Ruxolitinib With Radiation and Temozolomide Compared to Radiation and Temozolomide for Newly Diagnosed Glioblastoma

Korábbi kezelés

• Patients who are pregnant or breast-feeding. The anti-proliferative activity of this experimental drug and temozolomide may be harmful to the developing fetus or nursing infant.
• Patients receiving concurrent therapy for their brain tumor (e.g., chemotherapeutics or investigational agents).
• Patient has previously taken ruxolitinib or is allergic to any components of the study drug.
• Known Active hepatitis B virus (HBV) or hepatitis C virus infection that requires treatment or at risk for HBV reactivation. At risk for HBV reactivation is defined as hepatitis B surface antigen positive or anti-hepatitis B core antibody positive. Participants with previous positive serology results must have negative polymerase chain reaction results.
• Patients who have obtained the following vaccines ≤ 6 weeks prior to the start of the study: adenovirus, BCG, chikungunya, cholera, dengue, Ebola Zaire, Influenza (live/attenuated), Japanese encephalitis (live/attenuated), measles, mumps, rubella, varicella, poliovirus (live/bivalent/oral), rotavirus, smallpox (live), typhoid, yellow fever, zoster (live/attenuated).

Más betegség

• Patients with a concurrent or prior malignancy are ineligible unless they are patients with curatively treated carcinoma-in-situ or basal cell carcinoma of the skin. Patients who have been free of disease (any prior malignancy) for at least 3 years are eligible for this study.
• Uncontrolled immunodeficiency virus infection or active tuberculosis.
• Patients with active serious infections requiring systemic therapy.
• Patient has significant abnormalities on screening electrocardiogram (EKG) and active and significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, New York Heart Association (NYHA) Grade ≥2 heart failure, uncontrolled hypertension, valvular disease, pericarditis, myocardial infarction.
• Any other serious medical/psychiatric condition, in the judgement of the investigator, that likely to interfere or limit compliance with study requirements/treatment.

Egyéb

• Patients using warfarin.

• Provision of signed informed consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Individuals of any sex, gender, race, or ethnicity ≥ 18 years of age.
• Histologically confirmed glioblastoma as defined by the World Health Organization (WHO) 2021 Criteria (IDH-wildtype) that is either methylated, unmethylated, or indeterminate MGMT.
• Must have a Karnofsky performance status (KPS) ≥ 70% (i.e., the patient must be able to care for themself with occasional help from others).
• Adequate organ (liver and renal) and bone marrow function within 14 days before randomization. For all parameters listed below, the most recent results available must be used:
  • Absolute neutrophil count (ANC) ≥ 1500/mm³. Note: Granulocyte-colony stimulating factor (G-CSF) administration is not allowed within 1 week prior to screening assessment.
  • Platelet count ≥ 100,000/mm³. Note: Platelet transfusion is not allowed within 1 week prior to registration.
  • Total bilirubin (TBL) ≤ 1.5 × institutional upper limit of normal (ULN).
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN.
  • Serum albumin ≥ 2.5 g/dL.
  • Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) ≥ 50 mL/min
  • CrCl to be calculated using Cockcroft-Gault formula:
  • If actual body weight < Ideal body weight (IBW), use actual body weight
  • If ideal body weight < actual body weight < 1.25 ideal body weight, use ideal body weight
  • If actual body weight ≥ 1.25 ideal body weight, use adjusted body weight
  • Adjusted body weight = Ideal body weight + 0.4 (Actual body weight - ideal body weight)
  • IBW: Male IBW = 50 kg + 2.3 kg per inch over 5 feet or Female IBW = 45.5 kg + 2.3 kg per inch over 5 feet *Note: for patients whose serum creatinine exceeds 1.5 × ULN, a calculated creatinine ≥ 50 mL/min is required for eligibility
• Patients able to become pregnant: use of highly effective contraception for at least one (1) month prior to screening and agreement to use such a method. Should a participant become pregnant or suspect that they are pregnant while participating in this study, they should notify the treating physician immediately. Such individuals must have a negative pregnancy test.
• Patients must have no concurrent malignancy except curatively treated early-stage bladder and prostate cancer that has been completed resected, basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix and breast, adequately treated stage I or II cancer from which the patient is in complete remission. Patients with other prior malignancies must be disease-free for ≥ 3 years.
• The ability to swallow