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

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

NCT ID: NCT05956821

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

Conditions: Official terms:
Glioblastoma
Glioma
Astrocytoma
Oligodendroglioma
Diffuse Intrinsic Pontine Glioma
Bevacizumab
Cetuximab

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: SIACI of cetuximab and bevacizumab
Description: Subjects will receive monthly dosing of bevacizumab (15 mg/kg) and cetuximab (200mg/m2)
Arm group label: SIACI of cetuximab and bevacizumab

Other name: erbitux

Other name: avastin

Summary: 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.

Criteria for eligibility:
Criteria:
Inclusion 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 Exclusion Criteria: - 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

Gender: All

Minimum age: 1 Year

Maximum age: 21 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Jackson Memorial Hospital

Address:
City: Miami
Zip: 33136
Country: United States

Status: Recruiting

Contact:
Last name: Heather McCrea, MD

Phone: 305-585-3627
Email: hmccrea@med.miami.edu

Investigator:
Last name: Heather McCrea, MD
Email: Principal Investigator

Start date: December 1, 2024

Completion date: December 1, 2029

Lead sponsor:
Agency: University of Miami
Agency class: Other

Source: University of Miami

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05956821