Mycophenolate Mofetil + Radiation for Glioblastoma
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot have used bevacizumab within 8 weeks of joining the study. It's best to discuss your current medications with the study team.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, you cannot have used bevacizumab within 8 weeks of joining the study, and there are restrictions on certain conditions and treatments. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the treatment Mycophenolate Mofetil + Radiation for Glioblastoma?
Research on targeted radiotherapy for malignant gliomas suggests that advanced radiation techniques, like stereotactic radiotherapy and radiosurgery, can potentially improve treatment effectiveness while reducing damage to healthy tissue. This indicates that combining these advanced radiation methods with other therapies might enhance outcomes for glioblastoma patients.12345
What data supports the effectiveness of the treatment Mycophenolate Mofetil + Radiation for Glioblastoma?
Research on targeted radiotherapy for malignant gliomas suggests that advanced radiation techniques, like stereotactic radiotherapy and radiosurgery, can improve treatment effectiveness by focusing on the tumor while minimizing damage to healthy tissue. This approach may enhance the overall effectiveness of combining radiation with other therapies, such as Mycophenolate Mofetil, for glioblastoma.12345
Is the combination of Mycophenolate Mofetil and radiation therapy generally safe for humans?
Radiation therapy, including advanced forms like stereotactic body radiation therapy (SBRT), has been shown to be safe in treating various cancers, with studies indicating a safe tolerance profile when combined with other therapies. However, rare neurological complications can occur, so monitoring and management strategies are important.678910
Is the combination of Mycophenolate Mofetil and radiation therapy generally safe for humans?
Radiation therapy, including stereotactic body radiation therapy (SBRT), has been shown to be safe in treating various cancers, with studies indicating a safe tolerance profile when combined with other therapies. However, rare neurological complications like myelitis (inflammation of the spinal cord) can occur, but these are considered very rare.678910
How does the Mycophenolate Mofetil and Radiation treatment for glioblastoma differ from other treatments?
How is the treatment of Mycophenolate Mofetil and Radiation Therapy for glioblastoma different from other treatments?
What is the purpose of this trial?
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.
Research Team
Nathan Clarke, MD
Principal Investigator
University of Michigan Rogel Cancer Center
Eligibility Criteria
This trial is for adults with glioblastoma or gliosarcoma, either newly diagnosed or recurrent. They must be candidates for surgery, radiation therapy, and agree to use effective contraception. Excluded are those with serious infections, organ transplants, certain medical conditions like phenylketonuria or hypoxanthine-guanine phosphoribosyl-transferase deficiency, pregnant women, and anyone who can't undergo MRI scans.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Phase 0
Participants receive Mycophenolate Mofetil (MMF) for one week before undergoing a planned biopsy or re-resection of glioblastoma or gliosarcoma
Phase 1 - Treatment
Participants receive Mycophenolate Mofetil (MMF) combined with radiation therapy, and for newly diagnosed cases, also with temozolomide
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Participants are monitored for overall survival and progression-free survival
Treatment Details
Interventions
- Mycophenolate Mofetil
- Radiation Therapy
Mycophenolate Mofetil is already approved in European Union, United States, Canada, Japan for the following indications:
- Prevention of acute organ rejection in kidney, liver, and heart transplant patients
- Treatment of autoimmune diseases such as lupus nephritis and rheumatoid arthritis
- Prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac, or hepatic transplants
- Treatment of autoimmune diseases such as lupus nephritis and rheumatoid arthritis
- Prevention of acute organ rejection in kidney, liver, and heart transplant patients
- Treatment of autoimmune diseases such as lupus nephritis and rheumatoid arthritis
- Prevention of acute organ rejection in kidney, liver, and heart transplant patients
- Treatment of autoimmune diseases such as lupus nephritis and rheumatoid arthritis
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan Rogel Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator