Is NCT05465954 recruiting in Rochester, MN?

Yes, NCT05465954 is currently recruiting participants at its Rochester, MN location. This high grade astrocytic tumor clinical trial is actively enrolling qualified participants.

How do I join the high grade astrocytic tumor 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.

High Grade Astrocytic Tumor Clinical Trial in Rochester, MN

About This High Grade Astrocytic Tumor Study in Rochester

This phase II trial tests the safety and side effects of efineptakin alfa and pembrolizumab in treating patients with glioblastoma that has come back (recurrent). Efineptakin alfa is an immunotherapy drug that works by helping the immune system fight tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving efineptakin alfa and pembrolizumab may kill more tumor cells in patients with recurrent glioblastoma.

Sponsor: Mayo Clinic

Who Can Participate

Inclusion Criteria

Age \>= 18 years

Disease characteristics:

Tissue-confirmed progressive or recurrent World Health Organization (WHO) Grade IV IDH wildtype glioblastoma (including molecular glioblastoma and gliosarcoma)

Previously treated with maximum feasible resection or biopsy, radiation, and temozolomide

Have an enhancing mass on magnetic resonance imaging (MRI) amenable to resection or biopsy of the tumor (as determined by the neurosurgeon pre-operatively) and histological diagnosis of glioblastoma from a prior biopsy or surgery

Willing to undergo clinically indicated biopsy and/or resection of their glioblastoma at Mayo Clinic in Rochester, Minnesota (MN).

Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1 and Karnofsky Performance Scale (KPS) \>= 70 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) (without transfusion or erythropoietin \[EPO\] dependency =\< 7 days prior to assessment)

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)

Creatinine =\< 1.5 x upper limits of normal (ULN) OR measured or calculated creatinine clearance (per institutional standard) must be \>= 45 ml/min (obtained =\< 15 days prior to registration)

Total bilirubin =\<1.5 x ULN OR direct bilirubin =\< ULN for patients with total bilirubin levels \>1.5 x ULN (obtained =\< 15 days prior to registration)

Aspartate transaminase (AST) AND alanine transaminase (ALT) =\< 2.5 x ULN (obtained =\< 15 days prior to registration)

Prothrombin time (PT)/international normalized ratio (INR)/activated partial thromboplastin time (aPTT) =\< 1.5 x ULN OR if patient is receiving anticoagulant therapy then INR or aPTT is within target range of therapy (obtained =\< 15 days prior to registration)

Negative pregnancy test done =\< 7 days prior to registration, for persons of childbearing potential only (POCBP) Note: If testing done for eligibility is \> 72 hours prior to first dose, then pregnancy testing must be repeated, and result must be negative for patient to receive treatment.

POCBP or able to father a child must be willing to use adequate contraception starting with first dose through 180 days after last dose

Provide written informed consent

Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study).

Willing to provide tissue and blood samples for correlative research purposes

Exclusion Criteria

Any of the following because this study involves an investigational agent for which genotoxic, mutagenic, and teratogenic effects 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

Signs or symptoms of life-threatening raised intracranial pressure: as determined by the treating neurosurgeon, including severe headache, nausea, decreasing level of consciousness, precluding 4-7-day delay in scheduling neurosurgery (i.e., immediate surgery is indicated, and patient cannot wait).

Prior treatment

Received bevacizumab (AVASTIN) =\< 4 months prior to registration

Note: Bevacizumab is allowed for symptom control during the adjuvant phase of the study

Received a live vaccine =\< 30 days prior to registration.

Requirement for dexamethasone dose of \> 2mg/day =\< 2 days prior to registration

Failure to recover from any adverse events related to any of the following therapies received prior to registration:

Major surgery =\< 28 days prior to registration

Radiation therapy =\< 14 days prior to registration

Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment 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 prescribed regimens

Known history of human immunodeficiency virus (HIV) infection

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations (e.g., drug addiction) that would limit compliance with study requirements

Receiving any other investigational agent

Other active malignancy requiring systemic treatment =\< 1 year prior to registration

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 (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) =\< 2 years prior to registration NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment

Concurrent known active Hepatitis B (i.e., known positive hepatitis B virus \[HBV\] surface antigen \[HBsAg\] reactive) AND known active Hepatitis C (i.e., hepatitis C virus \[HCV\] ribonucleic acid \[RNA\] \[qualitative\] detected by polymerase chain reaction \[PCR\])

Note: No testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority

NOTE: Patients with known Hepatitis B OR Hepatitis C may be enrolled if they meet the following criteria:

Hepatitis B: Patients who are HBsAG positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization. Patients should remain on anti-viral therapy throughout the treatment phase of the trial and should follow local guidelines for HBV anti-viral therapy after completing study treatment

Hepatitis C: Patients with history of Hepatitis C infection are eligible if HCV viral load is undetectable at screening. Patients must have completed curative anti-viral therapy at least 4 weeks prior to registration

Known history of active TB (Bacillus Tuberculosis)

History of (non-infectious) pneumonitis or interstitial lung disease that required steroids, or current pneumonitis or interstitial lung disease

Hypersensitivity to pembrolizumab or any of its excipients

Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent within \< 12 months prior to registration

NOTE: If such therapy was given ≥ 12 months prior to registration, patient is eligible

History of allogenic tissue/solid organ transplant

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 (NCT05465954) 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.

High Grade Astrocytic Tumor Treatment Options in Rochester, MN

If you're searching for high grade astrocytic tumor treatment options in Rochester, MN, this clinical trial (NCT05465954) 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 high grade astrocytic tumor 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 high grade astrocytic tumor clinical trials near you to find additional studies recruiting in your area.

High Grade Astrocytic Tumor Clinical Trial in Rochester, MN

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