Study on Abemaciclib for Treating Recurrent Glioblastoma
Sponsor: Dana-Farber Cancer Institute
ClinicalTrials ID:NCT02981940
This clinical trial is exploring the use of Abemaciclib, a targeted therapy, to treat glioblastoma that has returned after initial treatment. The study aims to determine if Abemaciclib is safe and effective for this type of brain cancer.
Patient Parameters
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Program Overview
This study is testing a drug called Abemaciclib to see if it can help treat glioblastoma, a type of brain cancer that has come back after treatment. Abemaciclib is not yet approved by the FDA for any disease, but it has shown promise in lab studies by entering the brain and slowing tumor growth. The study will look at how safe and effective Abemaciclib is for patients with this cancer.
Description
This clinical trial is in two phases: Phase 0 and Phase II. Phase 0 involves giving small doses of the drug to a few patients to see how it behaves in the body. Phase II tests the drug's safety and effectiveness in treating glioblastoma. Glioblastoma often involves too much of a protein called cyclin D1, which leads to tumor growth. Abemaciclib works by blocking enzymes that help tumors grow. In lab tests, it has slowed tumor growth in mice. The study will see if it can do the same in humans and if it reaches the brain tumor in patients who have surgery.
Eligibility Criteria
Inclusion Criteria
- Must be able to understand and sign a consent form.
- Must follow the study schedule and keep a medication diary.
- Must be 18 years or older.
- Must have a performance status score of 60 or higher, meaning able to care for oneself with some help.
- Must be able to swallow pills.
- Must have a confirmed diagnosis of glioblastoma or related brain tumors.
- Must provide genetic test results showing specific gene changes related to the cancer.
- Must be at the first relapse of glioblastoma after initial treatment.
- Must show tumor progression on MRI or CT scan.
- Must have enough tissue samples from previous surgeries for study tests.
- Must have recovered from previous treatments and meet specific blood test requirements.
- Women of childbearing potential must use birth control during and for 3 months after treatment. Men must use birth control and not donate sperm during and for 3 months after treatment.
Exclusion Criteria
- Cannot have certain genetic changes in the tumor.
- Cannot have had previous treatment with CDK4/6 inhibitors or certain other cancer drugs.
- Cannot be taking certain medications that affect the liver or interact with the study drug.
- Cannot have uncontrolled illnesses or infections.
- Cannot have a history of severe allergic reactions to similar drugs.
- Cannot have significant heart problems or recent heart attacks.
- Cannot have gastrointestinal issues that affect drug absorption.
- Cannot have had major surgery within 2 weeks before starting the study drug.
- Cannot be pregnant or breastfeeding.
- Cannot have a history of bleeding disorders or significant recent bleeding.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of California Los Angeles | 90095 | Los Angeles | California |
| University of California, San Francisco | 94143-0372 | San Francisco | California |
| Massachusetts General Hospital | 02114 | Boston | Massachusetts |
| Dana Farber Cancer Institute | 02115 | Boston | Massachusetts |
| Memorial Sloan-Kettering Cancer Center | 10021 | New York | New York |
| UT, M.D. Anderson Cancer Center | 77030 | Houston | Texas |
| Huntsman Cancer Institute | 84112 | Salt Lake City | Utah |
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