Active, untreated central nervous system (CNS) metastasis (subjects with brain metastases who are identified at screening may be rescreened after the lesion[s] have been appropriately treated and subjects are off corticosteroids)
History of seizures, prior traumatic brain injury, prior stroke, or other predisposing risk of seizure (excluding CNS metastasis)
Have known active central nervous system (CNS) metastasis and/or carcinomatous meningitis. Participants with treated CNS metastases are eligible for this study if they have not received corticosteroids and/or anticonvulsants within  days of study treatment, and their disease is asymptomatic and radiographically stable for at least  days.
Any uncontrolled neurological symptom attributed to CNS metastasis
Symptomatic central nervous system (CNS) metastasis(es). Note: Baseline CT/MRI of the brain is required for SCLC patients enrolled in Arm . Patients with previously treated CNS metastasis(es) are eligible if the patients with previously treated CNS metastasis(es) are asymptomatic and radiographically/clinically stable and not requiring steroids within  weeks prior to first dose. Note: Non-SCLC patients without clinical signs or symptoms of CNS involvement are not required to have a computed tomography (CT)/magnetic resonance imaging (MRI) scan of the brain unless it is considered standard of care.
Symptomatic central nervous system (CNS) involvement or lymphangitic metastasis. Stable or improving CNS disease that is not under active treatment after receipt of adequate therapy is allowed.
Have central nervous system (CNS) metastasis with either radiotherapy or development of neurological changes ? days prior to receiving study treatment. Participants may be receiving a stable dose of corticosteroids. Screening of asymptomatic participants without history of CNS metastasis is not required. Untreated CNS metastases are not permitted.
Patients who have known brain metastasis; patients whose central nervous system (CNS) metastases have been treated by surgery or radiotherapy, who are no longer on corticosteroids, and who are neurologically stable are eligible
Subjects with central nervous system metastasis; with the exception of subjects who have stable brain metastases as defined as off steroids and no CNS progress for  months after CNS treatment.
At least one measurable CNS metastasis, defined as ?  mm in at least one dimension
Patients with secondary metastasis to the CNS are eligible if they have met certain criteria.
History of seizures, central nervous system tumors or CNS metastasis. Due to the incidence of silent CNS metastases in patients with advanced NSCLC, such patients must undergo mandatory screening with brain MRI or CT scan to determine eligibility.
Evidence of central nervous system (CNS) metastasis (negative imaging study, if clinically indicated, within  weeks of Screening Visit).
Patients with active central nervous system (CNS) metastases or leptomeningeal involvement by tumor (patients with a history of brain metastases who have successfully treated for brain metastasis by surgery or radiation and who have not had any evidence of the new or progressive CNS disease for more than  months are eligible)
Central nervous system (CNS) metastasis, unless asymptomatic and stable with no change in CNS disease status for at least two () weeks prior to initiating protocol-indicated treatment.\r\n* Anticonvulsant and/or corticosteroid prophylaxis (=<  mg/day prednisone or equivalent daily) will be allowed if patient is on a stable or decreasing dose of such treatment for at least  days prior to initiating protocol-indicated treatment.
Known active brain or central nervous system metastasis (less than  months out from definitive radiotherapy or surgery), seizures requiring anticonvulsant treatment (<  months) or clinically significant cerebrovascular accident (<  months); in order to be eligible patients must have repeat central nervous system (CNS) imaging at least two months after definitive treatment showing stable CNS disease; patients with evidence of intratumoral or peritumoral hemorrhage on baseline imaging are also excluded unless the hemorrhage is grade =<  and has been shown to be stable on two consecutive imaging scans
Patients must not have known non-controlled CNS metastasis.
Patients with history of prior central nervous system (CNS) metastasis must have been treated, must be asymptomatic, and must not have any of the following at the time of enrollment:
Uncontrolled central nervous system (CNS) metastasis; patients with CNS metastasis can be eligible if definitively treated with radiotherapy or surgery
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  month after completion of treatment
The participant has active central nervous system (CNS) or leptomeningeal metastasis (brain metastasis) at the time of enrollment (Phase b) or randomization (Phase ). 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  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 b) /randomization (Phase ) to rule out brain metastasis.
Active central nervous system (CNS) metastasis; NOTE: Patients with prior brain metastases that are asymptomatic without corticosteroid use and stable or improved >=  days after treatment with surgery or radiation are not excluded
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  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.
Central nervous system (CNS) metastasis, unless asymptomatic or previously treated and stable; and no evidence of CNS progression for at least  days prior to initiating protocol-indicated treatment; anticonvulsant and/or corticosteroid therapy will be allowed if patient is on a stable or decreasing dose of such treatment for at least  days prior to initiating protocol-indicated treatment
Carcinomatous meningitis, untreated central nervous system (CNS) disease or symptomatic CNS metastasis. Patients with previously treated CNS metastasis (excluding carcinomatous meningitis) may participate if they are stable (without evidence of progression by imaging, using identical imaging modality at each assessment, for at least  weeks prior to first dose of study treatment), have no evidence of new or emerging CNS metastasis, and are not using steroids for at least  days prior to first dose of study treatment
Patients with PDA metastases deemed likely to limit the patients ability to participate in the study for the complete duration (ie. >  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  liver metastases or one liver metastasis measuring more than  cm\r\n* Cancer antigen (CA)- >  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
Treated central nervous system (CNS) metastasis allowed if treatment is completed >=  weeks prior to enrollment; patients must be asymptomatic off systemic corticosteroids for at least  weeks after completion of radiation therapy; CNS disease must be stable or regressed on repeat imaging performed at least  weeks after completion of therapy
Central nervous system (CNS) metastasis, endometrial leiomyosarcoma, or endometrial stromal sarcoma.
Progressive or symptomatic central nervous system (CNS) metastases; patients with known brain metastasis must have stable disease following treatment surgery, radiation, or both
Central nervous system metastasis; Note: patients with previously treated (radiotherapy or surgery) brain metastasis that have been stable without steroid treatment for at least  months following prior treatment may be enrolled
Symptomatic and untreated central nervous system (CNS) metastasis; however, patients with  to  asymptomatic, less than  cm brain/CNS metastases without significant edema may be considered for treatment; if sub-centimeter CNS lesions are noted at study entry, then repeat imaging will be performed, if more than  weeks have elapsed from the last scan
Previously untreated CNS metastasis or progressive CNS metastasis
Patients with uncontrolled central nervous system (CNS) metastasis are not eligible; patients with CNS metastases are to be stable for >  months after treatment and off steroid treatment prior to study enrollment
There is no evidence of new or enlarging CNS metastasis or new neurological symptoms attributable to CNS metastases.
Subjects must either have no central nervous system (CNS) metastasis, or carcinomatous meningitis, or if CNS metastasis is present, must have stable treated cerebral metastases from BC, NSCLC, RCC, CRC, GEC, or melanoma. Subjects must not have symptomatic auto-immune disease or be immunosuppressed.
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
Non-ALK-positive NSCLC patients with CNS metastasis should have completed a course of therapy would be eligible for the study provided they are clinically stable for  month prior to entry as defined as: () no evidence of new or enlarging CNS metastasis () off steroids
Subjects who have metastasis to the brain are eligible for IV administration; however, any CNS lesion must be inactive; prior metastasis that has been treated and is no longer present is acceptable; no metastases to the CNS (brain or spine) of non-CNS solid tumors may be injected due to the potential for swelling at the injection site
Patients with CNS metastasis at presentation will not be eligible
Known central nervous system (CNS) primary tumor, CNS metastases or carcinomatous meningitis (Part A). Patients may be enrolled with CNS metastasis in certain circumstances in Part B.
Evidence of central nervous system (CNS) metastasis (negative imaging study, if clinically indicated, within  weeks of Screening Visit).
If they have untreated central nervous system (CNS) metastasis; patients whose CNS metastases have been treated by surgery or radiotherapy, who are no longer on corticosteroids, and who are neurologically stable may be enrolled in the dose escalation portion of the trial
Active central nervous system (CNS) metastasis, which has not been treated with radiation therapy. If treated with radiation therapy, treatment must end before  days prior to starting study treatment.
Asymptomatic or symptomatic CNS metastasis allowed
Previously-treated or untreated CNS metastasis allowed
Stable dose of corticosteroids for CNS metastasis for >  days
Patients must have no history of central nervous system (CNS) metastasis at the screening assessment\r\n* NOTE: Patients with stable brain metastases (mets) which have been treated are eligible; patients with suspected symptoms of CNS metastasis should undergo CNS imaging at the time of screening to rule out active 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  days (only if steroids are prescribed specifically for brain metastasis)
Untreated central nervous system (CNS) metastasis; if treated CNS metastasis/es, treatment of CNS disease (surgery or radiation) must have been completed at least  days prior to registration; patients could still be on steroids
Progressive or symptomatic central nervous system (CNS) metastases; patients with known brain metastasis must have stable disease following treatment with surgery, radiation or both; in addition, they must be off corticosteroids
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  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 a history of CNS metastases must have received therapy (surgery, radiotherapy, gamma knife) and be neurologically stable, asymptomatic, and not receiving corticosteroids for the purposes of maintaining neurologic integrity. Patients with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired. For patients with parenchymal CNS metastasis (or a history of CNS metastasis), baseline and subsequent radiological imaging must include evaluation of the brain (MRI preferred or CT with contrast)
Patients with known brain metastasis are eligible only if by central nervous system (CNS) imaging there is no evidence of CNS progression at least  days following definitive CNS treatment (resection or radiation)
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  days without the need for concomitant prednisone for symptom management. No leptomeningeal disease is allowed. Is receiving therapeutic doses of corticosteroids (> mg prednisone daily or equivalent);
Symptomatic CNS metastasis
CNS metastasis that is symptomatic or progressing or untretaed or that required current therapy (e.g. evidence of new or enlarging CNS metastasis or new neurological symptoms attributable to CNS metastases)
Have the presence of unstable central nervous system (CNS) metastasis. History of CNS metastasis or stable CNS metastases is allowed (no longer requiring active therapy such as steroid medications). Participants with a history of CNS metastases must have a brain scan (for example, magnetic resonance imaging [MRI]) within  days of randomization to document stability, even if there have been no changes in symptoms.
Parts A, B, D and E: Have central nervous system (CNS) metastasis with development of associated neurological changes  days prior to receiving study drug.
History or evidence of CNS disease. Radiographic screening of all participants without history of CNS metastasis is required.
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
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  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.
History of brain metastases; EXCEPTION: patients with a solitary brain metastasis that has been completely resected, and who have no ongoing central nervous system (CNS) symptoms and an MRI documenting no evidence of CNS disease at least  months after resection and within  days of registration, are eligible for treatment
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  weeks of no clinical symptoms or evidence of progression prior to study entry and corticosteroid therapy must have been discontinued
presence of a space occupying lesion in the brain including previously treated brain metastasis(es) or primary central nervous system (CNS) tumor,
Suspected or known CNS metastasis
Patients with symptomatic brain or spinal cord metastases or requiring steroid therapy and patients with leptomeningeal disease; patients with treated and stable central nervous system (CNS) metastasis for  months or more, off steroids are eligible for the study; no major surgery or radiation therapy within  days before starting treatment
History of central nervous system (CNS) metastasis; Note: participants without clinical signs and symptoms of CNS involvement are not required to have magnetic resonance imaging (MRI) of the brain; (exception: participants with treated brain metastases who are asymptomatic, not currently on steroid therapy, and clinically stable for >=  weeks will be eligible for protocol participation)
History or clinical evidence of central nervous system (CNS), meningeal, or epidural disease, including brain metastasis.
History or evidence upon physical/neurological examination of central nervous system (CNS) disease unrelated to cancer, unless adequately treated with standard medical therapy (e.g. uncontrolled seizures); symptomatic CNS metastasis
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  month after completion of treatment
For Dose Confirmation (Parts B, D, E, F and G): Have CNS metastasis that is radiographically or clinically unstable less than  days prior to receiving study drug, regardless of whether they are receiving corticosteroids
Patients with a history of central nervous system metastasis are allowed provided they have been treated (surgery, radiation, or radiosurgery) at least  weeks prior to initiating study drug and do not require medication(s) to control symptoms; patients with known leptomeningeal disease are not eligible
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 known intraparenchymal brain metastasis at study entry are excluded due to poor CNS penetration of SF.
Patients with asymptomatic treated CNS metastasis may be enrolled after discussion with the Medical Monitor.
Patients with diagnosis of retinoblastoma with metastasis to the central nervous system (CNS) must be confirmed by an ophthalmologist and/or a pathologist; in conjunction with the pediatric oncologist; metastasis to the CNS is defined as a mass in the chiasm or other site in the CNS, confirmed by magnetic resonance imaging (MRI)\r\n* At diagnosis\r\n* At relapse after conventional therapy\r\nIt is acceptable to have other sites of metastatic disease: lymphatic, bone, bone marrow or others, but these will not be considered for response
Patients with history of central nervous system (CNS) metastasis may not be enrolled on the study, unless control has been achieved with either radiation or surgical resection at least  months prior to enrollment on study
No evidence of new or enlarging CNS metastasis or new neurological symptoms attributable to CNS metastases.
Symptomatic and untreated central nervous system (CNS) metastasis; however, patients with - asymptomatic, less than  cm brain/CNS metastases without significant edema may be considered for treatment; if sub-centimeter CNS lesions are noted at study entry, then a repeat imaging will be performed if more than  weeks have elapsed from the last scan
Have symptomatic CNS malignancy (with the exception of medulloblastoma) or metastasis.
Have symptomatic central nervous system (CNS) malignancy or metastasis (screening not required). Participants with treated CNS metastases are eligible for this study if they are not currently receiving corticosteroids and/or anticonvulsants, and their disease is asymptomatic and radiographically stable for at least  days.
Subjects with known central nervous system (CNS) disease are not eligible, except for those subjects with treated brain metastasis.
Patients with brain metastasis treated or untreated, or other CNS disease
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  weeks of enrollment and has been on a stable dose of steroids for  or more weeks
No known central nervous system (CNS) metastases or neurological symptoms possibly related to active CNS metastasis
Patients must be without clinical evidence of central nervous system (CNS) disease; patients with a history of treated brain metastasis must be stable with no evidence of disease for  months
Stage IV patients are considered provided they have a single non-central nervous system (CNS) metastasis (that is amenable to treatment with radiation therapy)
Have symptomatic central nervous system (CNS) malignancy (with the exception of medulloblastoma) or metastasis (screening not required). Patients with treated CNS metastases are eligible for this study if they are not currently receiving corticosteroids and/or anticonvulsants, and their disease is asymptomatic and radiographically stable for at least  days.
Patients with history of central nervous system (CNS) metastasis, unless control has been achieved with either radiation or surgical resection at least  months prior to enrollment on study
Patients may have had prior central nervous system (CNS) metastasis providing: CNS disease has been previously treated and CNS disease has been clinically stable for  weeks prior to study entry (assessment must be made by computed tomography [CT] or magnetic resonance imaging [MRI])
Central nervous system (CNS) metastasis; NOTE: history of brain metastasis other than locally treatable lesions (i.e., lesions treatable with surgery or radiosurgery); patients with locally treatable disease may be considered for study if they have completed treatment without evidence of CNS progression for >  weeks after completion of treatment; patients with a history of brain or other CNS metastases not amenable to local therapy will not be eligible
Patients with active central nervous system (CNS) metastasis and/or carcinomatous meningitis; however, patients with CNS metastasis (except leptomeningeal disease) who have completed a therapy and are clinically stable for  weeks as defined as: () no evidence of new or enlarging CNS metastasis and () off steroids and/or anticonvulsants may be eligible
Known central nervous system (CNS) disease other than neurologically stable, treated brain metastases -- defined as metastasis having no evidence of progression or hemorrhage after treatment for at least  weeks
Known central nervous system (CNS) metastasis; once CNS metastasis have been treated these patients may participate if they are otherwise good trial candidates
Have central nervous system (CNS) metastasis with development of associated neurological changes  days prior to receiving study drug.