Clinical Trial Details
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NCT01925573 : Optune(NOVOTTF-100A)+ Bevacizumab+ Hypofractionated Stereotactic Irradiation Bevacizumab-Naive Recurrent Glioblastoma (GCC 1344)
AgesMin: 22 Years Max: N/A
Inclusion Criteria:

- 1 Patients with recurrent or progressive glioblastoma or other grade IV malignant
glioma (i.e. glioblastoma, gliosarcoma, giant cell glioblastoma, etc.) who have failed
prior radiation but who have not progressed/recurred on bevacizumab. Patients will be
eligible if the original histology was lower-grade glioma and subsequent diagnosis of
glioblastoma or gliosarcoma is made.

2 Patients with any number of recurrences are allowed. 3 Brain MRI demonstrates an
enhancing tumor < 8 cm in largest diameter. 4 Karnofsky performance status = 70%. 5
Age = 22 years old. 6 Patients must have the following laboratory values:

- Absolute neutrophil count (ANC) = 1.5 x 109/L

- Platelets = 100 x 109/L

- Hemoglobin (Hgb) > 10 g/dL

- Serum total bilirubin: = 1.5 x ULN

- ALT and AST = 3.0 x ULN

- Adequate Renal Function: BUN and Cr < 2.0 x ULN

- Blood coagulation parameters: international normalized ratio (INR) = 1.5 for
patients not on warfarin 7 Minimum interval since completion of radiation
treatment is 12 weeks. 8 History of standard dose CNS radiotherapy: radiation of
60 Gy in 30 fractions or 59.4 Gy in 1.8 Gy fractions, or equivalent or lower

9 Minimum interval since last major surgery, open biopsy, or significant
traumatic injury is 4 weeks 10 Minimum interval since last drug therapy:

- 3 weeks since last non-cytotoxic therapy

- 3 weeks must have elapsed since the completion of a non-nitrosourea-containing
chemotherapy regimen

- 6 weeks since the completion of a nitrosourea-containing chemotherapy regimen. 11
Patients must have signed an approved informed consent and authorization
permitting release of personal health information.

12 Patients with the potential for pregnancy or impregnating their partner must
agree to follow acceptable birth control methods to avoid conception. Female
patients of child-bearing potential must have a negative pregnancy test.

13 Patients with history of prior invasive malignancy (except non-melanomatous
skin cancer) must have been disease free for a minimum of 1 year.

14 Patients must be maintained on a stable corticosteroid regimen from the time
of their baseline scan until the start of treatment and/or for at least 5 days
before starting treatment.

15 Patients on full-dose anticoagulants (e.g., warfarin or LMW heparin) must meet
both of the following criteria: 16 No active bleeding or pathological condition
that carries a high risk of bleeding (e.g., tumor involving major vessels or
known varices) 17 In-range INR (max = 3) on a stable dose of oral anticoagulant
for greater than 1 month or on a stable dose of low molecular weight heparin

Exclusion Criteria:

- 1 Any prior therapy with bevacizumab 2 Any significant hemorrhage defined as > 1 cm
diameter of blood seen on the MRI or CT scan. If > 1 cm of acute blood is detected,
the patient will be ineligible for this trial.

3 Patients who have undergone major surgery (e.g. intra-thoracic, intra-abdominal or
intra-pelvic), open biopsy or significant traumatic injury = 4 weeks prior to starting
study drug, or patients who have had minor procedures, percutaneous biopsies or
placement of vascular access device = 1 week prior to starting study drug, or who have
not recovered from side effects of such procedure or injury.

4 Patients with impaired cardiac function or clinically significant cardiac diseases,
including any of the following:

- History or presence of serious uncontrolled ventricular arrhythmias

- Any of the following within 6 months prior to starting study drug: myocardial
infarction (MI), severe/unstable angina, Coronary Artery Bypass Graft (CABG),
Congestive Heart Failure (CHF), Cerebrovascular Accident (CVA), Transient
Ischemic Attack (TIA), Pulmonary Embolism (PE)

- Uncontrolled hypertension (defined by a SBP = 160 mm Hg or DBP = 100 mm Hg while
on anti-hypertensive medications) or history of hypertensive crisis or
hypertensive encephalopathy, stroke, TIA, symptomatic peripheral vascular
disease, or grade 2 CHF 5 Patients with cirrhosis, or active viral or non-viral
hepatitis. 6 Patients with peptic ulcer, abdominal fistula, gastrointestinal
perforation, intra-abdominal abscess within 6 months of enrollment.

7 Implanted pacemaker, defibrillator or deep brain stimulator, other implanted
electronic devices in the brain or documented clinically significant arrhythmias.

8 Infra-tentorial tumor. 9 Known sensitivity to conductive hydrogels. 10 Known
diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not

11 Other concurrent severe and/or uncontrolled concomitant medical conditions
(e.g. active or uncontrolled infection, uncontrolled diabetes) that could cause
unacceptable safety risks or compromise compliance with the protocol 12 Pregnant
or breast-feeding women. 13 Patients unwilling or unable to comply with the
protocol. 14 Patients treated on any other therapeutic clinical protocols within
3 weeks of starting on this study.
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