Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Letrozole Oral Tablet

    Drug

    Administration: Letrozole will be given orally once daily.

  • Temozolomide

    Drug

    50 mg/m2 TMZ administered orally once daily

Treatment groups

39 Participants
are divided into 3 treatment groups
Group A: LetrozoleExperimental treatment 1 intervention
Group B: Letrozole and temozolomideExperimental treatment 2 interventions
Group C: Previously Received letrozole and temozolomideExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Overall Letrozole AUC in tumor tissue.

Pharmacokinetic modeling will be used to determine the overall AUC in the tumor tissue to assess for letrozole penetration through blood brain barrier.

Time frame
5 days
2

Progression free survival in letrozole and temozolomide combination

Sub-study expansion cohort only: Progression free survival using RANO criteria at 6 months from the start of the combination of 15 mg letrozole and 50 mg/m2 temozolomide.

Time frame
6 months

Secondary outcomes

1

Adverse Events

The number of patients with treatment related toxicity will be assessed using CTCAE v4.0

Time frame
The time patients remain on treatment until 30 days after treatment completed
2

Progression free Survival

Patients will be followed for response using RANO criteria to determine time from start of treatment to progression.

Time frame
From start of treatment until time of progression assessed up to 1 year
3

Overall Survival

Patients will be followed from start of treatment until time of death

Time frame
From start of treatment until time of death assessed up to 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Cincinnati

Lead sponsor

Source ClinicalTrials.gov
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