Abemaciclib (LY2835219) in Patients With Recurrent Primary Brain Tumors

  • STATUS
    Recruiting
  • End date
    Jul 20, 2022
  • participants needed
    78
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 20 June 2021
corticosteroids
tyrosine
nitrosoureas
meningioma
ependymoma
growth factor
neutrophil count
bevacizumab
temozolomide
tumor progression
recurrent brain tumors
primary brain tumors

Summary

The purpose of this study is to test any good and bad effects of a study drug called abemaciclib (LY2835219) in patients with recurrent brain tumors.

Details
Condition Malignant neoplasm of brain, Brain Tumor (Pediatric), Brain Cancer, Brain Tumor, brain tumors
Treatment Abemaciclib
Clinical Study IdentifierNCT03220646
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on20 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Cohort A specific inclusion
Histologically confirmed IDHwt, RB intact, grade II or III glioma that has recurred after first line therapy (consisting of at least maximum feasible surgical resection and radiation therapy). There is no limit on the number of prior therapies or types of therapies patients can have received
Measurable disease on imaging (1cm) or measurable non-enhancing tumor
At least 12 weeks elapsed since prior radiotherapy
Cohort B specific inclusion
Patients with histologically confirmed glioma of any grade (II-IV) who are planned for a standard of care surgical debulking/resection and for whom participation in this study would not cause a medically unacceptable delay in surgery
Patients must have relapsed/progressed following therapy (consisting of at least maximum feasible surgical resection and radiation therapy)
Cohort C specific Inclusion
Histologically confirmed IDH mutant glioma, meningioma, schwanomma, PCNSL, ependymoma, or other Primary Brain Tumors that have recurred despite previous standard of care therapy. Because this cohort is, in part, meant to allow patients access to therapy who might not otherwise be eligible for other clinical trials - deviations from standard of care treatment or histological confirmation can be presented to and approved by the Principal Investigator for inclusion in the study
Histologically confirmed PCNSL that has recurred after prior methotrexate-based chemotherapy or for whom methotrexate-based chemotherapy is deemed medically not in the patient's best interest
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
All cohorts
Patients must provide written informed consent prior to any screening procedures
Age 18 years or older
KPS 60
Willing and able to comply with scheduled visits, treatment plan and laboratory tests
Patient is able to swallow and retain oral medication
Required baseline laboratory status
Hemoglobin > 8 g/dL (SI Units: 80 g/L). Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion
Platelet count 100 x 10^9/L
Absolute neutrophil count (ANC) 1.5 x 10^9/L without growth factor support
Total bilirubin 1.5 x upper limit of normal (ULN)
AST/SGOT and/or ALT/SGPT 3 x ULN
Serum Creatinine 1.5 x ULN
Stable dose of corticosteroids for > 5 days prior to baseline MRI
Before starting study treatment, patients must have recovered from toxic effects of prior therapies (except for residual alopecia or Grade 2 peripheral neuropathy) and at least 3 weeks must have elapsed since any prior signaling pathway modulators, (e.g., EGFR, FGFR, or other tyrosine kinase inhibitors), at least 3 weeks must have elapsed since temozolomide, 4 weeks must have elapsed since carboplatin or cisplatin, and at least 6 weeks from nitrosoureas (e.g., BCNU, CCNU). In general, at least 4 weeks must have elapsed from any other anticancer drug therapy (e.g. bevacizumab)
Patients must be able to undergo contrast enhanced MRI scans (or contrast enhanced CT scans for patients unable to tolerate MRI)
Patients must have shown unequivocal evidence for tumor progression by MRI (or CT for patients who cannot tolerate MRI) in comparison to a prior scan. The same type of scan, i.e., MRI (or CT for patients who cannot undergo MRI) must be used throughout the period of protocol treatment for tumor measurement
Life expectancy of greater than 8 weeks
If a female of childbearing potential, must have a negative serum pregnancy test within 7 days of the first dose of abemaciclib and agree to use a medically approved contraceptive method during the treatment period and for 3 months following the last dose of abemaciclib. If a male, agree to use a reliable method of birth control and to not donate sperm during the treatment period and for at least 3 months following the last dose of abemaciclib. Contraceptive methods may include an intrauterine device [IUD] or barrier method. If condoms are used as a barrier method, a spermicidal agent should be added as a double barrier protection
Note: Cases of pregnancy that occur during maternal exposures to abemaciclib
should be reported. If a patient or spouse/partner is determined to be
pregnant following abemaciclib initiation, she must discontinue treatment
immediately. Data on fetal outcome and breast-feeding are collected for
regulatory reporting and drug safety evaluation
Women must agree not to breast feed while on abemaciclib treatment and for at least three months following the last dose of study therapy

Exclusion Criteria

No limit on number of prior therapies
Evidence of significant intracranial hemorrhage
No other investigational or standard anti-tumor therapy allowed
Patients must not have a known history of allergic reactions attributed to compounds of similar chemical or biologic composition
Patients must not have a serious preexisting medical condition(s) or uncontrolled intercurrent illness that would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea) or psychiatric illness/social situations that would limit compliance with study requirements
Patients who have a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological original (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest
HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions. This applies only to patients who have a documented history of HIV; HIV testing is not otherwise required
Have an active systemic fungal and/or known viral infection (for example, human immunodeficiency virus antibodies, hepatitis B surface antigen, or hepatitis C antibodies)
Patients must not be on EIAEDs
Females who are pregnant or lactating
Must abstain from grapefruit juice
Patients must not have other active concurrent malignancy
Concurrent treatment on another clinical trial. Supportive care trials or non-therapeutic trials (i.e. Quality of life) are allowed
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