Have a histopathological diagnosis (fresh or banked tumor biopsy sample, preferably collected within the last  years) of nonresectable or metastatic cholangiocarcinoma and are not eligible for curative resection, transplantation, or ablative therapies.
Rectal tumor at baseline which would be considered to require complete TME
Medulloblastoma or medulloblastoma variants including posterior fossa primitive neuroectodermal tumor (PNET) as documented by an institutional pathologist
Central nervous system (CNS) embryonal tumor other than medulloblastoma or PNET in the posterior fossa, for example, patients with diagnosis of atypical teratoid/rhabdoid tumor (ATRT), supratentorial PNET, pineoblastoma, ependymoblastoma, embryonal tumor with abundant neuropil and true Rosettes (ETANTR) are excluded
For patients who undergo lumpectomy, the margins of the resected specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the local pathologist; if pathologic examination demonstrates tumor at the line of resection, additional excisions may be performed to obtain clear margins; if tumor is still present at the resected margin after re-excision(s), the patient must undergo mastectomy to be eligible; (patients with margins positive for lobular carcinoma in situ [LCIS] are eligible without additional resection)
For patients who undergo lumpectomy, the margins of the resected specimen or re-excision must be histologically free of invasive tumor and DCIS as determined by the local pathologist; additional operative procedures may be performed to obtain clear margins; if tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible; (patients with margins positive for lobular carcinoma in situ [LCIS] are eligible without additional resection)
Patients with, per the operative and/or pathology report, positive margin(s) (tumor present at the cut or inked edge of the tumor) which is not superceded by an additional margin of tumor-negative tissue, nodal extracapsular extension, and/or gross residual disease after surgery are not eligible
No immediate need for surgical intervention for the primary tumor or palliative diversion/bypass
Group A: patients <  months (<  days) of age with newly diagnosed INRG stage L neuroblastoma/ganglioneuroblastoma who meet the following criteria:\r\n* Greatest tumor diameter <  cm of adrenal or non-adrenal origin\r\n* Patients with non-adrenal primaries are eligible, but must have positive uptake on metaiodobenzylguanidine (MIBG) scan or elevated catecholamine metabolites (urine or serum) to support the diagnosis of neuroblastoma\r\n* No prior tumor resection or biopsy
Group B: patients <  months (<  days) of age with newly diagnosed INRG stage L neuroblastoma/ganglioneuroblastoma who meet the following criteria:\r\n* No life threatening symptoms or no impending neurologic or other organ function compromise (e.g. epidural or intraspinal tumors with existing or impending neurologic impairment, periorbital or calvarial-based lesions with existing or impending cranial nerve impairment, anatomic or mechanical compromise of critical organ function by tumor [abdominal compartment syndrome, urinary obstruction, etc.]); horner syndrome is not considered neurologic compromise\r\n* No prior tumor resection, tumor biopsy ONLY\r\n* Only patients with both favorable histology and favorable genomic features will remain on study as part of Group B; the institution will be notified of histologic and genomic results within  weeks of specimen submission on ANBLB or APECB
There is no minimum performance level; children with ependymoma may suffer neurologic sequelae as a result of their tumor or surgical measures taken to establish a diagnosis and resect the tumor; in the majority of cases, there is neurologic recovery; neurologic recovery is not likely to be impeded by protocol therapy
The tumor must be located in the supratentorial compartment only (any component involving the brain stem or cerebellum is not allowed)
Patients must have had cystoscopy confirming no visible papillary tumor within  days prior to registration; (CIS disease is not expected to have been completely excised)
Patients with histologically confirmed ovarian stromal tumor [granulosa cell tumor, ganulosa cell-theca cell tumor, Sertoli-Leydig cell tumor (androblastoma), steroid (lipid) cell tumor, gynandroblastoma, unclassified sex cord-stromal tumor, sex cord tumor with annular tubules]
Confirmation of GCT histology (both seminoma and nonseminoma) on pathologic review at the center of enrollment; tumor may have originated in any primary site\r\n* NOTE: in rare circumstances, patients will be allowed to enroll even if a pathologic diagnosis may not have been established; this would require a clinical situation consistent with the diagnosis of GCT (testicular, peritoneal, retroperitoneal or mediastinal mass, elevated tumor marker levels [HCG >= ; AFP >= ] and typical pattern of metastases)
Histologically confirmed diagnosis of inoperable PVNS/ dt-TGCT or potentially resectable tumor that would result in unacceptable functional loss or morbidity as determined by a qualified surgeon or multi-disciplinary tumor board (must be documented in the CRF during screening)
Germ cell tumor (GCTs), excluding immature teratoma, or teratoma with malignant transformation.
CNS GCT including pure germinoma and MMGCT; patients with histologically proven germinoma and MMGCT, including endodermal sinus tumor (yolk sac tumor), embryonal carcinoma, choriocarcinoma and mixed germ cell tumor will be eligible for the study; patients with mature/immature teratoma who have tumor marker elevations are eligible on this study; patient with ONLY mature and/or immature teratoma are ineligible in the absence of the tumor marker elevations
Resection of at least % of the volume of the tumor is feasible; resectability will be determined by the surgeon and radiologist after discussion among the multidisciplinary team
Tumor is deemed to be resectable with negative margins by conventional surgical standards
The maximum radiation target volume for GTV is  cc (per NRG Oncology guide); patient may be excluded after the first sMRI scan if the GTV volume is greater than  cc (we anticipate that contrast-enhancing tumor volume [residual tumor volume following tumor resection] would be less than  cc)
Upon the identification of an MTD or RPD, the Sponsor, in consultation with the study investigators, may open the enrollment of two of the following nonrandomized tumor specific extension cohorts:
The tumor must have been determined to be microsatellite stable (MSS).
Patients must have evidence of recurrent or metastatic carcinoma by one or more of the following:\r\n* The appearance of metastatic disease by standard imaging techniques\r\n* The appearance of rising serum tumor marker, AFP or beta-hCG\r\n* NOTE: If a rising tumor marker is the only evidence of progressive disease, at least  consecutive rising values at least one week apart are needed; patients with only evidence of disease is rising tumor marker AFP and beta-hCG will be provided alternate causes of increased serum levels of these markers are not present, such as cross reaction with luteinizing hormone (LH) (that can be tested if needed by testosterone suppression of LH), hepatitis, use of marijuana or second primary tumor, etc
Group A: Subjects with any solid tumor (including lymphomas).
Patients must have archival tumor tissue or agree to a tumor biopsy for mutation and biomarkers analysis unless previously discussed with sponsor's medical monitor or its designee (fresh tumor biopsies are recommended at baseline in patients with readily accessible tumor lesions and who consent to the biopsies). Patients with ovarian, fallopian tube, primary peritoneal, or breast cancer in Part A and all patients enrolled in Part B must also agree to provide fresh blood sample at the baseline for the evaluation of BRCA mutations and/or confirmation of prior BRCA results or other homologous reconstitution deficiency mutation even if it was previously tested.
All patients must have had an MRI of the brain and spine that has measurable tumor (not only diffuse leptomeningeal tumor) within two weeks prior to study enrollment; Note: central review of MRIs is required, but may be completed concurrently with patient registration; completion of central review is not required prior to starting treatment
Macrovascular tumor invasion.
Is willing to provide and there is confirmed availability of pre-existing diagnostic or resected tumor samples, such as paraffin-embedded sections. Providing fresh tumor biopsy is optional for subjects in Dose Escalation cohorts.
PIKCA MUTANT COHORT (closed //): Tumor PIKCA mutation present
Dental braces or prosthesis that interferes with tumor imaging
Has one of the following tumor locations/types:) NSCLC involving the superior sulcus; ) Large cell neuro-endocrine cancer (LCNEC); or ) Sarcomatoid tumor.
Known to be TM+ (on pre-treatment tumor or plasma) or known germline TM
Part A: subjects must have a FFPE tumor sample available (e.g., from their prior surgery) that is suitable for the next generation sequencing (NGS) required for this study
Participant must be willing to undergo tumor biopsies prior to treatment and on Cycle  Day . In the Phase  part of the trial, participants with bone-only disease, or participants for whom a biopsy is contra-indicated, may opt out of providing tumor biopsies. Note: A subset of participants in Phase  will be required to provide tumor tissue until tumor pairs have been collected from at least  ER?WT and  ER?mut (determined by sponsor-designated central laboratory test).
Known to be TM+ (on pre-treatment tumor or plasma) or known germline TM
Platelets ?x/?L (?  x ^/L) (superficial tumor dosing only)
Hemoglobin ? g/dL (? g/L) (superficial tumor dosing only)
Radiographic evidence of leptomeningeal dissemination, gliomatosis cerebri, infratentorial tumor, or disease at sites remote from the supratentorial brain.
Patients with pure WDLS, myxoid/round cell or pleomorphic tumor histologic subtypes.
largest tumor volume <  cc
Optic pathway tumors, including chiasmatic-hypothalamic, tumor without histologic confirmation; patients with chiasmatic lesions with or without contiguous extension of tumor into other regions of the visual pathways demonstrated on contrast magnetic resonance imaging (MRI) will be eligible for study without histopathologic confirmation with or without NF-
Can supply tumor tissue for study analyses (dependent on tumor type)
INCLUSION - INFUSION: EBV positive tumor
Pathological diagnosis for the resected tumor demonstrates transformation to higher grade (i.e. WHO grade III or IV) gliomas; if a patient is diagnosed as high-grade glioma (HGG) upon resection after receiving the pre-surgical treatment, the patient will be withdrawn from the study and considered for therapeutic options for HGG (trials for HGG or standard of care); the tumor tissue of such a case would be brought to the lab before the pathological diagnosis is made? and thus would be processed before the lab is informed of the final HGG diagnosis; will evaluate the tumor tissue to help us develop future approaches for HGG
A hypovascular tumor (defined as a tumor with all its parts less contrast-enhanced than the non-tumorous liver parenchyma on arterial phase computed tomography scans)
Patients with T primary tumor or T large volume tumor that has resulted in larynx dysfunction at baseline (for example tumor largely penetrating into base of tongue and resulting in inability to swallow at baseline)
RAS wild-type; both KRAS and NRAS testing are necessary; the presence of pathogenic mutations in KRAS or NRAS is exclusionary; primary tumor or metastatic tumor may be tested
Pathological diagnosis for the resected tumor demonstrates transformation to higher grade (i.e. WHO grade III or IV) gliomas; if a patient who received neoadjuvant vaccines is diagnosed as high grade glioma (HGG), the patient will be withdrawn from the study and considered for therapeutic options for HGG (trials for HGG or standard of care); the tumor tissue of such a case would be brought to the lab before the pathological diagnosis is made; and thus would be processed before the lab is informed of the final HGG diagnosis; because HGG tissue may still reflect the vaccine effects, we will evaluate the tumor tissue to help us develop future approaches for HGG
Patients must have evaluable tissue/blood for testing as specified by the concurrent FoundationOne criteria; this will be obtained during the standard of care tumor diagnosis and tumor staging evaluation
PHASE I: In order to perform a retrospective biomarker analysis with the next generation gene sequencing UW-OncoPlex assay; fresh tumor biopsies from metastatic or primary tumor lesion will be done if considered safe and feasible by treating physician and radiologist; Patients who already have OncoPlex or other equivalent gene sequencing assay (eg Foundation One, Perthera, Caris etc) test results available from prior tumor biopsy are eligible to participate, without the needed of a repeat tumor biopsy, but the test results need to be provided to the study principal investigator
PHASE IB: Fresh tumor biopsies from metastatic or primary tumor lesions will be done only if considered safe and feasible by treating physician and radiologist; patients who already have OncoPlex or other equivalent gene sequencing assay (eg Foundation One, Perthera, Caris etc) test results available from prior tumor biopsy are eligible to participate, without the needed of a repeat tumor biopsy, but the test results need to be available to the study principal investigator
Tumor suspected or known to invade the esophagus
Tumor: patient must have one of the following diagnoses to be eligible:
Patients with bulky tumor on imaging are ineligible; treating physicians are encouraged to contact the study chair to request a rapid central imaging review to confirm fulfilment of these eligibility criteria, if they have concerns\r\nBulk tumor is defined as:\r\n* Tumor with evidence of clinically significant uncal herniation or midline shift\r\n* Tumor with diameter of >  cm in one dimension on T/fluid attenuated inversion recovery (FLAIR)\r\n* Tumor that in the opinion of the site investigator, shows significant mass effect in either the brain or spine\r\n* Multi-focal/ metastatic disease: \r\nNote: A second focus of enhancement in a single FLAIR abnormality is permissible and will not exclude the subject\r\n** Patients with multi-focal parenchymal disease are ineligible\r\n** Patients with leptomeningeal metastatic disease are eligible\r\n* Strata B, D and E  patients whose tumor has a significant component involving the brainstem or with significant fourth ventricular compression are ineligible
Phase II: if surgical resection/debulking prior to MLA is not indicated, a biopsy of the tumor will be done at the same time of MLA to obtain tumor tissue for both diagnostic purposes and immune monitoring
-  Confirmed diagnosis of HCC >  mm with a characteristic -phase CT or dynamic\n             contrast enhanced MRI finding showing intense arterial uptake followed by \washout\ of\n             contrast in the venous-delayed phases per American Association for the Study of Liver\n             Disease (AASLD) criteria.\n\n          -  Patients between ages  and \n\n          -  Patients with single or multiple (- nodules) HCC who are unsuitable or unwilling for\n             surgical resection or RFA. The largest tumor nodule should be less than  cm in the\n             largest diameter. The total volume of tumor cannot exceed % of liver; or patients\n             with liver metastatic gastrointestinal cancer, including neuroendocrine tumor\n\n          -  Patients are candidates for TAE or Transarterial ChemoEmbolization (TACE). No tumor\n             invasion to portal vein or thrombosis in portal vein.\n\n          -  ECOG score - with no known cardiac, pulmonary or renal dysfunction\n\n          -  Child-Pugh score group A or B liver functional score\n\n          -  Prior local therapies such as surgical resection, radiofrequency ablation, or alcohol\n             injection are allowed as long as tumor progresses from the prior treatment and the\n             patients are still candidates for TAE. All prior therapy must be at least  weeks\n             prior to enrollment and free from treatment-related toxicity.\n\n          -  No TAE/TACE in the past\n\n          -  Patients have normal organ function: ANC ?  /L, Hemoglobin ?  gm/dL, Platelets ?\n             , /L, Creatinine ?  mg/dL, AST and ALT <  X upper normal limit of the current\n             institution; bilirubin ? . mg/dL, PT prolongation no more than  sec above upper\n             limit of normal.\n\n        For the expansion cohort of neuroendocrine tumor or metastatic gastrointestinal cancer\n\n          -  Unresectable, locally advanced or metastatic, well differentiated (low or intermediate\n             grade), neuroendocrine tumors (NET).\n\n          -  Liver metastatic gastrointestinal cancer.
Patients with a histologic diagnosis of malignant pleural mesothelioma (MPM), epithelioid subtype, who in the opinion of the attending thoracic surgeon can receive a macroscopically complete resection of tumor
Patients must be untreated with curative-intent surgery for current diagnosis of stage III, IVa, or IVb disease; diagnostic biopsy of primary tumor and/or nodal sites is permitted.  \r\n* Diagnostic simple tonsillectomy is permitted, provided patient has Response Evaluation Criteria in Solid Tumors (RECIST)-measurable residual tumor and/or nodal disease\r\n* Patients with a second HNSCC primary tumor are eligible for this study, provided more than  years have elapsed since the first diagnosis of HNSCC, the original tumor was managed with surgery only (no adjuvant chemotherapy/radiotherapy), and has not recurred
Cryoablation can be performed near vessels of the head and neck, and if deemed necessary tumor may be displaced using a saline injection (hydrodisplacement); tumor displacement from nerves may be required and will be performed as deemed appropriate to avoid nerve injury
Tumor must be deemed to be inoperable or unresectable either by clinical or radiographic criteria; these criteria include encasement of great vessels, vertebral invasion or undue peri-operative risk
Infra-tentorial tumor
Patient must have an original diagnosis, benefited by autologous transplantation, confirmed by biopsy* of solid tumor, including but not limited to: high-grade glial tumor, low-grade glial tumor, ependymoma, medulloblastoma, primitive neuro-ectodermal tumor (PNET), Wilms' tumor, rhabdomyosarcoma, Ewing's sarcoma, retinoblastoma, or miscellaneous poor-prognosis solid tumors; lymphomas and other lymphoid malignancies will not be studied in this protocol\r\n* Brain stem glioma patients who have progressed after radiation therapy do not require histologic confirmation; brain stem gliomas are defined as intrinsic tumors of the pons causing diffuse enlargement; these patients are diagnosed on clinical and radiographic appearance of the lesion and the biopsy requirement will be waived for this group
Patients with tumor morphology that predicts poor coverage of the majority of the tumor including bilateral thalamic involvement, or cysts that represent > % of cross-sectional areas of the pons. These subjects should be discussed with the study chairs.
Malignancy (solid tumor or lymphoma) that is currently not amenable to surgical intervention due to either medical contraindications or nonresectability of the tumor.
Has greater than % liver parenchyma replacement by tumor
Confirmation of: a) Cohort A: MSI-H CRC either by immunohistochemistry (IHC) for loss of protein expression in one of  mismatch repair proteins (MLH, MSH, MSH, PMS) or by detection of microsatellites within the tumor DNA as per institutional practices; b) Cohort B: CMS CRC classification on pretreatment primary tumor; c) Cohort C: MSI-H non-CRC solid tumor either by IHC for loss of protein expression in one of  mismatch repair proteins (MLH, MSH, MSH, PMS) or by detection of microsatellites within the tumor DNA as per institutional practices.
Willingness to have  tumor biopsies; the first before and the second while on therapy (optional for all patients and may become mandatory in order to ensure  patients at maximum tolerated dose [MTD] have paired biopsies).
Patient should have at least one remaining papillary LG tumor evaluated visually with a diameter of at least  mm.
Documentation of BRAFV wild-type status in melanoma tumor tissue through use of a clinical mutation test approved by the local health authority
Tumor test result shows MGMT methylated or indeterminate tumor subtype
Tumor test result shows MGMT unmethylated type
PHASE I: Patients with recurrent, refractory, or progressive non-hematologic malignancies (central nervous system [CNS] or solid tumors) associated with activation of the RAS/RAF/ERK pathway, including any LGG, any tumor in a patient with NF, or any tumor with a documented activating BRAF, NRAS, or KRAS mutation, will be eligible; LGG is defined as any World Health Organization (WHO) grade I or II (or equivalent) astrocytic, oligodendroglial, and/or glioneuronal tumor
Any tumor ER/PgR status, any HER-/neu status as measured by local hospital pathology laboratory and meets any tumor assay profile described in protocol section ..F
Documentation of Disease:\r\n* Histologic Documentation: Well- or moderately-differentiated neuroendocrine tumors of pancreatic and non-pancreatic (i.e. carcinoid) origin by local pathology\r\n** The pathology report must state ONE of the following: ) well- or moderately-differentiated neuroendocrine tumor, ) low- or intermediate-grade neuroendocrine tumor, or ) carcinoid tumor or atypical carcinoid tumor; documentation of histology from a primary or metastatic site is allowed\r\n** Patients with poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid tumor, or goblet cell carcinoid tumor are not eligible\r\n* Stage: Locally advanced/unresectable or metastatic disease\r\n* Tumor Site: Histological documentation of neuroendocrine tumor of pancreatic, gastrointestinal (GI), lung, or unknown primary site; GI, lung, and unknown primary NETs will enroll in the carcinoid tumor cohort of the study\r\n** Functional (associated with a clinical hormone syndrome) or nonfunctional tumors are allowed\r\n* Radiologic Evaluation: Target lesions must have shown evidence of disease progression by Response Evaluation Criteria in Solid Tumors (RECIST) version (v). criteria in the  months prior to registration; the radiologic images, imaging reports, and clinic notes indicating growth of existing lesions, development of new lesions, or treatment changes must be submitted
Tumor MGMT promoter deoxyribonucleic acid (DNA) not methylated (i.e., unmethylated) by central testing
Infra-tentorial tumor
Direct invasion of the duodenum by the primary tumor
Tumor is not impinging on Middle Cerebral Artery/speech-motor strip
Malignancy (solid tumor or lymphoma) that is currently not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumor.
Patients must have histologically or cytologically confirmed A) low lying (i.e. =<  cm from the anal verge) rectal adenocarcinoma eligible for concurrent chemoradiation therapy to rectal tumor, B) if the treatment is palliative in the metastatic setting, no additional requirements for tumor size or nodal involvement is needed; C) if the treatment is in the neoadjuvant setting, the tumor must ALSO be high-risk locally advanced rectal cancer defined as T-, N+, and/or at risk for a positive radial margin (as determined by the surgeon)
Patients must have a wild type or mutated RAS tumor status known prior to enrollment
Must have a growing tumor amenable to percutaneous image-guided cryoablation based on routine Interventional Radiology criteria
Patient has symptoms related to hormone production from tumor (i.e. functional tumor)
Biopsy-proven benign or malignant brain tumor requiring tumor bed or tumor irradiation; this may include, but is not limited to, low-grade or favorable high-grade glioma, pituitary adenoma, vestibular schwannoma (acoustic neuroma), and meningioma as the most common diagnoses; other tumor types that require irradiation and are deemed appropriate for proton radiation therapy are also eligible; patients with a presumed diagnosis based on imaging and clinical characteristics will be permitted on this trial without pathological diagnostic confirmation if it is within standard of care to offer radiation therapy without a biopsy
Histologically proven malignancy necessitating cranio-spinal irradiation; this will include patients with a diagnosis of medulloblastoma, supratentorial primitive neuroectodermal tumor (SPNET), disseminated ependymoma, embryonal tumor with abundant neuropil and true rosettes (ETANTR), atypical teratoid/rhabdoid tumor (ATRT), and disseminated low-grade glioma (LGG) or histologically confirmed germ cell tumor or elevated alpha-fetoprotein (AFP) (serum >  IU/L or cerebrospinal fluid [CSF] > than institutional norm) or B-HCG (serum or CSF > than institutional norm) in the setting of radiographic disease consistent with a germ cell tumor necessitating cranio-spinal irradiation
Patients must have a tumor or plaque that is refractory to conventional treatment including but not limited to one of the following (up to  lesions in a single field of PDT or RT will be considered for treatment):\r\n* Plaque stage disease that has failed at least  skin directed therapies (including topical steroids) or refractory plaques despite at least one systemic therapy or plaques with evidence of folliculotropism\r\n* The presence of a tumor of MF
The tumor must be confined to the supratentorial compartment
It must be the surgeons expectation that >=  of the tumor can be treated with LITT to the yellow TdT line (i.e.  degrees for  min)
Tumor must be unifocal & unilateral
Participation in Iowa Neuroendocrine Tumor Registry
HER-positive tumor status;
Participants with known microsatellite instability-high (MSI-H) genotype or known wild type tumor protein  (TP) per local testing.
Patients who are surgical or ablation candidates as determined by multidisciplinary hepatobiliary tumor conference
Subjects without baseline tumor imaging
Evidence of active tumor lysis syndrome based on laboratory assessment
Tumor deemed accessible by metastatectomy (TIL harvest) which expects to yield > . cm^ of resectable tumor amount
Patients with tumor(s) invading a major vascular structure (e.g. carotid artery) or other key anatomical structure (e.g. pulmonary airway) in the event of post treatment tumor swelling and/or necrosis (hepatic and portal vein involvement allowed)
Patients with liver tumors in a location that would potentially result in significant clinical adverse effects in the opinion of investigator if post-treatment tumor swelling were to occur, including at the site of the common bile duct
Intrahepatic lesion amenable to pre and post SBRT biopsies, unless the investigator determines that the tumor biopsies would be unsafe
Total tumor burden requiring ?  mL AvidinOX injection
Has at least one extracranial tumor safely treatable with radical-dose radiation therapy
Must have marker clip indicating location of target tumor in breast
Either the primary tumor and/or the metastatic tumor must be RB positive as defined below:\r\n* RB status: the invasive tumor must have greater than % of tumor cells staining positive for RB
Evidence of tumor expression of CA- based on IHC performed on tumor samples or elevated serum levels (?. x ULN) of CA- considered secondary to tumor
Patients will be eligible if tumor is metastatic, unresectable, progressive, or if complete tumor resection is not considered to be feasible without substantial risk or morbidity
(For cohort B): Primary tumor sample collected before NACT started (on ARTEMIS) and underwent molecular testing for integral biomarkers including immunohistochemical assessment of FRalpha
This study will include all patients clinically suspected or histologically confirmed solid or hematological malignancy who have undergone or will undergo genetic testing of their tumor; patients may have failed first-line or standard therapy for their disease (refractory) or have no options for curative therapies; rare cancers that are metastatic at diagnosis are by definition refractory and may be included in the first line setting, at the discretion of the principal investigators; rare cancers may not have standard of care therapies - a disease/tumor is considered rare if the incidence is < /,/year using the National Cancer Institute (NCI) RareCare tumor list, or if the disease is a molecular or biologically defined subset such that the annual incidence is < , in the United States
Patients with tumor morphology that predicts poor coverage of the majority of the tumor; this will be determined by the study chairs; patients with evidence of cystic changes greater than  cm in diameter will be excluded; these subjects should be discussed with the study chairs
Has or has ever had: upper tract TCC; urethral tumor (prostatic urethra included); any invasive bladder tumor known to be other than tumor Ta, low-grade (G-G); any evidence of lymph node or distant metastasis; any bladder tumor with histology other than TCC; or carcinoma in situ (CIS).
For subjects with recurrent tumor, the subject had at least a -month cystoscopically confirmed tumor-free interval between the last tumor recurrence and screening cystoscopic examination.
Original diagnosis has been confirmed through a histopathologic review of the primary tumor slides by an expert pathologist at the Principal Investigator's institution
Subjects that do not have a baseline tumor specimen/biopsy prior to starting study medications\r\n* Tumor specimens do not need to be at Jefferson at time of eligibility determination; tumor specimens held at outside institutions should be requested for analysis of pre-treatment tumor vs post-treatment tumor
Tumor which invades the ventricular system or located in the brain stem
Tumor is not impinging on Middle Cerebral Artery/speech-motor strip
Somatostatin receptor (SSTR) positive sites as demonstrated by either SSTR positivity (+ or + intensity and greater than % tumor cell occupying the receptors) or a nuclear medicine scan utilizing In-DTPA-phe-octreotide (Octreosca) or Ga-DOTA-tyr-octreotide within  months prior to anticipated cycle  day  (CD) demonstrating SSTR positive tumor sites
Subjects must demonstrate at least one of the following:\r\n* One or more MIBG+ and DOTATOC- tumors in addition to one or more DOTATOC+ tumors\r\n* One or more tumor sites where the calculated \safe\ radiation tumor dose is higher by at least % with a combination of I-MIBG and Y-DOTATOC than it is with Y DOTATOC alone
Tumor mitotic rate > / high-power field (hpf) and/or Ki index > % (if available)
FULL STUDY INCLUSION CRITERIA: Extent of baseline tumor burden will not interfere with causal assessment of treatment-emergent hepatotoxicity, at the investigators discretion
Primary tumor excised by radical inguinal orchiectomy and pathology consistent with pure seminoma with negative surgical margins
Patients/subjects with HER positive tumor that have not been treated with trastuzumab prior to enrollment
Tumor must be supratentorial only
No more than  days should elapse from the day study-specific tumor sample is taken at initial diagnosis (or subsequent procedure) to the time of the first intake of ODM-.
Patients must agree to enroll on the Neuro-Oncology Branch (NOB) Natural History protocol to allow the assessment of molecular tumor markers
Pathologic confirmation of solid tumor, including central nervous system tumor or lymphoma, or leukemia
Subjects that do not have a baseline tumor specimen/biopsy prior to starting study medications\r\n* Tumor specimens do not need to be at Jefferson at time of eligibility determination; tumor specimens held at outside institutions are not a reason for exclusion; samples from outside institutions should be requested for analysis of pre-treatment tumor versus (vs) post-treatment tumor
Inaccessible tumor or lack of consent for sequential biopsies
The tumor must be supratentorial
Primary tumor >=  cm (for all stages entered) to increase the likelihood that excess tumor will be available after resection
Low tumor burden according to GELF criteria defined as:
Based on clinical and radiographic evidence the tumor needs to be deemed resectable preoperatively by the surgeon and when necessary (determined by the surgeon) tumor board review
Patients deemed to have un-resectable disease by the treating surgeon or upon tumor board review
Radio-opaque markers must be present within the tumor bed; in patients who have undergone surgical resection, radio-opaque surgical clips within the tumor bed can be used as fiducials; patients without surgical clips in the tumor bed must be able to have fiducials placed endoscopically, laparoscopically, or through a computed tomography (CT)- or ultrasound-guided technique; if not, the tumor must be posterior and adjacent to the aorta, and treatment will only be permitted at the discretion of the principal investigator
Patients with evidence of gross tumor invasion into the lumen of the stomach or small bowel are not eligible; if imaging suggests luminal invasion of tumor, this must be ruled out endoscopically before the patient can be enrolled on study
Patients must be untreated with curative-intent surgery for current diagnosis of stage III, IVa, or IVb disease; diagnostic biopsy of primary tumor and/or nodal sites is permitted\r\n* Diagnostic simple tonsillectomy is permitted, provided patient has Response Evaluation Criteria in Solid Tumors (RECIST)-measurable nodal disease\r\n* Patients with a second HNSCC primary tumor are eligible for this study, provided more than  years have elapsed since the first diagnosis of HNSCC, the original tumor was managed with surgery only (no adjuvant chemotherapy or radiotherapy), and has not recurred
Surgical treatment of the breast with lumpectomy plus (+) clinical target volume (CTV) margin up to  cc's or  cm in maximum dimension with histologically confirmed margins free of tumor (negative margins defined as no tumor on ink in all directions); re-excision of surgical margins is permitted
Tumor located entirely in the infratentorium.
No clinically detectable (MR, endoscopy or digital rectal examination [DRE]) tumor present
Patients with del(p) by FISH (or known tumor protein p [TP] mutation)
Tumor replacement =< % of total liver volume
Need for urgent or emergent nephrectomy to relieve symptoms relating to the primary tumor
Unequivocal metastatic tumor at baseline
Contrast-enhancing tumor component crossing the midline, multi-focal tumor, or tumor dissemination (subependymal or leptomeningeal)
Patients considered for enrollment are strongly recommended to have been discussed at multidisciplinary tumor board with input from surgery, medical oncology and radiation oncology prior to enrollment
cPoP study: any tumor with at least  (sub)cutaneous tumor/metastases at least  cm apart which are RT nave with an indication for high dose palliative RT
Tumor for which adequate radiation dosage cannot be safely delivered
Participants must be eligible to undergo laparoscopic or robotic low anterior resection with or without a temporary diverting stoma, based on multidisciplinary tumor board consensus
Radiographic evidence of renal cancer with IVC tumor thrombus
Tumor thrombus must be >= level II
Patient eligible for IVC tumor thrombectomy as decided by the treating urologist
Based on clinical and radiographic evidence the tumor needs to be deemed resectable preoperatively
Androgen receptor positivity, defined as >= % of tumor cell nuclei with immunoreactivity for AR on central review at Vanderbilt
Primary tumor sample collected before NACT started and
Patients must have documented available tumor greater than  cm of bulk tumor mass or  cc of ascites fluid for tumor isolation prior to starting chemotherapy
An HRD score >=  on the Myriad HRD Assay as assessed on a metastatic tumor biopsy sample; in the case that an adequate metastatic tumor tissue biopsy is not feasible, we will assess the HRD score from the primary breast tumor
Patients already enrolled to the separate Tumor Genomic Analysis and Molecular Testing for Personalized Cancer Therapy study, for which a personalized therapeutic plan has been successfully created under that protocol and selected by the multidisciplinary tumor board of experts (MTBE) for use in this therapeutic clinical trial
Patients with any tumor obstructing the distal bile duct and causing an indwelling biliary SEMS occlusion
Patients with contrast-enhancing tumor component crossing the midline, actively growing multi-focal tumor, infratentorial tumor or tumor dissemination (subependymal or leptomeningeal)
Metastatic disease is allowed if investigator feels liver directed therapy could offer palliative benefit (i.e., minimal extrahepatic tumor burden)
Bilirubin < . mg/dL unless secondary to bile duct blockage by tumor
Patients with gastrointestinal stromal tumor (GIST)
Presence of nodules considered neoplastic in the same lobe or other ipsilateral lobe as the primary tumor (stage T-), unless the nodule can be encompassed in the stereotactic boost (gross tumor volume [GTV]boost) without exceeding a total GTVboost size of  cm as defined by the sum of the largest CT axial dimensions of each nodule
< % solid component of tumor on screening cross-sectional imaging
Pre-existing tumor-infiltrating lymphocytes in an archived tumor specimen or fresh biopsy, defined as an average of >=  TILs/high power field (HPF) in  consecutive HPFs, within the area with the highest TILs at low power; or, DNA mismatch repair deficiency, determined by immunohistochemistry or polymerase chain reaction per Memorial Sloan-Kettering Cancer Center (MSKCC) institutional standard practice; DNA mismatch repair deficient tumors may be TIL positive or negative
Tumor proliferation-related Ki- antigen (Ki) value is reported as low after  days of endocrine therapy
Participant must be in need of a craniotomy for tumor resection or a stereotactic brain biopsy for the purpose of diagnosis or differentiating between tumor progression versus treatment-induced effects following radiation therapy +/- chemotherapy
Based on the neurosurgeons judgment, there is no anticipated physical connection between the post-resection tumor cavity and the cerebral ventricles
T tumor
Documented recurrent disease: recurrent disease is defined either as radiological confirmation of the tumor, as an increase in tumor size of at least % based upon serial magnetic resonance (MR) images, or as development of a new site of disease\r\n* Tumor volume will be calculated using the sum of the largest cross-sectional perpendicular diameters of contrast-enhancing tumor, the sum of the largest cross-sectional perpendicular diameters of fluid attenuated inversion recovery (FLAIR) abnormality, or as worsened spectroscopic characteristics for any tumor type (development of >=  new voxels with choline to N-acetyl aspartate index [CNI] >= , or >= % increase in the sum of the CNI ratios within a group of previously abnormal voxels [where abnormal is defined as CNI ? ])\r\n* Disease must be evaluable, but does not need to be measurable\r\n* The target site for SRS does not need to be located in a previously-irradiated area
Participants must have histologically confirmed neuroblastoma or ganglioneuroblastoma or elevated urinary catecholamine metabolites; if tumor tissue was obtained, pathological review of surgical specimen at the Massachusetts General Hospital or other Dana-Farber (DF)/Harvard Cancer Center (HCC) institution is required, but preliminary report only required prior to enrollment; if no tumor tissue was obtained, urinary catecholamine metabolites are required
Patients with history of activating RAS mutation positive tumors regardless of interval from current study; however, patients may have concurrent BRAFV and RAS mutations in the tumor to be treated with protocol therapy
Less than  months from the date that local treatment (surgical or radiation) of the primary tumor was finalized
Tumor involvement which would require ventricular, brainstem, basal ganglia, or posterior fossa inoculation or would require access through a ventricle in order to deliver treatment
Patients tumor must have documentation of the presence of an IDH- and/or IDH- mutation of any type
Nonparenchymal tumor dissemination (e.g., subependymal or leptomeningeal)
Infratentorial, leptomeningeal, or multifocal tumor
A volume of enhancing tumor which falls within the treatment field volume being evaluated in the respective cohort
Tumor located in the brainstem
Tumor measures at least  centimeter on imaging or physical exam
The primary tumor involves true vocal cord(s) (glottis) or arytenoid(s)
Presence of a prolactinoma (prolactin-releasing pituitary tumor)
Patients must undergo pre-treatment direct laryngoscopy (DL) endoscopic tumor staging and CT scanning
A tumor sample must be shipped to a Novartis designated laboratory for identification of biomarkers (PIK activation status)
EBV positive tumor (can be pending)
EBV positive tumor
The tumor's not visible on the pre-therapy imaging
The tumor presenting the following imaging characteristics
The sonication pathway to the tumor involves
Patients must have either () a diagnosis of NB as defined by international criteria i.e., histopathology (confirmed by the Memorial Sloan-Kettering Cancer Center [MSKCC] Department of Pathology) or bone marrow (BM) metastases plus high urine catecholamine levels, or () a tumor that is GD-positive by immunostaining with mF\r\n* A non-NB tumor is defined as GD-positive by immunostaining with mF; if fresh or frozen tumor is not available for immunostaining, patients will be considered eligible if published reports show that > % of that tumor type is GD-positive by immunohistochemistry; (Note: tissues must be fresh/frozen as fixed, paraffin-embedded specimens are unsuitable for anti-GD immunostaining); tumors known to be GD-positive by this criteria do not need immunostaining; these include: melanoma (> %), desmoplastic small round cell tumors (%), osteosarcoma (%) and soft tissue sarcomas including liposarcoma, fibrosarcoma, malignant fibrous histiocytoma, leiomyosarcoma, and spindle cell sarcoma (%)
tumor that carries a missense HRAS mutation
Subject consents to provide at least  unstained tumor slides for retrospective testing of HRAS gene tumor status
ICGCT including pure germinoma and MMGCT; patients with histologically proven germinoma and MMGCT, including endodermal sinus tumor (yolk sac tumor), embryonal carcinoma, choriocarcinoma and mixed germ cell tumor will be eligible for the study; patients with mature/immature teratoma who have tumor marker elevations are eligible on this study; patient with ONLY mature and/or immature teratoma are ineligible in the absence of the tumor marker elevations
Tumor type demonstrated on imaging to be infiltrative, tumor volume > % of the target liver volume, or tumor nodules too numerous to count, or tumor volume > % combined with an albumin <  g/dL, or complete occlusion of the main portal vein.
WHO grade II: any tumor, either completely or incompletely excised; any recurrent tumor
WHO grade III and hemangiopericytoma: any tumor, either completely or incompletely excised; any recurrent tumor
Growing teratoma syndrome, defined as enlarging tumor masses with normal serum markers during chemotherapy for nonseminomatous GCT
The tumor volume must be a minimum of three times the injection volume; in the first and second dose levels, the lesion to be injected must be at least  mm in each of  dimensions as determined by computed tomography (CT) or magnetic resonance imaging (MRI) scans; lesions not meeting this requirement may be used if volumetric measurements show it to be >=  mL; in the third dose level, the lesion(s) to be injected must meet minimal tumor measurements and volume for each  mL fractionation of the injection volume (mL); a single lesion meeting this requirement may be injected or the total volume may be distributed in up to  lesions meeting measurement and volume requirements as follows:\r\n*  mL of HSV;  mm minimum tumor length in each dimension;  mL minimum tumor volume\r\n*  mL of HSV;  mm minimum tumor length in each dimension;  mL minimum tumor volume\r\n*  mL of HSV;  mm minimum tumor length in each dimension;  mL minimum tumor volume\r\n*  mL of HSV;  mm minimum tumor length in each dimension;  mL minimum tumor volume\r\n*  mL of HSV;  mm minimum tumor length in each dimension;  mL minimum tumor volume\r\n** Thus, the full  mL may be injected into a >=  mL tumor;  mL each may be injected into two >=  mL tumors plus  mL into a >=  mL, tumor, etc.; if a patient has multiple lesions but these criteria for injection cannot be met, they may be considered for the intravenous arm
Confirmed diagnosis of metastatic intrahepatic carcinoma; the histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for cancer or elevated tumor markers such as AFP
Confirmed diagnosis of intrahepatic carcinoma; the histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for cancer or elevated tumor markers such as alpha fetoprotein (AFP)
Patients must have a histologically confirmed diagnosis of a malignancy known to be H reactive; H expression must be confirmed by immunohistochemical staining of tumor and assessed by the Department of Pathology or by immunofluorescence of bone marrow except for patients confirmed to have neuroblastoma or an embryonal tumor (such as medulloblastoma, retinoblastoma, rhabdomyosarcoma and desmoplastic small round cell tumor [DSRCT])
Patients must have central nervous system (CNS)/ leptomeningeal disease which is refractory to conventional therapies or for which no conventional therapy exists OR recurrent brain tumors with a predilection for leptomeningeal dissemination (primitive neuroectodermal tumor [PNET], rhabdoid tumor)
Must be willing to release tumor biopsy specimen used for diagnosis of metastatic NSCLC (if available) for additional exploratory tumor molecular profiling.
Malignancy (solid tumor or lymphoma) that is currently not amenable to surgical intervention due to either medical contraindications or nonresectability of the tumor.
Apparent tumor invasion into organs located adjacent to the esophageal disease site (eg, aorta or respiratory tract) at an increased risk of fistula in the study treatment assessed by investigator
Patients with M stage according to the Tumor, Node and Metastasis Classification of Malignant Tumours (TNM)
Metastatic tumor that has been biopsied
Sufficient tumor available to determine if expresses a mutation in KIT
The targeted tumor(s) is (are) less than  points more painful compared to other non-targeted painful lesions on the site specific NRS.
Enough tumor material must be available for central confirmation of diagnosis, otherwise a new tumor biopsy is mandated.
The maximum tumor diameters for each Cohort for both Arm A and Arm B should achieve a dose of approximately x viral particles (vp)/cm of tumor volume. (see Table ). Please refer to Table for calculating tumor volume.
Staining for PD-L in less than half of the tumor cells using the C antibody (% staining is acceptable).
Tumor intended for immunotherapy manufacture is not embedded in bone and does not contain luminal tissue (e.g. bowel, ureter, bile duct).
History of other previous or concurrent cancer that would interfere with the determination of safety or efficacy assessment of RXDX- with respect to the qualifying solid tumor malignancy.
Tumor with androgen receptor (AR) expressed >=  copies/ug ribonucleic acid (RNA)
Patient has a tumor sample from C. novyi-NT planned injected tumor lesion (newly obtained biopsy) for PD-L and immunologic response assessments; patients must submit the tumor sample during screening at a central pathology laboratory
PRE-REGISTRATION: Patients older than  years must have a solid tumor considered by study doctor to be of the childhood cancer type.
Patients with non-bulky/non-bulky squamous cell carcinomas of the head and neck, with an indication for surgical therapy\r\n* TN-NB, T-N-Nb stage are generally eligible\r\n* If determined per tumor board that a low-volume/non-bulky tumor of another stage is appropriate for resection (e.g. small volume T with a small amount of bone invasion) such tumors may also be considered for this study if recommendation in tumor board is such
Tumor expressing PRAME and/or COLA.
Histopathologic documentation any metastatic gastrointestinal tumor
T tumor
Surgery is done prior to IMT if needed for palliation, tumor debulking, pathological documentation of tumor recurrence; the patients may continue on study therapy even if they do not have measurable disease
Severe increased intracranial pressure, status epilepticus, or other serious complications from the brain tumor, requiring emergency or urgent intervention
The presence of diffuse leptomeningeal disease will be an exclusion criterion for this study; this is secondary to the inadequacy of measuring the extent of the tumor burden within this setting and the very poor prognosis of these patients
Patients with bulky tumor on imaging are ineligible; bulky tumor is defined as:\r\n* Tumor with any evidence of uncal herniation or midline shift\r\n* Tumor that in the opinion of the site investigator, shows significant mass effect\r\n** Treating physicians are encouraged to contact the study chair to request a rapid central imaging review to confirm fulfilment of these eligibility criteria, if they have concerns
Documented RAS-mutated tumor without activating PIKCA mutations or PTEN mutation (loss of PTEN or silencing)
All patients treated at doses >  mg per day must have medullary thyroid cancer (MTC), or a RET-altered solid tumor per local assessment of tumor tissue and/or blood.
Diagnosis during dose expansion (Part ) - All patients in Groups ,  and  must have a RET-altered (excluding synonymous and nonsense mutations) solid tumor, as determined by local testing of tumor or circulating tumor nucleic acid in blood; as detailed below.
The primary tumor must be excised via breast conserving surgery (lumpectomy) with negative margins (no ink on tumor) in the final specimen
Phase  only: Infants from birth and older at CD with a locally advanced or metastatic infantile fibrosarcoma, patients with locally advanced infantile fibrosarcoma who would require, in the opinion of the Investigator, disfiguring surgery or limb amputation to achieve a complete surgical resection or birth through  years of age at CD with a locally advanced or metastatic solid tumor or primary CNS tumor that has relapsed, progressed or was nonresponsive to available therapies and for which no standard or available systemic curative therapy exists with a documented NTRK gene fusion (or in the case of infantile fibrosarcoma, congenital medoblastic nephroma or secretory breast cancer with documented ETV rearrangement by FISH or RT-PCR or a documented NTRK fusion by NGS) (identified through molecular assays as routinely performed at CLIA or other similarly-certified laboratories) or (including Expansion Phase) potential patients older than  years of age with a tumor diagnosis with histology typical of a pediatric patient and an NTRK fusion may be considered for enrollment following discussion between the local site Investigator and the Sponsor's Medical Monitor. Patients with NTRK-fusion positive benign tumors are also eligible.
Diagnosis of adenocarcinoma of the rectum with the major portion of the tumor intact; Note: prior to randomization, the investigator must specify and document each of the following: \r\n* Distance of the lowest tumor margin from the anal verge; and \r\n* Intent for sphincter sparing or non-sphincter sparing surgical resection according to the primary surgeon; and\r\n* The majority of the untreated tumor must be <  cm from the anal verge or below the peritoneal reflection as determined by the treating surgeon
Subjects with histologically confirmed CNS embryonal tumor (primitive neuroectodermal tumor [PNET], medulloblastoma, atypical teratoid rhabdoid tumor [ATRT], medulloepithelioma, pineoblastoma or ependymoblastoma), or germ cell tumor, are eligible; tumors must be relapsed or refractory to first-line therapy; diagnosis will be made on the basis of computed tomography (CT)-assisted or stereotactic biopsy, open biopsy, surgical resection, cerebrospinal fluid (CSF) cytology, or elevated tumor markers
The subject has an infra-tentorial tumor or multifocal disease
Patients must have at least  of the following high-risk pathologic features: extracapsular nodal extension or invasive cancer at the primary tumor resection margin (tumor on ink)
Patients with mature teratoma or completely resected immature teratoma with normal tumor markers are not eligible
Any tumor-specific or clinical features that make surgical intervention unsafe in the opinion of the treating neurosurgeon
Willing to consent to allow access to known archival tumor tissue (NOTE: designated pathologist from participating site OR lead principal investigator must sign-off to ensure sufficient tumor should be available for support of tumor imaging studies [multi-color immunofluorescence])
The tumor must be primarily supratentorial in location as determined by diagnostic imaging performed preoperatively
Extremely radiosensitive tumor (lymphoma, leukemia)
Radiographic evidence of contrast-enhancing tumor crossing midline, leptomeningeal dissemination, gliomatosis cerebri or infratentorial tumor
Patients with acute leukemia will be excluded because they will likely have a much greater circulating tumor burden, which would increase the risk of infusion of clonal tumor cells
Patients with newly diagnosed, biopsy confirmed, extracranial, non-metastatic Ewing sarcoma or primitive neuroectodermal tumor (PNET) of bone or soft tissue are eligible for this study; note:\r\n* For the purpose of this study, chest wall tumors with ipsilateral pleural effusions, ipsilateral positive pleural fluid cytology or ipsilateral pleural based secondary tumor nodules will be considered localized disease\r\n* Patients with regional node involvement, based on clinical suspicion confirmed by pathologic documentation are considered to be non-metastatic\r\n* Patients with discontinuous osseous lesions within the same bone are considered to be non-metastatic\r\n* Tumors arising in the bony skull (extra-dural) are considered to be extracranial
The tumor location must be suitable for either lobar or sublobar resection (wedge or segment)
Supratentorial primitive neuroectodermal tumor (PNET) (any M-stage) will be eligible for study entry
Brain tumor patient is planning to undergo tumor resection or biopsy for the purpose of differentiating between tumor progression versus treatment-induced effects following radiation therapy and/or chemotherapy\r\n* If a patient has magnetic resonance imaging (MRI) findings consistent with tumor but does not already have a histopathologic diagnosis of cancer, s/he may sign the consent form, but final eligibility for study enrollment will be determined based on results of the frozen section at time of surgery
Extracapsular tumor extension
Patients must be untreated with curative-intent surgery for current diagnosis of stage III, IVa, or IVb disease; diagnostic biopsy of primary tumor and/or nodal sites is permitted\r\n* Diagnostic simple tonsillectomy is permitted, provided patient has Response Evaluation Criteria in Solid Tumors (RECIST)-measurable nodal disease\r\n* Patients with a second HNSCC primary tumor are eligible for this study, provided more than  years have elapsed since the first diagnosis of HNSCC, the original tumor was managed with surgery only (no adjuvant chemotherapy or radiotherapy), and has not recurred
Imaging studies show evidence of recurrent, supratentorial tumor(s); the presence of infratentorial tumor is allowed as long as the patient also has supratentorial disease that is amenable to resection or biopsy
The patient must be in need of a craniotomy for tumor resection or a stereotactic brain biopsy for the purpose of diagnosis or differentiating between tumor progression versus treatment-induced effects following radiation therapy +/- chemotherapy
Based on the neurosurgeon's judgement, there is no anticipated physical connection between the post-resection tumor cavity and the cerebral ventricles
Submission of tumor samples is required for all patients; the local pathology department policy regarding release of tumor samples must be considered in the screening process; patients whose tumor samples are located in a pathology department that by policy will not submit any samples for research purposes should not be approached for participation in the B- trial
Positive staining of tumor tissue with antibodies to  or more of the following: human melanoma black (HMB)  for gp, or cancer-testis antigen (NY-ESO-)
Patients must have a paraffin embedded tumor specimen from the kidney or metastatic site available for central review of tumor histology; tumor samples will be shipped as specified
Rhabdoid tumor:
NI-negative tumor:
Patients must have stage cT-Ta N M disease; clinical T stage is based on the transurethral resection of bladder tumor (TURBT) sample and imaging studies; patients must undergo cystoscopy and TURBT as part of the staging procedure within  days prior to registration; to exclude non-bulky/low-risk tumors and ensure adequate tissue for assessment, subjects must have documented muscle invasion with at least one of the following:\r\n* Disease measuring at least  mm on cross-sectional imaging or by endoscopic assessment; bladder thickening on imaging without definable tumor is not adequate; pathology verification of >= . cm of viable tumor (longest diameter) from the biopsy sample and represented on the submitted slides is also acceptable\r\n* The presence of tumor-associated hydronephrosis
Patient must agree to undergo central tumor HRD testing
At least one tumor that can be measured on a radiographic scan
Patient is after surgical resection of the tumor where tumor was removed completely, with the final surgical specimen microscopic margins free from tumor and with available archival tumor tissue from the surgical specimen
Patients must agree to undergo tumor HRD testing and blood gBRCAmut status testing.
KRAS or NRAS mutation detected in tumor specimen
Tumor replacement <% of total liver volume
Has an adequate tumor sample
Five grams of resected tumor available for vaccine manufacture as determined by institutional pathologist; seven grams of tumor is preferred
All subjects must consent to provide archived tumor specimen
Locally advanced, relapsed, and/or metastatic cancer with low or minimal tumor burden which may or may not be measurable; no tumor size criteria are used.
Per the operative and/or pathology report, positive margin(s) (defined as tumor present at the cut or inked edge of the tumor), nodal extracapsular extension, and/or gross residual disease after surgery; note: patients whose tumors had focally positive margins in the main specimen but negative margins from re-excised samples in the region of the positive margin are eligible; for questions or ambiguities about an individual case, contact Dr. Machtay and/or Dr. Holsinger prior to enrolling the patient
Willing to submit an evaluable tumor tissue sample, preferably from a liver metastasis, unless tumor is considered inaccessible or biopsy is otherwise considered not in the subject's best interest
Date of Mayo Clinic Genomics Tumor Board review =<  months prior to registration
Tumor involves a weight-bearing long bone of the lower extremity with the tumor causing > % loss of cortical bone
Solid tumor contact with SMA > 
Tumor MGMT promoter hypermethylation determined by central testing at MD Anderson
Histologic diagnosis of a benign or borderline tumor (tumor of low malignant potential) or of a malignant tumor of non-epithelial origin (such as a germ cell tumor, sex-cord stromal tumor) of the ovary, fallopian tube or peritoneum
Patients with primary tumor of oral cavity, nasopharynx, sinuses or salivary glands.
Tumor replacement > % of total liver volume based on visual estimation by investigator OR tumor replacement >% of total liver volume in the presence of albumin < mg/dL
Patients with placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT)
Tumor sites that can be accessed for repeat biopsies
Tumor amenable to cryoablation as determined by radiologist
Tumor of the oropharynx
Tumor
Participation in Iowa Neuroendocrine Tumor Registry
Evidence of remaining tumor
Submission of copies of tumor measurements and scans
Patients must be able to enter into the study within ten weeks of their most recent diagnostic procedure, which is usually a diagnostic biopsy, a transurethral resection of bladder tumor (TURBT) procedure or positive urine cytology.
Patients with a history of obstructive jaundice due to the primary tumor must have a metal biliary stent in place
Bilirubin =< . x the institutional normal upper limit unless secondary to bile duct obstruction by tumor
Participants with multifocal tumors (more than one tumor confined to the same quadrant as the primary tumor) are eligible provided all discrete lesions are sampled and centrally confirmed as HER positive
Negative histologic margins of partial mastectomy or re-excision specimen; margins generally are positive if there is invasive or noninvasive tumor at the inked resection margin, close but negative if the tumor is within  mm of the inked margin and negative if the tumor is at least  mm away from the inked edge
Up to two () cancerous lesions may be identified in the prostate; each tumor is not more than  mm in maximal linear dimension; each tumor should comply with the maximal  Gleason score requirement.
Subjects with distance of the less than mm margin between the tumor and the prostate capsule
Patients must have an adequately functioning bladder as judged by the participating urologist and radiation oncologist and have undergone a re-staging TURBT by the participating urologist that showed (or was present in the outside pathology specimen) a high grade stage Ta or T tumor with uninvolved muscularis propria in the specimen and, if on prostatic urethral biopsy mucosal carcinoma is present, there is no evidence on biopsy in the prostatic stroma of tumor invasion
Evidence of tumor-related hydronephrosis
At the time of study enrollment, the patients treatment regimen must be identified; if the patients primary tumor was resected prior to the day of enrollment and a blood specimen for the determination of serum alpha fetoprotein was not obtained prior to that surgery, the patient will be considered to have alpha fetoprotein of greater than  ng/mL for the purpose of treatment assignment; if tumor samples obtained prior to the date of enrollment were not sufficient to determine whether small cell undifferentiated (SCU) histology was present, treatment assignment will be made assuming SCU is not present in the tumor
RAS (KRAS and NRAS) wild-type in primary or metastatic tumor tissue
METex skipping alterations, as determined by the central laboratory (plasma and/or tumor biopsy sample)
Patients with active tumor lysis syndrome (TLS) either from laboratory or clinical changes
For patients with recurrent tumor, the patient had at least a -month cystoscopically-confirmed tumor-free interval between the last tumor recurrence and screening cystoscopic examination.
Inability to undergo two sequential EUS-directed core biopsies of the primary tumor (for Immune Response Cohort only)
Centrally confirmed TM mutation positive tumor status from a tumor sample taken after confirmation of disease progression on the most recent anticancer treatment regimen
Documented survivin-positive tumor status
Patients who have had repeat craniotomy for tumor therapy after receiving RT and TMZ treatment
The final margins of the resected specimen must be histologically free of tumor
All tumor removed by either a modified radical mastectomy or a segmental mastectomy (lumpectomy)\r\n* NOTE: management of axillary lymph nodes is up to the treating provider; however, all surgical margins should be clear of invasive cancer or DCIS (i.e., no tumor on ink); the local pathologist must document negative margins of resection in the pathology report; if all other margins are clear, a positive posterior (deep) margin is permitted, provided the surgeon documents that the excision was performed down to the pectoral fascia and all tumor has been removed; likewise, if all other margins are clear, a positive anterior (superficial; abutting skin) margin is permitted provided the surgeon documents that all tumor has been removed
ELIGIBILITY FOR ENROLLMENT/SCREENING (ARMS  AND ): Patients must be able to provide blood and tumor samples and undergo the procedures required for this protocol
RAS wild-type tumor; Note: evidence of EGFR expression in the tumor is not required
Low risk for tumor lysis syndrome (TLS)
Tumor enhancement involving both hemispheres
Prior surgical therapy other than incisional or excisional biopsy and organ-sparing procedures such as debulking of airway-compromising tumors or neck dissection in a patient with an unknown primary tumor; residual tumor is required for enrollment on study
Histological confirmation of node positive (any T stage N-) proximal esophageal, distal esophagus or gastroesophageal (GE) junction adenocarcinoma (Siewert I, II, or III) after completing preoperative chemoradiation and surgery; supporting pathology report sufficient for registration; available tumor tissue from endoscopic biopsies prior to preoperative chemotherapy (chemo)/radiation therapy (RT), and tumor from surgical specimens will be submitted to Academic and Community Cancer Research United (ACCRU), but not be required prior registration; Note: if tissue is depleted, patient will still be eligible after discussion with the physician
Agreement to provide  tumor biopsies
Tumor location or involvement that would result in risk of ventricular penetration during tumor injection
Patients who have received or been treated with an tumor necrosis factor-alpha inhibitor such as adalimumab (Humira) within four weeks of starting on study
AT THE TIME OF INFUSION: EBV positive tumor
Archived neuroendocrine tumor sample or biopsy sample (will also be used for genetic testing).
The cancer can be biopsied (depending on the tumor type and/or the dose of drug received, tumor biopsies may be required)
Must have an FFPE tumor block with tumor cellularity of % or greater. NOTE: Prior to randomization, the tumor cellularity will be confirmed by central pathology review and percent values will be double checked at Paradigm (a Next Generation Sequencing Company).
Consent to preservation of frozen and fixed samples of tumor cores for evaluation
Metastatic disease that involves major airways or blood vessels, or centrally located mediastinal tumor masses
Has a locally determined non microsatellite instability high/ proficient mismatch repair (non-MSI-H/pMMR) tumor status
KIT-mutant tumor, including melanoma or gastrointestinal stromal tumor (GIST), for which there is no standard systemic therapy, or
Tumor is confirmed to be one of the following:\r\n* MSI-high, or\r\n* MMR-deficient, or\r\n* Hypermutated defined as >=  somatic mutations in the tumor by MSK-IMPACT
Patients with elevated liver function tests including jaundiced patients (due to tumor) can be selectively operated on without resolution of jaundice preoperatively according to the judgment of the operating surgeon
Tumor replacement > % of total liver volume based on visual estimation by the investigator OR tumor replacement > % of total liver volume in the presence of albumin <  mg/dL
Patients must have radiographically or clinically evaluable tumor
All tumor should be removed by either a modified radical mastectomy or a segmental mastectomy (lumpectomy), with either a sentinel node biopsy or axillary dissection\r\n* All margins should be clear of invasive cancer or DCIS (i.e. no tumor on ink); the local pathologist must document negative margins of resection in the pathology report; if all other margins are clear, a positive posterior (deep) margin is permitted, provided the surgeon documents that the excision was performed down to the pectoral fascia and all tumor has been removed; likewise, if all other margins are clear, a positive anterior (superficial; abutting skin) margin is permitted provided the surgeon documents that all tumor has been removed; radiation therapy to the conserved breast is required
The patient must be discussed at GI Tumor Board, NCI and suitability for the interventional procedure (TACE or RFA) re-affirmed
Patients must have a K-RAS wild-type (WT) tumor
Subjects must have a target VS with the following qualities:\r\n* Not amenable to surgery due to patient refusal, high risk for surgical complications (e.g., damage to lower cranial nerve function, tumor size >  cm in longest diameter, or multilobulated tumor appearance on MRI scan)\r\n* Associated with a word recognition score of < % and > %\r\n* Documented clinical progression defined as EITHER:\r\n** Progressive hearing loss (defined as a decline in word recognition score below the % critical difference interval from baseline score related to VS (i.e., not due to prior interventions such as surgery or radiation) OR\r\n** Progressive tumor growth in the preceding  months, defined as >= % increase in volume
Tumor of the patient is pwt
Patients must have either () a diagnosis of NB as defined by international criteria, i.e., histopathology (confirmed by the Memorial Sloan Kettering Cancer Center [MSKCC] Department of Pathology) or bone marrow (BM) metastases plus high urine catecholamine levels, or () a tumor that is GD-positive\r\n* A non-NB tumor is defined as GD-positive by immunostaining with monoclonal antibody F (mF); if fresh or frozen tumor is not available for immunostaining, patients will be considered eligible if published reports show that > % of that tumor type is GD-positive by immunohistochemistry; (note: tissues must be fresh/frozen as fixed, paraffin-embedded specimens are unsuitable for anti-GD immunostaining); tumors known to be GD-positive by this criteria do not need immunostaining; these include: melanoma (> %), desmoplastic small round cell tumors (%), osteosarcoma (%) and soft tissue sarcomas including liposarcoma, fibrosarcoma, malignant fibrous histiocytoma, leiomyosarcoma, and spindle cell sarcoma (%)
Tumor assayed for k-ras and other tumor genomic mutations
Patients with a history of obstructive jaundice due to the primary tumor must have a metal biliary stent in place (or a percutaneous biliary drain)
Tumor/vertebral body anatomy precluding fiducial placement
Histologic confirmation of prostatic adenocarcinoma by Memorial Sloan Kettering Cancer Center (MSKCC) inclusive of the following:\r\n*  or more positive biopsy cores or equivalent tumor specimen as confirmed by pathologist\r\n* At least  cores containing >=  mm of tissue with carcinoma or equivalent tumor specimen as confirmed by pathologist\r\n* A primary tumor Gleason score >= \r\n* Adequate primary biopsy tissue or equivalent tumor specimen as confirmed by pathologist available for protocol required analysis (i.e., bladder or transurethral resection of the prostate [TURP] specimen)
Evidence of laboratory tumor lysis syndrome (TLS) by Cairo-Bishop definition of tumor lysis syndrome; subjects may be enrolled upon correction of electrolyte abnormalities
Tumor is well visualized through x-ray mammography or ultrasound imaging and amenable to image guidance therapy (a tumor which is well visualized through imaging can be identified from surrounding breast tissue and does not have margins
Subjects with mammographic appearance of overall dense parenchymal tissue may be included, as long as a clearly evident marker is present at tumor site
Diagnosis of DIPG by MRI imaging defined as tumor that has a pontine epicenter and is diffuse (tumor that involves the majority [> %] of the brainstem) on T or fluid-attenuated inversion-recovery (FLAIR) imaging rather than focal; histologic confirmation is not required
Tumor must not invade the corpus callosum
Tumor must not invade the brainstem
All standard tumor-staging procedures necessary to define baseline extracranial disease status completed =<  days prior to pre-registration
Evidence of brainstem/cord/cauda or other neuromuscular or neurosensory malfunction from causes other than effects of local tumor growth or metabolic effects of tumor
Tumor must express Retinoblastoma (Rb) protein, as defined as any measureable staining by immunohistochemistry
The tumor must be supratentorial in location
Final surgical margins negative defined as no tumor on ink; lobular carcinoma in situ involving the final surgical margin will be disregarded
Confirmed RAS/RAF wild type tumor; paraffin-embedded tumor tissue obtained from the primary tumor or metastasis
High Tumor Mutation Burden
Oropharyngeal sites of tumor include tonsil, soft palate, base of tongue, lateral and posterior pharyngeal wall; laryngeal sites of tumor include the supraglottic, glottis and subglottic larynx; nasopharyngeal sites include the posterior nasopharyngeal wall, right and left fossa of Rosenmuller; the hypopharyngeal sites of tumor include the post-cricoid area, posterior pharyngeal wall and the pyriform sinuses
There must be documentation of evaluable tumor within four weeks of beginning therapy
Patients must have paraffin-embedded tumor specimen available for submission for pathological review and determination of p/q deletion status\r\n* NOTE: it is recommended that patients not be pre-registered until the required tumor specimens are on hand and ready for submission; if submission of tissue will be submitted more than  working days after pre-registration, immediately notify the Mayo Clinic Cytogenetics Laboratory via email
MGMT promoter methylation analysis of surgically resected tumor or tumor biopsy must demonstrate an unmethylated or hypomethylated MGMT promoter status
If there is brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size <  cm^) and the patient otherwise meets criteria for enrollment on the low-risk arm, the patient will be classified as low-risk
Amputation of the affected leg as treatment of tumor
Subjects must have evidence of recurrent or metastatic carcinoma by one or more of the following:\r\n* The appearance of metastatic disease on chest x-ray or computed tomography (CT) scan\r\n* The appearance of rising tumor marker: AFP or beta-human chorionic gonadotropin (HCG)\r\nNOTE: if a rising tumor marker is the only evidence of progressive disease, at least  consecutive rising values at least one week apart are needed; subjects with only evidence of disease as rising tumor marker AFP and beta-HCG will be assessed for alternate causes of increased serum levels of these markers, such as cross reaction with luteinizing hormone (LH) (can be tested if needed by testosterone suppression of LH), hepatitis, use of marijuana, or second primary tumor
Has ability to submit archived or fresh tumor sample during the screening period
FDG avid malignancy\r\n* Patients must have an FDG avid tumor(s)\r\n* FDG avid tumors are defined as a primary tumor with an increased uptake in the region of the tumor that has an SUV of > . or a tumor:liver SUV ratio of > .
Prior treatment with panitumumab for subjects with KRAS and NRAS wt tumor
The cancer can be biopsied (depending on the tumor type and/or the dose of drug received, tumor biopsies may be required)
Any treatment for the bladder tumor other than intravesical therapy between the pre-study cystoscopy or radiologic imaging which identified the suspected bladder tumor and the scheduled surgical removal or cystoscopy-guided biopsy of that tumor
The primary tumor must be in a location amendable to RFA within the kidney
There are no limitations based on location of the primary tumor within the kidney
Assessment by the attending thoracic surgeon that the primary tumor is resectable in pts with NSCLC and pleural spread; tumor will be deemed resectable if there is no extension through fascia, no bony chest or vertebral body involvement, and no radiographic evidence of mediastinal involvement
Location and extension of the tumor precludes an effective I-PDT
Radiographic evidence of contrast-enhancing tumor crossing midline, leptomeningeal dissemination, gliomatosis cerebri or infratentorial tumor
Clinical stage I-III invasive breast cancer with the intent to treat with surgical resection of the primary tumor; tumor must be >=  cm to provide adequate tissue
Tumor volume ? % of liver volume (determined by visual estimation)
Histologically confirmed diagnosis of glioblastoma (after initial tumor resection or biopsy) with radiographic evidence of recurrent tumor per RANO criteria.
Subjects must have at least one tumor lesion that is suitable for repeat biopsy, and must agree to two tumor biopsies (pre- and post- treatment).
Patients with a tumor involving a weight-bearing long bone of the lower extremity with the tumor causing > % loss of cortical bone
Tumor located in the supra-tentorial region of the brain
Unicentric tumor
Negative surgical margins, defined as no margin-labeling ink on tumor cells from margin evaluation
Patients with =<  cc largest tumor volume, and =<  cc total tumor volume
Tumor biopsy specimen with ? % of MUC expressing tumor cells determined by Immunohistochemistry (IHC) staining on fixed pathological material. Biopsy may come either from the primary tumor or from a metastasis. Cytological material is not accepted for this analysis
Androgen receptor expression testing confirms that the patients tumor is AR (+); AR is considered positive if >= % of cell nuclei are immunoreactive using the Dako antibody (clone androgen receptor antibody [AR]); receptor testing may be performed on either primary tumor specimen or tissue from a metastatic site; local testing permitted for eligibility but will require confirmation at Memorial Sloan-Kettering Cancer Center (MSKCC)
Part  (surgical) patients only: patients must be undergoing surgery that is clinically indicated as determined by their care providers; patients must be eligible for surgical resection according to the following criteria:\r\n* Expectation that the surgeon is able to resect at least  mg of tumor from enhancing tumor and at least  mg from non-enhancing tumor with low risk of inducing neurological injury
Histopathologic confirmation of the following tumor types (please refer to protocol for full details pertaining to eligible tumor types):
Availability of a tumor sample taken after progression on the most recent line of systemic tumor therapy or willing to undergo a tumor biopsy pre-study treatment.
Sarcoma or Wilms tumor diagnosis (Group C) will require evaluation by physician in the St. Jude Solid Tumor Division, other than the referring physician, attesting that autologous stem cell transplant (SCT) provides the prospect of direct benefit for the participant
Subjects with a neuroendocrine tumor of the pancreas, an acinar tumor of the pancreas or a pancreatic tumor with mixed histologies.
Well-differentiated liposarcoma or atypical lipomatous tumor
Gastrointestinal stromal tumor (GIST)
Solitary fibrous tumor
PEComa (perivascular epithelial cell tumor)
Myoepithelioma / mixed tumor
The tumor must be deemed as being borderline resectable; final computed tomography (CT) confirmation of surgical staging/eligibility will be at the discretion of the pancreatic surgeon of the patient
At least one tumor that can be measured
Metastatic disease that involve major airways or blood vessels, or centrally located mediastinal tumor masses (<  millimeter from the carina) of large volume
NET tumor other than PNET or GI-NET
Patient agrees to having a blood sample (approximately  mL) drawn and analyzed to compare their normal genetic profile to that of their tumor sample
Is willing to provide pre-existing diagnostic or resected tumor samples, such as paraffin-embedded sections. Providing a fresh tumor biopsy sample is optional.
Infra-tentorial tumor
Subjects must provide tumor biopsies before treatment
Calculated required PV- dose ?  mL (based on total tumor burden)
Direct tumor extension into aorta or pulmonary artery
Histologically confirmed all-rat sarcoma viral oncogene homolog (RAS) wild type; paraffin-embedded tumor tissue obtained from the primary tumor or metastasis
A tumor sample must be shipped to a central lab for identification of biomarkers (PIK activation status) before randomization
Neurosurgical patient population in the City of Hope brain and spinal tumor neurosurgical programs that have been diagnosed with a brain tumor
iDOS will be attempted for all quantities, consenting, and brain tumor patients; we anticipate approximately  initial patients will need to be imaged before signal to noise parameters are optimized; then  patient from the most common operative tumor types (e.g. low grade glioma, glioblastoma multiforme, astrocytoma, invasive meningioma, metastatic breast carcinoma, etc.) will be imaged to ascertain gross intrinsic optical spectroscopically differences that may distinguish these tumors from each other and normal white matter, gray matter, and blood vessels
Patients with stage IV renal cancer\r\n* Patients in the initial cohort receiving CT- alone are not required to have tumor resection as a part of protocol participation\r\n* Patients in the second cohort are eligible if they are undergo therapeutic debulking nephrectomy for independent clinical indications OR patients with other sites of accessible disease as defined by peripheral lung nodules approachable by thoracoscopy, malignant effusions, or cutaneous, subcutaneous or superficial lymph node involvement; patients should have an independent diagnostic or therapeutic indication for this purpose; tumor tissue should be at least . cm in longest dimension to provide an adequate source of tumor cells for vaccine generation
Tumor that lacks both estrogen and progesterone receptors
Have at least one BCC tumor (greater than mm in diameter) at any skin location, which needs to be biopsied and surgically removed
Tumor thickness must be clinically indicated for hyperthermia therapy, as measured by clinical exam or imaging studies (CT or MRI). The target local tumor lesion(s) must be able to be covered within two hyperthermia fields of treatment.
The participant must have a tumor measurable according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, measurable by elevated tumor markers (eg, -hour urine -HIAA, chromogranin A, adrenocorticotropin hormone (ACTH), gastrin, or other tumor specific biochemical markers), or both
Disruption of the lung pleura by tumor.
May not receive other investigational anti-tumor agents within  days prior to study entry or during active participation in the study (defined as from AdV-tk injection until tumor progression).
Other tumor histologies\r\n * Patients with tumor histologies not listed above will be considered on a case by case basis; to be eligible for this study, such patients must have an expected probability of survival =< % with other therapeutic modalities and must minimal disease criteria as defined in eligibility criteria
Primary tumor deemed unresectable by hepatobiliary surgeon
Patient is after surgical resection of the tumor where tumor was removed completely with surgical specimen microscopic margins free from tumor and with available archival tumor tissue from the surgical specimen
All patients must consent to provide archival tumor samples; non-availability of evaluable tumor samples does not exclude patient from the study
Tumor thickness is  mm or less (in the judgment of the physician)
Histologic diagnosis of a well- to moderately differentiated PNET (low-intermediate grade); NOTE: pathology report should state one of the following: low-grade, intermediate grade, moderately- or well-differentiated NET, pancreatic NET (or neuroendocrine carcinoma of the pancreas); patients who have tumors with a Ki of  % -  % are eligible if the pathologist determines the tumor has the appearance of a well- to moderately differentiated neuroendocrine tumor
Radiographic evidence of cavitary or necrotic tumor and local invasion of major blood vessels
The targeted tumor is less than  points more painful compared to other painful lesions on the site specific NRS.
Solid tumor survivors with no evidence of disease
Enrollment within  weeks of tumor board review
Biopsy-proven tumor invasion of the tracheobronchial tree or presence of tracheoesophageal fistula; recurrent laryngeal or phrenic nerve paralysis
Infra-tentorial tumor.
Any tumor grade
Any patient with a past medical history for a chronic disease (such as sickle cell disease), cancer (solid tumor, lymphoma, brain tumor) and have a current diagnosis which includes pain for which they are being treated, or currently undergoing bone marrow transplant  currently admitted to the hospital
Biopsy-proven neuroendocrine tumor with tumor burden dominant in the liver
Posterior fossa tumor/approach for tumor resection requiring the prone position
Patients with stable metastatic disease which is defined as (metastatic tumor demonstrates no increase in volume, tumor size or diameter and no evidence of new lesions, have been identified during last assessment by medical oncologist/radiologist or surgeons)
Individuals with progressive metastatic disease in which the tumor has increased in size, volume and diameter or evidence of new lesions, as noted by medical oncologists, radiologists and surgeons
Subjects must have or have had at initial diagnosis, histologic proof of their malignancy; additionally they must have radiographic, nuclear image, or biopsy proof that they have had a recurrence of their disease within four weeks prior to study entry; subjects must have failed or relapsed from standard first-line chemotherapy for their tumor; young children with primary embryonal brain tumor treated according to Head Start protocol are eligible as well; subjects with bone marrow involvement are NOT eligible for study
A personal history of cancer, tumor, or a related illness
In Arm , subjects must have residual visible tumor following TURBT. In Arm , subjects must be fully resected (i.e., no visible tumor or as little tumor as possible) after restaging TURBT - weeks prior to Study Day .
Metastatic disease that involves major airways or blood vessels, or centrally located mediastinal tumor masses of large volume. HCC participants (Arm A and F) with vascular invasion of the portal or hepatic veins may be enrolled
Tumor with known or expected RAS/RAF/MEK/ERK pathway involvement. Diagnosis must be one of the following tumor types: Central nervous system gliomas, including high- and low-grade gliomas, and diffuse intrinsic pontine glioma (DIPG) Embryonal rhabdomyosarcoma and other non-rhabdomyosarcoma soft tissue sarcomas Neuroblastoma Melanoma Malignant peripheral nerve sheath tumor Rhabdoid tumors, including atypical teratoid/rhabdoid tumor (ATRT) NF-associated tumor (including plexiform neurofibroma), schwannoma, or RASopathy-associated tumor that in the judgment of the investigator is life threatening, results in severe symptoms (including severe pain), or is in close proximity to vital structures
Disease-related criteria for Part  and Part : ) Histologically or cytologically documented non-small cell lung cancer (NSCLC) - adenocarcinoma; ) Stage III b or IV disease; ) Tested for presence of echinoderm microtubule-associated protein-like  anaplastic lymphoma kinase (EML-ALK) rearrangement; ) Received at least  prior lines of Food and Drug Administration (FDA)-approved systemic therapy, of which one therapy has to be a platinum-containing regimen OR failed or completed a first-line platinum-containing regimen and refused a second-line regimen despite being informed about the different therapeutic options and their specific clinical benefit by the investigator; the content of this informed consent discussion including the therapeutic options reviewed by the investigator needs to be documented and the subject needs to sign a specific consent form; Disease-related criteria for Cohort B only: ) Mesothelin protein overexpression, defined by immunohistochemistry (IHC) as detection of the protein by greater than or equal (>=)  percent (%) of tumor cells on archived tumor material; ) Primary tumor or metastatic lesion(s) amenable to tumor core biopsies
Participants with non-evaluable or non-measurable cancer are eligible if they have a confirmed increase in tumor antigens >= x upper limit of normal (ULN).
Tumor bed is less than  mm from the skin surface
Patients with =<  cc largest tumor volume, and =<  cc total tumor volume
Tumor extends beyond kidney into major veins, perinephric tissues, or adrenal gland
Has tumor(s) of the lips, sinuses, salivary glands, nasopharynx, glottic larynx, subglottic larynx or unknown primary tumor
? cm of tumor-free lung parenchyma between target tumor and pleura or fissure.
Patients undergo recanalization procedure of tumor during bronchoscopy
Tumor of the lips, larynx, hypopharynx, nasopharynx, sinuses, salivary glands or unknown primary tumor
Tumor involves a weight-bearing long bone of the lower extremity with the tumor causing > % loss of cortical bone
Has undergone prior ablation treatment of the index tumor
Surgery at the tumor site or surgery involving the cryoablation-treated tumor (index tumor)
Pre-enrollment tumor survey: Prior to enrollment on this study, a determination of mandatory disease staging must be performed:
Primary tumor sample was collected before NACT began and was evaluated for genomic testing (integral biomarker)
Patients must be eligible for surgical resection according to the following criteria:\r\n* Part  Patients: Expectation that the surgeon is able to resect at least  mg of tumor from enhancing tumor and at least  mg from non-enhancing tumor with low risk of inducing neurological injury\r\n* Part  Patients: Expectation that the surgeon is able to resect at least  mg from enhancing tumor and at least  mg from non-enhancing tumor with low risk of inducing neurological injury
In the event that a tumor is in contact with the capsule, the length of the contact should be ?  mm, on axial images.
Tumor distance, including tumor free margins, should not be more than mm from the rectal wall.
Subject's tumor(s) must meet AJCC Tumor Classification: Tis, T or T (<  cm), N, M
Eligible patients in the dose escalation phases of the trial must agree to biopsies of normal skin, unless they undergo optional tumor biopsies; the mandatory biopsy requirement can be waived at the discretion of principal investigator in the event of any medical contraindication (e.g. lidocaine allergy); patients enrolled to the expanded cohorts must agree to tumor sampling; patients on anticoagulation must be able to hold warfarin or low molecular weight heparin for a sufficient amount of time to make skin and tumor biopsies safe to perform; PT/INR and PTT should be =< . times the institutional upper limit of normal prior to performance of skin or tumor biopsies, with values re-checked after the eligibility screen as medically indicated
Patients must have proven positive tumor sample for NY-ESO- as follows:
Histologic diagnosis of solid malignancy (excluding brain tumors and lymphoma) that meets at least one of the following criteria:\r\n* Refractory, defined as tumor progression after initiation of standard first line therapy without having achieved a prior partial or complete remission OR biopsy proven residual disease at the completion of planned standard initial front-line therapy\r\n* Recurrent, defined as tumor progression after achieving a prior partial or complete remission\r\n* Newly diagnosed high risk disease, defined as having an expected event free survival of < % at  years\r\n* Lacks definitive diagnosis or classical genomic findings after histologic review and standard molecular testing (rare tumor group)\r\n** Examples include (eligibility not limited to these examples): \r\n*** Histology typically associated with a fusion in which fusion is not detected \r\n*** Ewing-like sarcoma \r\n*** Undifferentiated sarcoma\r\n*** Inflammatory myofibroblastic tumor without ALK fusion\r\n*** Infantile fibrosarcoma without NTRK fusion
Pre-operative spirometry that suggests the patient cannot undergo resection of the primary tumor by segmentectomy, lobectomy, bilobectomy, or pneumonectomy
Liver tumor ablation judged to be appropriate based on clinical assessment in the Brigham and Womens Hospital (BWH) Tumor Ablation Clinic by the tumor ablation interventional radiologist, per standard clinical practice
(Part , intracranial tumor patients ONLY): Radiographical or pathological evidence of an intracranial tumor
(Part , intracranial tumor patients ONLY): Other chemotherapy (besides what is being used to treat the intracranial tumor)
Subjects not deemed to be appropriate candidates for optimal resection of tumor based on location, involvement of eloquent brain, satellite lesions, or other factors not specifically listed here
Tumor(s) must be located near air cavities
Participation in the Iowa Neuroendocrine Tumor Registry
A patient who has not received systemic or loco-regional treatment of the tumor within the last month.
Patient is referred for Y SIRT radioembolization of liver tumor(s)
No known endobronchial tumor
Inoperable tumor/nodule
Metastatic or primary malignant tumor involving spinal column, with or without extension into the epidural space
Intradural extension of the tumor
Histopathologic or imaging and clinical features of tumor(s) diagnostic for hepatocellular carcinoma with at least one tumor >= . cm; imaging features diagnostic for hepatocellular carcinoma will be defined as Liver Imaging Reporting and Data System (LI-RADS)  or greater
Tumor amenable to transcatheter arterial embolization
Histologically diagnosed or suspected (pediatric only) neuroendocrine tumor or other tumor with probable somatostatin receptors subtype 
At least part of the tumor must be visible as observed in a diagnostic or planning CT
GROUPS , , AND : Must be consented for the Oregon Pancreatic Tumor Registry (OPTR)
Pathologically confirmed, locally advanced, malignancy of the rectum; based on multi-disciplinary tumor board discussion, patients are candidates for tri-modality treatment
Pathologically confirmed, locally advanced, malignancy of the esophagus; the cancer may involve the stomach up to  cm; based on multi-disciplinary tumor board discussion, patients are candidates for tri-modality treatment
Biopsy proven neuroendocrine tumor, neuroblastoma, medulloblastoma, or other somatostatin receptor positive tumor
Known or suspected somatostatin receptor positive tumor such as carcinoid; neuroendocrine tumor; neuroblastoma; pheochromocytoma; supporting evidence may include MRI, CT, biochemical markers, and or pathology report
The tumor will be evaluated by both mammography and ultrasound
MAGE-A/A positive tumor
Histologically proven: neuroblastoma, rhabdomyosarcoma, osteosarcoma, Ewing's sarcoma/ primitive neuroectodermal tumor, Wilms tumor, desmoplastic small round cell tumor or malignant solid tumors of any other histology that test positive for B-H .
Documentation of IDH or IDH mutation in any tumor specimen
Known or suspected somatostatin receptor positive tumor such as carcinoid; neuroendocrine tumor; neuroblastoma; medulloblastoma; pheochromocytoma; supporting evidence may include magnetic resonance imaging (MRI), CT, biochemical markers, and/or pathology report
Subjects not deemed to be appropriate candidates for optimal resection of tumor based on location, involvement of eloquent brain, satellite lesions, or other factors not specifically listed here
ERUS tumor state of T
. Patients with bladder cancer in follow-up for tumor recurrence (Note: Patients must be\n             included only at the first surveillance cystoscopy after a histologically confirmed\n             tumor. The histologically confirmed tumor could either be from a TURB or from a\n             surveillance cystoscopy where a biopsy was taken and a tumor was confirmed by\n             histology)\n\n          . History of one or more of the following:\n\n               -  Multiple tumors\n\n               -  Recurrent tumors\n\n               -  High grade tumor(s)\n\n        Exclusion Criteria:\n\n          . Gross haematuria. (Note: Gross haematuria is defined as a heavy bladder bleed\n             resulting in significant amounts of blood in the urine, which may visually limit\n             cystoscopy. Where the haematuria is light, the patient should not be excluded, if in\n             the investigator's opinion, rinsing and/or electro-cautery during cystoscopy will\n             alleviate the haematuria limitations to cystoscopy)\n\n          . Patients who cannot undergo in-office or operating room cystoscopy (Note: Training\n             patients are eligible even if they cannot undergo operating room cystoscopy)\n\n          . Patients who have received Bacillus Calmette-Gurin (BCG) immunotherapy or\n             intravesical chemotherapy within the past  weeks prior to the procedure\n\n          . Porphyria\n\n          . Known allergy to hexaminolevulinate hydrochloride or a similar compound\n\n          . Pregnancy or breast-feeding (all women of child-bearing potential must document a\n             negative urine pregnancy test before study inclusion and use adequate contraception\n             during the study\n\n          . Participation in other clinical studies with investigational drugs either concurrently\n             or within the last  days\n\n          . Patient is the investigator or any sub investigator, research assistant, pharmacist,\n             study coordinator, other staff or relative thereof directly involved in the conduct of\n             the protocol\n\n          . Patients that the investigator believes are unlikely to comply with the protocol, e.g.\n             mental condition rendering the patient unable to understand the nature, scope, and\n             possible consequences of participating in the clinical study, uncooperative attitude\n             or unlikelihood of completing the study
Fresh frozen tumor, and/or paraffin block of biopsy or resected tumor is recommended, but not required to determine expression of somatostatin receptors in tumor by immunohistochemistry and/or quantitative polymerase chain reaction (qPCR)
Known diagnosis of neuroendocrine tumor (NET) or suspected somatostatin receptor (SSTR) positive tumors
There are any other past medical, physiological or demographic concerns; this includes any patients with skin blemishes that are present at the dermis over the tumor, as these are of particular interest for use of this technique
Tumor sample shipped to Agendia with ? % tumor cells or that fails Quality Assurance or Quality Control criteria.
A tumor that is known to have a v-Ki-ras Kirsten rat sarcoma viral oncogene homolog (K-ras) mutation
Invasive malignant solid tumor of thoracic origin (e.g., lung, esophageal, thymus, mesothelioma, chest wall, mediastinum, trachea, pleura) with the intent to treat or biopsy by surgery as standard of care. Tumor must be >=  cm
Patients must have a potential germline mutation, as determined by the NCI-MATCH tumor profiling assay
Newly diagnosed breast tumor, female genital system tumor, colorectal tumor, and/or lymphoma/myeloma
Tumor treated with PDT within the last  months
Criteria , Metastatic liver lesions for injection must be without necrosis (dead tissue )and must be be located where any tumor swelling will not lead to gall bladder tract obstruction or lead to bleeding risk
Gastrointestinal stromal tumor (GIST).
Solid Tumor analyzed by Caris Molecular Intelligence Service Profile(s) and/or Caris\n             Next-Generation Sequencing
Subject at risk of airway compromise in the event of postinjection tumor swelling/inflammation based on investigator judgment.
Subject must consent to pretreatment and on treatment tumor biopsies
Tumor must harbor an IDH-RX mutation