[c09aa8]: / clusters / 9knumclustersv2 / clust_1758.txt

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Histologically confirmed oligodendroglioma or mixed glioma
Patients with a diagnosis of spinal cord ependymoma, myxopapillary ependymoma, subependymoma, ependymoblastoma, or mixed glioma are NOT eligible
Newly diagnosed and =< months from surgical diagnosis; patients are also eligible if they have had a prior surgical procedure > months earlier for low grade glioma, as long as the patient has not received prior radiation or prior chemotherapy
History of prior radiation therapy or chemotherapy for glioma; note: patients who have a history of prior low grade glioma (with or without a distant history of prior surgery for that glioma), but who have never received prior chemotherapy or radiation therapy for the glioma are eligible for the study
Patients with a histologically confirmed diagnosis of high-grade glioma (HGG), medulloblastoma, CNS embryonal tumor (not otherwise specified [NOS]), ependymoma, or atypical teratoid rhabdoid tumor (ATRT) that is recurrent, progressive or refractory
Patients with recurrent diffuse intrinsic pontine glioma (DIPG) with typical radiographic appearance who have undergone biopsy are eligible provided there is histologic confirmation of malignant glioma World Health Organization (WHO) II-IV; Rb screening for these patients is required only if adequate tissue is available
Patients with recurrent brainstem tumors with an atypical presentation who have undergone biopsy are eligible provided there is histologic confirmation of malignant glioma WHO II-IV; these patients must undergo Rb screening; these patients must have radiographic evidence of progression
Radiographically-confirmed progression of, or recurrent, primary or secondary Grade IV glioma, and must be on a stable or decreasing dose of steroid for at least five days prior to the date of informed consent.
Diagnosis of DIPG or high-grade glioma originating from the brain stem
Patients with biopsy proven low grade glioma or astrocytoma, ependymoma, craniopharyngioma, meningioma, neurocytoma, medulloblastoma or gangliogliomas or other rare tumor requiring tumor bed or tumor irradiation; patients with a presumed diagnosis of optic glioma or gliomas based on imaging and clinical characteristics will also be allowed on this trial as it may be against the standard of care to biopsy some of these individuals (for example, a patient with neurofibromatosis [NF]- and an optic glioma will not require a biopsy for diagnosis)
All patients must have radiographically progressive low-grade glioma (including NF related visual pathway gliomas) after failure of a carboplatin-containing regimen; patients do not require a biopsy to confirm the diagnosis
A patient with low grade glioma who has failed standard therapy
At the time of surgery, frozen biopsy confirmation of high grade or malignant glioma by neuropathologist; biopsy confirmation of glioma or infiltrative glioma at time of surgery will be acceptable, provided that subject has prior pathology confirmation of high-grade glioma; if subject had previous diagnosis of low grade glioma, then the biopsy must show high grade glioma\r\n* To be confirmed at time of surgery, after registration in OnCore
Recurrent glioma where injection in either arm A or B of the biologic agent would require access and/or considerable spillage into the ventricular system
Low grade glioma NOS
Histologically proven diagnosis of high-grade glioma, including anaplastic glioma (WHO grade III with p/q chromosomes intact), glioblastoma (WHO grade IV) or gliosarcoma (WHO Grade IV);
Presence of T gadolinium (Gd) enhancing lesions (on MRI) suggestive of high-grade glioma
Stratum B: Patients must have a histologically confirmed diagnosis of a non-brainstem high-grade glioma (NB-HGG) that is recurrent, progressive or refractory following therapy which included radiotherapy; spinal primary disease is eligible
EXCLUSION CRITERIA FOR STRATUM C: Patients with diffuse intrinsic pontine or other brainstem high-grade glioma and those with primary spinal cord tumors
There must be an interval of at least weeks from the completion of standard front line therapy to study registration unless there is unequivocal evidence for tumor recurrence per RANO criteria; when the interval is less than weeks, the use of perfusion imaging and/or positron emission tomography (PET) scan is allowed to differentiate between unequivocal evidence of tumor recurrence and pseudo-progression; standard front line therapy is as described below:\r\n* For grade IV malignant gliomas (GBM): standard front line therapy for newly diagnosed GBM must include maximal feasible surgical resection (biopsy alone allowed), radiotherapy, and temozolomide chemotherapy; if the tumor was initially diagnosed as either a grade II or III tumor and now has recurred or progressed as a grade IV GBM, it will be considered a secondary recurrent grade IV GBM and will be eligible for this study as long as prior treatment included maximal feasible surgical resection (biopsy alone allowed), radiotherapy, and temozolomide chemotherapy\r\n* For grade III malignant gliomas with p q codeletions: standard front line therapy for newly diagnosed grade III malignant gliomas must include maximal feasible surgical resection (biopsy alone allowed), radiotherapy, and chemotherapy (procarbazine, lomustine, and vincristine sulfate [PCV] or temozolomide); if the patient did not receive any or all components of the standard front line therapy as detailed above for newly diagnosed grade III gliomas with p q codeletions and the tumor then recurred or progressed, s/he must first receive at least one prior standard therapy or any appropriate combination of the components of standard therapy as detailed above and must experience further recurrence or progression before s/he is deemed eligible for this study; if the tumor was initially diagnosed as a grade II glioma with p q codeletions and now has recurred or progressed as a grade III tumor, it will be considered a secondary recurrent grade III glioma with p q codeletions and will be eligible for this study as long as prior treatment included maximal feasible surgical resection (biopsy alone allowed), radiotherapy, and chemotherapy (PCV or temozolomide)\r\n* For grade III malignant glioma without p q codeletions: standard front line therapy for newly diagnosed grade III malignant gliomas must include maximal feasible surgical resection (biopsy alone allowed), radiotherapy, and temozolomide chemotherapy; if the tumor was initially diagnosed as a grade II glioma without p q codeletions and now has recurred or progressed as a grade III tumor, it will be considered a secondary recurrent grade III glioma without p q codeletions and will be eligible for this study as long as prior treatment included maximal feasible surgical resection (biopsy alone allowed), radiotherapy, and temozolomide chemotherapy
Participants with a diagnosis of recurrent, progressive, or refractory low grade glioma (LGG)
STRATUM B: Participants with low grade glioma (LGG) or diffuse intrinsic pontine glioma (DIPG)
Participant has a prior histologically-confirmed diagnosis of a grade III or IV glioma, or has a prior histologically-confirmed diagnosis of a grade II glioma and now has radiographic progression consistent with a grade III or IV malignant glioma (MG)
NF- patients with radiographic evidence of a progressive, recurrent or refractory low grade glioma, with or without pre-treatment tumor tissue
Histopathologically proven previous diagnosis of medulloblastoma or grade III or IV glioma
Histologically confirmed diagnosis of high-grade glioma (any histology, including but not limited to glioblastoma, astrocytoma, and oligodendroglioma) in any tumor sample and presence of histone H KM mutation by a Clinical Laboratory Improvement Act (CLIA)-approved immunohistochemistry or deoxyribonucleic acid (DNA) sequencing test on any glioma tumor sample
Patients must have received no more than prior therapies for recurrent high grade glioma (rHGG)
Subject has a diagnosis of high-grade glioma, medulloblastoma, ependymoma or Diffuse intrinsic pontine glioma (DIPG) that is recurrent or progressive. Subjects with neurofibromatosis type (NF-) associated tumors are eligible if the meet all other eligibility criteria.
Subject has any prior history of malignancies, other than high-grade glioma, medulloblastoma, ependymoma or DIPG (Note: radiation-associated gliomas are excluded from enrollment)
Patients must have histologically confirmed low or high grade glioma (grade II-IV)
Histologically confirmed or radiographic evidence of recurrent/progressive high-grade glioma after treatment with bevacizumab
History of radiation therapy to the brain for prior diagnosis of glioma
Histopathologically proven diagnosis of ependymoma, medulloblastoma, pineoblastoma/pineocytoma, choroid plexus carcinoma/papilloma, chordoma, gliomatosis cerebri, brainstem glioma, midline glioma, ATRT, atypical/malignant meningioma, gliosarcoma or primary brain sarcoma prior to registration as confirmed by National Cancer Institute (NCI) Laboratory of Pathology
Patients must have a presumed newly identified high grade glioma based on clinical and radiologic evaluation; pathologic confirmation of high grade glioma must be made at the time of stereotactic biopsy or resection on frozen section by a neuropathologist prior to NSC-CRAd-S-pk injection; if this is not possible, the injection will not be performed and the subject will no longer be eligible for the study
Evidence of an active optic glioma or other low-grade glioma, requiring treatment with chemotherapy or radiation therapy; patients not requiring treatment are eligible for this protocol
Be at first or second relapse; Note: relapse is defined as progression following initial therapy (i.e., radiation +/- chemotherapy); for participants who had prior therapy for a low-grade glioma, the surgical diagnosis of a high-grade glioma will be considered the first relapse
Recurrent or multifocal high grade glioma (HGG)
Patients must have pathologically proven diagnosis of high grade glioma
Recurrent glioma, or tumor involving the brainstem or cerebellum; prior low-grade glioma without prior RT, now with malignant progression are eligible
Patients with recurrent diffuse intrinsic pontine glioma (DIPG)
Prior antitumor therapy for glioma (other than steroids)
Subjects must be within weeks of last major neurosurgical procedure for the high-grade glioma (craniotomy, open biopsy, or stereotactic biopsy)
Recurrent medulloblastoma or recurrent high grade glioma
First or second recurrence of MG (WHO grade III or IV glioma or astrocytoma) in surgically accessible areas with prior histologic diagnosis of MG
Patients with low grade glioma are not eligible
Eligibility Criteria\n\n - Age: - years.\n\n - Group or Group : histologically proven initial diagnosis of primary malignant brain\n tumor, with no known curative treatment options.\n\n - Group : histologically proven initial diagnosis of high-grade glioma (WHO grade III\n and IV), ependymoma, medulloblastoma, or other primary central nervous system tumor.\n\n - Group b: Patients with a radiographic diagnosis or histologically proven diagnosis of\n diffuse intrinsic pontine glioma (DIPG).\n\n - MRI confirmation of tumor progression or regrowth.\n\n - Patients must be able to swallow whole capsules.\n\n - Patients with metastatic disease are eligible for enrollment.\n\n - Lansky or Karnofsky performance status score must be > %.\n\n - Seizure disorders must be well controlled on antiepileptic medication.\n\n - DIPG patients enrolled to Group b must not have been previously treated with\n radiation or any medical therapy.\n\n - Patients previously treated with temozolomide, cyclophosphamide, and/or etoposide are\n eligible for enrollment.\n\n Exclusion Criteria\n\n - Prior invasive malignancy, other than the primary central nervous system tumor, unless\n the patient has been disease free and off therapy for that disease for a minimum of \n years\n\n - Patients with baseline QTc interval of more than msec at study entry, and patients\n with congenital long QTc syndrome.\n\n - Active autoimmune disease
Histologically confirmed diagnosis of supratentorial WHO grade III or IV glioma (high grade glioma) that has undergone surgical biopsy or resection followed by adjuvant chemoradiotherapy, that has evidence of recurrence or progression based on imaging studies and surgical resection of the enhancing tumor is clinically indicated
Recurrent high grade glioma
Patient with diagnosis of diffuse intrinsic pontine glioma
Patients must have a recurrent supratentorial WHO grade III or IV malignant glioma based on imaging studies
Prior histopathology consistent with a supratentorial WHO grade III or IV malignant glioma
Prior bevacizumab for treatment of glioblastoma or high grade glioma
Participant has a prior histologically-confirmed diagnosis of a grade III or IV glioma, or has a prior histologically-confirmed diagnosis of a grade II glioma and now has radiographic progression consistent with a grade III or IV malignant glioma (MG) after completing standard therapy
Clinical and/or radiographic, progressive and resectable grade II glioma
High-grade glioma has recurred or progressed after prior treatment with brain radiation and temozolomide
Patients must have a previously histologically or cytologically confirmed high grade glioma (astrocytic or oligodendroglial supratentorial tumors grade or ) that has been previously treated with fractionated radiation therapy and now shows evidence of recurrence
Patients will be eligible if the original histology was low-grade glioma and a subsequent histological diagnosis of a high grade glioma is made
Histologically confirmed glioma
Pathologically confirmed high-grade glioma (World Health Organization [WHO] grade or ), with documented computed tomography (CT) or magnetic resonance imaging (MRI) progression or recurrence; biopsy is also an acceptable method of confirming progression; if initial tumor was grade glioma, histological confirmation of high-grade recurrence is required\r\n* After first interim analysis, if the study proceeds to enrollment of selected patients (only those who have PDGFR alpha-positive tumors), patients will be pre-registered for PDGFR alpha analysis and registered to the combination treatment schema only if PDGFR alpha-positive and all other enrollment criteria are met
Intraoperative histological frozen section at the time of tumor resection compatible with high-grade glioma; if intraoperative diagnosis is not compatible with high grade glioma, the patient will not be treated
Tumors infiltrate the cerebellum, bilateral corpus callosum (butterfly glioma), ventricular system, or brain stem
Infratentorial high grade glioma
Patients must have a histologically confirmed diagnosis of supratentorial high-grade glioma or supratentorial ependymoma that is recurrent, progressive or refractory
Participants will not be eligible if the original diagnosis was a lower grade glioma and a subsequent histologic diagnosis revealed glioblastoma
Subjects with histologically confirmed high-grade glioma are eligible; diagnosis of high-grade glioma will be made on the basis of needle biopsy, open biopsy, or surgical resection
Confirmed histopathology of WHO grade III glioma or WHO grade IV GBM at primary diagnosis
Recurrent glioma, or tumor involving the brainstem or cerebellum. Prior low-grade glioma without prior RT, now with malignant progression are eligible.
Malignant glioma patients within weeks of completion of radiation concurrent temozolomide will be excluded
Inclusion Criteria:\n\n For more information regarding Bristol-Myers Squibb Clinical Trial participation, please\n visit www.BMSStudyConnect.com\n\n - Children and adolescents diagnosed with either:\n\n - Diffuse Intrinsic Pontine Glioma (DIPG), in first-line, after completion of standard\n radiotherapy\n\n - High Grade Glioma (HGG), recurrent or progressive\n\n - Medulloblastoma, recurrent or progressive\n\n - Ependymoma, recurrent or progressive\n\n - Other high-grade tumors of the central nervous system, recurrent or progressive\n\n - Lansky play score (LPS) for =< years of age or Karnofsky performance scale (KPS)\n for > years of age assessed within two weeks of enrollment must be >= \n\n - A tumor sample must be available for submission to central laboratory [not required\n for DIPG]\n\n Exclusion Criteria:\n\n - Participants with active, known or suspected autoimmune disease\n\n - Participants unable to taper steroids due to ongoing mass effect\n\n - Participants with low-grade gliomas or tumors of unknown malignant potential\n\n - Prior treatment with any drug that targets T cell co-stimulation pathways (such as\n checkpoint inhibitors)\n\n Other protocol defined inclusion/exclusion criteria could apply
Phase I: patients must have recurrent or refractory solid tumors or acute leukemia (limited to AML or ALL) or have been intolerant of prior therapies, confirmed by the Laboratory of Pathology, National Cancer Institute (NCI), e.g., solid tumors including rhabdomyosarcoma, Ewing sarcoma, soft tissue sarcomas; these may include primary neoplasms of the central nervous system, such as high-grade (World Health Organization [WHO] grade III-IV) glioma; patients with diffuse intrinsic pontine glioma (DIPG) or optic pathway glioma are exempt from histologic verification; for DIPG typical magnetic resonance imaging (MRI) findings must be present which include hypo- or isointense on T-weighted imaging, hyperintense on fluid attenuation inversion recovery (FLAIR) or T-weighted imaging, epicenter in the pons in the face of a typical clinical presentation; optic pathway glioma are located in the optic pathway and are typically hypo- or iso-intense on T and hyperintense on T-weighted images
Has more than three recurrences of high grade glioma; previous recurrences of low grade glioma is not considered
Recurrent grade or glioma, including astrocytoma, oligodendroglioma or mixed glioma with histologic confirmation at initial diagnosis or recurrence
Patient's high-grade glioma has recurred or progressed after prior treatment with brain radiation and temozolomide
After surgery, a pathological diagnosis of malignant glioma (WHO Grade III or IV) will need to be established
Patient must have evaluable disease by RECIST v. for patients without glioma or by RANO or RANO LGG criteria for patients with glioma
Patients with glioma must have a baseline brain MRI scan
Prior treatment with TMZ for low grade glioma or glioblastoma.
Patients with diffuse intrinsic brain stem glioma (DIPG) can be enrolled without the need for available tumor tissue for RB protein status confirmation.
High-grade Glioma (HGG)
Has more than three recurrences of high grade glioma
Radiographically proven recurrent (>= first relapse), intracranial glioma
Patients must be at first or second relapse and clinically require reoperation for tumor progression within to weeks; Note: relapse is defined as progression following initial therapy (i.e., radiation, chemotherapy, or radiation + chemotherapy); if the participant had a surgical resection for relapsed disease and no anti-tumor therapy instituted for up to weeks, this is considered one relapse; for participants who had prior therapy for a low grade glioma, the surgical diagnosis of a high grade glioma will be considered first relapse
Be at first or second relapse; Note: relapse is defined as progression following initial therapy (i.e., radiation +/- chemotherapy); if the participant had a surgical resection for relapsed disease and no antitumor therapy was instituted for up to weeks, this is considered one relapse; for participants who had prior therapy for a low-grade glioma, the surgical diagnosis of a high-grade glioma will be considered the first relapse
Expansion Cohort only: Patients with high grade glioma (grade and ) that are refractory to standard therapies, and who have progressive disease following radiation therapy. Patients with any number of prior treatments are allowed.
Subjects with primary CNS malignancy other than high grade glioma (Grade or )
Histologically confirmed diagnosis of supratentorial WHO grade III or IV glioma (high grade glioma) that has undergone surgical biopsy or resection followed by adjuvant chemoradiotherapy, that has evidence of recurrence or progression based on imaging studies and a stereotactic biopsy is indicated for confirmation of recurrence/progression
Prior radiation or chemotherapy for glioma
Patients must have received prior radiotherapy and prior temozolomide as treatment for the malignant glioma
Multiple intracranial malignant glioma lesions
Patients must have pathologically proven diagnosis of high grade glioma
Evidence of an active optic glioma or other low-grade glioma, requiring treatment with chemotherapy or radiation therapy; subjects not requiring treatment are eligible for this protocol
Subjects must have evaluable disease by RECIST v. for subjects without glioma or by RANO criteria for subjects with glioma.
Dose Expansion: Non-enhancing Glioma
Subjects must have progressive glioma that is solely non-enhancing on MRI.
Progression of glioma must have occurred over months or less.
Subjects with histologically confirmed Grade IV malignant glioma
Phase : Ewing sarcoma/peripheral primitive neuroectodermal tumor (pPNET), Rhabdomyosarcoma, High Grade Glioma (HGG) (all must have measurable disease); exclusion of Diffuse Intrinsic Pontine Glioma
Patients may have had treatment for no more than prior relapses; relapse is defined as progression following initial therapy (i.e. radiation +/- chemotherapy [chemo] if that was used as initial therapy); the intent therefore is that patients had no more than prior therapies (initial and treatment for relapses); if the patient had a surgical resection for relapsed disease and no anti-cancer therapy was instituted for up to weeks, and the patient undergoes another surgical resection, this is considered as relapse; for patients who had prior therapy for a low-grade glioma, the surgical diagnosis of a high-grade glioma will be considered the first relapse
Recurrent high grade glioma
Pathological diagnosis for the recurrent disease demonstrate transformation to higher grade (i.e. WHO grade III or IV) gliomas, even if the initial diagnosis was WHO grade II glioma
All patients require an initial diagnosis of a malignant glioma as outlined in the inclusion criteria which must be confirmed at the treating facility
Patients with histologically confirmed supratentorial high-grade glioma will be eligible for this protocol.
Patients must be registered on study within weeks after the surgical procedure that established the diagnosis of High Grade Glioma.
Multicentric glioma
Patients must have malignant glioma or recurrent ependymoma
LOW RISK HIGH-GRADE GLIOMA (patients must meet all of the following criteria):
Patients must have histologically confirmed supratentorial high grade glioma (grade III or IV glioma) that is progressive or recurrent following radiation therapy and chemotherapy; patients with grade IV glioma must have progressed or recurred after initial treatment with radiation and temozolomide; patients with grade III glioma must have received at least radiation and one regimen of chemotherapy (temozolomide or procarbazine, lomustine, vincristine [PCV] regimen)
Chemotherapy for glioma other than temozolomide or Gliadel wafers (steroids are allowed)
Measurable disease by RECIST v. for subjects with solid tumors without glioma, by modified RANO criteria for subjects with glioma, or by the revised IWG criteria for subjects with AITL
Histologically proven intracranial glioblastoma multiforme (WHO grade IV glioma) or gliosarcoma. In addition, the Phase b cohort will include patients with progressive WHO grade III glioma.
If most recent histology shows progression to high grade glioma, patients must have had prior radiotherapy in order to be eligible
Solid tumor, including central nervous tumors, that is recurrent or refractory to standard therapy or for which standard therapy is not available; all research participants must have a pathologic diagnosis either from their initial presentation, or at the time of recurrence or progression; the requirement for histologic verification may be waived for patients with brainstem glioma and optic pathway glioma
Must have presumed resectable or partially resectable malignant glioma based on clinical and radiologic evaluation (pathologic confirmation of malignant glioma must be made at the time of surgery if not previously determined). Patients who have previously received AdV-tk + prodrug on this study may receive an additional AdV-tk + prodrug course at recurrence if eligibility criteria are still met.
Patients with pontine glioma are not eligible
COHORT B SPECIFIC INCLUSION: Patients with histologically confirmed glioma of any grade (II-IV) who are planned for a standard of care surgical debulking/resection and for whom participation in this study would not cause a medically unacceptable delay in surgery
For Part A, participants must have histologically confirmed solid tumors, CNS tumors, or lymphoma based upon biopsy or surgery at initial diagnosis and/or relapse/progression; the only exception to histologic confirmation is for pediatric tumors that are routinely diagnosed exclusively by standard clinical imaging criteria: diffuse intrinsic pontine glioma and optic pathway glioma
PATIENT ONLY: Patients with a diagnosis of HGG or low grade glioma (LGG), based on radiographic or pathologic diagnosis of grade III or IV listed in the medical records, or patients with a malignancy that has metastasized to the brain
Diagnosis of localized low grade glioma (e.g., pilocytic astrocytoma, optic pathway glioma, oligodendroglioma, ganglioglioma, pleomorphic xanthoastrocytoma [PXA]), craniopharyngioma, ependymoma, or germ cell tumor
BRAIN CANCER: Histologically confirmed high grade glioma
SUBJECT: A child with diffuse intrinsic pontine glioma (DIPG) or recurrent high grade brain tumors will be excluded.
Patients must have histologically confirmed diagnosis of glioma (either low or high grade) and be either chemotherapy naive or non-naive and scheduled to receive temozolomide-based +/- bevacizumab-based chemotherapy; patients with recurrent disease whose diagnostic pathology confirmed glioma (either low or high grade) will not need re-biopsy
PATIENTS ONLY: Diagnosed with a primary glioma and going to receive at least weeks of radiotherapy with at least fractions
Patients must have had radiation therapy for a histologically confirmed CNS tumor including, but not restricted to glioma, astrocytoma, medulloblastoma or other embryonal tumors; patients with diffuse intrinsic pontine gliomas may be enrolled without pathologic confirmation
Pediatric patients who will receive cranial radiotherapy for brain tumors; this could include but is not limited to: low grade glioma, high grade glioma (to include grade III but not grade IV glioma), germ cell tumors, primitive neuroectodermal tumors, craniopharyngioma, or medulloblastoma
Patients with a suspected diagnosis of new, recurrent, or transformed glioma (WHO grade I-IV) scheduled for craniotomy at Duke University Medical Center (DUMC)
Histologically confirmed supratentorial glioblastoma or other WHO grade III or IV malignant glioma from archival tissue.
Individuals without a probable or expected grade IV glioma
Patients with histologically proven high grade glioma
Histologically-confirmed high-grade glioma
MRI findings compatible with newly diagnosed or recurrent high- or low-grade malignant glioma
Histologically confirmed newly diagnosed grade IV malignant glioma; Note: grade III patients are no longer being enrolled
Pathological or clinical/radiological diagnosis of a neoplasm, either primary (e.g., malignant glioma) or secondary (metastasis from systemic malignancy) with a history of brain radiation therapy
Suspected or histopathologically proven diagnosis of high or low grade glioma, or a tumor suspected to harbor an isocitrate dehydrogenase (IDH) mutation
Patients must have had prior central nervous system (CNS) radiotherapy for their glioma, including standard doses for low-grade or high-grade glioma as well as non-standard dose and fractionation, including hypofractionated regimens, stereotactic radiosurgery, etc
Subject must have either radiological or established histological diagnosis of the following general categories: \r\n* High-grade glioma/central nervous system (CNS) lymphoma or \r\n* Brain metastases
Suspected new diagnosis or suspected recurrence of glioma
Patients with low-grade (WHO grade I or II) glioma
Any patient with suspected new or recurrent high grade glioma on diagnostic MR imaging who will undergo a resection
Patients must have clinically documented primary brain tumor for which resection is clinically indicated; radiographic findings should be consistent with high grade glioma
Preoperative diagnosis of recurrent high-grade glioma having EGFR positive tissue from prior surgery
Glioma patients must have completed chemoradiotherapy at least weeks prior to screening and their baseline scan
Diagnosis of BRAF V mutant High Grade glioma that has relapsed, progressed or failed to respond to frontline therapy
Diagnosis of BRAF V mutant Low Grade glioma whose tumor is unresectable and who require treatment