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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 1 Year - 21 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05956821
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Miami
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Heather McCrea, MD
Principal Investigator Affiliation University of Miami
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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

Arms

Experimental: SIACI of cetuximab and bevacizumab

Participants in this group will receive Cetuximab and Bevacizumab infusion into an artery each month for up to approximately one year.

Interventions

Drug: - SIACI of cetuximab and bevacizumab

Subjects will receive monthly dosing of bevacizumab (15 mg/kg) and cetuximab (200mg/m2)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Jackson Memorial Hospital, Miami, Florida

Status

Recruiting

Address

Jackson Memorial Hospital

Miami, Florida, 33136

Site Contact

Heather McCrea, MD

hmccrea@med.miami.edu

305-585-3627

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