Trial Summary
What is the purpose of this trial?This trial tests if combining mycophenolate mofetil with temozolomide and radiation can better treat glioblastoma, an aggressive brain cancer. Mycophenolate mofetil may help chemotherapy work better by making cancer cells easier to kill. Temozolomide is a standard chemotherapeutic drug for glioblastoma, often combined with radiotherapy to improve patient survival.
Is the drug Mycophenolate Mofetil with Radiation Therapy and Temozolomide a promising treatment for glioblastoma?Yes, the combination of Radiation Therapy and Temozolomide is a promising treatment for glioblastoma, as it has been shown to improve survival rates. Temozolomide is a key drug in this treatment, and adding Mycophenolate Mofetil could potentially enhance its effectiveness.267811
What safety data is available for Mycophenolate Mofetil and standard care in glioblastoma treatment?The provided research primarily focuses on the safety and efficacy of temozolomide (TMZ) in combination with various forms of radiotherapy for glioblastoma treatment. Temozolomide has been shown to have a lower toxicity profile compared to conventional chemotherapy agents and is approved for use with radiotherapy in newly diagnosed glioblastoma multiforme. The studies indicate that TMZ, when used with radiotherapy, is associated with improved survival and manageable toxicity. However, specific safety data for Mycophenolate Mofetil in combination with standard care for glioblastoma is not directly addressed in the provided research.123910
Do I need to stop taking my current medications to join the trial?The trial protocol does not specify if you need to stop taking your current medications. However, you cannot be on other investigational agents, and there are restrictions on live vaccinations and viral-vector based therapy. It's best to discuss your current medications with the trial team.
What data supports the idea that Mycophenolate Mofetil + Standard Care for Glioblastoma is an effective treatment?The available research does not provide specific data on the effectiveness of Mycophenolate Mofetil combined with standard care for glioblastoma. Instead, it focuses on the use of another drug, Temozolomide, with radiation therapy. Studies show that Temozolomide, when used with radiation, improves survival rates for patients with glioblastoma. For example, one study found that this combination improved median and 2-year survival rates. However, there is no direct evidence in the provided research about Mycophenolate Mofetil's effectiveness for glioblastoma.24568
Eligibility Criteria
Adults diagnosed with glioblastoma, who've had surgery or biopsy and are stable on low-dose corticosteroids. They must be able to perform daily activities (Karnofsky score >=70), have adequate organ function, and agree to use contraception. Excluded are those with other cancers, certain infections, uncontrolled illnesses, pregnant/nursing women, inability to take oral meds, or known HIV/HBV/HCV.Inclusion Criteria
My brain tumor is confirmed as glioblastoma or has similar features.
I am mostly able to care for myself.
I have a new glioblastoma diagnosis and have had surgery or biopsy, with or without chemoradiation.
I am 18 years old or older.
Exclusion Criteria
I do not have uncontrolled epilepsy, another cancer needing treatment, severe infections, immune issues, major psychiatric illness, and I'm not pregnant or nursing. I also don't have trouble swallowing or a history of HIV, HBV, or HCV.
Treatment Details
The trial is testing the safety and optimal dose of Mycophenolate Mofetil when combined with standard treatments for glioblastoma: Temozolomide and Radiation Therapy. The goal is to see if this drug makes cancer cells more sensitive to treatment.
4Treatment groups
Experimental Treatment
Group I: Group S (pre-surgical MMF, TMZ)Experimental Treatment3 Interventions
Patients planning to undergo surgery receive MMF PO BID and TMZ PO QD for 5 days prior to surgery in the absence of disease progression or unacceptable toxicity.
Group II: Group 3 (TMZ, MMF, radiation therapy)Experimental Treatment4 Interventions
Patients who have already undergone surgery or biopsy receive TMZ PO QD on days 1-5 of each cycle and MMF PO BID. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Starting at the same time as TMZ and MMF administration, patients also receive radiation therapy daily, 5 days per week, for 6 weeks.
Group III: Group 2 (TMZ, MMF, radiation therapy)Experimental Treatment4 Interventions
Patients with unmethylated glioblastoma who have already undergone surgery or biopsy receive TMZ PO QD on days 1-5 of each cycle and MMF PO BID. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Starting at the same time as TMZ and MMF administration, patients also receive radiation therapy daily, 5 days per week, for 6 weeks.
Group IV: Group 1 (TMZ, MMF)Experimental Treatment3 Interventions
Patients who have already undergone surgery or biopsy followed by chemoradiation receive TMZ PO QD on days 1-5 of each cycle and MMF PO BID. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Mycophenolate Mofetil is already approved in European Union, United States, Canada, Japan, Australia 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
🇦🇺 Approved in Australia 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
Research locations nearbySelect from list below to view details:
Northwestern UniversityChicago, IL
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Who is running the clinical trial?
Northwestern UniversityLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Temozolomide in radio-chemotherapy combined treatment for newly-diagnosed glioblastoma multiforme: phase II clinical trial. [2018]Continuous research into new strategies and chemotherapy agents for the treatment of malignant high-grade gliomas have led to the synthesis of a new chemotherapy drug, temozolomide (TMZ), with a lower toxicity profile compared to conventional chemotherapy agents, such as nitrosoureas. Temozolomide is an oral alkylating chemotherapy agent licensed for the treatment of recurrent high-grade gliomas, anaplastic astrocytoma (AA) and glioblastoma multiforme (GBM). Because of its favorable pharmacokinetic and pharmacodynamic properties and improved tolerability, TMZ is now under investigation for concomitant use with radiotherapy in patients with newly-diagnosed GBM. We present a phase II clinical trial investigating the efficacy and safety of radio-chemotherapy combined treatment using TMZ, followed by six cycles of adjuvant chemotherapy with TMZ, in patients with newly-diagnosed GBM who have undergone debulking surgery or biopsy only.
Phase II study of temozolomide and thalidomide with radiation therapy for newly diagnosed glioblastoma multiforme. [2018]The chemotherapeutic agent temozolomide (TMZ) and the antiangiogenic agent thalidomide have both demonstrated antitumor activity in patients with recurrent malignant glioma. The objectives of this study were to determine if the combined strategy of these oral agents with radiation therapy (RT) is associated with an improved median survival of patients with newly diagnosed glioblastoma multiforme and to evaluate toxicity.
Food and Drug Administration Drug approval summary: temozolomide plus radiation therapy for the treatment of newly diagnosed glioblastoma multiforme. [2018]On March 15, 2005, the U.S. Food and Drug Administration approved temozolomide (Temodar capsules, Schering-Plough Research Institute) for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment. Five hundred seventy-three glioblastoma multiforme patients were randomized to receive either temozolomide + radiotherapy (n = 287) or radiotherapy alone (n = 286). Patients in the temozolomide + radiotherapy arm received concomitant temozolomide (75 mg/m2) once daily for the duration of radiation therapy (42-49 days). This was followed, 4 weeks later, by six cycles of temozolomide, 150 or 200 mg/m2 daily for 5 days, every 4 weeks. Patients in the control arm received radiotherapy only. In both arms, radiotherapy was delivered as 60 Gy/30 fractions to the tumor site with a 2 to 3 cm margin. Pneumocystis carinii pneumonia prophylaxis was required during temozolomide + radiotherapy treatment and was continued until recovery of lymphocytopenia (Common Toxicity Criteria grade
Early necrosis following concurrent Temodar and radiotherapy in patients with glioblastoma. [2022]Concurrent temozolomide (TMZ) and radiotherapy is the new standard of care for patients with newly diagnosed glioblastoma. In 51 consecutive patients treated according to this regimen, 7 patients (14%) manifested surgically confirmed early necrosis without evidence of recurrent tumor. This observation suggests that daily TMZ may represent a potent radiosensitizing regimen.
Temozolomide and radiation in low-grade and anaplastic gliomas: temoradiation. [2018]Recently completed trials suggest the addition of nitrosourea-based chemotherapy to radiotherapy increases the progression-free but not overall survival of grade II and III gliomas. Temozolomide has proven benefit in grade II/III gliomas progressive following standard therapy and when added to radiation for glioblastoma. Newly launched and planned phase III trials will explore whether the addition of temozolomide to radiotherapy improves overall survival in grade II/III as well as the prognostic and predictive value of 1p/19q analyses and MGMT promotor methylation status. Additionally, they will measure cognition and quality of life to determine if improvements in time to progression translate into better functional status and patient satisfaction.
Clinical outcome of concomitant chemoradiotherapy followed by adjuvant temozolomide therapy for glioblastaomas: single-center experience. [2018]The use of radiotherapy plus temozolomide administered concomitantly with and after radiotherapy for glioblastoma was recently shown to improve median and 2-year survival in a large international multicenter study. To compare this result in routine clinical practice, an audit of the management and outcome of patients with glioblastoma at our institute was performed.
Prognostic significance of concomitant radiotherapy in newly diagnosed glioblastoma multiforme: a multivariate analysis of 116 patients. [2021]Currently, radiotherapy with concomitant and adjuvant temozolomide has become the standard treatment for glioblastoma. The purpose of this study was to report our experience with radiation plus concomitant temozolomide in 116 patients with glioblastoma multiforme (GBM) and examine the value of different prognostic factors.
Age, Neurological Status MRC Scale, and Postoperative Morbidity are Prognostic Factors in Patients with Glioblastoma Treated by Chemoradiotherapy. [2020]Temozolomide and concomitant radiotherapy followed by temozolomide has been used as a standard therapy for the treatment of newly diagnosed glioblastoma multiform since 2005. A search for prognostic factors was conducted in patients with glioblastoma routinely treated by this strategy in our institution.
Treatment of high-grade gliomas using escalating doses of hypofractionated simultaneous integrated boost-intensity-modulated radiation therapy in combination with temozolomide: A modified Phase I clinical trial. [2022]Recent studies have shown that hypofractionated simultaneous integrated boost-intensity-modulated radiation therapy (SIB-IMRT) provided certain survival benefits over other fractionation methods for high-grade gliomas. However, the best hypofractionation mode and its efficacy have not been confirmed. The purpose of this study was to investigate the maximum tolerated dose (MTD) of hypofractionated SIB-IMRT with stepwise escalating doses combined with temozolomide (TMZ) for treating malignant gliomas.
Response and safety of whole-brain radiotherapy plus temozolomide for patients with brain metastases of non-small-cell lung cancer: A meta-analysis. [2022]The aim of the present work was to investigate the response and safety of whole-brain radiotherapy (WBRT) plus temozolomide (TMZ) for patients with brain metastases of non-small-cell lung cancer (NSCLC).
Temozolomide Resistance: A Multifarious Review on Mechanisms Beyond O-6-Methylguanine-DNA Methyltransferase. [2023]Chemotherapy with the oral alkylating agent temozolomide still prevails as a linchpin in the therapeutic regimen of glioblastoma alongside radiotherapy. Because of the impoverished prognosis and sparse chemotherapeutic medicaments associated with glioblastoma, the burgeoning resistance to temozolomide has made the whole condition almost irremediable.