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

Launched by UNIVERSITY OF MIAMI · Jul 14, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment for young patients under 22 years old who have certain types of brain tumors, specifically those that have come back or haven’t responded to previous treatments. The study is testing a method that delivers two medications, cetuximab and bevacizumab, directly to the brain to see how safe and effective it is. The trial is currently recruiting participants, and anyone interested must have a specific type of brain tumor and meet other health criteria.

To be eligible, patients need to have a confirmed diagnosis of certain brain tumors and must be in good enough health to participate. This means they should not have had chemotherapy for at least three weeks before starting the trial and must show that their blood counts and liver function are within acceptable ranges. Participants can expect to receive the treatment once a month and will be closely monitored for any side effects. It's also important for participants who are able to conceive to use effective birth control during and for three months after the study. This trial aims to find better options for treating these challenging brain tumors in young patients.

Gender

ALL

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