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New treatment option for Glioblastoma Multiforme
Official title Treatment of Relapsed/Refractory Intracranial Glioma in Patients Under 22 Years of Age
ClinicalTrials.gov ID: NCT05956821
What this study is testing
What is SIACI of cetuximab and bevacizumab?
SIACI of cetuximab and bevacizumab is an investigational medicine, given as a monthly infusion into a vein, being studied as a potential treatment for glioblastoma multiforme.
Also referred to as erbitux, avastin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 21. Healthy volunteers may be eligible.
You may be able to join if
- Documented histologic diagnosis of relapsed or refractory glioblastoma multiforme (GBM), anaplastic astrocytoma (AA), fibrillary astrocytomas (FA)...
- 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
You likely can't join if
- 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...
- Patients with significant concurrent medical or psychiatric conditions that would place them at increased risk or affect their ability to receive or...
See the full eligibility criteria
- Documented histologic diagnosis of relapsed or refractory glioblastoma multiforme (GBM), anaplastic astrocytoma (AA), fibrillary astrocytomas (FA), pilomyxoid astrocytoma (PXA), oligodendroglioma, or anaplastic mixed...
- 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 21 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.