Clinical Trial DRUG CBKM120E2102
- Phase Ib/II multicenter study of buparlisib plus carboplatin or lomustine in patients with recurrent glioblastoma multiforme (GBM)
- Principal Investigator
- Jeffrey Raizer
- Status: CLOSED
- Study Type: Therapeutic, Treatment
- Protocol No:.DRUG CBKM120E2102
- There are two purposes for this study. The purpose of the first phase of this study is to determine the highest safe dose of buparlisib given in combination with carboplatin or with lomustine in people with recurrent glioblastoma. The purpose of the second phase of this study is to determine whether, buparlisib given in combination with carboplatin and buparlisib given in combination with lomustine compared to lomustine alone, is effective and safe for patients in recurrent glioblastoma.
- Buparlisib (the study drug) is a medicine which has not been approved by the FDA (Food & Drug Administration) for the treatment of people with your medical condition. Buparlisib belongs to the class of medicines called PI3K inhibitors, as it binds to a protein called PI3K. When the drug binds to this protein, it can inhibit certain activities in cells that encourage tumors to grow and multiply. Experiments in animals have shown that buparlisib could prevent cancer cells from multiplying and therefore the tumor from growing. Carboplatin and lomustine may be used to treat recurrent glioblastoma.
Some of the eligibility criteria include:
- Participants must have a diagnosis of glioblastoma multiforme (GBM).
- Participants must have cancer that has returned (recurred) after prior standard therapy.
- Participants must be 18 or older.
- Description of Treatment
- Participants in this study will be randomly assigned to get either carboplatin and buparlisib or lomustine and buparlisib. Carboplatin is given through a vein (IV) every 3 weeks (21 days). Lomustine is given IV every 6 weeks. Buparlisib is taken daily by mouth.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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- A Phase 1/2 Study of SL-701, a Subcutaneously Injected Multivalent Glioma-Associated Antigen Vaccine, in Adult Patients with Recurrent Glioblastoma Multiforme
- Phase I/II Dose Escalation Trial to Assess Safety of Intrathecal Trastuzumab for the Treatment of Leptomeningeal Metastases in HER2 Positive Cancer
- A Phase II Study of the Efficacy of Hypofractionated Radiation Therapy with Bevacizumab and Temozolomide Followed by Maintenance Temozolomide and Bevacizumab for Recurrent High-Grade Gliomas
- A Phase II Trial of Oral Pazopanib plus Oral Topotecan Metronomic Antiangiogenic Therapy for Recurrent Glioblastoma Multiforme (A) without Prior Bevacizumab Exposure and (B) after Failing Prior Bevacizumab
last updated: 05-May-16 03:02 PM
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