Untreated central nervous system (CNS) metastases or CNS metastases that have progressed Untreated or active central nervous system metastases Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases; Active or untreated central nervous system (CNS) metastases Symptomatic and/or untreated central nervous system metastases Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases Participants with known untreated brain or other central nervous system metastases are excluded Any untreated central nervous system (CNS) lesion. Active or untreated central nervous system (CNS) metastases Symptomatic or untreated central nervous system (CNS) metastases Patients with untreated central nervous system metastases Presence of symptomatic or untreated central nervous system (CNS) metastases Symptomatic and/or untreated central nervous system metastases Untreated central nervous system (CNS) metastases Untreated, symptomatic Central nervous system (CNS) metastases Known, current central nervous system disease involvement or untreated brain metastases Untreated central nervous system (CNS) metastases Active or untreated central nervous system (CNS) metastases Exclusions Related to Cardiovascular Disease Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases Active, untreated central nervous system (CNS) metastases Patients with known brain metastases, active infection, or untreated central nervous system (CNS) leukemia Untreated or active central nervous system metastases - Ongoing or recent (within 5 years) evidence of significant autoimmune disease Untreated or progressive central nervous system leukemia Patients with symptomatic, untreated central nervous system (CNS) metastases are not eligible Patients with untreated brain metastases/central nervous system (CNS) disease will be excluded Symptomatic untreated metastases in the central nervous system Active or untreated central nervous system (CNS) metastases Active, untreated central nervous system metastases. Central nervous system metastases that are untreated or symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms within 14 days of study entry. Subjects with symptomatic, untreated metastases to the central nervous system (CNS) at the time of screening. Known untreated central nervous system (CNS) metastases; leptomeningeal disease will be an absolute exclusion criterion due to limited life expectancy Symptomatic or untreated central nervous system (CNS) metastases Untreated brain metastases or neurologically unstable central nervous system (CNS) metastases Active, untreated central nervous system metastases. Untreated central nervous system (CNS) metastases or CNS metastases that have progressed Untreated or symptomatic central nervous system (CNS) metastases known central nervous system (CNS) metastases that are untreated, symptomatic, or require steroids to control symptoms Known active or untreated central nervous system (CNS) metastases. - Pregnant, planning to become pregnant within 6 months of treatment, or nursing. Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases Subject has symptomatic and untreated central nervous system (CNS) disease Known and untreated brain metastases. Patients with primary CNS (central nervous system) malignancies are excluded. Known and untreated, or active central nervous system (CNS) metastases (progressing or requiring treatment) Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases Participant has untreated central nervous system (CNS) metastases. Untreated or active/progressing Central Nervous system (CNS) metastases Known untreated or active central nervous system (CNS) metastases Patients with untreated or symptomatic central nervous system (CNS) metastases Untreated or symptomatic central nervous system metastases. Symptomatic and/or untreated central nervous system metastases Known, current central nervous system disease involvement or untreated brain metastases Untreated or symptomatic central nervous system (CNS) metastases Untreated central nervous system metastatic disease l Untreated central nervous system (CNS) metastases Known active or untreated central nervous system (CNS) metastases Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases Patients with untreated central nervous system (CNS) or epidural tumor Any untreated central nervous system (CNS) lesion Presence of untreated/active central nervous system (CNS) metastases Symptomatic or untreated central nervous system (CNS) metastases requiring concurrent treatment Has active or untreated brain or central nervous system metastases. Untreated central nervous system (CNS) metastases or CNS metastases that have progressed after completion of radiotherapy. Active, untreated central nervous system metastases. Active, untreated central nervous system metastases. Active or untreated central nervous system (CNS) metastases Active or untreated central nervous system (CNS) lesions Untreated central nervous system (CNS) metastatic disease Presence of clinically apparent untreated central nervous system metastases. Untreated brain or central nervous system (CNS) metastases Untreated or active central nervous system (CNS) metastases. Participants with a history of treated CNS metastases may be eligible Untreated central nervous system metastases Active or untreated central nervous system (CNS) metastases Active or untreated central nervous system (CNS) metastases Patients with untreated central nervous system metastases or local treatment of brain metastases Symptomatic and/or untreated central nervous system metastases Untreated or active central nervous system (CNS) metastases. Untreated central nervous system metastases Untreated/active central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control) Untreated or active brain metastases or central nervous system cancer, as defined per protocol Untreated or active cerebral nervous system metastases Known untreated or active central nervous system (CNS) metastases Untreated or active central nervous system (CNS) metastases Primary central nervous system (CNS) malignancy or untreated/active CNS metastases Untreated central nervous system (CNS) metastases. Central nervous system (CNS) disease that is untreated, symptomatic, or requires therapy to control symptoms. Known and untreated, or active central nervous system metastases Known primary central nervous system (CNS) malignancy or untreated or active CNS metastases Subjects with untreated Central nervous system (CNS) metastases are excluded Symptomatic, untreated or unstable central nervous system or leptomeningeal metastases Active, untreated central nervous system metastases. Criteria 6, Active or untreated central nervous system (CNS) metastases per CT or MRI evaluation during screening Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases Untreated or symptomatic central nervous system (CNS) metastases (CNS imaging not required). Patients with asymptomatic CNS metastases are eligible provided they have been clinically stable for at least 4 weeks and do not require intervention such as surgery, radiation, or any corticosteroid therapy for management of symptoms related to CNS disease Symptomatic central nervous system (CNS) metastases or primary CNS lymphoma Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases Primary central nervous system (CNS) malignancy or CNS metastases. Presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require local CNS-directed therapy, or increasing doses of corticosteroids within the prior 2 weeks. Symptomatic central nervous system (CNS) involvement which are neurologically unstable or requiring increasing doses of steroids to control. Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases Symptomatic central nervous system (CNS) metastases. Patients with treated central nervous system (CNS) metastases will be eligible if not symptomatic, the CNS disease has been stable for a minimum of 6 weeks and the patient requires less than or equal to the equivalent of 2 mg/day of dexamethasone Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms Symptomatic central nervous system (CNS) metastases who are neurologically unstable or require increasing doses of steroids or local CNS-directed therapy (such as radiotherapy, surgery or intrathecal chemotherapy) to control their CNS disease Primary central nervous system (CNS) malignancy, untreated CNS metastases, or active CNS metastases (progressing or requiring corticosteroids for symptomatic control) Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable GENERAL: Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases. Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases. Symptomatic brain or central nervous system (CNS) metastases; previously treated and stable CNS disease is allowed Patients with known history of central nervous system (CNS) metastases are eligible if CNS disease has been radiographically and neurologically stable for at least 6 weeks prior to study registration and do not require corticosteroids (of any dose) for symptomatic management\r\n* NOTE: CNS imaging is only required at baseline for patients with known history of CNS metastases Active central nervous system (CNS) metastases and CNS metastases as the only sites of disease Subjects with symptomatic Central Nervous System (CNS) metastases Patients with history of central nervous system (CNS) metastases are eligible if CNS disease has been stable for at least 6 weeks prior to study registration in the opinion of the investigator and do not require corticosteroids (of any dose) for symptomatic management; NOTE: Patients are not required to have CNS imaging prior to study entry Uncontrolled central nervous system (CNS) metastases (i.e. known CNS lesions that are radiographically unstable, symptomatic and/or requiring escalating doses of corticosteroids) Patients with central nervous system (CNS) metastases who are neurologically unstable Individuals with the presence of symptomatic central nervous system (CNS) metastases requiring radiation treatment, surgery, or ongoing use of corticosteroids Evidence of clinically significant central nervous system (CNS) metastases or symptomatic CNS metastases within 30 days prior to dosing Patients with central nervous system (CNS) metastases or symptomatic CNS involvement (including cranial neuropathies or mass lesions) Symptomatic, untreated, or uncontrolled central nervous system (CNS) metastases or seizure disorder; NOTE: patients with treated CNS metastases without evidence of progression and without uncontrolled symptoms or need for steroids may enroll Symptomatic central nervous system (CNS) metastases or asymptomatic CNS metastases that have required steroids within 2 weeks prior to first dose of study treatment. Presence of symptomatic or uncontrolled central nervous system (CNS) metastases requiring local CNS-directed treatment. Symptomatic central nervous system (CNS) metastases who are neurologically unstable Known symptomatic central nervous system (CNS) metastases requiring steroids. Patients with previously diagnosed CNS metastases are eligible if they (1) have completed their treatment and have recovered from the acute effects of radiation therapy and/or surgery prior to enrollment, (2) have discontinued corticosteroid treatment for these metastases for at least 14 days, and (3) are neurologically stable; Symptomatic and/or untreated central nervous system (CNS) metastases; patients with asymptomatic previously treated CNS metastases are eligible provided they have been clinically stable for at least 4 weeks Symptomatic and/or untreated or actively progressing central nervous system (CNS) metastases or leptomeningeal disease. Patients with a history of treated CNS metastases are eligible, provided that all of the following criteria are met: Evidence of progressive or symptomatic central nervous system (CNS) metastases or leptomeningeal disease Central nervous system (CNS) metastases or a primary CNS tumor that is associated with progressive neurological symptoms. Patients with symptomatic central nervous system (CNS) metastases. Presence of symptomatic central nervous system (CNS) metastases Patients with known primary central nervous system (CNS) malignancy or symptomatic CNS metastases are excluded Symptomatic central nervous system (CNS) metastases requiring treatment Patient with uncontrolled or symptomatic central nervous system (CNS) metastases; patients with a history of CNS metastases or cord compression are eligible if they have been definitively treated with local therapy and are clinically stable and have discontinued prior treatment with anticonvulsants Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases Patients with central nervous system (CNS) metastases or symptomatic CNS involvement (including cranial neuropathies or mass lesions and spinal cord compression) Patients with central nervous system (CNS) metastases or a history of CNS metastases are ineligible Untreated central nervous system (CNS) metastases or symptomatic CNS metastases requiring escalating doses of corticosteroids Central nervous system (CNS) metastases that are symptomatic and/or requiring steroids Known symptomatic central nervous system (CNS) metastases. Participants with a history of treated or untreated asymptomatic CNS metastases may be eligible. Known symptomatic central nervous system (CNS) metastases Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases, except ATRT Have symptomatic or non stable central nervous system (CNS) malignancy. Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases Known primary central nervous system (CNS) malignancy, active or untreated CNS metastases, symptomatic CNS metastases, and/or leptomeningeal disease Presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require local CNS-directed therapy within prior 2 weeks. Presence of symptomatic or untreated central nervous system (CNS) metastases, or CNS metastases that require doses of corticosteroids within the prior 3 weeks to Study Day Patients with history of central nervous system (CNS) metastases are eligible if CNS disease has been radiographically and neurologically stable for at least 6 weeks prior to study registrations and do not require corticosteroids (of any dose) for symptomatic management Known primary central nervous system (CNS) malignancy or symptomatic or untreated CNS metastases Untreated central nervous system (CNS) metastasis that are > 1 cm or symptomatic are not allowed; (patients with CNS metastases > 1 cm or symptomatic that have been treated and demonstrated to be radiologically and clinically stable for at least 4 weeks are allowed) Leptomeningeal carcinomatosis or other untreated or symptomatic central nervous system (CNS) metastases; patients with asymptomatic CNS metastases, other than leptomeningeal disease, are eligible provided they have been clinically stable without requiring increase in steroid dose for at least 4 weeks Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or require increasing doses of steroids or local CNS-directed therapy to control their CNS disease Symptomatic central nervous system (CNS) NHL. Patient with symptomatic central nervous system (CNS) metastases who is neurologically unstable or has required increasing doses of steroids within the 2 weeks prior to screening to manage CNS symptoms. Any Central Nervous System (CNS) metastases or history of CNS metastases Untreated or symptomatic central nervous system (CNS) metastases. Patients with asymptomatic CNS metastases are eligible provided they have been clinically stable for at least 4 weeks. Symptomatic brain or central nervous system (CNS) metastases; previously treated and stable CNS disease is allowed Subjects with symptomatic central nervous system (CNS) metastases Known primary central nervous system (CNS) malignancy or symptomatic or untreated CNS metastases. Treated and stable CNS metastases are allowed. Symptomatic central nervous system (CNS) lesions, or CNS lesions that require therapy Patients with symptomatic central nervous system (CNS) metastases Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 1 week prior to study entry to manage CNS symptoms Patients with known symptomatic central nervous system (CNS) metastases requiring steroids Patients with untreated central nervous system (CNS) metastases; patients with treated CNS metastases who are off steroids are eligible Untreated central nervous system (CNS) metastases or active (progressing or requiring corticosteroids for symptomatic control) CNS metastases Has untreated or uncontrolled central nervous system (CNS) metastases, including patients who require glucocorticoid therapy for CNS metastases Symptomatic central nervous system (CNS) metastases requiring steroid use Primary central nervous system (CNS) malignancy, untreated CNS metastases, or active CNS metastases (progressing or requiring corticosteroids for symptomatic control) Patients with symptomatic central nervous system (CNS) metastases must have stable disease after treatment with surgery or radiation therapy Primary central nervous system (CNS) malignancy or untreated/active CNS metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control) Symptomatic Central Nervous System (CNS) metastases Patients with symptomatic central nervous system (CNS) metastases who were neurologically unstable or required increasing doses of steroids to control their CNS disease were excluded. Patients with symptomatic Central Nervous System (CNS) metastases Presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require local CNS-directed therapy (such as radiotherapy or surgery). Patients with prior history of primary central nervous system (CNS) cancer or CNS metastases Patient has symptomatic central nervous system (CNS) metastases or lesions for which treatment is required. Patients who received prophylactic CNS treatment are eligible Patients with a history of symptomatic central nervous system (CNS) unless they have been treated and are asymptomatic. Evidence of progression of central nervous system (CNS) metastases or symptomatic CNS metastases within 30 days prior to dosing. Participants with known or suspected CNS metastases, untreated CNS metastases, or with the CNS as the only site of disease (patients with controlled brain metastasis allowed to enroll) Has CNS metastases or symptomatic CNS involvement Known CNS disease including, but not limited to, metastases Known CNS metastases CNS metastases as shown by radiology records or clinical evidence of symptomatic CNS involvement in the last 3 months prior to randomization. Known CNS disease including, but not limited to, metastases Symptomatic CNS metastases which are neurologically unstable or requiring increasing doses of steroids to control their CNS disease. Patients with primary CNS tumors or symptomatic CNS metastases who have not undergone surgery and/or radiotherapy and/or who are not neurologically stable; Previously untreated CNS metastases or progressive CNS metastases Participants with known or suspected uncontrolled CNS metastases or with the CNS as the only site of active disease Symptomatic and/or untreated CNS metastases Patients with known symptomatic CNS metastases or lepotomeningeal disease requiring steroids. Subject has symptomatic CNS metastases. Subjects with a history of or active CNS tumors or metastases from non-CNS tumors. Radiographic evidence of CNS metastases Symptomatic central nervous system (CNS) metastases that are neurologically unstable or requiring > 5 mg/day of dexamethasone (or equivalent) to control CNS disease; note: patients with controlled CNS metastases are allowed; radiotherapy or surgery for CNS metastases must have been completed > 2 weeks prior to study entry; patients must be neurologically stable, having no new neurologic deficits on clinical examination, and no new findings on CNS imaging; steroid use for management of CNS metastases must be at a stable dose for two weeks preceding study entry Active (i.e., symptomatic or progressing) CNS metastases. Subjects with CNS metastases are eligible for the trial if: No progression of CNS metastases on MRI or CT for at least 14 days after last day of prior therapy for the CNS metastases Patients with treated or untreated asymptomatic CNS metastases may be allowed to enroll. Participants must not have suspected, known, or progressive CNS metastases, have untreated CNS metastases, or have the CNS as the only site of disease Participants with active central nervous system (CNS) metastases, untreated CNS metastases, or with the CNS as the only site of disease are excluded (controlled brain metastases will be allowed to enroll) have known uncontrolled or symptomatic CNS metastases; Subject has symptomatic CNS metastases. Patients are excluded if they have active CNS metastases. Patients with history of CNS metastases must have MRI scans that show stability of brain metastases for 8 weeks. At screening, patients with > 1 cm or > 3 in number treated CNS metastases may be included if there is no evidence of progressive CNS disease on brain imaging at least 90 days after treatment with surgery and/or radiation therapy, and if the patients with CNS metastases are not taking prednisone > 10 mg or equivalent daily Patients with > 3 untreated CNS metastases or evidence of peri-tumoral edema will be excluded, or patients with CNS metastases of any status who are taking prednisone > 10 mg or equivalent steroid daily will be excluded Patients with =< 3 untreated CNS metastases but with at least one lesion > 1 cm or peri-tumoral edema will be excluded, or patients with CNS metastases of any status who are taking prednisone > 10 mg or equivalent steroid daily will be excluded Patients with treated CNS metastases > 1 cm or > 3 in number will be excluded if there is evidence of progressive CNS disease on brain imaging at least 90 days after treatment with surgery and/or radiation therapy, or patients with CNS metastases of any status who are taking prednisone > 10 mg or equivalent will be excluded History of hemorrhagic CNS metastases Known CNS metastases, unless stable and asymptomatic. Subjects with CNS metastases may be eligible for the study, provided: Symptomatic CNS metastases or CNS metastases requiring steroids Uncontrolled CNS metastases Suspected, known, or progressive CNS metastases (Imaging required only if participants are symptomatic) Untreated CNS disease, metastases or carcinomatous meningitis. Patients with CNS metastases must be at least 2 weeks status post prior therapy to the brain and be off all steroids without progressing CNS disease or symptoms. Patients with symptomatic brain metastases are excluded; however, patients with asymptomatic central nervous system (CNS) metastases may participate in this trial; the patient must have completed any prior local treatment for CNS metastases > 28 days prior to study entry including radiotherapy or surgery; patients receiving steroids for CNS metastases may not participate on this study Patients with primary CNS tumors as well as patients with CNS metastases are excluded. Have either previously untreated intracranial CNS metastases or previously treated intracranial CNS metastases with radiologically documented new or progressing CNS lesions. Have or do not have active (untreated or progressing) CNS metastases. Uncontrolled CNS metastases, primary CNS tumors, or solid tumors with CNS metastases as only measurable disease; Active CNS metastases. Patients with CNS metastases with the following exceptions: Patients with symptomatic CNS metastases; Patients with symptomatic CNS metastases. Any active CNS metastases Patients with > 3 untreated CNS metastases or evidence of peri-tumoral edema will be excluded Patients with =< 3 untreated CNS metastases but with at least one lesion > 1 cm or peri-tumoral edema will be excluded Patients with > 3 untreated CNS metastases or evidence of peri-tumoral edema will be excluded Patients with =< 3 untreated CNS metastases but with at least one lesion > 1 cm or peri-tumoral edema will be excluded PHASE II: Patients with CNS metastases or a history of CNS metastases are ineligible Patients with active CNS metastases Patients with central nervous system (CNS) tumors or known CNS metastases are not eligible; patients with a history of CNS metastases that have been surgically resected are eligible only if the baseline evaluation shows no evidence of current CNS metastases; patients with any evidence of CNS metastases on baseline evaluation are not eligible, regardless of whether the lesions have been previously treated and/or appear stable Subjects with symptomatic CNS metastases. Subjects with untreated CNS metastases are excluded. CNS metastases Symptomatic, untreated CNS metastases Subjects with radiographic evidence of central nervous system (CNS) metastases as assessed by CT or MRI that are not well controlled (symptomatic or requiring control with continuous corticosteroid therapy [e.g., dexamethasone]) a. Note: Subjects with CNS metastases are permitted to participate in the study if the CNS metastases are medically well-controlled and stable for at least 28 days after receiving local therapy (irradiation, surgery, etc.) Symptomatic central nervous system (CNS) metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease\r\n* Note: patients with controlled CNS metastases are allowed; radiotherapy or surgery for CNS metastases must have been completed > 2 weeks prior to study entry; patients must be neurologically stable, having no new neurologic deficits on clinical examination, and no new findings on CNS imaging; steroid use for management of CNS metastases must be at a stable dose for two weeks preceding study entry History of brain or other CNS metastases. Known uncontrolled or symptomatic CNS metastases Patient with CNS metastases. Known uncontrolled or symptomatic CNS metastases Uncontrolled central nervous system (CNS) metastases; patients are considered to have controlled CNS metastases (and thus eligible) if they have completed local therapy (radiotherapy [XRT] and/or surgery) and are off steroids with clinical and radiographic stability 1 month from the end of CNS-directed therapy CNS metastases that are symptomatic and /or requiring escalating doses of steroids. Dose escalation and MTD/RP2D expansion cohort: Patients with symptomatic CNS metastases are excluded. Patients with treated CNS metastases or untreated asymptomatic CNS metastases not requiring immediate local therapy may be eligible. Enrollment of patients with metastases must be approved by the study medical monitor. Evidence of untreated CNS metastases Any untreated CNS metastases Active CNS metastases CNS or Brain metastases Active, untreated CNS metastases. Subjects with radiographic evidence of central nervous system (CNS) metastases as assessed by computerized tomography (CT) or magnetic resonance imaging (MRI) that are not well controlled (symptomatic or requiring control with continuous corticosteroid therapy [e.g., dexamethasone]). Note: Subjects with CNS metastases are permitted to participate in the study if the CNS metastases are medically well controlled prior to screening (as assessed by the Investigator) after receiving local therapy (irradiation, surgery, etc.) Participants with untreated CNS metastases are excluded Patients with asymptomatic CNS metastases are allowed Subjects with symptomatic or unstable CNS metastases Patient has symptomatic CNS metastases. Patients with asymptomatic CNS metastases may participate in this trial. The patient must have completed any prior local treatment for CNS metastases ? 28 days prior to the start of study treatment (including radiotherapy and/or surgery) and must have stable low dose of corticosteroid therapy; Known, uncontrolled CNS metastases Leptomeningeal carcinomatosis or other untreated or symptomatic CNS metastases (asymptomatic CNS metastases allowed if clinically stable without requirement for steroids within 2 weeks) Has untreated or uncontrolled CNS metastases, including patients who require glucocorticoid therapy for CNS metastases Active, untreated CNS metastases No 'active' CNS metastases. Prior CNS metastases are allowed, provided adequate palliative therapy has been administered and CNS disease control has been established prior to study entry. • A brain MRI scan, ? 28 days from day 1, is required CNS metastases that are symptomatic and /or requiring steroids. Known, uncontrolled CNS metastases or primary CNS lymphoma CNS metastases. Known or suspected central nervous system (CNS) metastases or with the CNS as the only site of active disease (controlled CNS metastases are allowed) Symptomatic CNS metastases Newly identified CNS malignancies or documented progression of CNS metastases; subjects will be allowed only if the CNS metastases have been adequately treated with radiotherapy or surgery. For subjects receiving steroid therapy please refer to Section 6.3 for allowed steroid maintenance therapy. Symptomatic CNS metastases Symptomatic CNS metastases Symptomatic CNS metastases Symptomatic CNS metastases Patients with active CNS or other brain metastases Have known active uncontrolled or symptomatic CNS metastases CNS tumor or clinically active brain metastases. Primary brain cancers or active CNS metastases should be excluded from this clinical trial Subjects with primary brain cancers or active CNS metastases should be excluded from this clinical trial Subjects with brain metastases should be excluded from this clinical trial unless all the metastasis are treated surgically or radio-surgically Subjects with brain metastases are excluded from this clinical trial unless all the metastases are adequately treated with surgery or radiation\r\n* Follow-up imaging showing treatment adequacy is not required Subjects with previously treated progressing brain metastases are excluded from the study Subjects with galactosemia will be excluded. Subjects will be screened and excluded per standard clinical protocol Known symptomatic brain metastases Patient has symptomatic brain metastases (i.e., metastases that are accompanied by neurological symptoms or that require treatment with corticosteroids) Participants with symptomatic brain metastases that require active treatment are excluded Known symptomatic brain metastases requiring ?10 mg/day of prednisolone (or its equivalent). Symptomatic or uncontrolled brain metastases Patients with brain metastases will be excluded if metastases have been symptomatic or actively treated within 4 weeks prior to enrollment Symptomatic or uncontrolled brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation and/or corticosteroids; patients with treated brain metastases are eligible as long as they completed prior brain radiation therapy more than 14 days prior to first dose of study therapy, are not experiencing seizures and are not receiving steroids for symptomatic brain metastases (for at least 7 days prior to first dose of study treatment) Symptomatic or clinically active brain metastases Patient has symptomatic brain or CNS metastases Symptomatic or uncontrolled brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation and/or corticosteroids Presence of symptomatic brain metastases or brain metastases requiring escalating doses of corticosteroids to control neurological symptoms Symptomatic brain metastases or leptomeningeal (LM) disease requiring corticosteroids for symptom management; asymptomatic brain metastases or LM will be allowed on study Symptomatic or unstable brain metastases. Symptomatic or uncontrolled brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation and/or corticosteroids Symptomatic or uncontrolled brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation and/or corticosteroids Patients with symptomatic extrahepatic metastases Symptomatic brain metastases Symptomatic or uncontrolled brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation and/or corticosteroids Symptomatic or uncontrolled brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation and/or corticosteroids Symptomatic or uncontrolled brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation and/or corticosteroids Symptomatic or uncontrolled brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation and/or corticosteroids Symptomatic or uncontrolled brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation and/or corticosteroids Symptomatic brain metastases; any neurologic symptoms present must have resolved with local therapy by the time of administration of study drug Symptomatic or uncontrolled brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation and/or corticosteroids Symptomatic brain metastases (baseline CT scan is not required in asymptomatic patients) Symptomatic brain metastases Symptomatic brain metastases Symptomatic or uncontrolled brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation and/or corticosteroids DOSE ESCALATION COHORT: Brain metastases: symptomatic, unstable, or disease requiring use of steroid treatment DOSE EXPANSION COHORT: Brain metastases: symptomatic, unstable, or disease requiring use of steroid treatment Symptomatic or uncontrolled brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation and/or corticosteroids Symptomatic brain or bone metastases; prior radiation and/or steroid therapy for brain or bone metastases (if applicable) must be completed >= 2 weeks prior to study enrollment Patients with symptomatic brain metastases are excluded from this study Histologically confirmed malignant melanoma with measurable metastases in the brain. Both asymptomatic and symptomatic patients. Symptomatic or uncontrolled brain metastases; Symptomatic or progressive brain metastases. Patients with symptomatic brain metastases. Symptomatic uncontrolled brain metastases Participants with symptomatic or growing brain metastases less than 4 weeks prior to enrollment. Symptomatic or uncontrolled brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation and/or corticosteroids The participant has brain metastases that are symptomatic. Known symptomatic or uncontrolled brain metastases or epidural disease Symptomatic or clinically active brain metastases Symptomatic brain metastases (prior treatment and stable metastases are allowed) Symptomatic OR Symptomatic or uncontrolled brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation and/or corticosteroids Subjects with symptomatic uncontrolled brain metastases; Patients with known active or symptomatic brain metastases prior to vaccination. Symptomatic brain metastases (patients with asymptomatic brain metastases may be eligible provided other criteria are met) Symptomatic brain metastases. Symptomatic brain metastases Symptomatic brain metastases Symptomatic brain metastases. Symptomatic brain metastases. Symptomatic brain metastases Patient has symptomatic brain metastases, ie, presence of neurological symptoms or requiring treatment with corticosteroids, or CNS leukemia. Patient with brain metastases that are symptomatic and/or require therapy. Symptomatic and progressive or corticosteroid-requiring documented brain metastases Patients who present with symptomatic brain radionecrosis after they have received radiosurgery for brain metastases from primary solid tumor including but not limited to lung, breast, colorectal cancer but excluding melanoma, choriocarcinoma, renal cell carcinoma or gliomas Presence of symptomatic brain metastases at time of study consent process; patients with history of treated brain metastases are eligible if they are not symptomatic at the time of study enrollment History of epilepsy, brain damage, use of anticonvulsants for seizure prevention, concurrently using ketamine, symptomatic brain metastases Patients with history of epilepsy, brain damage, or symptomatic brain metastases. Participants with symptomatic uncontrolled brain metastases; a scan to confirm the absence of brain metastases is not required Patients with symptomatic brain metastases are excluded from this study. Symptomatic brain metastases Participants with known brain metastases Participants with known metastases Participants with known brain metastases should be excluded; screening for brain metastases with head imaging is not required Participants with > 6 definitive lesions consistent with brain metastases Known intracranial metastases ENROLLMENT TO THE DOSE ESCALATION, EXPANSION AND PART II: Participants with known untreated brain metastases are excluded; patients with a history of brain metastases are permitted to enroll if they have been treated, are no longer taking corticosteroids, and have been stable for a minimum of one month on imaging; exceptions for participants with asymptomatic sub-centimeter metastases that, in the opinion of the treating investigator, do not require intervention may be possible following discussion and agreement with the overall principal investigator Participants with known untreated brain metastases should be excluded from this clinical trial; participants with a history of brain metastases that have been treated, are no longer taking corticosteroids, and have been stable on imaging for >= 4 weeks following the last date of treatment are permitted Participants with known untreated brain metastases should be excluded from this clinical trial; participants with a history of brain metastases that have been treated, are no longer taking corticosteroids, and have been stable on imaging for >= 4 weeks following the last date of treatment are permitted Participants with known untreated brain metastases should be excluded from this clinical trial; participants with a history of brain metastases that have been treated, are no longer taking corticosteroids, and have been stable on imaging for at least one month following the end of treatment are permitted. Participants with known brain metastases should be excluded Participants with active brain metastases Have no known metastases Patients with known brain metastases should be excluded Subjects with known metastases Patients with known brain metastases (treated or not) will be excluded Patients with known MIBG-avid parenchymal brain metastases are excluded Patients with known brain metastases are excluded Patients with known metastases are not eligible Participants with known uncontrolled brain metastases will be excluded from this clinical Participants with known brain metastases PHASE II: Participants with known brain metastases should be excluded Participants with known brain metastases Participants with known brain metastases Participants with known brain metastases Any known metastases Known presence of metastases Participants with metastases Patients with known brain metastases are excluded from this study Patients with known brain metastases will be excluded Participants with known brain metastases that are symptomatic and require corticosteroids are excluded Participants with known brain metastases Participants with known brain metastases, or any other metastases from cancer Participants with known uncontrolled brain metastases Patients with known brain active and untreated metastases should be excluded from this clinical trial Patients with known brain metastases should be excluded from this clinical trial except as those described below Participants with known untreated brain metastases are excluded from this clinical trial Participants with known brain metastases should be excluded from this clinical trial Participants with known brain metastases should be excluded from this clinical trial Subject with known brain metastases should be excluded from this clinical trial; however, baseline brain imaging is not required prior to enrollment in the study if patients are asymptomatic Those with known brain metastases should be excluded from this clinical trial Patients with known brain metastases should be excluded from this clinical trial Patients with known brain metastases should be excluded from this clinical trial; a scan to confirm the absence of brain metastasis is not required Patients with known brain metastases will be excluded from this clinical trial Patients with known brain metastases will be excluded from this clinical trial Subjects with known brain metastases should be excluded from this clinical trial Patients with known brain metastases should be excluded from this clinical trial Patients with known brain metastases should be excluded from this clinical trial Participants with symptomatic known brain metastases < 4 weeks from radiation treatment should be excluded from this clinical trial Patients with known brain metastases should be excluded from this clinical trial Patients with active brain metastases should be excluded from this clinical trial. Patients with known brain metastases should be excluded from this clinical trial Participants with known brain metastases should be excluded from this clinical trial Patients with known brain metastases will be excluded from this clinical trial Participants with known brain metastases should be excluded from this clinical trial Patients with known brain metastases will be excluded from this clinical trial Patients with known brain metastases should be excluded from this clinical trial Participants with known brain metastases from solid tumors should be excluded from this clinical trial Patients with known brain metastases should be excluded from this clinical trial Patients with known brain metastases are excluded from this clinical trial; patients with primary brain tumors amenable to surgery are allowed on this protocol Patients with known brain metastases should be excluded from this clinical trial Participants with known brain metastases should be excluded from this clinical trial Patients with known brain metastases should be excluded from this clinical trial; patients with brain metastases that are stable after >= 1 year after primary surgery or radiation will not be excluded Subject has known brain metastases; presence of brain metastases should be excluded from this clinical trial Known brain metastases; patients with known brain metastases must be excluded from this clinical trial Patients with known brain metastases or leptomeningeal metastases should be excluded from this clinical trial; patients with other extrapleural metastases are included in this study Patients with known brain metastases should be excluded from this clinical trial Subjects with known active brain metastases will be excluded from this clinical trial. Patients with brain metastases that have been treated and stable for >= 30 days following treatment will be eligible. Have a history of or current evidence of intracranial disease; patients with brain metastases must be excluded from this clinical trial Patients with known brain metastases should be excluded from this clinical trial Patients with symptomatic or recurrent brain metastases should be excluded from this clinical trial Patients with known, untreated or progressive brain metastases will be excluded from this clinical trial Patients with known brain metastases should be excluded from this clinical trial Patients with known brain metastases should be excluded from this clinical trial Patients with known brain metastases should be excluded from this clinical trial Patients with known brain metastases should be excluded from this clinical trial Patients with known brain metastases should be excluded from this clinical trial Subjects with known brain metastases should be excluded from this clinical trial Patients with untreated brain metastases should be excluded from this clinical trial Patients with known brain metastases should be excluded from this clinical trial Patients with known brain metastases should be excluded from this clinical trial Patients with known brain metastases should be excluded from this clinical trial Subjects with known brain metastases should be excluded from this clinical trial Patients with known active brain metastases, a history of seizure disorder, or other neurological disorders/dysfunction, should be excluded from this clinical trial Participants with known brain metastases should be excluded from this clinical trial Patients with known metastases would be excluded from this clinical trial Patients with previously untreated and or symptomatic brain metastases are excluded from this clinical trial Patients with known brain metastases should be excluded from this clinical trial Participants with known brain metastases should be excluded from this clinical trial Patients with known active or history of brain metastases should be excluded from this clinical trial Participants with known brain metastases should be excluded from this clinical trial Patients with known brain metastases should be excluded from this clinical trial Participants with known brain metastases should be excluded from this clinical trial Patients with known brain metastases should be excluded from this clinical trial Patients with known brain metastases should be excluded from this clinical trial Patients with known brain metastases should be excluded from early clinical trials Patients with known brain metastases should be excluded from this clinical trial Patients with known brain metastases should be excluded from this clinical trial Patients with known brain metastases should be excluded from this clinical trial Patients with known brain metastases with active symptoms or requiring anticonvulsive medications, or steroids should be excluded from this clinical trial Participants with known brain metastases should be excluded from this clinical trial Patients with known brain metastases should be excluded from this clinical trial Patients with symptomatic brain metastases are excluded from this clinical trial Patients with known brain metastases should be excluded from this clinical trial Patients with known brain metastases are excluded from this clinical trial; patients with primary brain tumors amenable to surgery are allowed on this protocol Patients with known brain metastases should be excluded from this clinical trial Patients with untreated brain metastases should be excluded from this clinical trial Patients with known brain metastases should be excluded from this clinical trial Patients with known brain metastases should be excluded from this clinical trial Participants with known brain metastases will be excluded from this clinical trial Patients with known brain metastases should be excluded from this clinical trial Patients with known brain metastases should be excluded from this clinical trial Participants with known brain metastases should be excluded from this clinical trial Patients with known brain metastases should be excluded from this clinical trial Patients with known brain metastases should be excluded from this clinical trial Patients with known brain metastases will be excluded from this clinical trial Participants with known brain metastases should be excluded from this clinical trial Patient must not have known brain metastases; patients with known brain metastases must be excluded from this clinical trial Participants with known brain metastases should be excluded from this clinical trial; does not apply to group C Patients with known brain metastases should be excluded from this clinical trial Patients with known brain metastases should be excluded from this clinical trial Patients with known brain metastases should be excluded from this clinical trial Patients with known brain metastases should be excluded from this clinical trial Patients with known brain metastases should be excluded from this clinical trial Participants with known brain metastases should be excluded from this clinical trial Patients with known brain metastases should be excluded from this clinical trial Patients with active brain metastases should be excluded from this clinical trial except as noted above Patients with known brain metastases will be excluded from this clinical trial Known brain metastases; patients with known brain metastases must be excluded from this clinical trial Patients with known brain metastases should be excluded from this clinical trial Patients with known brain metastases will be excluded from this portion of the clinical trial (which will assess PFS and TTP) Patients with primary brain cancer or known brain metastases should be excluded from this clinical trial Patients with known brain metastases are excluded from this clinical trial Patients with known brain metastases should be excluded from this clinical trial Patients with known brain metastases should be excluded from this clinical trial Patients with untreated brain metastases should be excluded from this clinical trial Patients with known brain metastases will be excluded from this clinical trial Patients with brain metastases should be excluded from this clinical trial except as noted above Patients with known brain metastases should be excluded from this clinical trial Patients with known brain metastases are excluded from this clinical trial Patients with known brain metastases should be excluded from this clinical trial Patients with known brain metastases should be excluded from this clinical trial Participants with known brain metastases should be excluded from this clinical trial Patients with untreated brain metastases, as determined by treating oncologist, will be excluded from this clinical trial; patients with treated brain metastasis are eligible for this trial, providing they have completed treatment at least one day prior to registration Patients with known brain metastases will be excluded from this clinical trial Participants with known metastatic disease should be excluded from this clinical trial Patients with known brain metastases should be excluded from this clinical trial Participants with known brain metastases should be excluded from this clinical trial Patients with known symptomatic brain metastases should be excluded from this clinical trial Participants with known brain metastases will be excluded from this clinical trial Patients with known brain metastases should be excluded from this clinical trial Participants with known brain metastases should be excluded from this clinical trial Participants with known brain metastases should be excluded from this clinical trial