Temozolomide, Memantine Hydrochloride, Mefloquine, and Metformin Hydrochloride in Treating Patients With Glioblastoma Multiforme After Radiation Therapy

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01430351
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mefloquine — DRUG
    Given PO
  • Memantine Hydrochloride — DRUG
    Given PO
  • Metformin Hydrochloride — DRUG
    Given PO
  • Temozolomide — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Sep 14, 2011
Status verified
May 2025
Primary completion
Feb 2, 2025
Completion
Feb 2, 2025

Study Design

Enrollment
144 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1 (temozolomide)
    Patients receive temozolomide PO QD on days 1-5.
  • Experimental: Arm 2 (temozolomide, memantine hydrochloride)
    Patients receive temozolomide PO as in Arm 1 and memantine hydrochloride PO BID.
  • Experimental: Arm 3 (temozolomide, mefloquine)
    Patients receive temozolomide PO as in Arm 1 and 30 mg mefloquine PO QD on days 1-3 of week 1 and then days 2, 4, and 6 every other week.
  • Experimental: Arm 4 (temozolomide, metformin hydrochloride)
    Patients receive temozolomide PO as in Arm 1 and metformin hydrochloride PO BID.
  • Experimental: Arm 5 (temozolomide, memantine hydrochloride, mefloquine)
    Patients receive temozolomide PO and memantine hydrochloride PO BID as in Arm 2, and mefloquine PO QD as in Arm 3.
  • Experimental: Arm 6 (temozolomide, memantine hydrochloride, metformin)
    Patients receive temozolomide PO and memantine hydrochloride PO BID as in Arm 2, and metformin hydrochloride PO BID as in Arm 4.
  • Experimental: Arm 7 (temozolomide, mefloquine, metformin hydrochloride)
    Patients receive temozolomide PO as in Arm 1, mefloquine PO QD as in Arm 3, and metformin hydrochloride PO BID as in Arm 4.
  • Experimental: Arm 8 (TMZ, memantine hydrochloride, metformin, mefloquine)
    Patients receive temozolomide PO and memantine hydrochloride PO BID as in Arm 2, metformin hydrochloride PO BID as in Arm 4, and mefloquine PO QD as in Arm 3.

Primary Outcome Measure

Incidence of toxicities graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: During first 28 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

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By specialty
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