Symptomatic brain metastasis or leptomeningeal disease
No evidence of residual cancer or metastasis after surgery
Cutaneous metastasis of NSCLC.
Known estrogen, progesterone, and HER2 status of either primary tumor or metastasis; \r\n* Note: estrogen, progesterone and HER2 status of metastasis preferred for stratification
All known disease amenable to metastasis-directed therapy with either SBRT or resection\r\n* NOTE: Symptomatic bone metastasis are allowed if ablative therapy can be delivered\r\n* NOTE: Sites for possible surgical excision include lung, liver, adrenal gland, bone, small intestine, large intestine, ovary, and amenable nodal disease sites\r\n* NOTE: Surgical stabilization is allowed for a metastasis if it is followed by conventionally fractionated external beam radiotherapy
Maximum diameter of individual metastasis in any dimension =< 5 cm
Patients with evidence of clinical T4b (unresectable) or M1 (distant metastasis) according to the AJCC 2010 staging system will be ineligible
Primary brain tumors or clinical evidence of active brain metastasis
Patients with symptomatic brain or bone metastasis are NOT eligible for participation; prior radiation and/or steroid therapy for brain or bone metastasis (mets) must be completed >= 2 weeks prior to study enrollment
Any evidence of tumor metastasis or co-existing malignant disease
Leptomeningeal disease or uncontrolled brain metastasis\r\n* NOTE: Metastases treated by surgery and/or radiotherapy such that patient is neurologically stable and off steroids >= 12 weeks prior to preregistration are eligible
Untreated or uncontrolled brain metastasis.
Any uncontrolled neurological symptom attributed to CNS metastasis
Patients with brain metastases are allowed onto the study as long as patients have completed their treatment for brain metastasis, no longer require corticosteroids, and are asymptomatic; subjects with neurological symptoms should undergo a head computed tomography (CT) scan or brain magnetic resonance imaging (MRI) to exclude brain metastasis, at the discretion of the treating physician
Patients with symptomatic brain metastases; subjects with untreated brain metastasis =< 1 cm can be considered eligible if deemed asymptomatic by the investigator upon consultation with the medical monitor and do not require immediate radiation or steroids; subjects with brain metastasis that is treated and stable for 1 month may be considered eligible if they are asymptomatic and on stable dose of steroids or if they do not require steroids following successful local therapy
Subjects who have a history of brain metastasis are eligible for the study provided all the following criteria are met:\r\n* Must have completed their treatment for brain metastasis\r\n* Must be asymptomatic\r\n* Must not have evidence of disease progression for >= 3 months or hemorrhage after treatment\r\n* Must be off-treatment from dexamethasone for 4 weeks prior to study registration and\r\n* Must not have an ongoing requirement for dexamethasone or anti-epileptic drugs
Cytologic or unequivocal radiographic confirmation of leptomeningeal metastasis by dural puncture and/or neuroimaging with or without known brain metastasis
Alkaline phosphatase =< 2.5 x IULN, unless bone metastasis is present in the absence of liver metastasis
Known or suspected brain metastasis or active leptomeningeal disease
Have brain metastasis without prior radiotherapy.
Primary brain tumor or active brain metastasis
Patients with distant metastasis (e.g. spread to distant areas outside the regional lymph nodes, clearly non contiguous areas of bone involvement, or distant metastasis to lung, brain, liver or other visceral organs) are ineligible
Active or previous brain metastasis
At least one measurable CNS metastasis, defined as ? 10 mm in at least one dimension
Known osteoblastic bony metastasis
Subjects with brain metastasis
Patients with secondary metastasis to the CNS are eligible if they have met certain criteria.
Known evidence of distant metastasis.
Or any history of leptomeningeal metastasis.
No prior history of organ transplantation or brain metastasis
Presence of untreated brain metastasis
Subjects with known brain metastasis are excluded from this study; patients with suspected brain metastasis must have brain imaging (either magnetic resonance imaging [MRI] brain or computed tomography [CT] brain with contrast) prior to enrollment
MK-1454+pembro (liver metastasis/lesions) Arm:
At least one measurable lesion per RANO-BM (Response Assessment in Neuro-Oncology Brain Metastases) Criteria for brain metastasis
Patients who have a single, operable brain metastasis
No history of intracranial brain metastasis
INCLUSION CRITERIA FOR REGISTRATION (HER2 MUTATION IDENTIFIED BY WASH U GPS LABORATORY): Patients with known treated brain metastasis are eligible, but must have received radiation and be off steroids and stable (without evidence of disease progression by imaging or exam) for 3 months
INCLUSION CRITERIA FOR REGISTRATION (HER2 MUTATION IDENTIFIED AT AN OUTSIDE CLIA CERTIFIED LOCATION): Patients with known treated brain metastasis are eligible, but must have received radiation and be off steroids and stable (without evidence of disease progression by imaging or exam) for 3 months
Presence of brain metastasis or leptomeningeal spread of the disease
Any known nodal (N1) or distant metastasis (M1)
Distant metastasis
Bulky intracranial metastatic disease with shift of midline structures or progressive brain metastasis such that ongoing therapy for these brain metastasis is required at the time of enrollment.
Brain metastasis and/or leptomeningeal disease (known or suspected)
No active brain metastasis; previously surgically treated or irradiated lesions are allowed if not clinically active
Evidence of distant metastasis (M1) involvement.
No symptomatic brain metastasis; (note: patients with treated brain metastasis must be off steroids or on tapering or stable doses of steroids and have completed radiation at least 14 days prior to registration for protocol therapy)
Patients with leptomeningeal metastasis.
Patients with a history of brain/leptomeningeal metastasis
At least one measurable lesion per Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) Criteria for brain metastasis
Presence of untreated brain metastases; if patients have had previous treatment for the brain metastasis, an MRI or CT scan of the brain must confirm the stabilization of the brain metastasis for more than 2 months
M1c disease (solid organ metastasis)
Leptomeningeal disease or uncontrolled brain metastasis
A subject with prior brain metastasis may be considered if they have completed their treatment for brain metastasis at least 4 weeks prior to study registration, have been off of corticosteroids for >= 2 weeks, and are asymptomatic
Known brain metastasis
Patients must not have known non-controlled CNS metastasis.
Acute neurological dysfunction as a result of bone metastasis.
No evidence of CNS metastasis by MRI or CT of the brain performed within 28 days of enrollment
Subjects with inactive central nervous system (CNS) metastasis are eligible; inactive CNS metastasis is defined as: no signs of cerebral edema after successful definitive treatment of brain metastases (surgical resection, whole brain irradiation, stereotactic radiation therapy, or a combination of these) with stable or improved radiographic appearance on magnetic resonance imaging (MRI) scan at least 1 month after completion of treatment
The participant has active central nervous system (CNS) or leptomeningeal metastasis (brain metastasis) at the time of enrollment (Phase 1b) or randomization (Phase 2). Participants with a history of a CNS metastasis previously treated with curative intent (for example, stereotactic radiation or surgery) that have not progressed on follow-up imaging, have been asymptomatic for at least 60 days, and are not receiving systemic corticosteroids and or/anticonvulsants, are eligible. Participants with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed before enrollment (Phase 1b) /randomization (Phase 2) to rule out brain metastasis.
Known, untreated brain metastasis. Patients with signs or symptoms of brain metastasis must have a CT or MRI performed within 4 weeks prior to randomization to specifically exclude the presence of radiographically-detected brain metastases
Any evidence of metastasis to distant organs (liver, lung, peritoneum)
No evidence of distant metastasis either prior to or after induction chemotherapy.
Have up to five measurable (by Response Assessment in Neuro-Oncology Criteria [RANO]) brain metastasis planned for stereotactic radiosurgery
AST and ALT with hepatic metastasis =< 5 x ULN
Known or suspected brain metastasis or active leptomeningeal disease
Patients with known symptomatic brain metastasis; subjects with controlled brain metastasis (no radiographic progression at least 4 weeks following radiation and/or surgical treatment and no neurological signs or symptoms) will be allowed
Have active central nervous system (CNS) or leptomeningeal metastasis (brain metastasis) at the time of enrollment. Participants with a history of CNS metastasis (previously treated with curative intent [for example, stereotactic radiation or surgery]) that has not progressed on follow-up imaging, have been asymptomatic for at least 60 days, and are not receiving systemic corticosteroids and/or anticonvulsants are eligible. Participants with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed before enrollment to rule out brain metastasis.
Patients with untreated brain metastasis; patients with metastatic lesions to the brain may be enrolled after completing stereotactic radiosurgery or whole brain radiation (may enroll 14 days after treatment and must be off corticosteroids for at least 14 days prior to the start of study treatment
No distant metastasis as verified by one of the study investigators
History of uncontrolled brain metastasis unless:
Distant metastasis or adenopathy below the clavicles
Subjects must have at least 1 bone metastasis of any size on imaging
Evidence of visceral metastasis to the liver.
Symptomatic brain metastasis requiring corticosteroids
Known or suspected brain metastasis or active leptomeningeal disease.
Patients with known or suspected brain metastasis
Barcelona Clinic Liver Cancer (BCLC) D = patients with distant metastasis
Primary brain tumors or known brain metastasis unless clinically stable and on stable or reducing doses of steroids.
Patient with brain metastasis must have had treatment of their brain metastasis completed at least 1 day prior to enrollment and be on stable dose of steroids or off steroids at the time of enrollment
Patients with PDA metastases deemed likely to limit the patient’s ability to participate in the study for the complete duration (ie. > 3 months), including but not limited to:\r\n* Presence of central nervous system (CNS) metastasis including brain metastasis or compromise resulting from extrinsic disease in the bone or dura\r\n* Presence of more than 5 liver metastases or one liver metastasis measuring more than 3 cm\r\n* Cancer antigen (CA)19-9 > 3000 U/mL\r\n* Oxygen requirement attributable to pleural effusion or other malignant process\r\n* Symptomatic ascites or radiographic evidence of more than trace ascites
Distant metastasis or adenopathy below the clavicles
Histological confirmation of malignant carcinoma/sarcoma (any site) with metastasis to lung; histologic confirmation of the lung metastasis is not required providing there has been pathologic confirmation of malignancy
History of leptomeningeal carcinomatosis or brain metastasis.
Untreated brain metastasis(es) that may be considered active
Patients with evidence of liver metastasis are excluded
Distant metastasis
Subjects with known or suspected brain metastasis, or brain as the only site of disease are excluded with the following exceptions
Subjects with controlled brain metastasis (no radiographic progression at least 4 weeks following radiation and/or surgical treatment, off steroids for at least 4 weeks, and have no new or progressing neurological signs or symptoms) will be allowed
Prior radiotherapy or gamma knife within 2 weeks of study treatment for non-brain metastasis; subjects must have recovered from all radiation related toxicities
Active/untreated brain metastasis; whole brain radiation or gamma knife radiosurgery performed less than 4 weeks prior to first administration of study drug; previously treated brain metastasis allowed as long as not requiring steroids and stable on imaging at least 4 weeks after completing radiation therapy
Prior radiotherapy or gamma knife within 2 weeks of study treatment for non-brain metastasis; subjects must have recovered from all radiation related toxicities
Active/untreated brain metastasis: whole brain radiation or gamma knife radiosurgery performed less than 4 weeks prior to first administration of study drug; previously treated brain metastasis allowed as long as not requiring steroids and stable on imaging at least 4 weeks after completing radiation therapy
Brain metastasis allowed if previously treated, stable and off steroids for a minimum of 56 days
Patients must have liver metastasis
No evidence of metastasis on bone scan within 120 days prior to registration
No evidence of distant metastasis either prior to or after induction chemotherapy
Patients with brain metastasis that have been treated with definitive surgery or radiation and have been clinically stable for 3 months are eligible
Patients with untreated brain metastasis are excluded; patients with a prior history of brain metastasis are eligible if they have received prior brain radiation, have improved or stable intracranial disease for at least 3 months after completion of last course of radiation, and are not taking corticosteroids for treatment of brain metastasis; patients with a prior history of brain metastases who meet other eligibility criteria
Known brain metastasis or leptomeningeal involvement
Central nervous system metastasis; Note: patients with previously treated (radiotherapy or surgery) brain metastasis that have been stable without steroid treatment for at least 3 months following prior treatment may be enrolled
Individuals with the presence of symptomatic central nervous system (CNS) metastasis requiring radiation, surgery, or ongoing use of corticosteroids; untreated or brain metastasis causing any symptoms; treated brain metastasis must be stable for 4 weeks prior to first dose of study drug and not requiring steroids for at least 7 days prior to study treatment
More than one brain metastasis (qualifying measurable brain lesions are any contrast enhancing metastases identifiable by the physician)
Patients with known or suspected brain metastasis or active leptomeningeal disease
Biopsy proven metastatic melanoma or non-squamous NSCLC with at least one untreated cerebral metastasis that is at least 5 mm AND twice the magnetic resonance imaging (MRI) slice thickness, but less than 20 mm, that is asymptomatic and does not require local therapy at the time of enrollment (“clinically evaluable lesion[s]”); an untreated brain metastasis is defined as a lesion not present at the time of whole brain radiation therapy or included in a stereotactic radiotherapy field (or within 2 mm of a treated lesion), or any lesion that is new or unequivocally progressing since prior radiation therapy
Patients with leptomeningeal metastasis
Leptomeningeal metastasis
Known parenchymal brain metastasis
Known parenchymal brain metastasis
Previously untreated CNS metastasis or progressive CNS metastasis
MRI scan consistent with brain metastasis as per radiology report
Untreated brain metastasis that may be considered active
Newly dignosed or active brain metastasis
Subject must have cytologically or histologically confirmed malignancy (this is the original malignancy, not the brain metastases); the largest measurable brain metastasis must be at least 1.0 cm in short axis dimension
Current or previously treated brain metastasis or active leptomeningeal disease; head imaging is required during screening in all patients to exclude the presence of central nervous system (CNS) metastatic disease
Patients with brain metastasis will be included as long as they are free of neurologic symptoms related to metastatic brain lesions and who do not require or receive systemic corticosteroid therapy in the 14 days prior to beginning MK-3475 therapy
Symptomatic brain metastasis
Evidence of distant metastasis
Alkaline phosphatase =< 2.5 x ULN, unless bone metastasis is present in the absence of liver metastasis
Bone-predominant metastatic castration resistant prostate cancer (CRPC): at least two skeletal metastases on bone scan with no lung, liver, and/or brain metastasis (lymph node metastasis is allowed)
Alkaline phosphatase =< 2.5 X upper limit of normal, unless bone metastasis is present in the absence of liver metastasis
Extra-cranial metastasis
Patients with brain metastasis will be included as long as they are free of neurologic symptoms related to metastatic brain lesions and who do not require or receive systemic corticosteroid therapy in the 14 days prior to beginning ipilimumab therapy
Have extrahepatic metastasis.
Distant metastasis to the lung, bone or brain; typically, most stage 4 uterine papillary serous cancer (UPSC) is confined to the abdomen on presentation
Biopsy proven metastatic melanoma or NSCLC as follows:\r\n* Patients with metastatic melanoma must have untreated brain metastases including:\r\n** At least one cerebral metastasis that requires local intervention and is amenable to craniotomy or LITT either due to symptoms, lesion size, location, edema or hemorrhage (“surgical lesion”); alternatively, a patient may be eligible if a cerebral metastasis was resected or biopsied any time prior to enrollment and there is tumor tissue available for analysis\r\n** At least one cerebral metastasis that is at least 5 mm AND twice the magnetic resonance imaging (MRI) slice thickness, but less than 20 mm, that is asymptomatic and does not require local therapy at the time of enrollment (“clinically evaluable lesion[s]”)\r\n* Patients with stage IV NSCLC with at least one cerebral metastasis that is at least 5 mm AND twice the MRI slice thickness, but less than 20 mm, that is asymptomatic and does not require local therapy at the time of enrollment (“clinically evaluable lesion[s]”)
Patients have known active brain metastasis
Any evidence of metastasis to distant organs (liver, lung, peritoneum)
Patients with known brain metastases are eligible only if he/she has been treated for brain metastasis, are asymptomatic after treatment, have a stable CT or MRI of the brain within 28 days of enrollment and are not receiving corticosteroid therapy to control symptoms from brain metastasis. Only a non-enzyme inducing anticonvulsant (e.g., Keppra) will be permitted for those patients requiring anticonvulsants. (Topical and/or inhaled steroids are allowed.)
Patient deemed medically unfit to undergo surgical resection of brain metastasis
Patients with documented central nervous system or leptomeningeal metastasis (brain metastasis) at the time of study entry; patients with prior brain metastasis may be considered if they have completed their treatment for brain metastasis, no longer require corticosteroids, and are asymptomatic
Symptomatic liver or visceral organ metastasis
Known brain metastasis
Para-aortic or inguinal metastasis
Distant metastasis
At least one brain metastasis (index tumor) must be within 2-6 cm in maximum diameter and deemed appropriate for surgical resection by the treating neurosurgeon
Active cerebrospinal fluid involvement with malignancy or brain metastasis
Patients with CNS metastasis at presentation will not be eligible
Known bone metastasis
Metastatic disease documented by CT/MRI or bone scan (not older than 28 days at enrollment) revealing at least one metastatic lymph-node, visceral metastasis and/or bone metastasis
Active brain or leptomeningeal metastasis.
No active central nervous system (CNS) metastases; subjects with neurological symptoms must undergo a head computed tomography (CT) scan or brain magnetic resonance imaging (MRI) to exclude brain metastasis within 28 days of registration; note: a subject with prior brain metastasis may be considered if they have completed their treatment for brain metastasis, no longer require corticosteroids, and are asymptomatic
History or presence of brain metastasis or leptomeningeal disease
Known metastasis or symptoms of metastasis to the central nervous system
Evidence of metastasis
Symptomatic and uncontrolled metastasis in the central nervous system or leptomeningeal or lymphangitic carcinomatosis
Have a history of brain metastasis
No evidence of distant metastasis
Evidence of distant metastasis apparent prior to randomization
Asymptomatic or symptomatic CNS metastasis allowed
Previously-treated or untreated CNS metastasis allowed
Known or suspected brain metastasis or active leptomeningeal disease
Known untreated brain metastasis or brain metastasis treated within 3 months prior to enrollment in this trial
Patients with brain metastasis
History of leptomeningeal carcinomatosis or brain metastasis
Melanoma patients with large or symptomatic brain metastasis, and in whom neurosurgical removal is indicated will not be eligible for this trial
Known or suspected brain metastasis or active leptomeningeal disease
Symptomatic or untreated brain metastasis
Leptomeningeal metastasis
Active central nervous system (CNS) metastases; subjects with neurological symptoms should undergo a head computed tomography (CT) scan or brain magnetic resonance imaging (MRI) to exclude brain metastasis, at the discretion of the treating physician\r\n* NOTE: A subject with prior brain metastasis may be considered if they have completed their treatment for brain metastasis, no longer require corticosteroids, and are asymptomatic
A subject with prior brain metastasis may be considered if they have completed their treatment for brain metastasis at least 4 weeks prior to study registration, have been off of corticosteroids for >= 2 weeks, and are asymptomatic.
Symptomatic brain metastasis
Patients with central nervous system (CNS) metastasis will be allowed on the study if the metastasis is treated, no clinical signs of metastasis progression following treatment, and the patient is off steroids for at least 3 days (only if steroids are prescribed specifically for brain metastasis)
One brain metastasis or brain metastasis resection cavity with maximal diameter >= 3 cm (or >= 14 cc) and =< 6 cm (or =< 113 cc)
Brain metastasis or resection cavity volume < 3 cm or 14 cc or > 6 cm or 113 cc
The subject has untreated, symptomatic or uncontrolled brain metastasis requiring current treatment including steroids and anti-convulsants; neurosurgical resection of brain metastasis or brain biopsy is permitted if completed at least 3 months before the first dose of study treatment
Hepatic metastasis permissible; appropriate candidates with metastasis to liver may be considered for ablative hypofractionation using SBRT
Subjects with brain metastasis
Untreated brain metastasis
Patients with treated brain metastasis as long as neurologically stable and not on steroids for at least 12 weeks
Patients with known brain metastasis
Patients with distant metastasis
Patients with documented central nervous system or leptomeningeal metastasis (brain metastasis) at the time of study entry; patients with prior brain metastasis may be considered if they have completed their treatment for brain metastasis and no longer require corticosteroids
No brain metastasis, history of seizures, encephalitis, or multiple sclerosis
Patients with brain metastasis have no signs of progressive disease 4 months after the completion of brain metastasis treatment (radiation therapy, surgery, etc.) do not require anticonvulsants or corticosteroids, and have been off such drugs for at least 7 days
Symptomatic brain metastasis or uncontrolled central nervous system (CNS) metastasis will not be permitted
Known brain metastasis
Alkaline phosphatase =< 2.5 X upper limit of normal, unless bone metastasis is present in the absence of liver metastasis
Patients must be classified as having intermediate or poor-risk germ cell tumor, as follows:\r\n* Intermediate-risk (modified*)\r\n** Testis or retroperitoneal primary non-seminomatous germ cell tumors (NSGCT) with lymph node and/or lung metastasis but without non-pulmonary visceral metastasis AND any of the following pretreatment serum tumor marker (STM) values:\r\n*** Lactate dehydrogenase (LDH) from 3 to < 10 x upper limit of normal (ULN) (*this differs from the original International Germ Cell Cancer Collaborative Group [IGCCCG] criteria which includes patients with LDH from 1.5 to 10 x ULN)\r\n*** Serum human chorionic gonadotrophin (HCG) from 5,000 to < 50,000 MIU/mL\r\n*** Serum alpha-fetoprotein (AFP) from 1,000 to < 10,000 ng/mL\r\n** Seminoma histology regardless the primary site or serum tumor markers with any non-pulmonary visceral metastasis (liver, bone, brain, etc)\r\n* Poor-risk (any of the following):\r\n** Testis or retroperitoneal NSGCT primary with non-pulmonary visceral metastasis (liver, bone, brain, etc) regardless the STM values\r\n** Mediastinal NSGCT primary site of disease regardless the presence/absence of visceral metastasis or STM values\r\n** Testis or retroperitoneal NSGCT primary without non-pulmonary visceral metastasis but with poor-risk STM values:\r\n*** LDH >= 10 x ULN\r\n*** HCG >= 50,000 MIU/mL\r\n*** AFP >= 10,000 ng/mL
Cohort A (asymptomatic patients): At least 1 measurable brain metastasis ? 0.5 cm in and ? 3 cm in longest diameter that has not been previously irradiated. No clinical requirement for local intervention (surgery, radiosurgery, corticosteroid therapy) or other systemic therapy Cohort B (symptomatic patients): Subjects with neurologic signs and symptoms related to metastatic brain lesions are eligibile. Subjects must have at least 1 measurable brain metastasis ? 0.5 cm in and ? 3 cm in longest diameter that has not been previously irradiated. No immediate requirement (within 3 weeks prior to first treatment) for local intervention (surgery, radiosurgery, corticosteroid therapy). Steroid use is permitted as defined in the protocol.
Alkaline phosphatase =< 2.5 times upper limit of normal, unless bone metastasis is present in the absence of liver metastasis
Presence of skeletal, and/or soft-tissue/visceral/nodal metastasis
For Cohort C:Has known or suspected brain metastasis or leptomeningeal carcinomatosis
Extensive active brain disease including symptomatic brain metastases or the presence of leptomeningeal disease, and all patients with infratentorial tumors\r\n* Note: patients with brain metastasis after definitive therapy with surgery or stereotactic radiation and stable off steroids for > 4 weeks are eligible as are patients with asymptomatic brain metastasis as long as less than 1 cm and thus deemed as not requiring therapy by the primary physician and the lesions(s) are not infratentorial
Definitive clinical or radiographic evidence of distant metastasis or adenopathy below the clavicles
Subjects with previously treated brain metastasis who are free of central nervous system (CNS) symptoms and are >= 14 days from treatment of brain metastasis are eligible; there must also be no requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration
Known or suspected brain metastasis or active leptomeningeal disease;
Known brain metastasis or leptomeningeal disease
Subject has known or suspected brain metastasis or active leptomeningeal disease.
Known or suspected brain metastasis or active leptomeningeal disease;
Have active central nervous system (CNS) or leptomeningeal metastasis (brain metastasis) at the time of enrollment. Participants with a history of a CNS metastasis previously treated with curative intent (for example, stereotactic radiation or surgery) that have not progressed on follow-up imaging, have been asymptomatic for at least 60 days and are not receiving systemic corticosteroids and or/anticonvulsants, are eligible. Participants with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed before enrollment to rule out brain metastasis.
The subject has current or previously treated brain metastasis or active leptomeningeal disease. Brain imaging is required during screening in all subjects to exclude the presence of unequivocal central nervous system disease.
Uncontrolled or symptomatic brain metastasis
Known brain metastasis or leptomeningeal disease
Have known central nervous system metastasis or primary tumor (Part A). Previously-treated, CNS metastasis is permitted in Part B. CNS metastasis must be small, discrete metastasis; stable for at least 30 days without the need for concomitant prednisone for symptom management. No leptomeningeal disease is allowed. Is receiving therapeutic doses of corticosteroids (>20 mg prednisone daily or equivalent);
Symptomatic CNS metastasis
Histological confirmation of recurrence of chest wall with or without distant metastasis disease
History of or active CNS metastasis (brain, leptomeningeal or cord compression). Brain imaging studies are not required for eligibility if the subject has no neurologic signs or symptoms suggestive of brain metastasis. Subjects with neurological symptoms are recommended to undergo a head CT scan (with or without intravenous contrast) or brain MRI (with or without intravenous contrast) to exclude brain metastasis. If brain imaging studies are performed, they must be negative for CNS disease. Skull bone involvement without neurological impact by prostate cancer is allowed.
Patients with any metastasis in the brain or meninx that is symptomatic or requires treatment
Has local or distant metastasis
Subjects with previously treated brain metastasis (es) that is asymptomatic or radiographically/clinically stable and not requiring steroids medications for 4 weeks prior to enrollment are permitted.
Alkaline phosphatase =< 2.5 times the upper limit of normal, unless bone metastasis is present in the absence of liver metastasis
MRI detected active brain metastasis witch require other therapies such as surgery and/or radiation therapy. Patients already treated for their brain metastasis, surgery or radiation therapy, and have had stable disease for more than two month and NOT requiring steroids may however be included in this study.
Known active brain metastasis unless they have been treated and shown documented radiographic stability for 28 days
Known or suspected brain metastasis
CNS metastasis except adequately treated brain metastasis documented by baseline CT or MRI scan that has not progressed since previous scans and that does not require corticosteroids for management of CNS symptoms
Subjects with known or suspected brain metastasis, or brain as the only site of disease are excluded with the following exceptions\r\n* Subjects with controlled brain metastasis (no radiographic progression at least 4 weeks following radiation and/or surgical treatment, off steroids for at least 4 weeks, and have no new or progressing neurological signs or symptoms) will be allowed\r\n* Subjects with a history of prior malignancy with the exception of carcinoma in situ of the cervix or other malignancy diagnosed > 2 years ago that has undergone potentially curative therapy with no evidence of disease for the last >= 2 years and that is deemed by the investigator to be at a low risk of recurrence
Presence of central nervous system metastasis (including active brain metastasis); active brain metastasis would be defined as untreated brain metastases; if the brain metastases have received prior treatment (usually either with surgery or radiation), they are no longer active
Subjects with metastasis limited to the bone only are excluded. However, subjects with current metastasis limited to the bone only and with a history of distant metastasis are eligible. Subjects with current metastasis limited to the bone only and with current breast tissue lesion are eligible.
Unstable or untreated brain/leptomeningeal metastasis
Subjects who have brain metastasis as the only measureable lesion
Patients with brain metastasis
Patients have known active brain metastasis
Patients with spinal cord compression, carcinomatous meningitis, or leptomeningeal disease are excluded; patients with a history of prior brain metastasis are permitted provided the lesions are fully treated, inactive, and patient is asymptomatic; subjects with new evidence of brain metastasis discovered during screening are allowed as long as the brain lesions have been irradiated; lesions must be stable as evidenced by repeat magnetic resonance imaging (MRI) brain imaging within 2 weeks prior to starting study treatment; patients must also be asymptomatic; patient must have had no steroids use for at least 28 days prior to start of treatment; centrally located tumors with radiographic evidence (computed tomography [CT] or MRI) of local invasion of major blood vessels
Patients with uncontrolled symptomatic brain metastases; a scan to confirm absence of brain metastasis is not required
Subject has known or suspected brain metastasis or active leptomeningeal disease.
Patients with any distant metastasis (liver, lung, bone, brain)
Patients with other malignancies or brain metastasis are not eligible; however, given the frequent coexistence of MCC with other malignancies, the following exceptions are allowed:
Active central nervous system (CNS) or leptomeningeal metastasis (brain metastasis) at the time of randomization. Participants with a history of a CNS metastasis previously treated with curative intent (for example, stereotactic radiation or surgery) that have not progressed on follow-up imaging, have been asymptomatic for at least 60 days and are not receiving systemic corticosteroids and or/anticonvulsants, are eligible. Participants with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed before randomization to rule out brain metastasis.
Bilirubin > 3 x ULN that cannot be attributed to NSCLC metastasis
Current or previously treated brain metastasis or active leptomeningeal disease;
Known osteoblastic bony metastasis.
Subject has a history of, or current symptomatic brain metastasis.
Known brain metastasis
Documented extracranial metastasis
If the patient has brain metastasis, they must have been stable (treated and/or asymptomatic) and the patient must have been off steroids for at least 2 weeks
A visceral metastasis greater than 8 cm
A visceral metastasis that due to its location cannot be safely treated with SABR
Known or suspected brain metastasis or active leptomeningeal disease
Patients with cutaneous metastasis of NSCLC
Two or more bone metastases on bone scan within 4 weeks prior to randomization with no lung, liver, other visceral and/or brain metastasis.
History of visceral metastasis, or presence of visceral metastasis detected by screening imaging examinations
History of or known brain metastasis.
History of visceral metastasis, or visceral metastases
Known brain metastasis
History of visceral metastasis, or visceral metastases
Evidence of active brain metastasis including leptomeningeal involvement\r\n* CNS metastasis controlled by prior surgery and/or radiotherapy is allowed; NOTE: to be considered controlled, there must be at least 4 weeks of no clinical symptoms or evidence of progression prior to study entry and corticosteroid therapy must have been discontinued
History of brain metastasis, active leptomeningeal disease or seizure
presence of a space occupying lesion in the brain including previously treated brain metastasis(es) or primary central nervous system (CNS) tumor,
The patient has a primary brain tumor(s) or brain metastasis (unless metastasis is treated and stable for > 28 days). In patients who are symptomatic, a brain scan is required to exclude metastasis.
Known brain metastasis
Patients with advanced malignant hepatic tumors (metastasis)
No evidence of distant metastasis either prior to or after induction chemotherapy
Suspected or known CNS metastasis
Symptomatic liver or visceral organ metastasis
Known brain metastasis
Symptomatic or uncontrolled brain metastasis; patients with neurological symptoms must undergo a computed tomography (CT) scan/magnetic resonance imaging (MRI) of the brain to exclude brain metastasis; previously treated brain metastases will be allowed as long as the patient is neurologically stable and is off steroids and anticonvulsants
Symptomatic or uncontrolled brain metastasis; patients with neurological symptoms must undergo a computed tomography (CT) scan/magnetic resonance imaging (MRI) of the brain to exclude brain metastasis; previously treated brain metastases will be allowed as long as the patient is neurologically stable and is off steroids and anticonvulsants at the time of registration
Patients with a history of brain/leptomeningeal metastasis
Known brain metastasis
Active brain metastasis or leptomeningeal metastasis
Symptomatic brain metastasis
Known CNS disease, except for treated brain metastasis
Participants may have brain metastasis
Patients must not have hemoptysis, squamous histology, brain metastasis
Symptomatic or uncontrolled brain metastasis or epidural disease requiring current treatment including steroids and anti-convulsant
Subjects with inactive central nervous system (CNS) metastasis are eligible; inactive CNS metastasis is defined as: no signs of cerebral edema after successful definitive treatment of brain metastases (surgical resection, whole brain irradiation, stereotactic radiation therapy, or a combination of these) with stable or improved radiographic appearance on magnetic resonance imaging (MRI) scan at least 1 month after completion of treatment
Radiographic evidence of regional or distant metastasis at the time of study enrollment or at the time of diagnosis
Presence or history of central nervous system metastasis (including brain)
Presence of life-limiting extra-hepatic metastasis that requires a systemic treatment within 3 months; patients with extra-hepatic metastasis that can be controlled with a loco-regional treatment are eligible
Presence of untreated brain metastases; if patients have had previous treatment for brain metastasis, an MRI or CT scan of the brain must confirm the stabilization of the brain metastasis for more than 4 weeks
Histologically confirmed stage IV melanoma including brain metastasis
Symptomatic brain metastasis
Patients with measurable brain metastasis outside a 5-mm margin around either hippocampus
Patients with measurable brain metastasis who have not been or will not be treated with stereotactic radiosurgery (SRS) or surgical resection (Note: these treatment options are only permitted at relapse)
Patients with measurable brain metastasis not resulting from small cell lung cancer and germ cell malignancy
Resection cavity must measure < 5.0 cm in maximal extent on the post-operative MRI or CT brain scan obtained =< 35 days prior to pre-registration; Note: it is permissible for the resection of a dominant brain metastasis to include a smaller “satellite” metastasis as long as the single resection cavity is less than the maximum size requirements
Widespread definitive leptomeningeal metastasis
Brain metastasis that is located =< 5 mm of the optic chiasm or within the brainstem
No clinical, radiographic or other evidence of distant metastasis
Known or suspected brain metastasis or active leptomeningeal disease
Known or suspected brain metastasis or active leptomeningeal disease
Patients with brain metastases are allowed onto the study as long as patients have completed their treatment for brain metastasis, no longer require corticosteroids, and are asymptomatic; subjects with neurological symptoms should undergo a head computed tomography (CT) scan or brain magnetic resonance imaging (MRI) to exclude brain metastasis, at the discretion of the treating physician
Patients with symptomatic brain metastasis requiring escalating doses of steroids
Cannot have distant metastasis (M0)
Bilateral pulmonary metastasis
>2 unilateral pulmonary metastasis
Distant metastasis to organs (local recurrence and regional lymph node recurrence are not considered as distant metastasis) other than bone
Prior radiation to site(s) of distant metastasis of bone
Any eligible histologic diagnosis other than desmoplastic medulloblastoma, with no evidence of CNS metastasis
Any eligible histologic diagnosis, with evidence of CNS metastasis
Evidence or history of central nervous system (CNS) disease, including primary brain tumors, seizures disorders, or any brain metastasis
Patients with brain metastasis that are unstable (i.e. presenting with neurologic symptoms that progress or require increasing doses of steroids within a 4-week period) or are untreated (i.e. not radiated) should be excluded
Patients with known intraparenchymal brain metastasis at study entry are excluded due to poor CNS penetration of SF1126.
Patients with asymptomatic treated CNS metastasis may be enrolled after discussion with the Medical Monitor.
Known brain metastasis
Inclusion:\n\n          1. Signed informed consent form (ICF)\n\n          2. Age ? 18 years (Age ? 19 years if required by local regulatory authorities)\n\n          3. ECOG PS of 0-1\n\n          4. Histologically or cytologically-confirmed epithelial ovarian, fallopian tube or\n             primary peritoneal cancer in recurrent stage\n\n          5. prOC (platinum-resistant ovarian cancers) defined as progression within > 1 to < 6\n             months (+ 2 weeks) of completing previous cycle of primary platinum-based therapy, or\n             during or within < 6 months (+ 2 weeks) of starting additional platinum based\n             therapies\n\n          6. Received ? 1 but ? 3 prior platinum-based regimens\n\n          7. Measurable disease according to RECIST 1.1\n\n          8. Left ventricular ejection fraction (LVEF) greater than or equal to at least 45% at\n             baseline assessment if subject is receiving PLD, and/or anthracycline is a concomitant\n             medication\n\n          9. No evidence of active (progressing) brain metastasis. (Treated brain metastasis\n             allowed with a posttreatment magnetic resonance imaging (MRI) or Computed Tomography\n             (CT) of brain showing no active (progressing) brain metastasis). Treatment of brain\n             metastasis may include surgery, radiosurgery (linear accelerator (LINAC), gamma\n             knife), or whole brain irradiation. Surgery for brain metastasis must be > 8 weeks\n             from study entry\n\n         10. Hemoglobin > 9 g/dl. Erythroid growth factors should not have been used in the 2 weeks\n             prior to study entry. Red blood cell transfusions are permitted to maintain the\n             hemoglobin level > 9 g/dl\n\n         11. Adequate bone marrow function in the investigator's opinion\n\n         12. Adequate hepatic function defined by the following:\n\n               -  Total bilirubin < 2 x Upper Limit of Normal (ULN)\n\n               -  Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 X ULN\n                  for the referenced lab (< 5 X ULN for subjects with liver metastases)\n\n         13. Adequate renal function defined by the following:\n\n             - Serum creatinine < 2 X ULN for the referenced lab\n\n         14. Subjects of childbearing potential must have a negative serum pregnancy test prior to\n             study entry and must be practicing a highly effective form of contraception\n\n         15. At least 2 weeks since prior radiotherapy and has recovered from any Grade 3\n             toxicities\n\n         16. Life expectancy ? 12 weeks\n\n        Exclusion:\n\n          1. Subjects who have received prior CA4P therapy\n\n          2. Previously having failed treatment with bevacizumab combined with the intended PCC.\n\n             - For clarity: Investigators should not select a bevacizumab + PCC combination for the\n             FOCUS trial if the patient has previously failed that same regimen, however they may\n             select a new PCC regimen to combine with bevacizumab. For example, a patient who\n             failed bevacizumab + weekly paclitaxel would be allowed to enroll in FOCUS only if\n             they are assigned to bevacizumab + PLD for the study.\n\n          3. Previous treatment with greater than three traditional chemotherapy treatment regimens\n\n          4. Untreated brain metastasis or leptomeningeal brain metastasis\n\n          5. Solid organ or bone marrow transplant\n\n          6. Primary platinum-refractory disease (defined as progression during dosing or within\n             one (1) month of completing the last cycle of patients first platinum-containing\n             regimen)\n\n          7. > Grade 2 peripheral neuropathy\n\n          8. Current thrombotic or hemorrhagic disorder/event or history of prior event within 6\n             months of start of Screening\n\n          9. History of prior cerebrovascular event, (including transient ischemic attack) within 6\n             months of start of Screening\n\n         10. Recent history (within 6 months of start of Screening) of angina pectoris, myocardial\n             infarction (including non-Q wave MI), or NYHA Class III and IV congestive heart\n             failure\n\n         11. History of torsade de pointes, ventricular tachycardia or fibrillation, pathologic\n             sinus bradycardia (<60 bpm), heart block (excluding 1st degree block, benign PR\n             interval prolongation only), congenital long QT syndrome or new ST segment elevation\n             or depression or new Q wave on ECG\n\n         12. Known uncontrolled HIV infection\n\n         13. Uncontrolled, clinically significant active infection\n\n         14. Serious non-healing wound, ulcer or bone fracture\n\n         15. Subjects with known hypersensitivity to any of the components of CA4P, paclitaxel,\n             PLD, or bevacizumab (paclitaxel and PLD dependent on whether PI plans they will be\n             dosed with that PCC)\n\n         16. Subjects who are currently or planning on receiving concurrent investigational therapy\n             or who have received investigational therapy for any indication within 30 days of the\n             first scheduled day of dosing\n\n         17. Subjects with any other intercurrent medical condition, including mental illness or\n             substance abuse, deemed by the Investigator to be likely to interfere with a subject's\n             ability to provide informed consent, cooperate and participate in the study, or to\n             interfere with the interpretation of the study results\n\n         18. Subjects with other invasive malignancies, with the exception of non-melanoma skin\n             cancer, or with previous cancer treatment that contraindicates this protocol therapy\n             within last 3 years\n\n         19. Prior radiation therapy to the pelvis or abdomen within 4 weeks of entry into the\n             study\n\n         20. History of fistula, gastrointestinal (GI) perforation or intra-abdominal abscess, or\n             invasive disease/metastases of the bowel which in the investigators opinion may\n             increase the risk of GI perforation with bevacizumab treatment.\n\n         21. Uncontrolled hypertension (HTN)\n\n             - Sustained BP greater than 150 mmHG SBP / 100 mmHG DBP\n\n         22. Uncontrolled elevated proteinuria levels in the investigator's opinion\n\n         23. Corrected QT interval ([QTc] Fridericia) > 480 ms\n\n         24. Significant vascular disease or recent peripheral arterial thrombosis\n\n         25. Subjects with active bleeding or pathologic conditions that carry high risk of\n             bleeding\n\n         26. Subjects who are pregnant or lactating
Palliative radiation for treatment of painful bone metastasis, control of hemoptysis or treatment of small asymptomatic brain metastasis that become symptomatic during on protocol treatment is allowed; protocol treatment will be delayed until recovery from radiation at the discretion of the treating physician
Known or suspected brain metastasis or leptomeningeal disease.
Have confirmed distant metastasis with or without local recurrence
Brain metastasis unless treated and neurologically stable
Symptomatic brain metastasis or asymptomatic brain metastasis that are 1 cm or greater in size; patients with asymptomatic sub-centimeter brain metastasis are eligible
Bilirubin > 3 x ULN which cannot be attributed to MCC metastasis
Patients with measurable brain metastasis(es) resulting from small cell lung cancer and/or germ cell malignancy
Patients with any history of brain or bone metastasis or who have developed progressive disease on first line 5-FU based therapy
Has active brain metastasis or leptomeningeal carcinomatosis; patients with adequately treated brain metastases are eligible if they meet certain criteria
Known brain metastasis; patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis
Patients with more than a single brain metastasis ( >1 cm)
No evidence of distant metastasis either prior to or after induction chemotherapy
Alkaline phosphatase =< 2.5 X upper limit of normal, unless bone metastasis in present in the absence of liver metastasis
Known central nervous system (CNS) disease, except for those participants with treated brain metastasis who are stable for at least 1 month, having no evidence of progression or hemorrhage after treatment and no ongoing requirement for corticosteroids, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period.
Known brain metastasis.
Patients may have a history of brain metastasis provided certain protocol criteria are met
Known brain metastasis
Have symptomatic CNS malignancy (with the exception of medulloblastoma) or metastasis.
Participant with a brain metastasis with symptoms or requiring treatment.
Any other malignancies within 5 years except those with negligible risk of metastasis or death
Any history of leptomeningeal metastasis.
Active brain metastasis or treatment for brain metastasis within 1 month of scheduled dosing day 1. a. Dose of corticosteroid, if any, for brain metastasis must be tolerated in terms of glucose tolerance ? Grade 2 (symptomatic; dietary modification or oral agent indicated) and hyperglycemia ? Grade 2 (fasting glucose value >160 - 250 mg/dL [> 8.9
Brain metastasis
Symptomatic uncontrolled brain metastasis
Recurrent and/or metastatic resectable colorectal cancer, including disease within the abdomen and pelvis with no evidence of extra-abdominal metastases; intra-abdominal disease includes: isolated hepatic metastasis/metastases (see next inclusion criteria point), isolated peritoneal metastasis, or a combination of hepatic and extrahepatic metastasis
Known brain metastasis or leptomeningeal disease
Alkaline phosphatase =< 2.5 X institutional upper limit of normal, unless bone metastasis is present in the absence of liver metastasis
Patients who are symptomatic from brain metastasis
Symptomatic brain metastasis. Patients previously treated or untreated for these conditions that are asymptomatic in the absence of corticosteroid and anti-epileptic therapy are allowed to enroll
Presence of 1 or more bone metastasis
Patients with brain metastasis treated or untreated, or other CNS disease
Patients with symptomatic brain metastasis requiring escalating doses of steroids
Evidence of distant metastasis
Any presence of leptomeningeal disease or any parenchymal brain metastasis
ALP ? 3 x ULN or ? 5 x ULN if bone metastasis is present
Leptomeningeal metastasis.
Known parenchymal brain metastasis
Patients with known brain metastasis
Subjects with brain metastasis or central nervous system (CNS) disease are considered eligible if the subject has not received radiation therapy for brain metastasis within 2 weeks of enrollment and has been on a stable dose of steroids for 2 or more weeks
Known active, or symptomatic, brain metastasis
Brain metastasis are excluded unless
Brain metastasis, leptomeningeal disease.
Presence or history of visceral melanoma metastasis
Known brain metastasis
Radiologic evidence of new and/or progressive brain metastasis (>= 10 mm in longest dimension) by magnetic resonance (MR) imaging of the brain
Known or suspected brain metastasis;
Known brain metastasis
Known central nervous system (CNS) or brain metastasis that are either symptomatic or untreated; Note: patients with neurological symptoms must undergo a computed tomography (CT) scan/magnetic resonance imaging (MRI) of the brain to exclude brain metastasis\r\n* Note: patients with CNS metastases that have been treated and are stable without symptoms for >= 4 weeks after completion of treatment are eligible
Subjects with known or suspected brain metastasis unless previously treated and without evidence of progression
Pulmonary or brain metastasis, liver metastasis is allowed if LFTs are not elevated
Single brain metastasis status post surgical resection with =< 1 cc of residual enhancing tumor
Symptomatic primary tumors or metastasis of brain and/or central nervous system that are uncontrolled with antiepileptics and requiring high doses of steroids
Uveal Melanoma with liver metastasis
Patients who have a solitary bone metastasis that has been irradiated are not eligible.
Symptomatic brain metastasis; patients with treated brain metastasis must be completely weaned off of steroid therapy for at least 14 days prior to starting protocol therapy
Known brain metastasis; patients with neurological symptoms must undergo a computed tomography (CT) scan/MRI of the brain to exclude brain metastasis
No active brain metastases. Patients with neurological symptoms must undergo a head CT scan or brain MRI to exclude brain metastasis within 30 days prior to registration on protocol therapy. NOTE: A patient with prior brain metastasis are eligible if they have completed their radiation treatment for brain metastasis ?30 days prior to registration for protocol therapy, are off steroids, and are asymptomatic.
Presence of clinically apparent or suspected brain metastasis.
Known brain metastasis or visceral organ metastasis
Alkaline phosphatase < 2.5 times the upper limit of normal, unless bone metastasis is present in the absence of liver metastasis
Documented cerebral metastasis
Maximum diameter of brain metastasis or resection cavity is 6 cm
Patients will be excluded if they have brain metastasis
Known or suspected brain metastasis or active leptomeningeal disease
Known or suspected brain metastasis or leptomeningeal disease
ALT and AST <2.5 × ULN or, in patients with documented hepatic metastasis, ?5.0 × ULN.
Active known or suspected brain metastasis or active leptomeningeal disease needing treatment
Active known or suspected brain metastasis or active leptomeningeal disease undergoing or requiring treatment.
Brain metastasis
No clinical neurologic signs or symptoms of brain metastasis (brain imaging only required for symptomatic individuals per 2014 National Comprehensive Cancer Network [NCCN] Guidelines)
Have lesion or metastasis of bone
Pathologically (histologically or cytologically) proven diagnosis of solid tumor malignancy within 5 years prior to Step 2 registration; if the original histologic proof of malignancy is greater than 5 years, then pathological (i.e., more recent) confirmation is required (e.g., from a systemic metastasis or brain metastasis)
Patients with measurable brain metastasis(es) resulting from small cell lung cancer and/or germ cell malignancy
Subjects with a history of brain metastasis.
Solid organ malignancy with documented bone metastasis by imaging
Active central nervous system (CNS) metastases; patients with neurological symptoms should undergo a head computed tomography (CT) scan or brain magnetic resonance imaging (MRI) to exclude brain metastasis, at the discretion of the treating physician; NOTE: patients with prior brain metastasis may be considered if they have completed their treatment for brain metastasis, no longer require corticosteroids, and are asymptomatic
Evidence of metastasis
Known brain metastasis
Patients with brain metastases are allowed onto the study as long as patients have completed their treatment for brain metastasis, no longer require corticosteroids, and are asymptomatic; subjects with neurological symptoms should undergo a head computed tomography (CT) scan or brain magnetic resonance imaging (MRI) to exclude brain metastasis, at the discretion of the treating physician
Leptomeningeal metastases; please note: leptomeningeal metastases may be allowed if it is limited to cranial metastasis (MRI spine should be completed, within 4 weeks of enrollment, to show that no other leptomeningeal metastases is present) and is not the only metastasis present in the brain
Prior brain tumor treatment, including surgical resection, radiation therapy or chemotherapy for a primary brain neoplasm. Previous biopsy will not disqualify the patient from participation. Remote history (> 6 month) of non-CNS malignancy in remission, without evidence of current/ prior brain metastasis, will also not disqualify patient from participating.
Definitive findings of systemic metastasis on conventional imaging
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
Subjects with radiographically suspected, histologically or cytologically confirmed primary brain tumors or brain metastasis are eligible
Known brain metastasis
At least one brain metastasis must be >= 1 cm to allow adequate quantitative imaging measurement for DSC-PMR
At least 1 site of metastasis >= 20 mm in mean diameter must be identified
Symptomatic primary tumors or metastasis of brain and/or central nervous system, uncontrolled with antiepileptic and requiring high doses of steroids.
No evidence of CNS disease by MRI or CT of the brain. Note: Prior brain metastasis which have been treated with definitive therapy are eligible.
Evidence of peritoneal or distant metastasis on preoperative imaging
OR confirmed or suspected recurrent brain cancer or brain metastasis for which the primary tumor has been histologically confirmed,
Evidence of metastasis
Patients with brain metastasis that have been treated, asymptomatic and off any steroid use are permitted for study
Patients with local regional recurrence only or brain only metastasis.
The participant has symptomatic brain or leptomeningeal metastasis.
The participant has symptomatic brain or leptomeningeal metastasis.
Have a history of brain metastasis provided that all of the following criteria are met: