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New treatment option for Anaplastic Oligodendroglioma
Official title Retifanlimab With or Without Difluoromethylornithine for the Treatment of Progressive High Grade Gliomas
ClinicalTrials.gov ID: NCT07468136
What this study is testing
What is Eflornithine?
Eflornithine is an investigational medicine, being studied as a potential treatment for anaplastic oligodendroglioma.
Also referred to as Alpha-Difluoromethylornithine, DFMO.
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 phase I/II trial tests the safety, side effects best dose and effect of retifanlimab with or without difluoromethylornithine (DFMO) for the treatment of high grade gliomas that are growing, spreading, or getting worse (progressive). Immunotherapy with monoclonal antibodies, such as retifanlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
- 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 18 and older
You may be able to join if
- Age ≥ 18 years
- Diagnosis of high-grade glioma, including any of the following:
- Glioblastoma, IDH-wild type (WT)
- Grade 3 or 4 IDH1/2 mutant astrocytoma or
- Grade 3 oligodendroglioma
You likely can't join if
- Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the...
- Pregnant persons
- Nursing persons
- Persons of childbearing potential or able to father a child who are unwilling to employ adequate contraception
- Uncontrolled intercurrent illness that by the judgement of the investigator would make the patient inappropriate for entry into this study or...
- ongoing or active infection (e.g., pneumonia, sepsis, etc.) requiring systemic therapy
See the full eligibility criteria
- Age ≥ 18 years
- Diagnosis of high-grade glioma, including any of the following:
- Glioblastoma, IDH-wild type (WT)
- Grade 3 or 4 IDH1/2 mutant astrocytoma or
- Grade 3 oligodendroglioma
- Any prior grade 2 astrocytoma or oligodendroglioma that is suspected to have recurred at a higher grade
- Other high-grade glioma
- Plan for surgical resection as part of routine clinical care
- Radiographic disease progression, with or without tissue confirmation
- Measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2 and Karnofsky Performance Status (KPS) ≥ 60
- NOTE: PS must be assessed (again) within 7 days prior to first dose of study drug
- Hemoglobin ≥ 9.0 g/dL (obtained ≤ 15 days prior to registration)
- Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (obtained ≤ 15 days prior to registration)
- Platelet count ≥ 100,000/mm\^3 (obtained ≤ 15 days prior to registration)
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 15 days prior to registration)
- Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) (obtained ≤ 15 days prior to registration)
- Calculated creatinine clearance ≥ 45 ml/min using the Cockcroft-Gault formula (obtained ≤ 15 days prior to registration)
- Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only
- Provide written informed consent for the current study
- Willing to provide consent for the Neuro-oncology biorepository (IRB 12-003458) for archiving of tissue, cerebrospinal fluid (CSF), and/or blood samples
- Ability to complete forms by themselves or with assistance
- Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
- Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the developing fetus and newborn are unknown:
- Pregnant persons
- Nursing persons
- Persons of childbearing potential or able to father a child who are unwilling to employ adequate contraception
- Uncontrolled intercurrent illness that by the judgement of the investigator would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of...
- ongoing or active infection (e.g., pneumonia, sepsis, etc.) requiring systemic therapy
- current diagnosis or previous history of immune-related (non-infectious) pneumonitis or interstitial lung disease that requires or required steroids
- active autoimmune disease that required systemic treatment other than replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroids) ≤ 2 years prior to registration
- symptomatic congestive heart failure
- unstable angina pectoris
- psychiatric illness/social situations that would limit compliance with study requirements (e.g., drug addiction)
- concurrent active Hepatitis B (defined as hepatitis B surface antigen [HBsAg] positive and/or detectable hepatitis B virus [HBV] deoxyribonucleic acid [DNA]) and Hepatitis C virus (defined as anti-hepatitis C virus...
- Patients with evidence of hepatitis B virus (HBV) infection (HBsAg positive) must have completed at least 4 weeks of HBV antiviral therapy, and the HBV viral load must be undetectable at the time of registration
- Patients with a history of hepatitis C virus (HCV) are eligible if they have an undetectable HCV viral load. Patients must have completed curative anti-viral treatment ≥ 4 weeks prior to registration.
- NOTE: Patients without symptoms or prior history do not require testing prior to registration
- Co-morbid systemic illnesses or other severe concurrent disease that would make the patient inappropriate for entry into the study or interfere with proper assessment of safety and toxicity
- History of myocardial infarction ≤ 6 months prior to registration or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
- Active autoimmune disease that has required systemic treatment (other than replacement therapy) ≤ 1 year prior to registration
- History of allogeneic stem cell transplant
- Receiving any other investigational agent with therapeutic intent
- Participants who are unable to swallow the DFMO solution or who are at risk for impaired absorption of oral medication.
- NOTE: This restriction includes, but is not limited to, refractory vomiting, gastric resection/bypass, and duodenal/jejunal resection
- Patients with known hypersensitivity or allergy to DFMO or retifanlimab
- Contraindication to MRI or administration of gadolinium
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, 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.