What side effects are associated with this type of intervention?

Common treatments for brain tumors, particularly those involving CDK4/6 inhibitors like Abemaciclib, often include chemotherapy, radiation therapy, and targeted therapies. Known side effects of these treatments can include myelosuppression (decreased bone marrow activity leading to fewer blood cells), fatigue, gastrointestinal issues (nausea, vomiting, diarrhea), and increased risk of infections. Specific to CDK4/6 inhibitors, side effects may also include neutropenia (low levels of neutrophils), liver enzyme abnormalities, and gastrointestinal disturbances. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for brain tumors, though specific approvals for CDK4/6 inhibitors like Abemaciclib are limited. One notable CDK4/6 inhibitor, trilaciclib, is approved for reducing chemotherapy-induced myelosuppression in extensive-stage small cell lung cancer, but not specifically for brain tumors. Other treatments for brain tumors include temozolomide, bevacizumab, and various investigational therapies such as ONC201 and DNX-2401, which are under active investigation for their efficacy in treating recurrent high-grade gliomas and diffuse intrinsic pontine glioma.

What other types of research exist?

Promising alternatives to Abemaciclib for brain tumor patients include Bevacizumab, which has shown efficacy in treating vestibular schwannomas and glioblastomas, and Everolimus, which has been effective in treating neurofibromatosis type 2-related schwannomatosis and meningiomas. Additionally, immune checkpoint inhibitors like Nivolumab and Pembrolizumab have shown potential in treating high-grade gliomas and recurrent meningiomas.

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CDK4/6 Inhibitor

Abemaciclib for Brain Cancer

Phase 2

Waitlist Available

Led By Thomas Kaley, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Glioma patients: Standard of care next generation sequencing via a CLIA certified platform must be available, or planned and at a minimum include IDH, and RB status

Patients must be able to undergo contrast enhanced MRI scans (or contrast enhanced CT scans for patients unable to tolerate MRI) and have shown unequivocal evidence for tumor progression by MRI (or CT for patients who cannot tolerate MRI) in comparison to a prior scan

Must not have

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

HIV-positive patients on combination antiretroviral therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a drug called abemaciclib in patients whose brain tumors have come back after treatment. The drug aims to stop the growth of cancer cells by blocking certain proteins that help them multiply. Researchers want to see both the positive and negative effects of this treatment. Abemaciclib is used primarily for treating metastatic breast cancer.

Who is the study for?

This trial is for adults with recurrent brain tumors, specifically IDH wildtype and RB intact gliomas or other primary brain tumors. Participants must have had prior therapy, be able to swallow pills, consent to use birth control, and not be on certain medications or have specific health conditions that could interfere with the study.

What is being tested?

The trial is testing abemaciclib (LY2835219) effects on patients with recurrent brain tumors. It aims to understand both the potential benefits and adverse reactions of this drug in individuals who have seen their tumor return after initial treatment.

What are the potential side effects?

While not explicitly listed here, side effects may include typical reactions to cancer drugs such as nausea, fatigue, blood count changes, liver function alterations, and potential risks related to fertility for both men and women.

Eligibility Criteria

Inclusion Criteria

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

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My glioma has been or will be tested for specific genetic changes.

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I can have MRI or CT scans, and my scans show my tumor is growing.

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I have a glioma that has worsened after treatment and am scheduled for surgery.

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I am over 18, can take pills, follow a treatment plan, and my lab results meet the study's needs.

Exclusion Criteria

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

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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 am HIV-positive and on antiretroviral therapy.

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I am taking enzyme-inducing anti-epileptic drugs.

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I am not pregnant or breastfeeding.

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I do not have any other active cancer.

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I am not currently receiving any other cancer treatment.

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I have an active fungal or viral infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

progression free survival (PFS)

radiographic response rate

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: C:All other recurrent brain tumorsExperimental Treatment1 Intervention

This is an exploratory cohort including patients with recurrent IDH mutant glioma, meningioma, recurrent ependymoma, and recurrent PCNSL,and other primary brain tumors.

Group II: B:Recurrent glioma any gradeExperimental Treatment1 Intervention

Ten patients who require standard of care cytoreductive surgery for recurrent astrocytoma, oligodendroglioma, or glioblastoma, will be offered pre-surgical abemaciclib and then resume the drug following recovery from surgery, continuing until disease progression or unacceptable toxicity analogous to the non-surgical patients in cohort A and C. This arm is closed to accrual.

Group III: A:recurrent IDH wildtype RB1 intact grade II and III gliomasExperimental Treatment1 Intervention

The main study cohort will consist of patients with recurrent IDH wildtype, RB1 wildtype, WHO grade II and III gliomas that have failed previous therapy. This arm is currently on hold.

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for brain tumors include chemotherapy, radiation therapy, and targeted therapies such as CDK4/6 inhibitors. Chemotherapy, like temozolomide, works by damaging the DNA of cancer cells, preventing their replication. Radiation therapy uses high-energy rays to kill or damage cancer cells in a targeted area. CDK4/6 inhibitors, such as Abemaciclib, block proteins (CDK4 and CDK6) that are essential for cell division, thereby slowing the growth of cancer cells. These treatments are crucial for brain tumor patients as they target the rapid and uncontrolled cell division characteristic of tumors, potentially improving survival rates and quality of life.