Study of Letrozole in Recurrent Gliomas
ConditionBrain Tumor
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Cincinnati
About this trial
The purpose of this study is to determine the ability of letrozole to penetrate the blood brain barrier and concentrate in gliomas.
Eligibility criteria
Qualifiers
Radiographically, histologically or cytologically confirmed recurrent brain high grade glioma with plan for resection or biopsy.
Age >18 years.
ECOG performance status 0 -2 (Karnofsky >60%, see Appendix A).
Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3;
Disqualifiers
Patients may not be receiving any other investigational agents.
History of allergic reactions attributed to letrozole or other agents used in study.
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.
Patients attempting to conceive, and pregnant or nursing women are excluded from this study.
Trial design
Treatments tested in this trial
- Letrozole Oral Tablet
- Temozolomide
Treatment groups
39 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov