RECRUITING

Repeated Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab With Temozolomide and Radiation Compared to Temozolomide and Radiation Alone in Newly Diagnosed GBM

Conditions

Glioblastoma Glioblastoma Multiforme Glioma, Malignant GBM Brain Cancer Glioblastoma, IDH-wildtype Glioblastoma Multiforme, Adult

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Primary brain cancer kills up to 10,000 Americans a year. These brain tumors are typically treated by surgery, radiation therapy and chemotherapy, either individually or in combination. Present therapies are inadequate, as evidenced by the low 5-year survival rate for brain cancer patients, with median survival at approximately 12 months. Glioma is the most common form of primary brain cancer, afflicting approximately 7,000 patients in the United States each year. These highly malignant cancers remain a significant unmet clinical need in oncology. The investigators have completed a Phase I clinical trial that has shown that Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab (BV) is safe up to a dose of 15mg/kg in patients with recurrent malignant glioma. Additionally, the investigators have shown in a recently completed Phase I/II clinical trial, that SIACI BV improves the median progression free survival (PFS) from 4-6 months to 11.5 months and overall survival (OS) from 12-15 months to 23 months in patients with newly diagnosed GBM. Therefore, this two-arm, randomized trial (2:1) is a follow up study to these trials and will ask simple questions: Will this repeated SIACI treatment regimen increase progression free survival (PFS-primary endpoint) and overall survival (OS-secondary endpoint) when compared with standard of care in patients with newly diagnosed GBM? Exploratory endpoints will include adverse events and safety analysis as well as quality of life (QOL) assessments. The investigators expect that this project will provide important information regarding the utility of repeated SIACI BV therapy for newly diagnosed GBM and may alter the way these drugs are delivered to our patients in the near future.

Official Title

A Phase III Randomized Trial of Repeated Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab (Avastin) With Temozolomide and Radiation Compared to Temozolomide and Radiation Alone in Newly Diagnosed Glioblastoma (GBM)

Quick Facts

Study Start:2022-04-27

Study Completion:2028-04-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05271240

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Subject is a male or female 18 years of age or older. 2. Subject has a confirmed diagnosis of GBM according to the 2021 WHO Classification of Tumors of the CNS. Accordingly, eligible GBM patients will comprise only IDH-wild type astrocytomas with microvascular proliferation or necrosis or one or more of 3 genetic parameters (TERT promoter mutations, EGFR gene amplification, or combined gain of entire chromosome 7 and loss of entire chromosome 10). 3. Subject has a Karnofsky Performance Status (KPS) 70% or greater. 4. Subject has a life expectancy of at least 6 months, in the opinion of the Investigator. 5. Subject must be able to undergo MRI evaluation. 6. Subject meets the following laboratory criteria: 7. Females of reproductive potential must have a negative serum pregnancy test and be willing to use an acceptable method of birth control. 8. Males of reproductive potential must be willing to use an acceptable method of birth control to ensure effective contraception with partner. 9. Able to understand and willing to sign an institutional review board (IRB)-approved written informed consent document (legally authorized representative permitted).	1. Subject has initiated chemotherapy or radiation treatment for diagnosis of or GBM. 2. Subject has an IDH mutant astrocytoma or other non GBM brain tumor according to the 2021 WHO classification of Tumors of the CNS. 3. Subject intends to participate in another clinical trial 4. Subject has an active infection requiring treatment. 5. Subject has radiographic evidence of multi-focal disease or leptomeningeal dissemination. 6. Subject has a history of other malignancy unless the patient has been disease-free for at least 5 years. Adequately treated basal cell carcinoma or squamous cell skin cancer is acceptable regardless of time, as well as localized prostate carcinoma or cervical carcinoma in situ after curative treatment 7. Subject has a known positive test for human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection. 8. Subject has a history or evidence of any other clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion. 9. Subject, if female, is pregnant or is breast feeding.

Inclusion Criteria

Exclusion Criteria

1. Subject is a male or female 18 years of age or older.
2. Subject has a confirmed diagnosis of GBM according to the 2021 WHO Classification of Tumors of the CNS. Accordingly, eligible GBM patients will comprise only IDH-wild type astrocytomas with microvascular proliferation or necrosis or one or more of 3 genetic parameters (TERT promoter mutations, EGFR gene amplification, or combined gain of entire chromosome 7 and loss of entire chromosome 10).
3. Subject has a Karnofsky Performance Status (KPS) 70% or greater.
4. Subject has a life expectancy of at least 6 months, in the opinion of the Investigator.
5. Subject must be able to undergo MRI evaluation.
6. Subject meets the following laboratory criteria:
7. Females of reproductive potential must have a negative serum pregnancy test and be willing to use an acceptable method of birth control.
8. Males of reproductive potential must be willing to use an acceptable method of birth control to ensure effective contraception with partner.
9. Able to understand and willing to sign an institutional review board (IRB)-approved written informed consent document (legally authorized representative permitted).

1. Subject has initiated chemotherapy or radiation treatment for diagnosis of or GBM.
2. Subject has an IDH mutant astrocytoma or other non GBM brain tumor according to the 2021 WHO classification of Tumors of the CNS.
3. Subject intends to participate in another clinical trial
4. Subject has an active infection requiring treatment.
5. Subject has radiographic evidence of multi-focal disease or leptomeningeal dissemination.
6. Subject has a history of other malignancy unless the patient has been disease-free for at least 5 years. Adequately treated basal cell carcinoma or squamous cell skin cancer is acceptable regardless of time, as well as localized prostate carcinoma or cervical carcinoma in situ after curative treatment
7. Subject has a known positive test for human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection.
8. Subject has a history or evidence of any other clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
9. Subject, if female, is pregnant or is breast feeding.

Contacts and Locations

Study Contact

John Boockvar, MD

CONTACT

212-434-3900

jboockvar@northwell.edu

Tamika Wong, MPH

CONTACT

212-434-4836

twong4@northwell.edu

Principal Investigator

John Boockvar, MD

PRINCIPAL_INVESTIGATOR

Feinstein Institute for Medical Research/Lenox Hill Hospital

Study Locations (Sites)

Lenox Hill Brain Tumor Center

New York, New York, 10075

United States

Collaborators and Investigators

Sponsor: Northwell Health

John Boockvar, MD, PRINCIPAL_INVESTIGATOR, Feinstein Institute for Medical Research/Lenox Hill Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-27

Study Completion Date2028-04-01

Study Record Updates

Study Start Date2022-04-27

Study Completion Date2028-04-01

Terms related to this study

Additional Relevant MeSH Terms

Glioblastoma
Glioblastoma Multiforme
Glioma, Malignant
GBM
Brain Cancer
Glioblastoma, IDH-wildtype
Glioblastoma Multiforme, Adult