144 Participants Needed

Drug Combination for Glioblastoma

Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase I trial studies the side effects and best dose of combination chemotherapy in treating patients with glioblastoma multiforme after radiation therapy. Drugs used in chemotherapy, such as temozolomide, memantine hydrochloride, and metformin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing them or stopping them from dividing. Mefloquine may help temozolomide, memantine hydrochloride, and metformin hydrochloride kill more cancer cells by making tumor cells more sensitive to the drug. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

Who Is on the Research Team?

Vinay K. Puduvalli | MD Anderson Cancer ...

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

Women of childbearing potential must have a negative serum or urine beta-human chorionic gonadotropin (B-HCG) pregnancy test documented within 72 hours of start of therapy
I completed my chemoradiation treatment less than 5 weeks ago.
All patients must sign an informed consent indicating awareness of the investigational nature of the study and be registered prior to treatment with study drug
See 6 more

Exclusion Criteria

Patients with significant medical illnesses that cannot be adequately controlled with therapy or would compromise tolerance to treatment
I am currently being treated with a drug involved in the study.
My heart's electrical activity is normal, with no long QT interval or irregular rhythms.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants complete external beam radiotherapy in combination with chemotherapy for newly diagnosed glioblastoma multiforme

6 weeks

Treatment

Participants receive temozolomide and a combination of memantine, mefloquine, and/or metformin as post-radiation adjuvant therapy

24 months
Courses repeat every 28 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

Ongoing every 3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Mefloquine
  • Memantine Hydrochloride
  • Metformin Hydrochloride
  • Temozolomide
Trial Overview The study tests the safety and optimal doses of temozolomide combined with memantine hydrochloride, mefloquine, and metformin hydrochloride in treating brain tumors after radiation. It aims to see if this drug combo can make cancer cells more sensitive to treatment.
How Is the Trial Designed?
8Treatment groups
Experimental Treatment
Group I: Arm 8 (TMZ, memantine hydrochloride, metformin, mefloquine)Experimental Treatment4 Interventions
Group II: Arm 7 (temozolomide, mefloquine, metformin hydrochloride)Experimental Treatment3 Interventions
Group III: Arm 6 (temozolomide, memantine hydrochloride, metformin)Experimental Treatment3 Interventions
Group IV: Arm 5 (temozolomide, memantine hydrochloride, mefloquine)Experimental Treatment3 Interventions
Group V: Arm 4 (temozolomide, metformin hydrochloride)Experimental Treatment2 Interventions
Group VI: Arm 3 (temozolomide, mefloquine)Experimental Treatment2 Interventions
Group VII: Arm 2 (temozolomide, memantine hydrochloride)Experimental Treatment2 Interventions
Group VIII: Arm 1 (temozolomide)Experimental Treatment1 Intervention

Temozolomide is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as Temodal for:
🇺🇸
Approved in United States as Temodar for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+
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