RECRUITING

Treatment of Relapsed/Refractory Intracranial Glioma in Patients Under 22 Years of Age

Conditions

Glioblastoma Multiforme Anaplastic Astrocytoma Fibrillary Astrocytomas Oligodendroglioma Diffuse Intrinsic Brainstem Glioma Diffuse Intrinsic Pontine Glioma DIPG Brain Tumor H3 K27M

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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

This study assesses the safety and efficacy of repeat monthly dosing of super-selective intra-arterial cerebral infusion (SIACI) of cetuximab and bevacizumab in patients \< 22 years of age.

Official Title

Phase I/II Trial of Repeat Dosing of Super-Selective Intraarterial Infusion of Erbitux (Cetuximab) and Avastin (Bevacizumab) for Treatment of Relapsed/Refractory Intracranial Glioma in Patients Under 22 Years of Age

Quick Facts

Study Start:2025-03-01

Study Completion:2029-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05956821

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:1 Year to 21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
* Documented histologic diagnosis of relapsed or refractory glioblastoma multiforme (GBM), anaplastic astrocytoma (AA), fibrillary astrocytomas (FA), pilomyxoid astrocytoma (PXA), oligodendroglioma, or anaplastic mixed oligoastrocytoma (AOA), or radiologically diagnosed diffuse intrinsic brainstem glioma (DIPG) * Must have at least one confirmed and evaluable tumor site * Must have a Karnofsky or Lansky performance status ≥60%. * No chemotherapy for three weeks prior to treatment * Patients must have adequate hematologic reserve with absolute neutrophils≥1000/mm3 and platelets ≥100,000/ mm3 * Pre-enrollment chemistry parameters must show: bilirubin\<1.5x the institutional upper limit of normal (IUNL); Aspartate Aminotransferase( AST) or Alanine transaminase (ALT)\<2.5x IUNL and creatinine\<1.5x IUNL * Pre-enrollment coagulation parameters (PT and PTT) must be ≤1.5x the IUNL * Growth factor(s): Must not have received within 1 week of entry onto this study * Steroids: Systemic corticosteroid therapy is permissible in patients with Central Nervous System (CNS) tumors for treatment of increased intracranial pressure or symptomatic tumor edema. Patients with CNS tumors who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to study entry. * Patients of reproductive age must agree to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the research study * Patients or their parents/guardians must be able to understand and give written informed consent. Informed consent must be obtained at the time of patient screening * Because of known concerns with Avastin and wound healing, craniotomy patients are eligible for the treatment if they have had a craniotomy greater than two weeks prior to Intra-Arterial (IA) therapy. Craniotomy or major procedure after SIACI Avastin therapy should wait 4 weeks. Minor surgeries may be performed after two weeks	* Females who are pregnant or lactating * Females of childbearing potential and fertile men will be informed as to the potential risk of procreation while participating in this research trial and will be advised that they must use effective contraception during and for a period of three months after the treatment period. If they do not agree, they will be ineligible for the study * Patients with significant concurrent medical or psychiatric conditions that would place them at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring

Inclusion Criteria

Exclusion Criteria

* Documented histologic diagnosis of relapsed or refractory glioblastoma multiforme (GBM), anaplastic astrocytoma (AA), fibrillary astrocytomas (FA), pilomyxoid astrocytoma (PXA), oligodendroglioma, or anaplastic mixed oligoastrocytoma (AOA), or radiologically diagnosed diffuse intrinsic brainstem glioma (DIPG)
* Must have at least one confirmed and evaluable tumor site
* Must have a Karnofsky or Lansky performance status ≥60%.
* No chemotherapy for three weeks prior to treatment
* Patients must have adequate hematologic reserve with absolute neutrophils≥1000/mm3 and platelets ≥100,000/ mm3
* Pre-enrollment chemistry parameters must show: bilirubin\<1.5x the institutional upper limit of normal (IUNL); Aspartate Aminotransferase( AST) or Alanine transaminase (ALT)\<2.5x IUNL and creatinine\<1.5x IUNL
* Pre-enrollment coagulation parameters (PT and PTT) must be ≤1.5x the IUNL
* Growth factor(s): Must not have received within 1 week of entry onto this study
* Steroids: Systemic corticosteroid therapy is permissible in patients with Central Nervous System (CNS) tumors for treatment of increased intracranial pressure or symptomatic tumor edema. Patients with CNS tumors who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to study entry.
* Patients of reproductive age must agree to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the research study
* Patients or their parents/guardians must be able to understand and give written informed consent. Informed consent must be obtained at the time of patient screening
* Because of known concerns with Avastin and wound healing, craniotomy patients are eligible for the treatment if they have had a craniotomy greater than two weeks prior to Intra-Arterial (IA) therapy. Craniotomy or major procedure after SIACI Avastin therapy should wait 4 weeks. Minor surgeries may be performed after two weeks

* Females who are pregnant or lactating
* Females of childbearing potential and fertile men will be informed as to the potential risk of procreation while participating in this research trial and will be advised that they must use effective contraception during and for a period of three months after the treatment period. If they do not agree, they will be ineligible for the study
* Patients with significant concurrent medical or psychiatric conditions that would place them at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring

Contacts and Locations

Study Contact

Heather McCrea, MD

CONTACT

305-585-3627

hmccrea@med.miami.edu

Principal Investigator

Heather McCrea, MD

PRINCIPAL_INVESTIGATOR

University of Miami

Study Locations (Sites)

Jackson Memorial Hospital

Miami, Florida, 33136

United States

Collaborators and Investigators

Sponsor: University of Miami

Heather McCrea, MD, PRINCIPAL_INVESTIGATOR, University of Miami

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 Date2025-03-01

Study Completion Date2029-12-01

Study Record Updates

Study Start Date2025-03-01

Study Completion Date2029-12-01

Terms related to this study

Additional Relevant MeSH Terms

Glioblastoma Multiforme
Anaplastic Astrocytoma
Fibrillary Astrocytomas
Oligodendroglioma
Diffuse Intrinsic Brainstem Glioma
Diffuse Intrinsic Pontine Glioma
DIPG Brain Tumor
H3 K27M