles that follow radiation, is able to delay tumor growth, shrink tumors, or impact how long people with newly diagnosed high-grade glioma.
A Phase II, Randomized, Open-Label, Parallel-Group Study to Evaluate the Efficacy and Safety of Autologous Dendritic Cell Vaccination (ADCV01) as an Add-On Treatment for Primary Glioblastoma Multiforme (GBM) Patients
This study is designed with open-label and randomized parallel group to evaluate the efficacy and safety of autologous dendritic cell vaccination (ADCV01) as an add-on treatment for primary glioblastoma multiforme
A Phase II Study of Optune (NovoTTF) in Combination With Bevacizumab (BEV) and Temozolomide (TMZ) in Patients With Newly Diagnosed Unresectable Glioblastoma (GBM)
All patients will complete best standard of care radiation, temozolomide and bevacizumab (6 weeks). Within two weeks of completion of this initial treatment period, study patients will be fitted with the NovoTTF-100A System and treated continuously. They will be treated with TTFields for 12 months for an average of 18 hours per day. The patient may elect to take a treatment break for a total of 3 days per month, for each month and still be in compliance. This will consist of wearing four electrically insulated electrode arrays on the head. The patients will also continue with maintenance temozolomide/ bevacizumab.
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