Drug Combination for Glioblastoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a combination of chemotherapy drugs to determine the best dose and understand the side effects for treating glioblastoma multiforme, an aggressive brain cancer, after radiation therapy. The treatment uses several drugs together, such as temozolomide, memantine, metformin, and mefloquine, to assess their effectiveness in stopping or killing cancer cells. Different groups receive various combinations of these drugs to identify the most effective approach. The trial is suitable for individuals who have completed standard radiation therapy with temozolomide and show no signs of cancer progression on recent scans. As a Phase 1 trial, the research focuses on understanding how the treatment works in people.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop all current medications, but if you are on enzyme-inducing anticonvulsants, you will need to stop them and wait for 2 weeks before starting the trial. Also, if you are on any of the study drugs already, you cannot join the trial for that specific drug.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Earlier studies have found temozolomide safe for patients over 65, helping them live longer when used after radiation therapy for glioblastoma, a type of brain cancer. In a study of 932 patients, a small number over 70 experienced serious blood-related side effects. While temozolomide works well, its safety for children remains unconfirmed.
Research indicates that adding metformin to temozolomide for glioblastoma treatment is generally safe and might extend patient survival compared to using temozolomide alone. Metformin is considered safe even for those without diabetes.
Memantine, often used for brain health, has been safely combined with temozolomide in past trials. Mefloquine, which increases cancer cells' sensitivity to treatment, has also proven safe when used with temozolomide and other drugs for glioblastoma.
Overall, these drug combinations are being tested to ensure safety and effectiveness. The goal is to find the best dose that patients can handle while maximizing treatment benefits.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for glioblastoma because they combine temozolomide, a standard chemotherapy drug, with other agents like memantine hydrochloride, metformin, and mefloquine. These combinations aim to enhance the effectiveness of temozolomide by targeting different pathways involved in tumor growth and resistance. For instance, metformin is primarily a diabetes drug but may help in reducing cancer cell energy production, while memantine is typically used for Alzheimer's and might protect brain function during treatment. Mefloquine, an anti-malarial, could potentially disrupt cancer cell membranes. By combining these agents, the treatments might overcome the limitations of current options, potentially leading to better outcomes for patients.
What evidence suggests that this trial's treatments could be effective for glioblastoma?
Research has shown that combining temozolomide with radiation therapy extends the lives of glioblastoma patients more than radiation alone. This trial tests different treatment combinations. Some participants will receive temozolomide with memantine and metformin, which studies suggest might improve survival rates. Others will receive temozolomide with mefloquine, as adding mefloquine could make cancer cells more responsive to treatment. Early trials indicated that these drugs can be safely combined and may increase the chances of destroying more tumor cells.16789
Who Is on the Research Team?
Vinay Puduvalli, MD
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with glioblastoma or gliosarcoma who've finished radiation therapy. They must have a decent performance status, stable blood counts, normal liver and kidney function, and no progressive disease post-treatment. Women should not be pregnant and all participants must agree to use effective contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Radiation
Participants complete external beam radiotherapy in combination with chemotherapy for newly diagnosed glioblastoma multiforme
Treatment
Participants receive temozolomide and a combination of memantine, mefloquine, and/or metformin as post-radiation adjuvant therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Mefloquine
- Memantine Hydrochloride
- Metformin Hydrochloride
- Temozolomide
Temozolomide is already approved in European Union, United States for the following indications:
- Newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and subsequently as monotherapy treatment
- Children from the age of three years, adolescents and adults with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy
- Newly diagnosed glioblastoma concomitantly with radiotherapy and subsequently as monotherapy treatment
- Newly diagnosed or refractory anaplastic astrocytoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator