BridgeMD
New treatment option for Glioma
Official title PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
ClinicalTrials.gov ID: NCT06161519
What this study is testing
What is PLX038?
PLX038 is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for glioma.
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
- Background: About 90,000 new cases of brain and spinal cord tumors are diagnosed annually in the United States. Most of these tumors are benign; however, about 30% are malignant, and 35% of people with malignant tumors in the brain and spinal cord will die within 5 years.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 120
You may be able to join if
- Participants must have documented pathologic diagnosis of confirmed primary central nervous system (CNS) tumor with one of the below diagnoses:
- Cohort Phase I: Any recurrent or progressive primary CNS tumor, regardless of molecular features.
- Cohort Phase IIA: Newly diagnosed MYCN amplified ependymoma after surgery and radiation.
- Cohort Phase IIB:
- Recurrent or progressive MYCN amplified ependymoma, OR
You likely can't join if
- History of allergic reactions to compounds of similar chemical composition to PLX038.
- Major surgery within 2 weeks prior to study treatment initiation. NOTE: The surgery is considered major if a mesenchymal barrier is opened (pleural...
- Participants who require treatment with strong inhibitors or inducers of CYP3A or with UGT1A1 inhibitors during the planned period of investigational...
- History of treatment with pegylated topoisomerase inhibitors.
- Has documented \>= grade 2 PHOTON craniospinal irradiation (CSI) induced GI dysfunction.
- Participants with history of homozygous for the UGT1A1\ 28 variant allele with severely reduced UGT1A1 activity.
See the full eligibility criteria
Who can join
- Participants must have documented pathologic diagnosis of confirmed primary central nervous system (CNS) tumor with one of the below diagnoses:
- Cohort Phase I: Any recurrent or progressive primary CNS tumor, regardless of molecular features.
- Cohort Phase IIA: Newly diagnosed MYCN amplified ependymoma after surgery and radiation.
- Cohort Phase IIB:
- Recurrent or progressive MYCN amplified ependymoma, OR
- Recurrent or progressive medulloblastoma with MYC or MYCN amplifications
- Cohort Phase IIC: Any other recurrent or progressive primary CNS tumor with MYC or MYCN amplifications.
- Cohort Phase IID: Any recurrent glioblastoma without MYC or MYCN amplifications. NOTE 1: Recurrence or progression may involve CNS, extra CNS, or both. NOTE 2: The presence of MYCN or MYC amplification will be...
- Participants must have archival tumor tissue (either a block or 15 formalin-fixed paraffin-embedded (FFPE) unstained slides) available for NCI LP review of MYC or MYCN amplification status and for correlative studies:
- Cohorts Phase I, Phase IIB, Phase IIC, and Phase IID: tumor tissue obtained at any point before trial treatment initiation, but preferably from most recent surgical resection before study treatment initiation.
- Cohort Phase IIA: tumor tissue obtained at original diagnosis.
- Participants in Cohort Phase IIA must have completed surgery followed by radiation at least 4 weeks and no more than 10 weeks from the last dose of radiation prior to study treatment initiation.
- Participants in Cohorts Phase I, Phase IIB, Phase IIC, and Phase IID must have completed prior cytotoxic chemotherapy or radiation at least 4 weeks prior to study treatment initiation (at least 6 weeks if the last...
- Age \>= 18 years.
- Karnofsky \>= 70%. NOTE: Participants with severe paraparesis/paraplegia who need minimal assistance for self-care due to their motor deficit but are otherwise functionally independent will be eligible.
- Participants must have adequate organ and marrow function as defined below:
- leukocytes \>=3,000/microliter
- absolute neutrophil count \>1,500/microliter
- platelets \>100,000/microliter
- hemoglobin \>= 9 g/ dL (may be transfused within 2 weeks prior to treatment to achieve this level)
- total bilirubin within normal institutional limits
- aspartate aminotransferase (AST) / alanine aminotransferase (ALT) \<2.5 X institutional upper limit of normal (ULN)
- creatinine within normal institutional limits OR
- estimated glomerular filtrate rate (eGFR) using chronic kidney disease epidemiology collaboration) (CKD-EPI) equation:\>= 60 mL/min/1.73 m\^2 for participants with creatinine levels above institutional normal
- Women of child-bearing potential (WOCBP) and those who can father children must agree to use effective contraception (barrier, hormonal contraception, intrauterine device (IUD), surgical sterilization, barrier at the...
- Breastfeeding participants must be willing to discontinue breastfeeding from study treatment initiation through 6 months after the last dose of the study drug.
- Ability to self-report symptoms and physical function as determined by assessment of the clinical team performed at screening.
- Participants must be able to understand and willing to sign a written informed consent document.
What rules you out
- History of allergic reactions to compounds of similar chemical composition to PLX038.
- Major surgery within 2 weeks prior to study treatment initiation. NOTE: The surgery is considered major if a mesenchymal barrier is opened (pleural cavity, peritoneum, meninges).
- Participants who require treatment with strong inhibitors or inducers of CYP3A or with UGT1A1 inhibitors during the planned period of investigational treatment with PLX038. Lists including medications and substances...
- History of treatment with pegylated topoisomerase inhibitors.
- Has documented \>= grade 2 PHOTON craniospinal irradiation (CSI) induced GI dysfunction.
- Participants with history of homozygous for the UGT1A1\ 28 variant allele with severely reduced UGT1A1 activity.
- Participants positive for Human immunodeficiency virus (HIV), Hepatitis C virus (HCV), and Hepatitis B virus (HBV).
- Pregnancy (confirmed with beta human chorionic gonadotropin (beta-HCG) serum or urine pregnancy test performed in females of childbearing potential at screening).
- Participants unable to have MRIs.
- Prior or concurrent malignancy unless its natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen...
- Uncontrolled intercurrent illness evaluated by history, weight, and physical exam that would limit compliance with study requirements.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, 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 study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, 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.