Golden Halo, Static Magnetic and Electric Field Device, in Recurrent Glioblastoma

Inclusion Criteria

• •All participating subjects must meet the following criteria on the screening examination to be eligible to participate in the study:
• •Participants must be able to understand and willing to sign a written informed consent document. The study requires authorization for collection, utilization and storage of biological materials (blood, plasma, serum) to be used for research on the effects of sBE on tissues.
• •If the participant lives with a partner/spouse and they choose to participate in the study as part of Cohort 2, the partner/spouse must be able to understand and be willing to sign a written informed consent document. If the partner chooses not to participate they will be given specific instructions for sleeping arrangements and not being exposed to sBE therapy.
• •Participants must allow the research team to assemble the sBE device in their homes and conduct in-person visits or video conference calls for technical support. Participants must reside within a 100 mile radius of Iowa City. Participants must participate in in-person training of use of the sBE device and understand how to safely use the sBE device, and agree to adhere to use only as instructed in the instruction manual (see Appendix I).
• •Participants must be able to adhere to using the sBE device daily for at least 8 hours, adhere to the scheduled visits, and agree to record sBE device usage hours accurately and consistently in a daily diary.
• •Participants must be 18 years of age or older on the day of signing the informed consent document.
• •Participants must have a Karnofsky Performance Status (KPS) ≥ 60 (see Appendix B).
• •Participants must be able to physically operate the sBE device independently or with the assistance of a caretaker (see Appendix I).
• •Participants must allow a collection of blood/plasma during scheduled visits where labs will be collected for translational research study purposes.
• •Participants must allow the study team to disassemble the sBE device and retrieve static magnetic and electric generating components at the termination of the study. Participants may keep the foam mattress or have it removed by the research team at the time of sBE device disassembly.
• •Patients must have histologically confirmed GBM (primary) with unequivocal first progression of disease (confirmed by MRI or CT within 2 weeks of study registration).
• •Patients must have previous history of failing temozolamide and radiation with this being the first recurrence after standard of care therapy.
• •Patients must have no history of bleeding diathesis, previous intracranial hemmorhage, previous intolerance to lomustine or bevacizimab.
• •If the patient has had surgical re-resection of the tumor, the following must be true:
• •* The surgery must confirm the recurrence, but residual or measurable disease after surgery is not a requirement
• •* An MRI must be taken within 48-96 hours following the surgery
• •* Surgery must have been completed at least 2 weeks before starting treatment with the sBE device
• •Patients must have recovered from acute sequelae of surgery. When use of the sBE device is initiated, the craniotomy or intracranial biopsy site must be adequately healed as determined by:
• •* No drainage or cellulitis
• •* No residual sutures or staples
• •* Intact underlying cranioplasty (no craniectomy)
• •Initiation of use with the sBE device must be \> 2 weeks after the last tumor related surgical procedure.
• •If the patient is taking steroids, the dose must be stable or decreasing for at least 5 days before the baseline scan and up to the start of the study therapy.
• •Absence of any recent hemorrhagic or thrombotic events in the brain.
• •Clinical labs - must be performed within 14 business days prior to registration and determined to be within the reference ranges listed below:
• •Hematology:
• •* Absolute neutrophil count (ANC) ≥ 1.5 x 109 cells/L
• •* Platelet count ≥ 100 x 109 cells/L
• •* Hemoglobin ≥ 9.9 g/dL
• •Biochemistry:
• •* Bilirubin \< 1.5 x 1.2 mg/dL
• •* AST \< 2.5 x 40 U/L (males) and \< 2.5 x 32 U/L (females)
• •* ALT \< 2.5 x 41 U/L (males) and \< 2.5 x 33 U/L (females)
• •* ALP \< 2.5 x 129 U/L (males) and \< 2.5 x 104 (females)
• •* Plasma amylase ≤ 1.5 x 100 U/L
• •* Plasma lipase ≤ 1.5 x 60 U/L
• •* Creatinine \< 1.5 x 1.2 mg/dL (males) and \<1.5 x 1.0 mg/dL (females) or calculated 24 hour creatinine clearance ≥ 50 mL/min
• •* Proteinuria (by urine dipstick) \< 2. If ≥ 2 proteinuria on dipstick urinalysis at baseline, will need to undergo 24 hour urine collection and show ≤ 1 g protein within a 24 hour period.
• •* Total plasma calcium (corrected for plasma albumin as needed) or ionized calcium within UIHC's reference range (8.6 - 10.3 mg/dL).
• •Coagulation studies:
• •* INR \< 1.5
• •* aPTT \< 1.5 x 35 s, unless receiving therapeutic low molecular weight heparin
• •Patients with a buffer range from the normal values of ± 5% for hematology and ± 10% for biochemistry are acceptable as determined by the investigator.
• •Pregnancy and Reproduction
• •Women of child-bearing potential (WOCBP) must agree to use a medical contraceptive method during the treatment period and 6 months after the last dose of lomustine and bevacizumab or with sBE device use, whichever is later. WOCBP include any female who is not postmenopausal or has not undergone successful surgical sterilization (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy). Women must not be breastfeeding. In general, appropriate methods of preventing pregnancy should be discussed and agreed upon by the investigator and study participant.
• •* Acceptable contraception methods may include oral contraceptives, other hormonal contraceptives (implants, an intrauterine device \[IUD\] or barrier method. If condoms are used as a barrier method, a spermicidal agent should be added as a double barrier protection.
• •* Post-menopause and not of child bearing potential is defined as 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with plasma FSH levels \> 40 mIU/mL and estradiol \< 20 pg/mL.
• •* WOCBP must have a negative plasma or urine pregnancy test within 3 days prior to starting treatment with the sBE device.
• •Men must agree to use a reliable method of birth control and to not donate sperm during the treatment period and for at least 6 months after the last dose of lomustine and bevacizumab or treatment with the sBE device, whichever is later.
• •All substudy participants must meet the following criteria on the screening examination to be eligible to participate in the study:
• •Able to understand and willing to sign a written informed consent document.
• •Be the partner/spouse of a patient with rGBM and be cohabitating and sharing a bed with said patient with rGBM.
• •Agree to allow the research team to assemble the sBE device in their homes and conduct in-person visits or video conference calls for technical support.
• •Agree and be able to adhere to using the sBE device daily for at least 8 hours, adhere to the scheduled visits, and agree to record the number of hours using the sBE device accurately and consistently in a daily diary.
• •Agree to getting a blood/plasma collection for translational research study purposes at scheduled visits where blood collections are outlined.
• •Agree to accompany their partner with rGBM to all clinical visits where feasibility and safety assessments of the sBE device are being conducted.
• •18 years of age or older on the day of signing the informed consent document.
• •Healthy as determined by screening assessment and the judgement of the principle investigator.
• •Able to physically operate the sBE device according to the provided instruction manual (see Appendix I).
• •Willing to end treatment with the sBE device when their partner with rGBM terminates treatment with the sBE device.
• •Willing to allow the study team to disassemble and retrieve the static magnetic and electric generating components of the sBE device at the termination of the study.
• •WOCBP must agree to use a medical contraceptive method during the 2-month period of using the sBE device and 6 months after the treatment with the sBE device. WOCBP include any female who is not postmenopausal or has not undergone successful surgical sterilization (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy). Women must not be breastfeeding. In general, appropriate methods of preventing pregnancy should be discussed and agreed upon by the investigator and study participant.
• •Acceptable contraception methods may include oral contraceptives, other hormonal contraceptives (implants, an intrauterine device \[IUD\] or barrier method. If condoms are used as a barrier method, a spermicidal agent should be added as a double barrier protection.
• •* Post-menopause and not of child bearing potential is defined as 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with plasma FSH levels \> 40 mIU/mL and estradiol \< 20 pg/mL.
• •* WOCBP must have a negative plasma or urine pregnancy test within 3 days prior to starting treatment with the sBE device.
• •Men must agree to use a reliable method of birth control and to not donate sperm during the treatment period and for at least 6 months after treatment with the sBE device.