Early Phase 1 Brain Cancer Trial, Recruiting NCT03122197 Sponsor: University of Cincinnati Condition: Brain Cancer
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Early Phase 1 Brain Cancer Trial, Recruiting

NCT03122197
Recruiting Early Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Your brain tumor (high-grade glioma) has come back, and this has been confirmed by a scan, tissue sample, or cell sample — and there is a plan for surgery or biopsy (or, for a sub-part of the trial, surgery or biopsy may not be required).
  • You are older than 18 years of age.
  • You are fairly active and able to carry out daily activities with little or no difficulty (your doctor can assess this using a standard scale).
  • A recent blood test (within the past 28 days) shows your bone marrow is working well enough — meaning your infection-fighting cells, clotting cells, and red blood cells are all above certain minimum levels.
  • Your liver is working well enough, based on blood tests taken within the past 14 days showing certain liver-related levels are not too high.
  • Your kidneys are working well enough, based on a blood test or measurement of kidney function.
  • If you are a woman who could become pregnant, you have had a negative pregnancy test within the past 2 weeks before joining the trial.
  • You have had a brain scan (MRI, ideally with contrast dye) before starting treatment.
  • You are able to understand the trial information and are willing to sign a consent form agreeing to take part.
  • For a sub-part of the trial only: Your tumor can be measured on a scan taken within 28 days of starting treatment (confirm with trial site).

Who may not be able to join:

  • You are currently taking part in another clinical trial involving an experimental treatment.
  • You have had a serious allergic reaction to letrozole or other medicines used in this trial (for the sub-part of the trial, this includes a medicine called TMZ/temozolomide).
  • You have a serious uncontrolled illness, such as a recent heart attack or unstable heart condition in the last 6 months, a serious active infection, HIV/AIDS, active hepatitis B or C, or a mental health or personal condition that the trial doctor feels would make it difficult for you to take part safely.
  • You are currently pregnant, breastfeeding, or actively trying to become pregnant.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

Contact this trial

Principal Investigator: Trisha Wise-Draper, MD, PhD, University of Cincinnati

Phone: 513-584-7698

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Early Phase 1
Sponsor
University of Cincinnati
Registry
ClinicalTrials.gov
Start date
16 May 2017
Est. completion
1 September 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Overall Letrozole AUC in tumor tissue.; Progression free survival in letrozole and temozolomide combination

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov