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This is a multi-center, phase Ib/ II study (two parts) with patients that have recurrent glioblastoma multiforme. The first part (phase Ib) will investigate the maximum tolerated dose/Recommended phase ll dose (MTD/RP2D) of once daily buparlisib in combination with every-three-week carboplatin or buparlisib once daily in combination with every-six-week lomustine (CCNU) using a Bayesian model. Once MTD/ RP2D is established in either of the 2 arms, the corresponding phase II portion of the study will start. Phase II will assess the treatment effect of buparlisib in combination with carboplatin in terms of Progression Free Survival (PFS) and will compare the treatment effect of buparlisib with lomustine versus lomustine plus placebo in terms of PFS.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Recurrent Glioblastoma Multiforme (rGBM)
buparlisib, carboplatin, lomustine, placebo
Ironwood Cancer and Research Centers SC
Published on BioPortfolio: 2014-10-01T16:53:22-0400
This protocol will test the activity of Enzastaurin vs. Lomustine in the treatment of recurrent brain cancer (specifically intracranial glioblastoma multiforme).
The purpose of this study is to see how effective cediranib is in treating a brain tumour called recurrent glioblastoma. Two drugs are being tested in this study. Lomustine is an approved...
This is an open-label, dose finding, multiple-dose study in subjects with recurring/relapsing glioblastoma multiforme. Three dose levels of MPC-6827 will be administered with carboplatin ...
This is an adaptive design, randomized controlled, open-label Phase 3 clinical trial in patients with glioblastoma multiforme (GBM) or gliosarcoma (GS), previously treated with surgery (if...
The goal of this clinical research study is to learn if the combination of bevacizumab and lomustine can help to control glioblastoma. The safety of this combination will also be studied.
In the last decade, significant advances have been made in Glioblastoma Multiforme treatment with the novel use of alternating electrical fields, also termed as tumour treating fields (TTFs). This mod...
GTV definition for re-irradiation treatment planning in recurrent glioblastoma (rGBM) is usually based on contrast-enhanced MRI (GdT1w-MRI) and, for an increased specificity, on amino acid PET. Diffus...
Glioblastoma multiforme (GBM) is a rare and deadly disease, with a reported average incidence rate of 3.19 cases per 100,000 inhabitants. Fotemustine, a third-generation nitrosourea with an alanine ph...
In MRI of patients with recurrent glioblastoma, bevacizumab-induced normalization of tumor vascularity can be difficult to differentiate from antitumor effects. The aim of this study was to assess the...
Glioblastoma multiforme (GBM) mostly affects elderly patients. Adequate therapy especially in case of tumor recurrence is still under discussion, since most studies focus on patients under 65 years. W...
Benign and malignant central nervous system neoplasms derived from glial cells (i.e., astrocytes, oligodendrocytes, and ependymocytes). Astrocytes may give rise to astrocytomas (ASTROCYTOMA) or glioblastoma multiforme (see GLIOBLASTOMA). Oligodendrocytes give rise to oligodendrogliomas (OLIGODENDROGLIOMA) and ependymocytes may undergo transformation to become EPENDYMOMA; CHOROID PLEXUS NEOPLASMS; or colloid cysts of the third ventricle. (From Escourolle et al., Manual of Basic Neuropathology, 2nd ed, p21)
An organoplatinum compound that possesses antineoplastic activity.
An alkylating agent of value against both hematologic malignancies and solid tumors.
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
4-Methyl derivative of LOMUSTINE; (CCNU). An antineoplastic agent which functions as an alkylating agent.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
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