Study on Abemaciclib for Patients with Recurrent Brain Tumors
Sponsor: Memorial Sloan Kettering Cancer Center
Sponsor score: 60
ClinicalTrials ID:NCT03220646
This clinical trial is testing the effects of a drug called abemaciclib on patients with brain tumors that have returned after previous treatment. The study aims to understand both the benefits and side effects of this medication.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to evaluate the effects of abemaciclib, a study drug, on patients with brain tumors that have come back after initial treatment. Researchers want to see how well the drug works and what side effects it might cause.
Eligibility Criteria
Inclusion Criteria
- For Cohort A: Patients with specific types of brain tumors (IDHwt, RB intact, grade II or III glioma) that have returned after initial treatment, including surgery and radiation. No limit on previous treatments.
- For Cohort B: Patients with any grade of glioma who are scheduled for surgery and whose participation won't delay their surgery.
- For Cohort C: Patients with certain types of brain tumors (IDH mutant glioma, meningioma, schwannoma, PCNSL, ependymoma) that have returned after standard treatment. Special cases may be considered for inclusion.
- All patients must be 18 years or older, able to swallow pills, and in good enough health to participate (KPS score of 60 or higher).
- Must have specific blood test results and be stable on any steroid medication for more than 5 days before the study starts.
- Must have recovered from previous treatments and be able to undergo MRI or CT scans.
- Women of childbearing potential must have a negative pregnancy test and agree to use contraception during and after the study. Men must also agree to use birth control.
- Must provide informed consent and be willing to follow the study schedule.
Exclusion Criteria
- No limit on previous treatments.
- Cannot have significant bleeding in the brain.
- Cannot be on other cancer treatments.
- Cannot have allergies to similar drugs or serious medical conditions that would interfere with the study.
- Cannot have a history of certain heart conditions or be HIV-positive on antiretroviral therapy.
- Cannot have active fungal or viral infections.
- Cannot be on certain medications or be pregnant or breastfeeding.
- Must avoid grapefruit juice.
- Cannot have another active cancer or be in another treatment trial, except for supportive care or quality of life studies.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Hartford Healthcare Cancer Institute @ Hartford Hospital (Data collection only) | 06102 | Hartford | Connecticut |
| Memorial Sloan Kettering Basking Ridge (All Protocol Activities) | 07920 | Basking Ridge | New Jersey |
| Memorial Sloan Kettering Monmouth (All Protocol Activities) | 07748 | Middletown | New Jersey |
| Memorial Sloan Kettering Bergen (All Protocol Activities) | 07645 | Montvale | New Jersey |
| Memorial Sloan Kettering Commack (All Protocol Activities) | 11725 | Commack | New York |
| Memorial Sloan Kettering Westchester (All Protocol Activities) | 10604 | Harrison | New York |
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | 10065 | New York | New York |
| Lehigh Valley Health Network | 18103 | Allentown | Pennsylvania |
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