Recruiting
Phase 2

Radiation with Raloxifene & Memantidine

Sponsor:

The University of Texas Health Science Center at San Antonio

Code:

NCT07470606

Conditions

Brain Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Memantine

Raloxifene

Study Details

Brief summary:

The study investigators are testing to see if patients receiving radiation treatment for brain cancer along with raloxifene plus memantidine take longer to develop memory issues.

The study will include anyone over the age of 18 who will be treated with radiation for brain cancer.

Conditions

Brain Tumor

Study ID

NCT07470606

Start date

Jul 6, 2026

Status verified date

Sep, 2026

Completion date

Jul, 2031

Anticipated

Primary completion date

Jul, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age ≥ 18 years.
2. Ability to provide informed written consent in either English or Spanish.
3. All individuals of childbearing potential must have a negative serum pregnancy test and male and female subjects must agree to use effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an Intrauterine device (IUD)) with their partner from entry into the study through 24 weeks after the last dose of Raloxifene.
4. Patients undergoing radiation therapy to the brain as a part of solid tumor cancer therapy, using intensity modulated radiation therapy (IMRT) or whole brain radiation therapy (WBRT).Willingness to adhere to planned study drug regimen, including obtaining medication from an outside pharmacy via prescription.
5. Patients must have a creatinine clearance ≥ 50 mL/min (using Cockcroft-Gault Equation).
6. Patients must not have hepatic impairment greater than Child-Pugh Score "Class A".

Exclusion Criteria:

1. History of prior radiotherapy to the brain.
2. Life expectancy of < 6 months.
3. Radiation Therapy planned is ≤ 5 fractions (e.g.stereotactic radiosurgery (SRS)or Steriotactic radiotherapy (SRT), or 5-fraction whole brain).
4. Contraindications to taking memantine and/or raloxifene based on package inserts and the clinical judgement of the treating physician .
5. The subject is unable to undergo magnetic resonance imaging (MRI) scan (e.g., has an MRI incompatible pacemaker).
6. Conditions or situations which, in the opinion of the investigator, imply the patient will be unable or not suitable to complete trial requirements or at excessive risk from trial participation.
7. Known allergy to either of the medications (Memantine or Raloxifene) used in this study or their excipients.
8. Cognitive failure as assessed by Mini Mental State Exam (MMSE) score <17

Study Design

Enrollment

108 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Group A: Standard of Care

Patients will start Memantine as SOC around the time of radiation. Memantine may be continued as SOC as prescribed by the treating physician after the 24 weeks.

experimental: Group B: Standard of Care plus raloxifene

Patients will start Memantine as SOC around the time of radiation. Memantine may be continued as SOC as prescribed by the treating physician after the 24 weeks.

If randomized to group B patients will be recommended to start the assigned Raloxifene at least one week before their anticipated RT treatment start date.

Interventions

Memantine

The goal dose for Immediate Release Memantine is 10 mg oral twice daily. The goal-dose for Extended-Release Memantine is 21 mg daily.

Raloxifene

Raloxifene will be administered at 120mg orally every day

Primary outcome measure

  • Hippocampal volume changes [ Time Frame: Baseline to 48 weeks ]

Central Contacts and Locations

Central contacts

Andrew J Brenner, MD, PhD

210-562-4090brennera@uthscsa.edu

Eva M Galvan, MD

210-450-1093GalvanE@uthscsa.edu

Locations

Mays Cancer Center, UT Health San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Kayla Chamberlin

210-450-5964chamberlink@uthscsa.edu

Principal Investigator:

Andrew J Brenner, MD, PhD

More Information

Sponsor

The University of Texas Health Science Center at San Antonio

Last update posted

Sep 22, 2026

Last verified

Sep, 2026

Keywords

  • Radiation therapy
  • Solid tumor cancer
  • Intensity modulated radiation therapy (IMRT)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio on 2026-09-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.