Is NCT07468136 recruiting in Rochester, MN?

Yes, NCT07468136 is currently recruiting participants at its Rochester, MN location. This anaplastic oligodendroglioma clinical trial is actively enrolling qualified participants.

How do I join the anaplastic oligodendroglioma clinical trial in Rochester?

To join this clinical trial in Rochester, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Rochester clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Anaplastic Oligodendroglioma Clinical Trial in Rochester, MN

About This Anaplastic Oligodendroglioma Study in Rochester

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. DFMO is in a class of medications called ornithine decarboxylase (ODC) inhibitors. It works by blocking the action of a substance that signals tumor cells to multiply. This helps stop or slow the spread of tumor cells. Giving retifanlimab with or without DFMO mat be safe, tolerable and/or effective in treating patients with progressive high grade glioma.

Sponsor: Mayo Clinic

Who Can Participate

Inclusion 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)

Exclusion Criteria

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 the regimens including, but not limited to:

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 \[HCV\] antibody \[Ab\] positive and detectable HCV ribonucleic acid \[RNA\]) infection EXCEPTIONS:

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Rochester?

Yes, this clinical trial (NCT07468136) has an active research site in Rochester, MN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Anaplastic Oligodendroglioma Treatment Options in Rochester, MN

If you're searching for anaplastic oligodendroglioma treatment options in Rochester, MN, this clinical trial (NCT07468136) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Rochester research site is actively enrolling participants for this clinical trial. You'll receive care from experienced anaplastic oligodendroglioma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all anaplastic oligodendroglioma clinical trials near you to find additional studies recruiting in your area.

Anaplastic Oligodendroglioma Clinical Trial in Rochester, MN

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IRB Approved

No-Cost Care

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