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CDK4/6 Inhibitor

Abemaciclib + Temozolomide for Brain Cancer

Phase 1

Recruiting

Led By Sadhana Jackson, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants with cortical high grade gliomas must have previous intra-operative pathology confirming disease

Ability to swallow tablets/pills

Must not have

Active systemic bacterial infection, fungal infection, or detectable viral infection

Personal history of syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin, or sudden cardiac arrest

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 years post-enrollment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether abemaciclib can help treat brain tumors by measuring the drug's levels in participants' brain tumors and brain fluid.

Who is the study for?

This trial is for young adults aged 18 to 39 with recurrent high-grade glioma or diffuse midline glioma. They must have recovered from previous treatments, have good organ function, and not be pregnant. Participants should be able to swallow pills and avoid grapefruit during the study.

What is being tested?

The trial tests if abemaciclib levels can be measured in brain tumors and fluid after intake. It involves taking abemaciclib orally, surgery for tumor biopsy or resection, and cerebral fluid collection via a catheter. If effective, participants may continue treatment with abemaciclib plus temozolomide.

What are the potential side effects?

Potential side effects of abemaciclib include nausea, vomiting, diarrhea, blood disorders like low white cell count (increasing infection risk), liver issues indicated by abnormal enzyme levels in the blood, fatigue due to anemia (low red cell count), and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My high-grade brain tumor was confirmed by tests during surgery.

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I can swallow pills.

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I finished radiotherapy at least 14 days ago and have recovered from its immediate effects.

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I can do most of my daily activities by myself.

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I agree to use effective birth control during and after the study as required.

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My cancer is a high grade or midline glioma that has come back.

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I am between 18 and 39 years old.

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I have never been treated with abemaciclib or similar medications.

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I have recovered from chemotherapy side effects, except for hair loss or mild nerve damage.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any active infections.

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I have a history of fainting due to heart issues, irregular heartbeats, or sudden cardiac arrest.

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I have severe nausea and vomiting that could interfere with taking medication.

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I cannot safely have a biopsy due to health risks.

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I do not have any severe illnesses that would stop me from following the study's requirements.

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I need medication that affects liver enzymes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 years post-enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 years post-enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years post-enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

adverse events

concentration of abemaciclib

intra-tumoral sampling adequacy

Secondary study objectives

relationship between abemaciclib PK and PD studies on subsequent treatment and participant outcome

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 1/Abemaciclib and microdialysis monitoringExperimental Treatment4 Interventions

Abemaciclib orally BID for 4.5 days followed by resection or biopsy and microdialysis catheter placement with continuous monitoring for 48 hours post-operative and genomic sampling of tissue/blood; followed by abemaciclib+temozolomide maintenance therapy

0 / 15Eligibility criteria met