NU-0129 in Treating Patients With Recurrent Glioblastoma or Gliosarcoma Undergoing Surgery

Inclusion Criteria:

• Patients must have histologically proven glioblastoma multiforme (GBM) or gliosarcoma (GS)
• Patients must have measurable disease by Response Assessment in Neuro-Oncology (RANO) 2010 criteria at the time of registration (pre-operative)
• Patients must have failed at least one regimen of chemo or radiation therapy; NOTE:There is no limit to the number or types of prior therapy
• The patient must be a candidate for surgical debulking (either subtotal or gross totalresection); biopsy-only candidates will not be eligible
• All patients must be capable to voluntarily sign an informed consent indicating thatthey are aware of the investigational nature of this study prior to registration
• Patients must have a Karnofsky performance status of >= 70
• Patients must have adequate bone marrow, liver, coagulation and renal function within 7days prior to study registration, as defined below:
• White blood cell count (WBC) >= 3,000/uL
• Absolute neutrophil count (ANC) >= 1,500/mm^3
• Platelet count of >= 100,000/mm^3 (Note: Transfusion or growth factor may be used foreligibility outside of 7 days)
• Hemoglobin >= 8 mg/dL (Note: Transfusion may be used for eligibility outside of 7days)
• Bilirubin =< 2 x upper limit of normal (ULN)
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2 x ULN
• Creatinine =< 1.5 x ULN
• Urine protein =< 3 x ULN
• Cholesterol =< 300 mg/dL
• International normalized ration (INR) =< 1.5 x ULN
• Prothrombin time (PT)/partial thromboplastin time (PTT) =< 1.5 x ULN
• Any patient who has had a recent surgery should have recovered from all effects of thesurgery and be cleared by their surgeon
• Patients must have confirmed availability of archival or freshly biopsied tumor tissuemeeting protocol-defined specifications (10 unstained slides) prior to studyenrollment
• Females of child-bearing potential (FOCBP) and males must agree to use adequatecontraception (e.g. hormonal or barrier method of birth control; abstinence) prior tostudy entry, for the duration of study participation, and for 28 days followingcompletion of therapy; should a female patient, or a male patient's partner, becomepregnant or suspect she is pregnant while participating in this study, the patientshould inform her or his treating physician immediately
• NOTE: A FOCBP is any woman (regardless of sexual orientation, having undergone atubal ligation, or remaining celibate by choice) who meets the followingcriteria:
• Has not undergone a hysterectomy or bilateral oophorectomy
• Has had menses at any time in the preceding 12 consecutive months (andtherefore has not been naturally postmenopausal for > 12 months)
• FOCBP must have a negative pregnancy test (either urine or serum) within 14 days priorto registration

Exclusion Criteria:

• Patients must not have any significant infections or medical illnesses that in theinvestigator's opinion cannot be adequately controlled with appropriate therapy orwould compromise the patient's ability to tolerate NU-0129
• Patients must not have a history of any other cancer unless they are in completeremission and off of all therapy for that disease for a minimum of 3 years
• Note: Non-melanoma skin cancer or carcinoma in-situ of the cervix are exceptionsand may be permitted after discussion with study quality assurance manager (QAM)
• Patients must not have had radiation therapy within 12 weeks prior to registration
• Patients must not have had prior cancer therapy (including biologic, cytotoxic, andexperimental therapies, nitrosoureas, and Gliadel wafers or other surgicallyimplantable antitumor treatment) within 21 days of registration; if questions arise,please ask the principal investigator (PI)
• NOTE: Patients must not have Novocure within 24 hours
• Hormonal tumor therapies should not be administered within 14 days of registration;exceptions may be discussed with the PI
• Patients must not have symptomatic hypertension
• Patients with known human immunodeficiency virus (HIV) infection or chronic or acutehepatitis B or C are not eligible; Note: Patients do not need to have HIV, hepatitisB, or hepatitis C testing at screening
• Female patients who are pregnant or breast feeding are not eligible
• Patients are not eligible if they are unwilling or unable to comply with the protocol