Ibrutinib With Radiation and Temozolomide in Patients With Newly Diagnosed Glioblastoma

STATUS

Recruiting
End date

Dec 21, 2022
participants needed

36
sponsor

Case Comprehensive Cancer Center

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Updated on 21 March 2022

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cancer

MRI

neutrophil count

aptt

temozolomide

methylated

combined modality therapy

stereotactic biopsy

Summary

Safety of combination of ibrutinib and radiation at various dose levels in unmethylated o6-methylguanine-DNA-methyltransferase (MGMT) glioblastoma and study of ibrutinib, temozolomide, and radiation combination therapy in methylated MGMT glioblastoma.

Description

There are a number of brain tumor studies including those in NCI consortium that are not including temozolomide for increased toxicity with novel agents or other drugs when added to temozolomide and radiation. However, if the combination of ibrutinib and radiation in unmethylated MGMT glioblastoma patient population is safe at every dose level we can study the safety of ibrutinib, radiation and Temozolomide in the methylated patient population. Concomitant use of radiation will lead to break down of the blood brain barrier and increase ibrutinib delivery to the brain tumor and hence the rationale to combine ibrutinib with radiation with or without temozolomide.

November 2020:

420 mg of ibrutinib plus temozolomide and radiation was found to be safe - up to 36 participants can be treated at the expansion cohort in both arm 1 and arm 2.

Details

Condition	Glioblastoma
Treatment	Ibrutinib, Radiation, Temozolomide (TMZ)
Clinical Study Identifier	NCT03535350
Sponsor	Case Comprehensive Cancer Center
Last Modified on	21 March 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Arm 1
	Supratentorial unmethylated MGMT glioblastoma
	Gadolinium MRI or contrast CT within 28 days of starting treatment
	Karnofsky performance ≥ 70% (<http://www.npcrc.org/files/news/karnofsky_performance_scale.pdf>)
	Absolute neutrophil count > 1500/mm3, platelets > 100,000/mm3, Creatinine ≤ 1.7 mg/dl, total bilirubin ≤ 1.5mg/dl, transaminases ≤ 3 times above the upper limits of normal
	Must be able to provide written informed consent
	Patients of reproductive potential must use an acceptable form of birth control to avoid contraception during the period of therapy and up to 90 days after the last dose of study drug. (eg. implants, injectable, oral contraceptives, intrauterine device (IUD), abstinence, and a barrier method which includes, but is not limited to condoms, vaginal rings, and sponges)
	Female patients must have a negative pregnancy test upon study entry
	No concurrent malignancy with the exception of curatively treated early stage bladder and prostate cancer, basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix and breast, adequately treated stage I or II cancer from which the patient is in complete remission. Any other prior malignancies must be disease free for ≥ 3 years
	Prothrombin time (PT) / international normalized ratio (INR) < 1.5 x upper limit of normal (ULN) and partial thromboplastin time (PTT) (aPTT) < 1.5 x ULN
	Patient with any surgery more than stereotactic biopsy are eligible so that there is enough tissue for MGMT analysis
	Arm 2
	Arm 1 inclusion criteria must be met with the exception of the histology of the cancer, which must be methylated MGMT glioblastoma
Exclusion Criteria
	Serious concurrent infection or illness
	Patients who are pregnant or breastfeeding
	Patients receiving concurrent therapy for their tumor
	Concurrent or prior malignancy unless curatively treated carcinoma-in-situ or basal cell carcinoma of the skin
	Repeat craniotomy for tumor therapy after receiving radiation and TMZ treatment
	Patients who received other chemotherapy or investigational agents in addition to radiation therapy and accompanying TMZ treatment
	Previous ibrutinib or other Bruton's tyrosine kinase (BTK) inhibitor use or allergies to components of the study drug
	Use of anticoagulants (including warfarin, other coumadin-derivative anticoagulant, vitamin K antagonists, or low molecular weight heparin)
	Use of drugs known to be moderate and strong inhibitor or inducers of the P450 isoenzyme CYP3A. Participants must be off P450/CYP3A inhibitors and inducers for at least a week prior to starting the study drug
	Active, significant liver impairment (Child-Pugh class B or C)
	Patient is using systemic immunosuppressant therapy, including cyclosporineA, tacrolimus, sirolimus, and other such medications, or chronic administration of > 5 mg/day or prednisone or the equivalent.Participants must be off of immunosuppressant therapy for at least 21days prior to the first dose of the study drug. Patients can be on steroids for brain edema
	Significant EKG abnormalities and active and significant cardiovascular disease within 6 months of screening
	Pregnant or breastfeeding women. Male patients that intend to father a child while enrolled or 90 days after the last dose of the study drug
	Unwillingness to comply with the protocol
	Uncontrolled, active systemic infection
	Major surgery within 4 weeks of first dose of study drug
	Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug
	Recent infection requiring systemic treatment that was completed ≤ 14 days before the first dose of study drug
	Known bleeding disorders

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Ibrutinib With Radiation and Temozolomide in Patients With Newly Diagnosed Glioblastoma