68 Participants Needed

Mycophenolate Mofetil + Radiation for Glioblastoma

Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: University of Michigan Rogel Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

This treatment combines Mycophenolate Mofetil, which is typically used to suppress the immune system, with advanced radiation techniques like stereotactic radiotherapy to target glioblastoma more precisely, potentially improving effectiveness while reducing damage to healthy tissue.12111213

How is the treatment of Mycophenolate Mofetil and Radiation Therapy for glioblastoma different from other treatments?

This treatment combines Mycophenolate Mofetil, an immunosuppressant drug, with advanced radiation techniques like stereotactic radiotherapy, which allows for more precise targeting of the tumor, potentially improving effectiveness while reducing damage to healthy tissue.12111213

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

NC

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

I can care for myself but may need occasional help.
Ability to understand and the willingness to sign a written informed consent.
Patient (men and childbearing age women) agrees to the use of highly effective contraception during study participation and for at least 6 weeks for female patients and 90 days for male patients after final MMF administration.
See 5 more

Exclusion Criteria

My cancer has spread to the lining of my brain and spinal cord.
I have not had chemotherapy or radiation for my newly diagnosed glioblastoma or gliosarcoma.
I have been diagnosed with HIV.
See 20 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 0

Participants receive Mycophenolate Mofetil (MMF) for one week before undergoing a planned biopsy or re-resection of glioblastoma or gliosarcoma

1 week
1 visit (in-person) for biopsy or re-resection

Phase 1 - Treatment

Participants receive Mycophenolate Mofetil (MMF) combined with radiation therapy, and for newly diagnosed cases, also with temozolomide

Up to 11 weeks
Multiple visits (in-person) for treatment administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term Follow-up

Participants are monitored for overall survival and progression-free survival

Up to 3 years

Treatment Details

Interventions

  • Mycophenolate Mofetil
  • Radiation Therapy
Trial Overview The study tests the highest dose of Mycophenolate Mofetil (MMF) that patients can tolerate alongside radiation therapy for brain cancer treatment. It's a phase 0/1 trial where doses increase gradually to find the safe limit. Standard treatments like surgery and Temozolomide may also be used.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Phase 1 - Recurrent GBM / GSExperimental Treatment2 Interventions
Mycophenolate mofetil; radiation therapy
Group II: Phase 1 - Newly Diagnosed GBM / GSExperimental Treatment3 Interventions
Mycophenolate mofetil; radiation therapy; temozolomide
Group III: Phase 0 - Recurrent glioblastoma (GBM) / gliosarcoma (GS)Experimental Treatment2 Interventions
Mycophenolate mofetil

Mycophenolate Mofetil is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Cellcept for:
  • Prevention of acute organ rejection in kidney, liver, and heart transplant patients
  • Treatment of autoimmune diseases such as lupus nephritis and rheumatoid arthritis
🇺🇸
Approved in United States as Cellcept for:
  • Prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac, or hepatic transplants
  • Treatment of autoimmune diseases such as lupus nephritis and rheumatoid arthritis
🇨🇦
Approved in Canada as Cellcept for:
  • Prevention of acute organ rejection in kidney, liver, and heart transplant patients
  • Treatment of autoimmune diseases such as lupus nephritis and rheumatoid arthritis
🇯🇵
Approved in Japan as Cellcept for:
  • 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

Trials
303
Recruited
20,700+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

Recent advances in radiation therapy for malignant glioma, such as stereotactic radiotherapy and charged particle therapy, aim to improve treatment efficacy while reducing damage to healthy tissues.
Combining these advanced radiation techniques with targeted biochemotherapies may enhance therapeutic outcomes for patients with malignant glioma, which has historically had a poor prognosis.
Targeted radiotherapy for malignant gliomas.Oh, DS., Adamson, DC., Kirkpatrick, JP.[2019]
Radiation oncologists are exploring various innovative approaches, such as interstitial implants and stereotactic radiosurgery, to enhance cure rates for primary brain tumors while aiming to reduce long-term side effects.
These new radiation techniques must be integrated into a comprehensive treatment plan that includes other therapies to effectively manage primary malignant brain tumors.
Improving radiotherapy for brain tumors.Woo, SY., Maor, MH.[2005]
Concurrent involved-field radiation therapy (IFRT) and intrathecal chemotherapy (IC) with methotrexate or cytarabine showed a clinical response rate of 34% in 53 patients with leptomeningeal metastasis, indicating its effectiveness as a treatment option.
The treatment had an acceptable safety profile, with 28% of patients experiencing adverse events, and a median overall survival of 6.5 months, suggesting it can be a viable option even for patients who developed leptomeningeal metastasis while on targeted therapy.
A phase II study of concurrent involved-field radiotherapy and intrathecal chemotherapy for leptomeningeal metastasis from solid tumors.Pan, Z., Chen, K., He, H., et al.[2023]

References

1.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Targeted radiotherapy for malignant gliomas. [2019]
Improving radiotherapy for brain tumors. [2005]
A phase II study of concurrent involved-field radiotherapy and intrathecal chemotherapy for leptomeningeal metastasis from solid tumors. [2023]
Treatment of meningeal leukemia. [2019]
Intralesional radioimmunotherapy of malignant gliomas. An effective treatment in recurrent tumors. [2019]
Safety and Tolerability of Metastasis-Directed Radiation Therapy in the Era of Evolving Systemic, Immune, and Targeted Therapies. [2022]
Improved Survival Associated with Local Tumor Response Following Multisite Radiotherapy and Pembrolizumab: Secondary Analysis of a Phase I Trial. [2021]
Stereotactic body radiation therapy for early-stage primary lung cancer, is an active breath coordinator necessary? An audit from a tertiary cancer care center. [2018]
Radiation myelitis after pembrolizumab administration, with favorable clinical evolution and safe rechallenge: a case report and review of the literature. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
Proton stereotactic body radiation therapy for clinically challenging cases of centrally and superiorly located stage I non-small-cell lung cancer. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Radiation oncology in brain tumors: current approaches and clinical trials in progress. [2022]
Agonist anti-GITR monoclonal antibody and stereotactic radiation induce immune-mediated survival advantage in murine intracranial glioma. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
Spiromustine and intracarotid artery cisplatin in the treatment of glioblastoma multiforme. [2019]
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