NCT03122197 Study of Letrozole in Recurrent Gliomas
| NCT ID | NCT03122197 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of Cincinnati |
| Condition | Brain Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 39 participants |
| Start Date | 2017-05-16 |
| Primary Completion | 2027-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 39 participants in total. It began in 2017-05-16 with a primary completion date of 2027-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to determine the ability of letrozole to penetrate the blood brain barrier and concentrate in gliomas.
Eligibility Criteria
Inclusion Criteria 1. Radiographically, histologically or cytologically confirmed recurrent brain high grade glioma with plan for resection or biopsy. \- Inclusion #1 for Sub-study Only: Radiographically, histologically or cytologically confirmed recurrent brain high grade glioma. 2. Age \>18 years. 3. ECOG performance status 0 -2 (Karnofsky \>60%, see Appendix A). 4. CBC/differential obtained within 28 days prior to registration on study, with adequate bone marrow function defined as follows: * Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3; * Platelets ≥ 100,000 cells/mm3; * Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable). 5. Adequate hepatic function, defined as follows: * Total bilirubin \< 2 x institutional ULN within 14 days prior to registration; * AST or ALT \< 3 x institutional ULN within 14 days prior to registration. 6. Adequate renal function, defined as GFR \> 30 ml/min or Cr \< 1.5. 7. Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential. 8. Imaging prior to treatment including MRI of brain (with contrast preferred but not required). 9. Ability to understand and the willingness to sign a written informed consent document. 10. Inclusion #10 for Sub-study Only: Measurable disease per RANO criteria within 28 days of starting treatment on this study. Exclusion Criteria 1. Patients may not be receiving any other investigational agents. 2. History of allergic reactions attributed to letrozole or other agents used in study. Exclusion #2 for Sub-study Only: History of allergic reactions attributed to letrozole or TMZ. 3. Uncontrolled intercurrent illness including, but not limited to, ongoing significant or serious active cardiovascular disease (CHF exacerbation, unstable angina or MI in last 6 months), or infection including the diagnosis of AIDS or active hepatitis B or C infection, or psychiatric illness or medical or personal conditions that in the opinion of the investigator would limit the patient's ability to participate. 4. Patients attempting to conceive, and pregnant or nursing women are excluded from this study.
Contact & Investigator
Trisha Wise-Draper, MD, PhD
PRINCIPAL INVESTIGATOR
University of Cincinnati
Frequently Asked Questions
Who can join the NCT03122197 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Brain Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03122197 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03122197 currently recruiting?
Yes, NCT03122197 is actively recruiting participants. Contact the research team at cancer@uchealth.com for enrollment information.
Where is the NCT03122197 trial being conducted?
This trial is being conducted at Cincinnati, United States.
Who is sponsoring the NCT03122197 clinical trial?
NCT03122197 is sponsored by University of Cincinnati. The principal investigator is Trisha Wise-Draper, MD, PhD at University of Cincinnati. The trial plans to enroll 39 participants.