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Recruiting NCT05700955

Neoadjuvant Chemoimmunotherapy in Recurrent Glioblastoma

Conditions: Glioblastoma

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: PHASE1
Enrollment: 30
Sponsor: University of Louisville

Location: United States

Summary

The primary purpose of this study is to test the safety of Pembrolizumab and Temozolomide in treating recurrent glioblastoma and to characterize the effect of this treatment on the participants tumor and immune system..

Eligibility Criteria

Inclusion Criteria:-Inclusion Criteria Patients are eligible to be included in the only if they meet all of the following criteriaHistopathologically proven diagnosis of glioblastoma prior to registration, by pathology report;The tumor must be confined to the supratentorial compartmentThe tumor tissue block from the primary diagnosis must be available to be sent for pathology review, after registration.History/physical examination within 7 days prior to registrationKarnofsky performance status ≥ 60 within 7 days prior to registration.Adequate Organ Function Laboratory ValuesAbsolute neutrophil count (ANC) ≥1,500/mcLPlatelets ≥100,000/mcLHemoglobin ≥9.0 g/gL or ≥5.6 mmol/L, without recent transfusionCreatine ≤1.7 x upper limit of normal (ULN) or Measure or Calculated creatinine clearance ≥ 60.0mL/min for subject with creatinine levels > 1.5 X institutional ULN (GFR can also be used in place of creatinine or CrCl)Total bilirubin ≤ 1.5 x ULN or Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 x ULNAST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN or ≤ 5 x ULN for subjects with liver metastasesThe patient must have completed chemoradiation with Radiotherapy and Temozolomide of the primary tumor according to standard of care.Patients must have received no more than 3 prior therapies for Recurrent High Grade Glioma.Subjects must have the ability to understand and willingness to sign a written informed consent document.Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication.Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.Exclusion Criteria:-Exclusion Criteria Patients will be excluded from the study if they meet any of the following criteriaPrevious use of an immunotherapy such as a vaccine therapy, dendritic cell vaccine or intracavitary or convectional enhanced delivery of therapy.Prior invasive malignancy (except non-melanomatous skin cancer) within the previous three yearsSevere, active co-morbidity defined as follows:Transmural myocardial infarction or unstable angina within the last 6 months prior to registrationHistory of stroke, cerebral vascular accident (CVA) or transient ischemic attack within 6 months prior to registrationSignificant vascular disease (e.g., aortic aneurysm, history of aortic dissection) or clinically significant peripheral vascular diseaseKnown history of Tuberculosis or acute bacterial or fungal infection requiring intravenous antibiotics at the time of registrationChronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registrationPatients with active autoimmune disease or history of autoimmune disease that might recur, will be considered on an individual basisAny other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy.Is pregnant or breastfeedingHas received prior therapy with an anti-Programmed Death 1 (PD-1), anti- Programmed Death-ligand 1 (PD-L1), or anti- Programmed Death-ligand 1 (PD-L2) agent.Patient must have < 1.5 cm midline shift pre-operativeHistory of severe hypersensitivity reaction to any monoclonal antibody including pembrolizumab.Patients who cannot safely undergo MRI due to non-MRI compatible pacemaker, or other reason.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05700955). StuddyBuddy aggregates publicly available trial information.