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Clinical Trials

CANCER RESEARCH

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Breast

Primary Site	Sponsor/Study ID NCT#	Protocol Description	Eligibility
Advanced breast Cancer, metastatic breast cancer	Pfizer A5481082 NCT03280303	POLARIS: Palbociclib in Hormone Receptor Positive Advanced Breast Cancer: A Prospective Multicenter Non-Interventional Study	Age ≥ 18 years or older. Diagnosis of adenocarcinoma of the breast with evidence of metastatic disease or advanced disease not amenable to treatment with curative intent. Documented HR+ (ER+ and/or PR+) tumor based on local standards Documented HER2- tumor based on local standards Physician had determined that treatment with palbociclib is indicated

Gastrointestinal

Primary Site	Sponsor/Study ID NCT#	Protocol Description	Eligibility
Liver Humanitarian Device TX	MDS Nordion Contact Dr. George Khoriaty	Treatment of Unresectable Hepatocellular Carcinoma with TheraSphere® (Yttrium-90 Glass Microspheres): An HDE Treatment Protocol	Hepatocellular carcinoma of the liver ECOG PS score of ≤ 2 with a life expectancy of > 3 months > 4 weeks since prior RT or surgery > 1 month post other chemotherapy. Excludes contraindications to angiography and selective visceral catheterization Excludes extra-hepatic disease representing an imminent life-threatening outcome or active infection
Pancreas	AstraZenca D081FC00001 POLO NTC02184195	A Phase III, Randomized, Double Blind, Placebo Controlled, Multicentre Study of Maintenance Olaparib Monotherapy in Patients with gBRCA Mutated Metastatic Pancreatic Cancer whose Disease Has Not Progressed on First Line Platinum Based Chemotherapy	Histologic/pathologic confirmation pancreatic adenocarcinoma Receiving initial chemotherapy for metastatic disease and without evidence of disease progression on treatment 1^st Line with platinum-based regimen received a minimum of 16 weeks of continuous platinum treatment with no evidence of progression Documented mutation in gBRACA1 or gBRACA2 that is predicted to be deleterious or suspected deleterious ECOG performance status 0-1
Met. Colorectal	BTG International Inc. TS-102 EPOCH NCT01483027	A Phase III Clinical Trial Evaluating TheraSphere® in Patients with Metastatic Colorectal Carcinoma of the Liver who have Failed First Line Chemotherapy	ECOG PS 0-1 through screening to first treatment on study Unresectable metastatic disease to the liver with disease progression in the liver with oxaliplatin or irinotecan based 1st line chemotherapy No prior external beam radiation treatment to liver or any prior intra-arterial liver directed therapy No clinically evident ascites Tumor replacement <50% of total liver volume
Pancreas	ARMO Biosciences AM0010-301 NCT02923921	A Randomized Phase 3 Study of AM0010 in Combination with FOLFOX Compared with FOLFOX Alone as Second-line Therapy in Patients with Metastatic Pancreatic Cancer that has Progressed During or Following a First-Line Gemcitabine Containing Regimen	Presence of metastatic pancreatic adenocarcinoma Tumor progression on 1^st line therapy/li> Only one prior gemcitabine containing therapy and no other prior therapies for metastatic disease ECOG performance status 0-1 Complete prior chemotherapy and any investigational therapy at least 2 weeks prior to randomization No prior radiation therapy or surgery for treatment of pancreatic cancer

Multiple Myeloma

Primary Site	Sponsor/Study ID NCT#	Protocol Description	Eligibility
MM, relapsed / refractory	Millennium Pharmaceuticals Inc. C16029 NCT03170882	A Phase 2/3, Randomized, Open-Label Study Comparing Oral Ixazomib/Dexamethasone and Oral Pomalidomide/Dexamethasone in Relapsed and/or Refractory Multiple Myeloma	Male/female,18 years or older Relapse or PD after having received 2 or more prior lines of systemic therapy. Refractory to lenalidomide, defined as having received at least 2 consecutive cycles Received at least 2 consecutive cycles of a bortezomib- or carfilzomib-containing regimen ECOG score 0 - 2 Measurable disease defined by serum M-protein or urine M-protein and documented MM isotype by immunofixation

Lymphoma

Primary Site	Sponsor/Study ID NCT#	Protocol Description	Eligibility
DLBCL 2^nd line	Novartis CPDR001XUS01 NCT03365791	Modular phase 2 study to link combination immune-therapyto patients with advanced solid and hematologic malignancies Module 9: PDR001 plus LAG525 for patients with advanced solid and hematologic malignancies DLBCL is only cohort open to enrollment.	At least one prior line of therapy for disease and not be beyond 4th progression/relapse of disease (5 maximum prior lines) Pathology confirmed diagnosis of a solid tumor or lymphoma listed in the section “condition”. Patients must have measurable disease as per appropriate guidelines (Solid Tumors by RECIST 1.1 and Diffuse Large B-cell Lymphoma by Revised Response Criteria for Malignant Lymphoma - Cheson et al 2007). Expansion cohorts only: patient must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution’s guidelines. Exceptions may be considered after discussion with the sponsor.

Chronic Lymphocytic Leukemia

Primary Site	Sponsor/Study ID NCT#	Protocol Description	Eligibility
CLL, PD while on UTX-TGR-304	TG Therapeutics UTX-TGR-204 NCT02612311	A multi-center, open-label, study to evaluate the safety and efficacy of Ublituximab (TG-1101) in combination with TGR-1202 for patients previously enrolled in protocol UTX-TGR-304	ECOG PS ≤ 2 After confirmed progression receiving treatment and randomized onto Arms B, C, or D while on UTX-TGR-304
NHL	TG Therapeutics UTX-TGR-205 NCT02793583	UTX-TGR-205: A Phase 2b Randomized Study To Assess the Efficacy and Safety of the Combination of Ublituximab + TGR-1202 with or without Bendamustine and TGR-1202 alone in Patients with previously Treated Non-Hodgkin's Lymphoma.	Histologically confirmed diagnosis of B-cell NHL FL/SLL patients: relapsed or refractory after ≥ 2 prior lines of systemic therapy. MZL patients: prior treatment with one or more lines of therapy. Measurable disease, defined as at least 1 measurable disease lesion >1.5 cm in at least one diameter by CT/CT-PET or MRI. ECOG performance status ≤ 2. Ability to swallow and retain oral medication.

GENITOURINARY

Primary Site	Sponsor/Study ID NTC#	Protocol Description	Eligibility
Metastatic CRPC	Clovis Oncology, Inc. CO-338-052 TRITON2 NCT02952534	A Multicenter, Open-label Phase 2 Study of Rucaparib in patients with Metastatic Castration-resistant Prostate Cancer Associated with Homologous Recombination Deficiency	ECOG PS: 0 to 1 Histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma of prostate Castrate level of serum testosterone of ≤ 50 ng/dL (1.73 nM). For patients currently being treated with LHRH agonists therapy must be continued throughout the study Have a deleterious mutation in BRCA1/2 or ATM, or molecular evidence of other homologous recombination deficiency No prior treatment with any PARP inhibitor, mitoxantrone, cyclophosphamide or any platinum-based chemotherapy
Metastatic CRPC	Clovis Oncology, Inc. CO-338-063 TRITON3 NCT02975934	Multicenter, Randomized, Open-label Phase 3 Study of Rucaparib versus Physician’s Choice of Therapy for Patients with Metastatic Castration-resistant Prostate Cancer Associated with Homologous Recombination Deficiency	ECOG PS: 0 to 1 Surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dL (1.73 nM) Have a deleterious mutation in a BRCA1/2 or ATM gene Eligible for treatment with physician’s choice of comparator treatment PD after treatment with one prior next-generation AR-targeted therapy for castration-resistant disease
Metastatic CRPC	F. Hoffman-La Roche Ltd CO39303 NCT03072238	A phase III, randomized, double-blind, placebo-controlled, multicenter trial testing Ipatasertib plus Abiraterone plus prednisone/prednisolone, relative to placebo plus Abiraterone plus prednisone/prednisolone in patients with asymptomatic or mildly symptomatic, metastatic castrate resistant prostate cancer with PTEN diagnostic positive tumors	Histologically confirmed prostate adenocarcinoma without neuroendocrine differentiation or small-cell features Consent to provide FFPE tissue block Valid PTEN IHC result (central testing) Metastatic disease documented by bone lesion on bone scan or soft tissue disease by CT or MRI Asymtomatic or mildly symptomatic form of prostate cancer Progress disease defined using at least one; a) two rising PSA levels ≥ 1 ng/mL measured ≥ 1 week apart b) radiographic evidence of disease progression in soft tissue
Renal	Eisai Inc. E7080-G-000-307 NCT02811861	E7080-G-000-307: A Multicenter, Open-label, Randomized, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination with Everolimus or Pembrolizumab Versus Sunitinib Alone in First-Line Treatment of Subjects with Advanced Renal Cell Carcinoma (CLEAR).	Histological or cytological confirmation of RCC with a clear-cell component At least 1 measurable target lesion per RECIST 1.1 KPS of ≥ 70 Adequately controlled BP with or without antihypertensive meds, defined as BP ≤ 150/90 m mHg at screening and no change in antihypertensive meds within 1 week prior to C1D1 Adequate organ function per blood work
Renal Adjuvant monotherapy	Merck MK3475-564 NCT03142334	A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (KEYNOTE-564)	18 years and older Histologically confirmed diagnosis of RCC with clear cell component with or without sarcomatoid features Intermediate-high risk, high risk, or M1 NED RCC as defined per protocol No prior systemic therapy for advanced RCC Undergone a partial nephroprotective or radical complete nephrectomy with negative surgical margins Undergone a nephrectomy and/or metastasectomy ≥28 days before signing consent and ≤12 weeks before randomization Tumor free as assessed by investigator and validated by CT or MRI and bone scan ≤28 before randomization Provided adequate tissue per protocol ECOG PS 0 or 1 Adequate organ function

Lung

Primary Site	Sponsor/Study ID NCT#	Protocol Description	Eligibility
Resected Stage IB-IIIA NSCLC	Roche GO29527 NCT02486718	A Phase III, open label, randomized study to investigate the efficacy and safety of MPDL3280A (Anti-PD-L1 Antibody) compared with best supportive care following adjuvant cisplatin based chemotherapy in PD-L1 selected patients with completely resected stage IB-IIIA non-small-cell lung cancer	ECOG PS: 0 or 1 Histological or cytological diagnosis of Stage IB (tumors ≥ 4 cm)−IIIA (T2−3 N0,T1−3 N1, T1-3 N2) Tumor PD-L1 expression of TC3 or IC3 performed by central lab No prior treatment with systemic chemotherapy No segmentectomy or wedge resection
IIIA, II or IB Resected Non-Squamous NSCLC	NCI A151216 ALCHEMIST NCT02194738	Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST) This is the pre-registration study which randomizes to either A081105 or E4512	ECOG PS: 0 or 1 No neoadjuvant (chemo or radio-therapy) for this lung cancer No prior treatment with agents targeting EGFR mutation or ALK rearrangement No pure squamous carcinoma Pre-surgical: Suspected clinical stage of IIIA, II or large IB (defined as size ≥4cm) Post-surgical: Pathologic stage IIIA, II or IB (defined as size ≥4 cm) Patients may be receiving adjuvant chemotherapy at the time of registration. Adequate FFPE tissue for central EGRF and ALK genotyping for all patients, include those already locally tested Complete resection.
IIIA, II or IB Resected Non-Squamous NSCLC	NCI A081105 ALCHEMIST NCT029193282	Randomized double blind placebo controlled study of erlotinib or placebo in patients with completely resected epidermal growth factor receptor (EGFR) mutant non-small cell lung center (NSCLC)	ECOG PS: 0 or 1 Registered to A151216 with result of EGFR exon 19 deletion or L858R mutation Completely resected stage IB (≥ 4cm), II, or IIIA non-squamous NSCLC with negative margins Patients with known resistant mutations in the EGFR TK domain (T790M) are not eligible. Patients that are both EGFR mutant and ALK rearrangements will be registered to A081105
IIIA, II or IB Resected Non-Squamous NSCLC	NCI E4512 ALCHEMIST NCT02201992	A Phase III Double-Blind Trial for Surgically Resecte d Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein	ECOG PS: 0 or 1 Pre-registered to A151216 Completely resected stage IB (> 4cm), II, or IIIA non-squamous NSCLC with negative margins Positive for translocation or inversion events involving the ALK gene locus No prior treatment with crizotinib or another ALK inhibitor No known interstitial fibrosis or interstitial lung disease.
Locally advanced or metastatic NSCLC	Incyte INCB 39110-207 NCT2917993	An Open-Label Phase 1/2 Study of INCB039110 in Combination with Osimertinib in Subjects with Locally Advanced or Metastatic Non-Small Cell Lung Cancer LCI is participating in Phase 2	Histologically or cytologically confirmed unresectable locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC Documented evidence of somatic activating mutation in EGFR (eg, G719X, exon 19 deletion, L858R, L861Q) in a tumor tissue sample Must not have received more than 1 prior line of therapy Radiographically measurable or evaluable disease per RECIST ECOG performance status 0 or 1 Life expectancy of at least 12 weeks from screening Completion of previous therapy regimen before the initiation of study therapy
SCLC	Pharma Mar PM1183-C-003-14 Atlantis NCT02566993	Phase III randomized clinical trial of Lurbinectedin (PM01183)/ Doxorubicin (DOX) versus Cyclophosphamide (CTX), Doxorubicin (DOX) and Vincristine (VCR) (CAV) or Topotecan as treatment in patients with Small Cell Lung Cancer (SCLC) who failed one prior platinum-containing line	ECOG PS ≤ 2 Histologically or cytologically confirmed limited or extensive SCLC 4 weeks since completion whole brain RT and two weeks since PCI completion No more than one prior chemotherapy containing regimen and not treated with PM01183, topotecan or anthracyclines
NSCLC Unknown EGFR status	Biodesix BDX-00146 No NCT #	An Observational Study Assessing the Clinical Effectiveness of VeriStrat® and Validating Immunotherapy Tests in Subjects with Non-Small Cell Lung Cancer	EGFR mutation status wildtype or unknown If prior treatment then documented disease progression prior to VeriStrat
Advanced ALK positive NSCLC	Pfizer B7461006 NCT03052608	A Phase 3, Randomized, Open-Label Study of Lorlatinib (PF-06463922) Monotherapy Versus Crizotinib Monotherapy in the First-Line Treatment of Patiets with Advanced ALK-Positive Non-Small Cell Lung Cancer	Histologically or cytologically confirmed diagnosis of locally advanced or metastatic ALK positive NSCLC At least 1 extracranial measurable lesion per RECIST Archival FFPE tissue block must be available. If not, then mandatory de novo biopsy required. No prior systemic NSCLC treatment. Adjuvant/neoadjuvant treatment allowed if completed >12 months prior to randomization ECOG performance status 0-2
Screening for tumor antigen & HLA sub-type in lung cancer	Adaptimmune ADP-0000-001 NCT02636855	A Screening Protocol to Determine Tumor Antigen Expression and HLA Sub-Type for Eligibility Determination for Clinical Trials Evaluating the Safety and Efficacy of Autologous T Cells Expressing Enhanced TCRs in Subjects with Solid or Hematological Malignancies	Histologically- or cytologically-confirmed diagnosis of advanced solid or hematologic malignancy or recurrent disease as described in the respective Adaptimmune clinical treatment protocol (including, but not limited to myeloma, melanoma, NSCLC, head & neck, gastric and bladder cancer) Male or female ≥ 18 years of age Life expectancy > 3 months Ability to provide a blood sample Ability to provide one of the following tumor tissue samples: Formalin-fixed, paraffin-embedded (FFPE) tumor block or tissue sections from a current lesion/the most current setting, or fresh biopsy is feasible OR A FFPE archival primary tumor block or tissue sections

General Oncology

Primary Site	Sponsor/Study ID NCT #	Protocol Description	Eligibility
Newly diagnosed cancer	LCI Senior Exercise Project/SPP-2014-38-LCI No NCT #	Senior Adult Cancer Treatment Optimization of Performance Project (Pilot study)	70 years or older at time of cancer diagnosis Understand and adhere to study related assessments/procedures No prior cancer treatment Scheduled to start cytotoxic chemotherapy and/or radiation therapy No restriction on tumor stage
High risk Genetics Registry	City of Hope National Medical Center 96144 No NCT # GENETICS STUDY	Molecular Genetic Studies of Cancer Patients and Their Relatives	Personal history or family history of cancer suggestive of presence of an inherited predisposition In a group known or suspected to have increased risk of carrying genetic alteration or of sustaining exposure that would place them at risk of cancer Willing historian to provide information or access Young age cancer diagnosis Multiple primary neoplasms in affected member Presence of rare tumor types in family Congential malformations Any other family clustering of cancer Any other cancer-predisposing genetic disease/conditions
General Oncology: adult solid tumor	Mitra Biotech Inc. MIT-201701 NCT03253575	CANscript™ Clinical OutcomEs in a Real-World Setting (ANCERS)-2: A Prospective, Multicenter, Observational Study Examining the Clinical Utility of CANscript™ in Routine Clinical Practice	18 years and older ECOG performance status of ≤2 Patient’s tumor must be amenable to a tumor biopsy sampling, so that CANscript can be performed Patient must have disease that is measurable by standard imaging techniques, per the RECIST 1.1 Histologically- or cytologically-confirmed, locally advanced or metastatic: HNSCC TNBC Stage 3b or 4 NSCLS after failure of appropriate 1st line therapy Epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, after failure of 1st line platinum-based chemotherapy Stage IV metastatic CRC

Neuro-Oncology

Primary Site	Sponsor/Study ID NCT#	Protocol Description	Eligibility
Recurrent GBM (Glioblastoma)	ECOG-ACRIN MDNA55-05EAF-151 NCT03115333	Change in Relative Cerebral Blood Volume as a Biomarker for Early Response to Bevacizumab in Patients with Recurrent Glioblastoma	Histologically proven intracranial glioblastoma or gliosarcoma at initial surgery Karnofsky performance status >= 70 Women must not be pregnant or breast-feeding Progression of disease assessed by local site using Revised Assessment in Neuro-Oncology (RANO) criteria, with plan to give whole-dose bevacizumab therapeutically, either as single therapy or in conjunction with other chemotherapeutic regimens; patients getting bevacizumab to support additional radiation therapy or immunotherapy, or primarily for reduction of edema rather than for tumor treatment, are excluded; this must be the patient's initial recurrence Patient must not have been treated previously with immunotherapies (vaccines, checkpoint inhibitors, T-cells)
Newly diagnosed GBM (Glioblastoma)	Nativis NAT-109 NCT03276286	A Feasibility Study of the Nativis Voyager System in Patients with Newly Diagnosed Glioblastoma Multiforme (GBM)	KPS >or=60 Pathological evidence of GBM Maximal debulking surgery Investigational study device is given concomitant with standard of care radiation therapy & Temozolamide
Recurrent GBM	Medicenna Therapeutics Inc. MDNA55-05 NCT02858895	An Open-Label Non-Randomized, Multi-Center Phase-2 Study of Convection-Enhanced Delivery (CED) of MDNA55 in Adults with Recurrent or Progressive Glioblastoma	KPS >or=70. Life expectancy at least 12 weeks Histological confirmed primary GBM-de novo-that has recurred or progressed (first or second recurrence, including this recurrence) after treatment including surgery & radiotherapy with or without chemotherapy. More than 12 weeks since completion of XRT at time of study entry Access to archival tissue from 1^st diagnosis of GBM Recurrent tumor must be solid, suprastentorial, contrast enhancing GB no smaller than 1 x1 cm & no larger than 4 cm max. in a single diameter based on MRI taken within 14 days prior to catheter placement.
Recurrent GBM	Nativis, Inc. NAT-101 NCT02296580	A Feasibility Study of the Nativis Voyager System in Patients With Recurrent Glioblastoma Multiforme (GBM)	KPS ≥ 60 Histologically confirmed dx of GBM Failed or intolerant to: radiotherapy and temozolomide therapy Progressive disease with at least 1 measurable lesion on MRI or CT No surgery within last 4 weeks No active implantable or electromagnetic device or metal implant that are incompatible with MRI
Recurrent Anaplastic Astrocytoma	Orbus therapeutics STELLAR OT-15-001 NCT02796261	A Phase 3, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Eflornithine with Lomustine Compared to Lomustine Alone in Patients with Anaplastic Astrocytoma That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy.	KPS > 70 Surgical or biopsy-proven diagnosis of WHO grade 3 AA Stained, unstained slides or tumor tissue block(s) are available from their most recent tumor surgery for central histological confirmation Completion of EBRT ≥ 6 months prior to randomization Life expectancy ≥ 6 months
Anaplastic Glioma or Low Grade Glioma	National Cancer Institute/Alliance N0577 NCT00887146	Phase III Intergroup Study of Temozolomide Alone versus Radiotherapy with Concomitant and Adjuvant Temozolomide versus Radiotherapy with Adjuvant PCV Chemotherapy in Patients with 1p/19q Co-deleted Anaplastic Glioma or Low Grade Glioma	ECOG PS: 0, 1 or 2 Newly diagnosed and ≤ 3 months from surgical diagnosis Histological confirmation of anaplastic glioma or low grade glioma by central pathology review submission Surgery (partial or gross total resection or biopsy) performed ≥ 2 weeks prior to registration with recovering from effects of surgery. Tumor must show 1p/19q codeletion
Meningioma Grade II	National Cancer Institute NRG-BN003 NCT 03180268	Phase III Trial of Observation versus Irradiation for a Gross Totally Resected grade II Meningioma	Newly diagnosed unifocal intracranial meningioma Gross totally resection with modified Simpson grade 1-3 Histologically confirmation of WHO grade II meningioma Previous radiotherapy to the scalp, cranium, brain or skull base & radiation-induced meningiomas are excluded
Adult Glioma and Meningioma	National Cancer Institute / Moffitt Cancer 15004 No NCT #	Southeastern Study of Cancer and the Environment	Primary diagnosis of glioma or meningioma any grade GBM dx within 1 year, Anaplastic astrocytoma grade III dx within 5 years, grate 2 or less gliomas no restrictions. At least 18 years of age Residents of the US
Brain Metastasis	NCI A221208 NCT02490878	Randomized Phase II Study: Corticosteroids and Bevacizumab vs. Corticosteroids and Placebo (BeSt) for Radionecrosis after Radiosurgery for Brain Metastases	KPS > or = 60. Symptomatic brain radionecrosis after radiosurgery for brain metastasis from primary solid tumor including but not limited to lung, breast, colorectal cancer, excluding melanoma, choriocarcinoma, renal cell CA or gliomas. Radionecrosis at 3-24 months following radiosurgery New or increase headache associated with mass effect, sensory or motor abnormality, cognitive changes, speech difficulty, balance or coordination difficulty, cranial nerve deficits. Symptoms persistent or worsening despite administration of at least dexamethasone 4 mg/day for 1 week. No Bevacizumab (Avastin) < or = 3 months of study registration. No systemic therapy within 2 weeks prior to registration Central imaging review to confirm radionecrosis for eligibility
Brain Tumor	NCI A221101 NCT01781468	A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil) To Reduce Cancer Related Fatigue in Patients With High Grade Glioma	ECOG of 0, 1, 2 or 3 Diagnosed with GBM, gliosarcoma, anaplastic astrocytoma, anaplastic oligodendroglioma or anaplastic oligoastrocytoma who are clinically stable & have completed radiation therapy (excluding stereotactic radiosurgery) > 21 days & < or = 24 months prior to enrollment. Stable dose of corticosteroid > or = 14 days prior registration Concurrent chemotherapy &/or Optune device is allowed
Brain Tumor	State of Florida NCT00811148	Florida Center for Brain Tumor Research	All patients with brain tumors (or other problems requiring cranial surgery) are eligible