Treatment for young patients with relapsed or refractory brain tumors
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
This study is testing a new way to deliver cancer drugs directly to the brain tumors of young patients under 22 who have not responded to other treatments, to see if it helps them feel better.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 1 Year to 21 Years |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Drugs / interventions | chemotherapy, cetuximab, bevacizumab |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT05956821 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of a treatment involving super-selective intra-arterial cerebral infusion (SIACI) of cetuximab and bevacizumab in patients under 22 years old who have relapsed or refractory intracranial gliomas. The treatment aims to deliver medication directly to the tumor site to improve outcomes. Participants must have a confirmed diagnosis of specific types of gliomas and meet certain health criteria to ensure safety during the treatment process.
Who should consider this trial
Good fit: Ideal candidates are patients under 22 years of age with relapsed or refractory glioblastoma multiforme or other specified types of gliomas.
Not a fit: Patients who have not had a confirmed tumor diagnosis or those who do not meet the health criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for young patients with difficult-to-treat brain tumors.
How similar studies have performed: While there have been studies on similar treatments, this specific approach using SIACI with cetuximab and bevacizumab in this age group is novel.
Eligibility criteria
Show full 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
Where this trial is running
Miami, Florida
- Jackson Memorial Hospital — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Heather McCrea, MD — University of Miami
- Study coordinator: Heather McCrea, MD
- Email: hmccrea@med.miami.edu
- Phone: 305-585-3627
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.