A Study of Selinexor in Combination With Standard of Care Therapy for Newly Diagnosed or Recurrent Glioblastoma
Trial Summary
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, there are restrictions on certain prior treatments, such as chemotherapy and investigational agents, which must be stopped at least 4 weeks before starting the study treatment.
What data supports the effectiveness of the drug combination including Bevacizumab, Carmustine, Lomustine, Selinexor, and Temozolomide for treating brain tumors?
Research shows that Temozolomide (TMZ) is effective in treating malignant brain gliomas, and when combined with other drugs like Carmustine (BCNU) and Lomustine (CCNU), it can be part of a successful treatment plan for brain tumors. Additionally, studies indicate that combining TMZ with radiotherapy can be safe and effective for treating anaplastic astrocytoma, a type of brain tumor.12345
Is the treatment generally safe for humans?
Research shows that temozolomide (TMZ) and carmustine (BCNU) have been studied for safety in treating brain tumors. Some patients experienced myelosuppression (a decrease in bone marrow activity leading to fewer blood cells) as a side effect, indicating that while the treatment is feasible, it may have significant side effects.12467
What makes the drug combination of Carmustine, Lomustine, Selinexor, Radiation therapy, and Temozolomide unique?
This drug combination is unique because it includes Selinexor, a novel agent that inhibits nuclear export, potentially enhancing the effectiveness of chemotherapy and radiation therapy by keeping tumor-suppressing proteins inside the cell nucleus where they can work. This approach may offer a new mechanism of action compared to traditional treatments.89101112
What is the purpose of this trial?
This trial tests selinexor combined with standard treatments for patients with new or recurring brain cancer. Selinexor aims to stop cancer cells from growing and make them more susceptible to other therapies. Selinexor has shown positive responses and manageable side effects in patients with recurrent glioblastoma.
Research Team
Andrew B Lassman, MD
Principal Investigator
Columbia University
Eligibility Criteria
Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Phase 1a Dose Finding
Participants receive selinexor in combination with standard of care to determine the maximum tolerated dose
Phase 1b Dose Expansion
Participants continue to receive selinexor at the recommended phase 2 dose to further evaluate safety and efficacy
Phase 2 Randomized Efficacy Exploration
Participants are randomized to different treatment arms to evaluate the efficacy of selinexor in combination with various therapies
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Bevacizumab
- Carmustine
- Lomustine (CCNU)
- Selinexor
- Standard Fractionated Radiation therapy (RT)
- Temozolomide (TMZ)
- TTField
Carmustine is already approved in United States, European Union, Canada for the following indications:
- Brain tumors
- Multiple myeloma
- Hodgkin's disease
- Non-Hodgkin's lymphoma
- Brain tumors
- Multiple myeloma
- Hodgkin's disease
- Non-Hodgkin's lymphoma
- Brain tumors
- Multiple myeloma
- Hodgkin's disease
- Non-Hodgkin's lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Karyopharm Therapeutics Inc
Lead Sponsor
Richard Paulson
Karyopharm Therapeutics Inc
Chief Executive Officer since 2021
MBA from the University of Toronto's Rotman School of Management
Reshma Rangwala
Karyopharm Therapeutics Inc
Chief Medical Officer since 2023
MD, PhD