Imaging Acetadote Metabolism in Glioblastoma

Korábbi kezelés

• 1.Chemotherapy, radiotherapy, or other cancer therapy within 4 weeks prior to starting study treatment.
• 2. Subjects must have recovered from prior treatment-related toxicities to grade 2 or baseline (excluding alopecia and clinically stable toxicities requiring ongoing medical management, such as hypothyroidism from prior immune checkpoint inhibitor treatment).
• 3. Subjects may not be receiving any other investigational agents for the treatment of the cancer under study.

Más betegség

• 5. History of allergic or hypersensitivity reactions attributed to compounds of similar chemical or biologic composition to Acetadote.
• 6. 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 that, in the opinion of the investigator, would limit compliance with study requirements.

Egyéb

• 4. Brain metastases
• 7. Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.

• 1. Glioblastoma
• 2. Newly diagnosed with no prior surgery, radiation, chemotherapy, or other tumor-treating agent
• 3. Age ≥18 years
• 4. KPS > 70
• 5. Adequate organ and marrow function as defined below:
• - Bilirubin ≤1.5 times upper limit of normal
• - AST and ALT ≤ 3 times ULN
• - Creatinine ≤ 1.5 x ULN and/or GFR ≤ 60 mL/min
• -ANC ≥ 1000 cells/ul
• - Platelet ≥ 100,000/ul
• - Hemoglobin ≥ 9 g/dl
• 6. All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 7 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• 6a. A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
• - Has not undergone a hysterectomy or bilateral oophorectomy; or
• - Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
• 7. Ability to understand and the willingness to sign a written informed consent.