FOLFIRI therapy is appropriate for the patient and is recommended by the Investigator.
Patient must consent to provision of a sample of blood in order that the specific correlative marker assays may be conducted.
Protocol treatment is to begin within  calendar days of patient randomization.
Patient has undergone total resection of the primary tumor with curative intent\r\n* NOTE: Patient is to be pre-registered to screening (Step ) and tissue submitted to Foundation Medicine as soon as possible after surgery in order to meet the  week deadline to register the patient to Step  after surgery; full assay minimum turn-around time is - days
Patient must have undergone extended surgical staging including mediastinoscopy or endobronchial ultrasound; at minimum, samples must be obtained from the mediastinal stations R,  (subcarinal), and L; this surgical staging must be performed within  days prior to step  registration; patient must be T- and N-N (single station)
Patient may have discontinued RT early due to toxicity or other reasons
If the patient is a primary English speaker, the patient must participate in the NCF and patient reported outcomes part of the study; if the patient is a primary French or Spanish speaker, the patient must participate in the patient reported outcomes part of the study
In emergency situations when a patient meets all other eligibility criteria and has had baseline required observations, but is too ill to undergo a biopsy safely, the patient may be enrolled without a biopsy\r\n* Clinical situations in which emergent treatment may be indicated include, but are not limited to, the following circumstances:\r\n** Anatomic or mechanical compromise of critical organ function by tumor (e.g., respiratory distress/failure, abdominal compartment syndrome, urinary obstruction, etc.)\r\n** Uncorrectable coagulopathy\r\n* For a patient to maintain eligibility for AHEP when emergent treatment is given, the following must occur:\r\n** The patient must have a clinical diagnosis of hepatoblastoma, including an elevated alphafetoprotein (AFP), and must meet all AHEP eligibility criteria at the time of emergent treatment\r\n** Patient must be enrolled on AHEP prior to initiating protocol therapy; a patient will be ineligible if any chemotherapy is administered prior to AHEP enrollment\r\n* Note: If the patient receives AHEP chemotherapy emergently PRIOR to undergoing a diagnostic biopsy, pathologic review of material obtained in the future during either biopsy or surgical resection must either confirm the diagnosis of hepatoblastoma or not reveal another pathological diagnosis to be included in the analysis of the study aims
Patient declines participation in NANT -, the NANT Biology Study
If cardiorespiratory abnormalities are identified, please refer the patient to his managing physician for further assessment and diagnosis.
RER is not a criteria of the test. This objective measure should only be used to assist practitioners with patient management and decision-making.
If sexually active female, patient must be/have one of the following:
If sexually active male, patient must:
Previous imatinib treatment should be permanently discontinued within  days prior randomisation and patient should have recovered from potential toxicity related to imatinib
Psychiatric condition making the patient unlikely to comply with protocol therapy, required tests and follow-up.
Prior history of temozolomide chemotherapy provided concurrent to external beam radiotherapy and after as per current standard of care; however, temozolomide would not be required to have been provided concomitantly or after radiation if the patient had unmethylated MGMT promoter or if the patient initially was diagnosed with a low grade glioma; at least  weeks must have passed from the last dose of temozolomide and first dose of cyclophosphamide and/or rQNestin.v.
Confirmation that the patients health insurance will pay for the treatment in this study (patients may still be responsible for some costs, such as co-pays and deductibles); if the patients insurance will not cover a specific treatment in this study and the patient still wants to participate, confirmation that the patient would be responsible for paying for any treatment received
Patient must sign informed consent form to indicate patient's understanding study's purpose and procedures and willingness to participate. Should patient be incapable of giving consent, the patient's legally authorized representative (as defined by local regulation) must give consent. However, should patient, in any manner, choose not to participate this takes precedence and will be respected.
Depending on the stage of the protocol, pathway activation based on p-S will need to be done in real time to assess if patient is eligible
Willingness and ability of participants to use the electronic device to report selected study outcomes; Caregivers and site staff can assist with patient diary input but patient must be able to independently comprehend and answer the questionnaires
Patient with irregular cycles (more than once a month)
Patient selected to undergo Whipple procedure or distal pancreatectomy
Any patient with an open oral ulceration(s) should avoid dosing with AZD oral suspension.
The patient is receiving digoxin, digitoxin, lanatoside C or any type of digitalis alkaloids.
Disease status: patients with malignancy are to be referred in remission for evaluation, except in cases of virus-associated malignancy who may be referred at any time; should a patient have progressive disease or a donor becomes unavailable after enrollment, the patient will be referred back to his/her primary hematologist-oncologist for treatment; if this course of action is not in the best interest of the patient according to the clinical judgment of the PI, then the patient may receive standard treatment for the malignant disease under the current study, although this should only occur as a bridge to transplant; if under either of these settings, it becomes apparent that the patient will not be able to proceed to transplant, then he/she must come off the study; patients receiving standard therapy will be told about the therapy, associated risks, potential benefits, alternatives to the proposed therapy, and the availability of receiving the same treatment elsewhere, outside of a research protocol
The patient should have received all established therapies where there is a clear, superior available regimen available for the patient and the patient should have demonstrated progressive disease on or since completion of the last treatment regimen
Patient with clinically positive nodal disease
Patients who have a history of another primary malignancy from which the patient has been disease free for <  years at the time of enrollment, with the exceptions of: a patient with a familial cancer syndrome-associated NETs including MEN, VHL, NF-, and thymidylate synthetase (TS)
The presence of any of the following criteria will exclude the patient from the study:
Patient is more than  months since the last dose of FOLFIRI
Patient must complete all required tests in section .
Women with post-surgical temporary breast expanders will require individual assessment. Depending on the manufacturing product and other treatment planning-specific details the patient may be eligible or may be deemed ineligible, as determined by treating investigator.
For Cohorts ,  and , contraindication to chemotherapy as first-line therapy due to patient age, comorbidity or patient preference
Patient's medical history does not contraindicate treatment with at least one of the following antibiotics: ampicillin, clindamycin and erythromycin/clarithromycin.
Patient re-enrollment: This study permits the re-enrollment of a patient that has discontinued the study as a screen failure (ie, patient has not been dosed/has not been treated); if re-enrolled, the patient must be re-consented and satisfy all eligibility criteria
The patient has a contra-indication for using a CPAP device.
The patient is uncooperative.
The patient has reduced consciousness.
The patient has sustained trauma or burns to the face.
Patient is actively being treated or intends to be treated with systemic chemotherapy during the duration of the trial.
Patient must have metal stent in place if duodenal stent is required. If patient has plastic stent, this must be replaced prior to radiation.
Patient has been previously permanently discontinued from study treatment in the parent protocol.
Patient's indication is commercially available and reimbursed in the local country.
Any other condition that would cause a risk to the patient if he/she participated in the trial.
Active genital infection at the time of enrollment (if present initially, can be treated and then patient can be re-evaluated for eligibility)
Patient agrees to have  week follow-up visit at a participating Johns Hopkins facility
Any underlying condition which prevents the patient from being able to undergo the required number of sessions of PDT or RT and required follow up
Patient has a history of interstitial cystitis
Patient has sufficient stored T cell product to manufacture appropriate doses of T-APCs
Patient has salivary gland primary
Prior treatment with everolimus is allowed, if the patient was able to tolerate  mg daily everolimus with acceptable side effects, and if everolimus was not given in combination with fosbretabulin; a  week washout period will be required if patient was previously on everolimus
Any reason, at the investigators discretion, that the participation of the patient in this protocol would not be in patients best interest, or where the patient would be unable to adhere to the study requirements
Systemic estrogens or androgens within  days before initiating therapy; vaginal estrogens are allowed if necessary for patient comfort
Systemic estrogens or androgens within  days before initiating therapy; vaginal estrogens are allowed if necessary for patient comfort
No known infection with HIV. Due to the mechanism of action of ipilimumab, activity and side effects in an immune compromised patient are unknown.
Patient is currently participating in an Immunocore-sponsored study of IMCgp and is actively receiving IMCgp. Patient must have fulfilled all required assessments in the parent study (unless the study is being terminated)
Patient has demonstrated compliance with the parent study requirements, as assessed by the principal investigator and patient is able to comply with the necessary visits and assessments as part of the rollover study
Patient has been permanently discontinued from any IMCgp study or from IMCgp treatment in the parent study due to unequivocal progressive disease, unacceptable toxicity, non-compliance to study procedures, withdrawal of consent, or any other reason
Patient must have a graded prognostic assessment (GPA) score . or greater
Patient must be a candidate for SBRT to at least one intrahepatic lesion; there is no limit on the number of intrahepatic lesions the patient may have
Patient on anti-retroviral medication (as these medications may alter patient metabolism)
Patient or legally appropriate proxy must be able to understand study instructions and sign consent
Any of the following because this study involves an agent where the genotoxic, mutagenic and teratogenic effects are unknown:\r\n* Pregnant or breastfeeding\r\n* Patient of childbearing potential who is unwilling to employ adequate contraception
Multidisciplinary evaluation of the patient must be performed with a consensus recommendation for reirradiation
Patient must be able to maintain a  second breath hold
Patient has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug
Patient has received intervening therapy for lymphoma after CTL infusion
This study permits the re-enrollment of a patient who has discontinued the study for a reason other than treatment failure or adverse event(s) of the study treatment; the patient must be re-consented and assigned a new subject number
Investigator does not believe study participation, for any reason, is in the best interest of the patient
Patient must be able to have gold fiducial markers placed in the prostate or, if patient already has fiducial markers placed, they must be in accordance with the protocol specifications
The patient is eligible for TSEBT
Have biopsiable disease; if biopsy is attempted and unsuccessful (the patient undergoes an invasive procedure), the patient may still be treated
Young patient age between    could be included in only  centers (Bordeaux, Lyon, Villejuif, Lille, Marseille and Paris)
Inclusion Criteria:\n\n        All Patients (Stages  and ):\n\n          . The patient is ? years old\n\n          . The patient has an Eastern Cooperative Oncology Group (ECOG) performance score of -\n\n          . The patient has adequate baseline organ function, including cardiac, renal, and\n             hepatic function:\n\n               -  Left ventricular ejection fraction (LVEF) ? institutional lower limit of normal\n                  as measured by multigated acquisition scan or -dimensional (-D) echocardiogram\n                  within  days prior to start of therapy and no clinically significant\n                  abnormalities on a -lead electrocardiogram (ECG)\n\n               -  Serum creatinine ?. mg/dL (or ? mol/L)\n\n               -  Serum albumin ?. g/dL (or ? g/L) in the absence of receipt of (IV) albumin\n                  within the previous  hours\n\n               -  Bilirubin ?. mg/dL (or ? mol/L)\n\n               -  Aspartate transaminase (AST) and alanine transaminase (ALT) ?. times the upper\n                  limit of normal (ULN)\n\n               -  CPK ?. times the ULN\n\n          . If a woman of child bearing potential, the patient has a negative serum or urine\n             pregnancy test within  week prior to SL- treatment (intervals shorter than  week\n             are acceptable, if required by institutional guidelines)\n\n          . The patient has signed informed consent prior to initiation of any study-specific\n             procedures or treatment\n\n          . The patient is able to adhere to the study visit schedule and other protocol\n             requirements, including follow-up for response assessments\n\n          . The patient agrees to use acceptable contraceptive methods for the duration of time in\n             the study, and to continue to use acceptable contraceptive methods for  months after\n             the last SL- infusion\n\n          . Patient has an absolute neutrophil count (ANC) ?.?/L\n\n        Additional Inclusion Criteria Specific to Patients with MF and CMML (Stages  and )\n\n        Exclusion Criteria:\n\n        All Patients (Stages  and ):\n\n          . Patient has persistent clinically significant toxicities Grade ? from previous\n             chemotherapy not readily controlled by supportive measures (excluding alopecia,\n             nausea, and fatigue)\n\n          . Patient has received treatment with chemotherapy, wide-field radiation, or biologic\n             therapy within  days of study entry\n\n          . Patient has received treatment with another investigational agent within  days of\n             study entry or concurrent treatment with another investigational agent.\n\n          . Patient has previously received treatment with SL- or has a known hypersensitivity\n             to any components of the drug product\n\n          . Patient has an active malignancy and/or cancer history (excluding myeloproliferative\n             disorders and concomitant myeloid malignancies as specified in the inclusion criteria)\n             that can confound the assessment of the study endpoints. Patients with a past cancer\n             history (within  years of entry) and/or ongoing active malignancy or substantial\n             potential for recurrence must be discussed with the Sponsor before study entry.\n             Patients with the following neoplastic diagnoses are eligible: non-melanoma skin\n             cancer, carcinoma in situ (including superficial bladder cancer), cervical\n             intraepithelial neoplasia, or organ-confined prostate cancer with no evidence of\n             progressive disease\n\n          . Patient has clinically significant cardiovascular disease (e.g., uncontrolled or any\n             New York Heart Association Class  or  congestive heart failure, uncontrolled angina,\n             history of myocardial infarction or stroke within  months of study entry,\n             uncontrolled hypertension or clinically significant arrhythmias not controlled by\n             medication)\n\n          . Patient has uncontrolled, clinically significant pulmonary disease (e.g., chronic\n             obstructive pulmonary disease, pulmonary hypertension) that, in the Investigator's\n             opinion, would put the patient at significant risk for pulmonary complications during\n             the study\n\n          . Patient has known active or suspected disease involvement of the central nervous\n             system (CNS). If suspected due to clinical findings, CNS disease should be ruled out\n             with relevant imaging and/or examination of cerebrospinal fluid\n\n          . Patient is receiving immunosuppressive therapy, with the exception of corticosteroids\n             as specified in the inclusion criteria and tacrolimus, for treatment or prophylaxis of\n             graft-versus-host disease (GVHD). If the patient has been on immunosuppressive\n             treatment or prophylaxis for GVHD, the treatment(s) must have been discontinued at\n             least  days prior to study drug and there must be no evidence of Grade ? GVHD\n\n         . Patient has uncontrolled intercurrent illness including, but not limited to,\n             uncontrolled infection, disseminated intravascular coagulation, or psychiatric illness\n             that would limit compliance with study requirements\n\n         . Patient is pregnant or breast feeding\n\n         . Patient has known human immunodeficiency virus (HIV)\n\n         . Patient has evidence of active or chronic Hepatitis B or Hepatitis C infection.\n\n         . Patient is oxygen-dependent\n\n         . Patient has any medical condition that in the Investigator's opinion place the patient\n             at an unacceptably high risk for toxicities\n\n        Additional Exclusion Criteria Specific to Patients with MF and CMML (Stages  and )
Willingness to take varenicline OR nicotine patch (patient choice)
Patient is mentally or legally incapacitated at the time of the study
Patient must have injectable disease (direct injection or ultrasound guided)
Patient may have a hepatitis C infection; however, each patient will require a hepatology consultation; the risk/benefit profile of transplant and hepatitis C will be discussed with the patient and eligibility determined by the PI or the LAI
Patient has completed participation in one of the ONC protocol, has not shown tumor progression while on study treatment, and has tolerated the study drug without unacceptable toxicities
Patient will have opted for SBRT among definitive treatment choices
Patient able and willing to complete the QoL, economics and other questionnaires. The baseline assessment must already have been completed within required timelines prior to randomization. Inability (illiteracy, loss of sight, or other equivalent reason) to complete the questionnaires will not make the patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible
Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate
Protocol treatment is to begin within  working days of patient randomization
Patient must be >  years
Infiltrative form of HCC on imaging; if there is at least one measurable lesion per modified RECIST (mRECIST) criteria and otherwise patient is eligible for the study, the patient can be enrolled
One of the following must be satisfied:\r\n* The patient is undergoing mobilization to collect and store for an autologous PBSC transplant in the future\r\n* The patient is eligible to undergo autologous PBSC transplantation on institutional protocols in the future
Patient not candidate for orthotopic liver transplantation at the Hospital of the University of Pennsylvania based on review of patient imaging and history at multidisciplinary Hepatic Tumor Conference at the Hospital of the University of Pennsylvania
The patient is a prisoner
The patient is allergic to naproxen or ibuprofen
Inclusion criteria at the time of Procurement:\n\n          -  Patient with malignant or nonmalignant diseases who are candidates for transplant.\n\n          -  Patients must have a CB unit (or units) matched with the patient at , , or / HLA\n             class I (serological) and II (molecular) antigens.\n\n        Inclusion criteria at the time of CTL infusion:\n\n          -  Recipients of at least one unmanipulated cord blood unit fractionated into  fractions\n             (i.e. from a HLA matched or mismatched unrelated donor) transplant at risk for or with\n             CMV/Adenoviral disease or reactivation.\n\n          -  Lansky/Karnofsky scores >\n\n          -  Absolute neutrophil count (ANC) greater than /ul.\n\n          -  No evidence of GVHD > Grade II at time of enrollment.\n\n          -  Life expectancy >  days\n\n          -  Absence of severe renal disease (Creatinine > x  normal for age)\n\n          -  Absence of severe hepatic disease. Direct bilirubin must be <  mg/dl and AST < x\n             upper limit of normal.\n\n          -  Patient must be at least  days post transplant to be eligible to receive CTL\n\n          -  Written informed consent and/or signed assent line from patient, parent or guardian.\n\n          -  Patient not on Fi of >%\n\n        Exclusion criteria at the time of Procurement\n\n          -  Pregnant or lactating\n\n          -  Patients with active central nervous system disease\n\n          -  Patients with Karnofsky performance status <%\n\n          -  Patients with grade  or  or primary myelofibrosis\n\n          -  Patients with suitable related donors\n\n        Exclusion criteria at the time of CTL infusion\n\n          -  Pregnant or lactating\n\n          -  Unable to wean steroids to ?. mg/kg/day prednisone.\n\n          -  Patients with other uncontrolled infections (except CMV and/or adenovirus and/or\n             EBVemia).\n\n          -  Patients with less than % donor chimerism in either peripheral blood or bone marrow\n             or patients with relapse of original disease.
Patient must be eligible for HD IL- treatment
RECIPIENT: Patients are to be referred in remission for evaluation; should a patient have progressive disease, or a donor becomes not available after enrollment, the patient will be referred back to their primary hematologist-oncologist for treatment; if this course of action is not in the best interest of the patient according to the clinical judgment of the principal investigator (PI)/lead associate investigator (LAI), then the patient may receive standard treatment for the malignant disease under the current study; if under either of these settings, it becomes apparent that the patient will not be able to proceed to transplant, then he/she must come off study; recipient-subjects receiving a standard therapy will be told about the therapy, associated risks, benefits alternatives of the proposed therapy, and availability of receiving the same treatment elsewhere, outside of a research protocol
Patient has demonstrated compliance, as assessed by the investigator, with the parent study requirements
Patient has been permanently discontinued from pasireotide study treatment in the parent study due to unacceptable toxicity, non-compliance to study procedures, withdrawal of consent or any other reason
Must be a patient to be treated with SBRT only at Johns Hopkins Hospital
Patient agrees that intravenous (IV) bisphosphonates will be withheld for the first  weeks of dasatinib therapy due to risk of hypocalcemia
Patient has any disease that will obscure toxicity or dangerously alter drug metabolism
Patient must live within  minutes of the treating physicians office during outpatient treatment
Any patient with hematologic or oncologic diagnosis in which allogeneic HSCT is thought to be beneficial, and in whom front-line therapy has already been applied; patients treated on this protocol will be without morphological evidence of disease, or if the patient has evidence of disease, the patient must have had at least a good partial response (PR) to the most recent therapy and the disease must be chemo-responsive
Patients with malignancy are to be referred in remission for evaluation, except in the case of viral associated malignancies; should a patient have progressive disease or a donor becomes unavailable after enrollment, the patient will be referred back to their primary hematologist-oncologist for treatment; if this course of action is not in the best interest of the patient according to the clinical judgment of the principal investigator (PI)/lead associate investigator (LAI), then the patient may receive standard treatment for the malignant disease under the current study; if under either of these settings, it becomes apparent that the patient will not be able to proceed to transplant, then he/she must come off study; recipient-subjects receiving a standard therapy will be told about the therapy, associated risks, benefits alternatives of the proposed therapy, and availability of receiving the same treatment elsewhere, outside of a research protocol
Completion of patient questionnaires
Presence of the t(;) (q;q) or bcr-abl fusion in the leukemic cells (if data are not known, patient still may be eligible)
Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate.
Protocol treatment is to begin within  working days of patient enrolment.
not completed treatment as defined in the base protocol for reasons that are not considered critical and unmanageable for the safety of the patient (as evaluated by the investigator and/or the sponsor) and the patient clearly showed response of PR or better.
Patient has anemia due to HbS or HbC disease, alpha or beta thalassaemia
Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.
Patient has been permanently and prematurely discontinued from ceritinib study treatment in the parent study due to any reason.
Patient has been permanently discontinued from everolimus study treatment in the parent study.
Patient is currently enrolled in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs study receiving imatinib and has fulfilled all their requirements in the parent study. .Patient is currently benefiting from the treatment with imatinib, as determined by the investigator. . Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.. Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures. . Written informed consent obtained prior to enrolling in roll-over study.
Patient has been permanently discontinued from imatinib treatment in the parent study due to unacceptable toxicity, non-compliance to study procedures, withdrawal of consent or any other reason.
Patient has participated in a Novartis sponsored combination trial where imatinib was dispensed in combination with another study medication and patient is still receiving combination therapy.
Inclusion Criteria:\n\n        -Patient is currently enrolled in a Novartis-sponsored, Oncology Clinical Development &\n        Medical Affairs study receiving nilotinib and has fulfilled all their requirements in the\n        parent study -Patient is currently benefiting from the treatment with nilotinib, as\n        determined by the investigator -Patient has demonstrated compliance, as assessed by the\n        investigator, with the parent study protocol requirements -Willingness and ability to\n        comply with scheduled visits, treatment plans and any other study procedures -Written\n        informed consent obtained prior to enrolling in roll-over study\n\n        Exclusion Criteria:\n\n        - Patient has been permanently discontinued from nilotinib treatment in the parent study\n        due to unacceptable toxicity, non-compliance to study procedures, withdrawal of consent or\n        any other reason - Patient has participated in a Novartis sponsored combination trial where\n        nilotinib was dispensed in combination with another study medication and patient is still\n        receiving combination therapy -Patients who are currently receiving treatment with any\n        medications that have the potential to prolong the QT interval or inducing Torsade de\n        Pointes and the treatment cannot be either safely discontinued at least one week prior to\n        nilotinib treatment or switched to a different medication prior to start of nilotinib\n        treatment and for the duration of the study -Pregnant or nursing (lactating) women, where\n        pregnancy is defined as the state of a female after conception and until the termination of\n        gestation, confirmed by a positive hcG laboratory test. -Women of child-bearing potential,\n        defined as all women physiologically capable of becoming pregnant, unless they are using\n        highly effective methods of contraception during the study and for  days after the final\n        dose of nilotinib.
Patient must consent to mandatory correlative sample collection
Patient refractory to dacarbazine defined as patient presenting a disease progression after  months of dacarbazine therapy.
Nave patient or patient previously treated with imatinib as neoadjuvant/adjuvant who relapsed after imatinib discontinuation
Patients who have completed the End of Treatment assessments in their originating study. Every effort should e made to conduct the End of Treatment visit such that the patient does not have any interruption in sorafenib dosing.
Inclusion Criteria:\n\n          -   Patient has a non-palpable breast lesion that requires excision\n\n               -  Lesion depth ?  cm from the skin surface in the supine position\n\n               -  Patient is scheduled for excision or BCT at a participating institution\n\n               -  Patient is between the ages of  and  years\n\n               -  Patient is female\n\n               -  Patient is willing and able to comply with all study procedures and be available\n                  to follow-up for the duration of the study\n\n               -  For lesions requiring multiple reflectors for localization, they must allow for\n                  reflectors to be placed ? cm from one another relative to the coronal plane\n                  Subject Exclusion Criteria\n\n        An individual who meets any of the following criteria will be excluded from participation\n        in this study:\n\n          -  Patient had a previous ipsilateral breast cancer\n\n          -  Patient has multicentric breast cancer\n\n          -  Patient has Stage IV breast cancer\n\n          -  Patient has been treated with neoadjuvant chemotherapy\n\n          -  Patient is pregnant or lactating\n\n        Exclusion Criteria:
Patient declines participation in NANT -, the NANT Biology Study
Patient must state willingness to undergo pre- and post-treatment biopsies. According to the investigators judgement, the planned biopsies should not expose the patient to substantially increased risk of complications
Patient is anticipated to continue for at least  days with an EGFR inhibitor or restart ?  days of registration and continue for at least  days
Patient must complete baseline quality of life (QOL) packet
Patient is able to stay within  minutes driving time of an emergency room for  days after dosing with C. novyi-NT
FOR PDX-GUIDED THERAPY THROUGH ONGOING TRIALS AT MD ANDERSON OR OFF-PROTOCOL WITH STANDARD OF CARE (PART ): The patient condition remains suitable for the selected therapy. If the patient receives prior therapy with a given agent (X) and progressed, but the testing in Part  found this agent to be effective in a combination, the patient remains eligible for this combination that includes agent X.
Patient had last menstrual period within the last  months or
Patient must have:
Patient must be able to swallow capsules and have no surgical or anatomic condition that will preclude the patient from swallowing and absorbing oral medications on an ongoing basis
If the patient is determined to be cirrhotic (based on criteria outlined earlier), the patient must have an ultrasound done within  months prior to enrollment with no evidence of hepatocellular carcinoma
Patient is allergic to -FC, leucovorin, or -FU
Patient must be tolerating oral intake
Patient agrees that intravenous (IV) bisphosphonates will be withheld during the first  weeks of dasatinib therapy due to risk of hypocalcemia
Patient agrees to stay within a reasonable distance (i.e.  minutes travel time) of the study site for the duration of the first treatment cycle through  hours after the last dose
Potential patients referred for the study may not be eligible for the experimental protocol therapy due to reasons such as uncertainty about donor HLA typing or need to control malignant disease, infection, or metabolic abnormality such as hypercalcemia on an emergent basis; should a referred patient present to us in such a scenario, the patient will be referred back to their primary hematologist-oncologist for treatment; however, if referral back to the referring physician is not in the best interest of the patient according to the clinical judgment of the PI, then the patient may receive standard treatment for the malignant disease or complicating conditions (infection, metabolic problems) under the current study; in other cases, a patient may have reasonable control of malignancy but does not meet the CD cell cut-off of  cells per microliter required for cohort  therapy (or, absolute lymphocyte count [ALC] value of < ); in such cases, standard care chemotherapy regimens may be administered for the specific goal of reducing the CD count (that is, immune depleting regimens such as the pentostatin plus cyclophosphamide combination, administered similar to the manner that we have developed on protocol -C-); if it becomes apparent that the patient will not be able to proceed to experimental therapy, then he/she must come off study; recipient-subjects receiving a standard therapy will be told about the therapy, associated risks, benefits alternatives of the proposed therapy, and availability of receiving the same treatment elsewhere, outside of a research protocol; because such standard care therapy is not experimental, it is not necessary to complete the eligibility criteria prior to receiving such standard care; however, prior to initiation of the experimental therapy, the patient must meet each of the eligibility criteria detailed above; attempts will be made to standardize such pre-transplant chemotherapy (by administration of EPOCH-FR chemotherapy); however, other regimens using approved agents will be allowed if such regimens are thought to be in the best interest of the patient
Patient has undergone more than  debulking surgeries
A morbidity (per the prescribing information) that would require starting a patient at a reduced dose of axitinib.
Operative report or other source documentation in the patient record
Patient must have undergone nephrectomy or partial nephrectomy to remove primary renal cell carcinoma (at any time in the past)
Patient has identified PIKCA status
Patient with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator's best judgment
Patient must be planning to undergo complete cytoreduction of all peritoneal disease
Before starting therapy the patient should be able to maintain adequate oral nutrition of >=  calories estimated caloric intake per day and be free of significant nausea and vomiting
If surgical margin status cannot be determined after consultation with the operating surgeon and the institutional pathologist, the patient will be ineligible
Patient has been permanently discontinued from ribociclib (LEE) in the parent protocol for any reason.
Patient meets all sub-protocol specific criteria of each applicable sub-protocol
Patient must be on a stable dose of octreotide (Sandostatin) long-acting release (LAR) or lanreotide for  months prior to study enrollment
Before enrolling a patient, the institution must verify the availability of an adequate supply of methotrexate for a full course of therapy
Known peripheral neuropathy > grade  (absence of deep tendon reflexes as the sole neurological abnormality does not render the patient ineligible)
Main inclusion criteria:\n\n          . Female patient, with histologically or cytologically confirmed advanced / metastatic\n             epithelial ovarian cancer either :\n\n               -  refractory to first line platinum treatment (defined as progressive disease while\n                  receiving or persistent disease after platinum-based therapy, according to GOG),\n                  or\n\n               -  candidate to third line treatment.\n\n          . Patient has recovered of all acute toxic side effects of prior therapy or surgical\n             procedures to grade ? National Cancer Institute-Common Toxicity Criteria (NCI-CTCAE\n             v.), except for the laboratory values\n\n          . Patient has at least one target lesion that can be measured in one dimension,\n             according to the Response Evaluation Criteria in Solid Tumors (RECIST)\n\n          . ECOG Performance status ? \n\n          . Patient with adequate organ function per laboratory tests evaluations\n\n          . Patient with life expectancy >  months\n\n          . Patient weight >  kg and BMI > \n\n          . Female patient ?  years\n\n          . Patient with nutritional risk index (NRI) ? ., i.e. with no or moderate\n             malnutrition;\n\n         . Female patient of childbearing potential (entering the study after a menstrual period\n             and who have a negative pregnancy test), who agrees to use two methods (one for the\n             patient and one for the partner) of medically acceptable forms of contraception during\n             the study and for  months after the last treatment intake.\n\n        Main exclusion criteria:\n\n          . Patient intolerant to gemcitabine\n\n          . Patient who has not recovered from any significant treatment toxicities prior to\n             baseline (?Grade )\n\n          . Patient presenting with serious cardiac disorders defined in the protocol\n\n          . Pregnant or nursing female patient\n\n          . Patient with active central nervous system (CNS) metastasis or with history of CNS\n             metastasis\n\n          . Patient treated for a cancer other than epithelial ovarian cancer within  years\n             before enrolment, with the exception of basal cell carcinoma or cervical cancer in\n             situ\n\n        WASH-OUT:\n\n          . Patient is at least  weeks from any major surgery (at baseline/W)\n\n          . Patient treated with any investigational agent within  weeks prior baseline\n\n          . Patient who had systemic chemotherapy within  weeks before baseline\n\n          . Patient who had radiotherapy within  weeks before baseline
Patient with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator's best judgment.
household contact with hepatitis B infected patient(s),
household contact of hepatitis C infected patient(s),
Patient that had TURP procedure before
Patient with baseline symptoms of incontinence defined as urine leak in any of the following circumstances: .. Before the patient can get to the toilet .. When coughing or sneezing .. While being asleep .. While being physically active/exercising .. After finishing urinating and being dressed .. Leaking for no obvious reason
Patient with baseline impotence scoring  or below in the IIEF- (SHIM) questionnaire
Patients must have a high grade urothelial carcinoma stage Ta or T that has recurred within  days after completion of the initial treatment (transurethral resection bladder tumor [TURBT] and intravesical bacillus Calmette-Guerin [BCG] immunotherapy) or on initial presentation with a T high grade tumor, the participating urologist judged BCG therapy is contraindicated or unsuitable because the patient is found to be intolerant of BCG therapy or because this patient may be immuno-compromised in ways other than that mentioned in severe, active co-morbidity or because the patient refuses BCG therapy
In emergency situations when a patient meets all other eligibility criteria and has had baseline required observations, but is too ill to undergo a biopsy safely, the patient may be enrolled on AHEP without a biopsy\r\n* Clinical situations in which such emergent treatment may be indicated include, but are not limited to, the following circumstances:\r\n** Anatomic or mechanical compromise of critical organ function by tumor (eg, respiratory distress/failure, abdominal compartment syndrome, urinary obstruction, etc)\r\n** Uncorrectable coagulopathy\r\n* For a patient to maintain eligibility for AHEP when emergent treatment is given, the following must occur:\r\n** The patient must have a clinical diagnosis of hepatoblastoma, including an elevated alpha fetoprotein, and must meet all AHEP eligibility criteria at the time of emergent treatment\r\n** Patient must be enrolled on AHEP prior to initiating protocol therapy; a patient will be ineligible if any chemotherapy is administered prior to AHEP enrollment\r\n** If the patient receives AHEP chemotherapy PRIOR to undergoing a diagnostic biopsy, pathologic review of material obtained in the future during either biopsy or surgical resection must either confirm the diagnosis of hepatoblastoma or not reveal another pathological diagnosis to be included in the analysis of the study aims
Patient who received DAC inhibitors
Patient has score of  or  on the neurotoxicity evaluation, as determined by the healthcare provider
Patient has or has ever had
Patient has a history of interstitial cystitis.
Pregnancy; patient attestation that they are not pregnant will be acceptable as per standard policy for MRIs at Dartmouth Hitchcock Medical Center (DHMC)
Standard chemotherapy/trastuzumab declined by patient OR patient is deemed by physician for any reason to not be a candidate for standard therapy (i.e. patient and/or provider choose not to pursue standard trastuzumab-based chemotherapy regimen because of concerns related to toxicity or patient preference)
Patient plans to receive treatment at MD Anderson
Patient is mentally or legally incapacitated at the time of the study
Patient has valvular heart disease that requires antibiotic prophylaxis for prevention of endocarditis
The presence of any of the following will exclude a patient from enrollment:
Patient has up to  local pulmonary metastases targetable by cryoablation.
Prior grade  hypersensitivity to cetuximab requiring discontinuation\r\n* An exception is for a patient who could subsequently receive cetuximab without a reaction.
Measurable disease is required unless patient is post-operative and in that case patient can have no evidence of disease
Patients who have liver function test (LFTs) (including total bilirubin, aspartate aminotransferase [AST] and alanine aminotransferase [ALT]) >= twice the upper limit of normal should be evaluated by a gastrointestinal (GI) physician unless there is a clear precipitating factor (such as an azole, methotrexate, Bactrim or another drug); if the GI physician considers that HCT on protocol  is contraindicated for that patient the patient will be excluded from the protocol; patients with Gilberts syndrome and no other known liver function abnormality and patients with reversible drug-related transaminitis do not necessarily require GI consultation and may be included on the protocol
Patient may not be receiving any other antineoplastic agents (hydroxyurea is allowed)
Patient must NOT have absorption issues that would limit the ability to absorb study agents
Patient is eligible for Low-Dose Cytarabine (LDAC) treatment.
Depending upon patient prior treatment the following apply:
Patient ever attempted to permanently discontinue imatinib or nilotinib treatment
Patient's disease must show extracapsular spread (ECS) in their nodal metastasis
Patient with known incompatibility to CT Scans with I.V. contrast due to allergic reaction or renal insufficiency. If such a patient can be imaged with MRI, then the patient would not be excluded.
Patient must be consented to the study prior to salvage assessment
If radiotherapy is required in a given patient, that patient should be withdrawn from the study
For patients with carcinoid tumors, patients must have progressed on, be currently receiving, or be intolerant to octreotide therapy; for patients with pancreatic neuroendocrine tumors, the prior or current use of octreotide or somatostatin analogues is permitted, but not required; if the patient is on octreotide, regardless of whether the patient has a carcinoid or pancreatic neuroendocrine tumor, the patient must be on a stable dose of somatostatin analogue for at least two months
Patient must be able to swallow capsules and has no surgical or anatomical condition that will preclude the patient from swallowing and absorbing oral medications on an ongoing basis
Patient has a history of listeriosis or prior ADXS- therapy
Patients must have unresectable disease as determined by the multidisciplinary evaluation or patient is not considered operable due to medical reasons
Patients on Coumadin therapy are eligible for study; there have been some reports of prolonged INR in this patient population and regular screening is recommend in this population, but this should not exclude a patient from participation
Platelets >= ,/mm^; this requirement may be waived if patient has hematologic relapse of disease or if patient has not yet recovered counts from chemotherapy
Patients with acute leukemia or myelodysplastic syndrome or chronic myelomonocytic leukemia must be in a hematologic remission, defined as < % blasts present in both blood and marrow to be referred for evaluation; should a patient have > % blasts or a donor not be available by the time the patient is ready for enrollment, the patient will be referred back to their primary hematologist-oncologist for treatment; patients with diseases other than acute leukemia including but not limited to Hodgkins and Non-Hodgkins lymphoma, CLL/SLL, natural killer T-cell lymphoma (NKTCL), peripheral T-cell lymphoma (PTCL), must have stable disease to their most recent regimen received within  weeks if chemo/radiotherapy or within  weeks after prior autologous stem cell transplantation; should a patient in either of these scenarios have progressive disease or a donor not be available after enrollment, the patient will be referred back to their primary hematologist-oncologist for treatment; if either of these scenarios are not in the best interest of the patient according to the clinical judgment of the PI, then the patient may receive standard treatment for the malignant disease under the current study; if under either of these settings, it becomes apparent that the patient will not be able to proceed to transplant, then he/she must come off study; recipient-subjects receiving a standard therapy will be told about the therapy, associated risks, benefits alternatives of the proposed therapy, and availability of receiving the same treatment elsewhere, outside of a research protocol
Patient declines participation in NANT -, the NANT Biology Study.
Any co-morbid condition or social situation, which has a high likelihood of causing poor compliance with the study protocol or jeopardizes the patient's safety.
Patient who underwent TCD boost without counts recovery and are considered for another TCD boost will be treated off protocol
Inclusion Criteria:\n\n        For patients with solid tumors:\n\n          -  documented cKit-positive neoplasms\n\n          -  Patient must have progressive disease as defined by any of the following:\n\n          -  SCLC: patient has progressed after at least  prior therapy\n\n          -  GIST : patient has relapsed or has refractory disease, and no further approved\n             effective therapeutic option exists\n\n          -  Patients with other cKit-positive solid tumors: patient has progressed after at least\n             one prior line of therapy and no further approved effective therapeutic option exists\n\n          -  Patient has measurable disease as per RECIST v. criteria\n\n        For patients with AML:\n\n          -  documented cKit-positive acute myelogenous leukemia\n\n          -  Consent to newly obtained bone marrow aspirate\n\n          -  Patient must have progressive disease defined as relapsed or refractory non-PML AML\n             following standard therapy or for whom no effective therapy exists.\n\n          -  Blast count < ,/mm\n\n        Exclusion Criteria:\n\n        For patients with solid tumors:\n\n          -  Patient has central nervous system (CNS) metastatic involvement unless the CNS\n             metastases have been previously treated and the patient is clinically stable and on a\n             stable dose of corticosteroids for at least  weeks prior to enrollment.\n\n          -  Patient has the presence of other clinically significant hematologic, cardiac,\n             respiratory, gastrointestinal, renal, hepatic or neurological conditions.\n\n          -  Patient has a history of serious allergic reactions, which in the opinion of the\n             investigator may pose an increased risk of serious infusion reactions\n\n          -  Patient has been previously treated with cKit directed antibodies\n\n          -  Pregnant or nursing women\n\n        For patients with AML:\n\n          -  Patient has received prior allogeneic bone marrow transplant (BMT).\n\n          -  Patient has the presence of other clinically significant cardiac, respiratory,\n             gastrointestinal, renal, hepatic or neurological disease\n\n          -  Patient has a history of serious allergic reactions, which in the opinion of the\n             investigator may pose an increased risk of serious infusion reactions\n\n          -  Patient has been previously treated with cKit directed antibodies\n\n          -  Pregnant or nursing women
Patient has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive chemotherapy and/or radiation therapy
Patient has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive chemotherapy and/or radiation therapy
Patient has:
Patient has:
Patient with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator's best judgment.
FOR PHASE I: If patient is on erlotinib at the time of signed consent, the patient does NOT need to be discontinued prior to initiation of erlotinib and onalespib; other EGFR-TKIs must be discontinued at least  days prior to initiation of erlotinib and onalespib
FOR PHASE II COHORT A: If patient is on erlotinib at the time of signed consent, erlotinib does NOT need to be discontinued prior to receiving treatment erlotinib and onalespib; last dose of erlotinib must be less than  days from when patient signs consent
Patient must have a palpable femoral/radial pulse in the affected extremity
Patient is able to stay within  minutes driving time of an emergency room for  days after doing.
Patient has received  cycles of DI-Leu-IL on Protocol AO-
Written patient assent (as appropriate).
Patient Re-enrollment: This study permits the re-enrollment of a patient that has discontinued the study as a screen failure (ie, patient has not been dosed/has not been treated). If re-enrolled, the patient must be re-consented.
Patient better served by concurrent chemoradiotherapy: the protocol recognizes that institutional standards regarding which patients are best served by operative and nonoperative approaches vary; therefore, consistent with the American College of Chest Physicians (ACCP) guidelines, the protocol recommends multidisciplinary discussion of each patient and enrollment only of patients felt best served by the approach described herein
Patient has no evidence of jaundice at the time of enrollment; if stent is required to alleviate jaundice, it should be metallic; if patient has a previously placed stent and this is plastic, this should be changed to metallic
Inclusion Criteria Include:\n\n          -  Patient has histologically- or cytologically- confirmed metastatic or advanced-stage\n             solid malignant tumor that is refractory to standard therapy and for whom no therapy\n             exists that would be curative or might provide significant benefit and therefore for\n             whom experimental therapy is a reasonable option.\n\n          -  Patient experienced progressive disease during or following or was intolerant of their\n             most recent treatment regimen.\n\n          -  Patient is male or female aged ? years.\n\n          -  Patient has an ECOG performance status of  (fully active, able to carry out all\n             pre-disease activities without restriction) or  (unable to perform physically\n             strenuous activity but ambulatory and able to carry out work of a light or sedentary\n             nature), as assessed on CD, before the first dose of TVB .\n\n          -  Patient has adequate renal function (creatinine ?. times the upper limit of normal\n             [ULN]) or a glomerular filtration rate (GFR) of ? mL/min.\n\n          -  Patient has adequate hepatic function,\n\n          -  Patient has adequate bone marrow function\n\n          -  Patient has no significant ischemic heart disease or myocardial infarction (MI) within\n              months before the first dose of TVB  and currently has adequate cardiac function\n\n        For the Monotherapy Expansion Cohorts of the Study ONLY:\n\n          -  Patient has a specific tumor-type and histology, as designated by the Sponsor based on\n             nonclinical and clinical data obtained prior to enrollment in the Expansion Cohort.\n\n          -  Patient has measurable disease, as determined by the Investigator using RECIST,\n             version . ().\n\n        For the Combination Cohorts ONLY:\n\n          -  In addition to meeting monotherapy criteria above, the commercially-available\n             anticancer agent of interest being investigated in combination with TVB-,\n             administered according to the dose regimen in the prescribing information, is deemed\n             appropriate for the patient's disease and clinical status.\n\n        Exclusion Criteria Include:\n\n          -  Patient is unable to swallow oral medications or has impairment of GI function or GI\n             disease that may significantly alter drug absorption\n\n          -  Patient has uncontrolled or severe intercurrent medical condition (including\n             uncontrolled brain metastases).\n\n          -  Patient underwent major surgery within  weeks before the first dose of TVB  or\n             received cancer-directed therapy or an investigational drug or device within  weeks\n             ( weeks for mitomycin C and nitrosoureas) or  half-lives of that agent (whichever is\n             shorter) before the first dose of TVB .\n\n          -  If female, patient is pregnant or breast-feeding.\n\n          -  Patient has evidence of a serious active infection\n\n          -  Patient has a history of other malignancy treated with curative intent within the\n             previous  years with the exception of adequately treated non-melanoma skin cancer or\n             carcinoma in situ of the cervix.
Part A only: For patient who has been treated with afatinib: last treatment at reduced dose below the assigned dose level
Patient must consent to provision of a sample of blood in order that the specific correlative marker assays may be conducted.
Protocol treatment is to begin within  working days of patient randomization.
Patient is contraindicated for endoscopic procedure for any reason
Patient presents with esophagorespiratory fistula
Any other factor identified by the Investigator that would disqualify the prospective patient from participation in the study including but not limited to coagulative disorders and anesthetic risk.
patient was currently benefiting from treatment with single agent oral dovitinib or dovitinib and fulvestrant coadministration as determined by the guidelines of the parent protocol and according to the investigator's clinical judgment.
patient had been permanently discontinued from oral dovitinib study treatment, either alone or in combination with fulvestrant, in the parent study
Patient has a GAD- mood scale score ? .
Patient declines participation in NANT -. (Neuroblastoma Biology Study)
Patient must consent to provision of samples of blood in order that the specific correlative marker assays described in the protocol may be conducted
Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements; each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate\r\n* A similar process must be followed for sites outside of Canada as per their respective cooperative groups procedures
In accordance with CCTG policy, protocol treatment is to begin within  weeks of patient randomization
Patient must agree to complete PROs (quality of life [QoL] questionnaire) throughout the study, including after study treatment discontinuation.
If any patient develops symptomatic diabetes requiring drug therapy, he must receive such a therapy, which may include metformin; this must be documented, and the patient will not continue on the study
Inclusion Criteria (must all be answered \Yes\):\n\n          -  Has the patient given written informed consent?\n\n          -  Is the patient between  years old and  years old inclusive?\n\n          -  Has the patient had histologically proven HGG with recurrence or progression following\n             initial definitive therapy(s) such as surgery with or without adjuvant radiation\n             therapy and/or chemotherapy (confirmed by diagnostic biopsy or contrast-enhanced MRI\n             and evaluable by Macdonald criteria)? Note if first recurrence of GBM is documented by\n             MRI, an interval of at least  weeks after the end of prior radiation therapy is\n             required unless there is either: i) histopathologic confirmation of recurrent tumor,\n             or ii) new enhancement on MRI outside of the radiotherapy treatment field.\n\n          -  Does the patient have a single, HGG tumor recurrence/progression that is ?  cm in its\n             greatest dimension?\n\n          -  Based on the pre-operative evaluation, is the tumor recurrence/progression a candidate\n             for ? % resection?\n\n          -  Has the patient elected not to undergo treatment with the Gliadel wafer?\n\n          -  Does the patient have a Karnofsky performance status ? ?\n\n          -  Does the patient have an absolute neutrophil count (ANC) ? /mm?\n\n          -  Does the patient have an absolute lymphocyte count ? /mm?\n\n          -  Does the patient have a platelet count ? ,/mm?\n\n          -  Does the patient have a Hgb ?  g/dL?\n\n          -  Does the patient have a normal PT/PTT? (subnormal PT/PTT acceptable)\n\n          -  Does the patient have an estimated glomerular filtration rate of at least  mL/min\n             (inclusive) by the Cockcroft-Gault formula?\n\n          -  Does the patient have an ALT <  times the upper limit of the laboratory reference\n             range and total bilirubin < . mg/dL?\n\n          -  If the patient is a female of childbearing potential, has she had a negative serum\n             pregnancy test within the past  days?\n\n          -  Is the patient willing to use condoms for contraception for  months after receiving\n             Toca  or until there is no evidence of the virus in his/her blood, whichever is\n             longer. If the patient is a fertile female, is she willing to use contraception for at\n             least  months?\n\n          -  Is the patient willing and able to abide by the protocol?\n\n        Exclusion Criteria (must all be answered \No\):\n\n          -  Has the patient received cytotoxic chemotherapy within the past  weeks ( weeks for\n             nitrosoureas) of the planned surgery date?\n\n          -  Does the patient have, or has the subject had, within the past  weeks any infection\n             requiring antibiotic, antifungal or antiviral therapy?\n\n          -  Has the patient had a surgical procedure in the last  days or a surgical wound that\n             is not healed?\n\n          -  Does the patient have any bleeding diathesis, or must the subject take any\n             anticoagulants, or antiplatelet agents, including NSAIDs that cannot be stopped for\n             surgery?\n\n          -  Does the patient have a history of allergy or intolerance to flucytosine?\n\n          -  Is the patient HIV positive?\n\n          -  Does the patient have any gastrointestinal disease that would prevent him or her from\n             being able to ingest or absorb flucytosine?\n\n          -  Has the patient received any investigational treatment within the past  days?\n\n          -  Is the patient breast feeding?\n\n          -  Has the patient received Avastin (bevacizumab) for this recurrence/progression, or\n             within the past  weeks?\n\n          -  Does the patient have a history of prior malignancy, excluding basal or squamous cell\n             carcinoma of the skin, with an expected survival of less than five years?
Fatigue which interferes with the patient's quality of life
The patient has received Fludarabine, Clofarabine or Cloretazine within  months preceding the ASCI treat-ment.
The patient has other concurrent severe medical prob-lems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
Patients with metastatic renal cell carcinoma referred for the study may not be eligible for the experimental protocol therapy due to reasons such as uncertainty about donor HLA typing or need to control malignant disease, infection, or metabolic abnormality such as hypercalcemia on an emergent basis; should a referred patient present to us in such a scenario, the patient will be referred back to their primary hematologist-oncologist for treatment; however, if referral back to the referring physician is not in the best interest of the patient according to the clinical judgment of the PI, then the patient may receive standard treatment for the malignant disease or complicating conditions (infection, metabolic problems) under the current study; if it becomes apparent that the patient will not be able to proceed to experimental therapy, then he/she must come off study; recipient-subjects receiving a standard therapy will be told about the therapy, associated risks, benefits alternatives of the proposed therapy, and availability of receiving the same treatment elsewhere, outside of a research protocol; it is not necessary to complete the eligibility criteria prior to receiving such standard care; however, prior to initiation of the experimental therapy (starting with the pentostatin-cyclophosphamide [PC] regimen), the patient must meet each of the eligibility criteria
The patient has other concurrent severe medical prob-lems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
No more than  days lapse in gefitinib treatment between the patient completing the preceding gefitinib clinical study and beginning of this study except when agreed by the AstraZeneca physician.
Hematology and biochemistry laboratory results within the limits normally expected for the patient population, without evidence of major organ failure
Patient must be without clinical evidence of loco-regional and distant disease, as evaluated according to institutional assessment standards and documented in the patient record
Written consent to biological material submission, indicating the patient has been informed of and agrees to tissue and blood material use, transfer and handling, must be signed and dated by the patient and the investigator prior to any procedures specific for this trial
The patient has been informed of and agrees to data transfer and handling, in accordance with national data protection guidelines
PATIENT: Lives in a state where their institutions PC clinicians are licensed to practice
Patient enrollment must occur within  calendar months following completion of CRT\r\n* Reminder: after patient enrollment, baseline testing followed by randomization must occur within - months after completion of CRT
Patient and partner are married or cohabitating and relationship duration >=  year
Patient with a history of a thrombotic event within  months of starting nintedanib treatment
Patient has constipation that was not primarily caused by opioids, as determined by the investigator
A treating clinician that feels the patient is inappropriate for the study
Patient lives with a partner (spouse/significant other  includes homo- and heterosexual couples)
PHASE I: Significant developmental delay per patient, parent, or physician report
Thrombocytopenia with untransfused platelet counts <  x ^/L in the out-patient or in the in-patient setting and one of the following criteria:
Patient receiving antiplatelet agents
Patient has had no clinically significant change in renal status within  months prior to screening, according to Investigator's review of clinical patient records.
Patient must not have a history of Raynauds disease
PATIENT: >=  years
Patient reports a score of >  on the Activities and Function item from the Patient Generated Subjective Global Assessment (PG-SGA; the patient-reported version of the Eastern Cooperative Oncology Group score)
Patient has bradyarrhythmia
Patient receiving active intravenous, intraperitoneal or oral chemotherapy
Patient at University of Michigan Gynecologic Oncology Clinic
DCG: Identifies himself/herself as a DCG for the patient
DCG: Lives >  hour travel time away from the patient
Patient reports pain, spasms, or urgency symptoms after stent placement, which are thought to be unrelated to other causes as per the patient or healthcare provider or both (documentation in the medical record is unnecessary)
History of patient reported PONV, chemotherapy-induced nausea and vomiting (CINV) or motion sickness
Patient must be able to ambulate and complete the  minute walk test without use of a walker, cane, or any assist devices
Any patient who is unable to comprehend and operate the activity tracker at the discretion of the enrolling provider
Patient is a prisoner or incarcerated
Participants will be recruited by BMT registered nurse (RN) coordinators and physicians prior to patient admission to the Pediatric BMT Unit; caregiver (age  years or older) of any patient eligible to undergo autologous or allogeneic BMT and any patient (age  years or older) eligible to undergo autologous or allogeneic BMT will be recruited during the Pre-Transplant Work-up stage in the outpatient setting
Patient who will be hospitalized to undergo first-time autologous or allogeneic BMT will be given the opportunity to assent/consent and participate in the study; with his/her permission, the patient will also be provided with their own iPad BMT Roadmap information system to use
Inability to complete or perform measures of patient-reported outcomes or neurocognitive testing on the computer
Lower extremity neuropathy per patient report attributable to oxaliplatin, docetaxel or paclitaxel (neurotoxic chemotherapeutic agent) as determined by patient history of neurotoxic agent administration and no history of other attributable causes such as diabetic neuropathy
PATIENT:
Necessity of awake procedure requiring intraoperative participation of patient due to the presence of the lesion in eloquent brain areas
Patients MUST also be ready to receive a cycle of chemotherapy that predictably renders neutropenia at least % of the time OR has a risk of febrile neutropenia of at least %; this can be any cycle number; it does NOT need to be the FIRST cycle of chemotherapy they are to receive; it is also OK if the patient will be getting granulocyte stimulation factor support; however, if the patient meets above criteria and the chemotherapy he/she will receive causes neutropenia % of the time or confers a risk of febrile neutropenia of at least %, but is not listed, please contact study Karen Moody, MD, overall study principal investigator, for clarification of eligibility
Patient should describe fatigue as being present for a minimum of four days
If patient agrees to participate in the optional patient reported outcomes portion of the study, patient must be English speaking and willing to complete the MD Anderson Symptom Inventory (MDASI) questionnaires
Planning to live with the patient for the duration of RT
Participants will be recruited by BMT register nurse (RN) coordinators and physicians prior to patient admission to the BMT Unit; caregiver of any patient eligible to undergo autologous or allogeneic BMT and any patient eligible to undergo autologous or allogeneic BMT will be recruited during the Pre-Transplant Work-up stage in the outpatient setting
Patient-assessed ability to walk unassisted
Able to provide informed consent or, if the oncology physician determines the patient to not have decision-making capacity, a patient-designated health care proxy (per institutional policies) must sign consent by the baseline visit
Treatment expected to last no longer than  months (patient)
Prior use of oxybutynin during the period in which patient has had hot flashes
Patient with known tracheobronchial anatomical anomalies
Patient requiring emergency operations
Patient requiring sizes not available in DLT or VDLT
The patient cannot receive text messages
CANCER PATIENT GROUP: Caucasian or African-American/Black
NON-CANCER PATIENT GROUP: Caucasian or African-American/Black
NON-CANCER PATIENT GROUP: Sedentary defined as <  minutes of recreation or work requiring modest PA/week
A relative or a friend, identified by the patient who either lives with the patient or has in-person contact with him or her at least twice per week
The patient must be less than   in height
The patient must feel comfortable in the prone position
Patient cannot comfortably be set up in the prone position (i.e. physical disability)
Patient has a Patient Generated Subjective Global Assessment (PG-SGA; the patient-reported version of the Eastern Cooperative Oncology Group score) > 
Patients spouse, adult child, sibling, parent, other relative, or significant other (defined by the patient as a partner)
Clear indication for antiplatelet agents (e.g., cardiac stents); a patient receiving aspirin for primary prevention prior to index stroke may be enrolled as long as study investigators believe it would be safe for the patient to stop aspirin if the patient was randomized to the enoxaparin arm
Relative or friend of patient participant who will likely accompany the patient to clinic visits
Prisoner or patient in custody
Patient on psychiatric hold
Insomnia present for >=  days per patient report
Patient must have adequate kidney function as measured by eGFR greater than or equal to  calculated from a standard care serum creatinine performed within  days prior to the PN; patient must be able to give written informed consent
Radiation oncology and medical oncology consults must deem patient suitable for protocol treatment
Pre-morbid condition that prevents patient from ambulating
Patient deprived of freedom, under supervision or guardianship
Patient must have a valid mailing address within the United States to receive study materials
Patient is expected to receive  weekly doses of vincristine as outlined by the Total XVI or as per TOTXVI protocol while on study drug (i.e. no known dosage reductions or planned missed doses)
Patient with poor bowel preparation
INHALATION: Patient has known respiration problems (i.e., emphysema)
MD Anderson patient
Patient elects to undergo active surveillance
Patient has taken finasteride or dutasteride during the prior  months
Patients <  years of age must be approved by the principal investigator and by a relevant patient review committee, such as the Fred Hutchinson Cancer Research Center (FHCRC) Patient Care Conference (PCC)
Patient has used a probiotic dietary supplement within the previous  days of enrollment; (consumption of yogurt products is allowed)
Patient is allergic to the third or fourth generation celphalosporins, carbapenem, or aminoglycosides which are used to empirically treat LBP bacteremia
Inclusion Criteria:\n\n        Diagnosis and Criteria for Inclusion:\n\n        All patients:\n\n        To be considered eligible to participate in this study, all of the following requirements\n        must be met:\n\n          . Patient, male or female, is at least  years of age.\n\n          . Patient has a diagnosis of advanced solid malignancy that has failed standard therapy\n             or for which standard therapy is not likely to provide meaningful benefit, or patient\n             has refused standard therapy.\n\n          . Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of  to .\n\n          . Patient is able to take oral medications.\n\n          . Female patient, if of childbearing potential, has a negative serum pregnancy test\n             within  hours prior to taking study drug and agrees to abstain from activities that\n             could result in pregnancy from enrollment through  days after the last dose of\n             study treatment, or be of non-childbearing potential. Non-childbearing potential is\n             defined as (by other than medical reasons):\n\n               -  ? years of age and has not had menses for >  year.\n\n               -  Amenorrheic for <  years without a hysterectomy Post hysterectomy, bilateral\n                  oophorectomy, or tubal ligation..\n\n             Note: Abstinence is acceptable if this is the established and preferred contraception\n             for the patient.\n\n          . Male patient agrees to use an adequate method of contraception starting with the first\n             dose of study treatment through  days after the last dose of study treatment..\n\n          . Patient is able to understand the study procedures and agrees to participate in the\n             study by providing written informed consent.\n\n        Patients with normal hepatic function (Group ):\n\n        Patients screened for the normal hepatic function group must meet the following additional\n        criteria to be eligible for enrollment:\n\n          . Patient has no history of hepatic impairment.\n\n          . Patient has liver function test (LFT) results within normal range:\n\n               -  Total bilirubin ? ULN\n\n               -  Aspartate aminotransferase (AST) ? ULN.\n\n               -  INR ?. X ULN unless the patient is receiving anticoagulant therapy and the INR\n                  is within therapeutic range of intended use of anticoagulants.\n\n          . Patient has adequate hematologic and renal function as defined below:\n\n               -  Absolute neutrophil count ?/L\n\n               -  Platelets ?,/L\n\n               -  Hemoglobin ? g/dL\n\n               -  Serum creatinine ?.  ULN or a calculated creatinine clearance ? mL/min using\n                  the Cockcroft-Gault equation.\n\n        Patients with moderate hepatic impairment (Group ):\n\n        Patients screened for the moderate hepatic impairment group must meet the following\n        additional criteria to be eligible for enrollment:\n\n          . Patient has stable, moderate hepatic impairment, defined as:\n\n               -  BILI: >.  to   ULN, for at least  weeks prior to Day \n\n               -  AST: Any value\n\n               -  INR less than . unless the patient is receiving anticoagulant therapy and the\n                  INR is within therapeutic range of intended use of anticoagulants.\n\n          . Patient has hematologic and renal function as defined below:\n\n               -  Absolute neutrophil count ?/L\n\n               -  Platelets ?,/L\n\n               -  Hemoglobin ? g/dL\n\n               -  Serum creatinine ?.  ULN or a calculated creatinine clearance ? mL/min using\n                  the Cockcroft-Gault equation.\n\n          . Patient's hepatic disease is deemed stable by the Investigator\n\n        Criteria for Exclusion:\n\n        Patients will not be eligible for study entry if any of the following criteria are met:\n\n        All patients:\n\n          . Patient has undergone palliative radiotherapy within  week of study drug\n             administration, encompassing >% of the bone marrow.\n\n          . Patient is starting chemotherapy within  weeks of study drug administration.\n\n          . Patient has a known hypersensitivity to the components of niraparib or excipients\n\n          . Patients who received colony-stimulating factors within  weeks prior to the first\n             dose of study treatment are not eligible.\n\n          . Patient has persistent chemotherapy associated Grade  or greater toxicity except for\n             neuropathy, alopecia or fatigue.\n\n          . Patient has symptomatic uncontrolled brain or leptomeningeal metastases.\n\n          . Patient has undergone major surgery within  weeks of starting the study or patient\n             has not recovered from any effects of any major surgery.\n\n          . Patient is considered a poor medical risk due to a serious, uncontrolled medical\n             disorder (other than hepatic impairment) or active, uncontrolled infection.\n\n          . Patient has received a transfusion (platelets or red blood cells) within  weeks of\n             receiving niraparib.\n\n         . Patient is pregnant, breastfeeding, or expecting to conceive children while receiving\n             study treatment or for  months after the last dose of study treatment.\n\n         . Patient has a known history of myelodysplastic syndrome (MDS) or acute myeloid\n             leukemia (AML).\n\n             NOTE: Exclusion Criteria - apply patients participating in the PK phase of the\n             study.\n\n         . Patient is currently receiving, or unable to refrain from taking from  days prior to\n             dosing until the time of the last PK blood draw, any of the following cytochrome (CYP)\n             A substrates: alosetron, duloxetine, melatonin, ramelteon, tacrine, tizanidine, and\n             theophylline.\n\n         . Patient is unable to refrain from any intake of grapefruit or grapefruit juice within\n              days of the first administration of niraparib until the final PK sample collection.\n\n         . Patient is currently receiving, or unable to refrain from taking from  days prior to\n             dosing until the last PK blood draw, any of the following P-glycoprotein (P-gp)\n             inhibitors: amiodarone, azithromycin, captopril, carvedilol, clarithromycin,\n             conivaptan, cyclosporine, diltiazem, dronedarone, erythromycin, felodipine,\n             itraconazole, ketoconazole, lopinavir and ritonavir, quercetin, quinidine, ranolazine,\n             ticagrelor and verapamil.\n\n         . Patient is taking proton pump inhibitors, antacids, or histamine  (H) blockers\n             within  hours prior to niraparib administration, and/or within  hours after\n             niraparib administration.\n\n         . Patient has esophagogastrointestinal disease or resection that is likely to interfere\n             with the absorption of niraparib.\n\n        Patients with moderate hepatic impairment (Group ):\n\n        Patients screened for the moderate hepatic impairment group who meet any of the following\n        additional criteria will be excluded from the study:\n\n          . Patient has hepatic encephalopathy, severe portal hypertension and/or porto-systemic\n             shunt.\n\n          . Patient has fluctuating or rapidly deteriorating hepatic function as determined by the\n             investigator within the screening period.\n\n          . Patient has acute liver disease caused by drug toxicity or by an infection.\n\n          . Patient has biliary obstruction or other causes of hepatic impairment not related to\n             parenchymal disorder and/or disease of the liver.\n\n          . Patient has esophageal variceal bleeding within the past  months.\n\n          . Patient is receiving anticoagulant therapy with warfarin or related coumarins.\n\n          . Patient has a history of hepatic transplant, systemic lupus erythematosus, or hepatic\n             coma.
Patient choosing PSDO or RRSO must desire permanent sterilization
Patients with recent/ongoing pneumonia (<  days from initial surgical patient evaluation)
HIV-positive patient at Thomas Street Health Center
The patient has diagnosed cancer of the cervix, vulva, or endometrium
The patient has an intermediate risk of malignancy (-% per the Mayo Model) and is in need of diagnosis for alternative treatment, OR The patient has a high probability of cancer (>%) and will be referred for surgical evaluation or stereotactic body radiation therapy (SBRT). Note: If the patient refuses surgery or if the surgeon requests a definitive diagnosis prior to surgery the patient will have the option to be included in this study,
Patient capable of making informed decisions regarding his/her treatment
Pregnancy or lactation. Future plans for pregnancy do not exclude patient participation. Patient should not become pregnant within one month of completion of F-DA PET scan
As per patient report or as confirmed by the medical record, if the patient is taking anti-depression or anti-anxiety medication, <  months on these medications or a change in the prescribed dose in the past  months
Patient agrees to participate in the clinical study and to complete all required visits and evaluations. The pediatric population has a different disease profile from the glioma patients we hope to recruit. To reduce heterogeneity in the patient population we will not consider patients younger than  for this study.
Patient may be of any race/ethnicity
Patient with metastatic disease (from primaries other than lung) who have suspicious mediastinal or hilar LN that require sampling
Acute respiratory failure with hypercapnia (unless the patient is intubated and ventilated)
Patient is being considered for SBRT
Patient must be seen at the St. Louis Childrens Hospital Neurofibromatosis (NF) Clinic
Patient must have histological or cytological confirmed breast cancer and fall into one of the following categories:\r\n* New diagnosis with plans for at least  months of neoadjuvant ET or any amount of neoadjuvant ET if surgery is planned as this will be used for response assessment \r\n* Patients with newly diagnosed metastatic breast cancer or patient with known metastatic disease who has progressed while on therapy (no washout period is needed if the patient was treated with aromatase inhibitors [AIs] or chemotherapy, but  months washout period is needed if the patient was treated with tamoxifen) who are going to be treated with ET
CHILD: If applicable, willingness of the patient to shave axillary (armpit) hair
History of cardiovascular disease that may adversely affect patient participation at the discretion of the primary investigator
Any patient with tachycardia defined as heart rate (HR) of  or higher at the day of SPECT will not be eligible for this study
Patient to be treated with neoadjuvant chemotherapy or patient to be treated with definitive radiation therapy (RT), sequential chemotherapy (chemo)-RT, or concurrent chemo-RT (minimum dose of  Gy in  fractions)
The patient should not participate in this study is any of the following applies to the patient: the patients has a pacemaker, metallic cardiac valve(s), magnetic material such as surgical clips, implanted electronic infusion pumps or any other condition that would interfere with the MRI, the patient has a stent somewhere in the body, the patient has a history of allergic reaction to any metals, contrast agents, x-ray dyes, the patient has claustrophobia
Patient is ?  years old at the time of the drug administration (Patient may be male or female of any race / ethnicity.)
Patient is able to remain still for duration of imaging procedure (about one hour)
Patient declines procedures that might be necessary for optimal primary cytoreduction (i.e. colostomy or splenectomy)
Patient is unable to receive high dose rate prostate brachytherapy
Patient is able to remain still for duration of imaging procedure (about one hour)
Patient with sinonasal carcinoma
Patient is mentally incompetent or a prisoner
The clinician/patient has made the decision as to whether the patient will proceed to wide local excision or mastectomy or patient has been diagnosed with invasive disease\r\n* NOTE: if surgical decision is delayed greater than  weeks after the MRI or patient is diagnosed with invasive disease, the patient should register to Step , arm B, and proceed to follow-up to capture all relevant data
The Oncotype DX Patient Report of the DCIS Score from the Oncotype DX Breast Cancer Assay performed by Genomic Health on the excision tissue have been uploaded by the site into the Rave electronic case report forms (eCRF)\r\n* NOTE: Prior to registration to Step , the institution must upload a redacted copy of the first page of the Oncotype DX Patient Report to the DCIS Score eCRF in Rave; after submission of the Oncotype DX Patient Report, the institution may proceed to register the patient to Step 
Patient must be planning to receive chemoradiation therapy with cisplatin
the investigational PET or SPECT tracer administration was well tolerated by the patient.
Investigator precludes participation for scientific reasons, for reasons of compliance (e.g., concurrent disease which could compromise the subject's study completion), or for reasons of the patient's safety
Female or male adult patient (patient having reached legal majority age)
Patient with national health insurance (according to local regulatory requirements)
Patient presenting with any condition which, based on the investigator's clinical judgment, would prevent the patient from completing all trial assessments and visits
Patient is being evaluated or receiving treatment by the pediatric oncology division at the University of Kentucky
Patient must agree to receive standard or dose-dense adriamyacin, cyclophosphamide, and taxane-based\r\nchemotherapy given preoperatively
Subject must be a patient undergoing diagnostic bronchoscopy and/or thoracoscopy at University of California Irvine Medical Center (UCIMC)
Patient gives informed or surrogate consent
Patient will have vocal fold leukoplakia or other abnormal epithelial changes
A member of the patients surgical team must indicate equipoise for the benefit of the surgical treatment for MBO; the surgeon must respond Yes to each of the following questions and sign the S Surgical Equipoise Documentation form for the patient to be eligible:\r\n* Is surgery for treatment of malignant bowel obstruction (MBO) being considered for this patient?\r\n* Do you have equipoise? if the treating team finds that an operation is required (e.g., for acute abdomen), or they would not offer the patient an operation (e.g., patient is too weak to tolerate surgery), then there is no equipoise
PATIENT: MSK patients
PATIENT: Undergoing treatment for cancer by one of the consented HCPs as per the HCP and/or EMR
Patient on the gynecologic oncology service
Patient is mentally incompetent or a prisoner
Any patient who has lost MMR and is eligible for re-starting dasatinib therapy must not have developed a condition that precludes dasatinib use.
The patient is receiving digoxin, digitoxin, lanatoside C or any type of digitalis alkaloids.
Before the patient is enrolled, the consent form, including any addenda, must be signed and dated by the patient and the person who explains the study to that patient
Women who are pregnant or lactating, if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus
Ineligible for high dose cisplatin therapy; the reason for ineligibility must be defined; acceptable reasons for ineligibility include the following:\r\n* Abnormal renal function (glomerular filtration rate [GFR] < lower limit of institutional normal (< lower limit of institutional normal [LLN])\r\n* Abnormal hearing (patient or audiology defined)\r\n* Pre-existing tinnitus\r\n* Neuropathy (bilateral paresthesias or loss of deep tendon reflexes in upper and/or lower extremities)\r\n* Diabetes mellitus\r\n* Oncologist-certification that patient would not be considered eligible for high dose cisplatin when given as standard of care (for example, due to age or another medical problem); reason should be documented\r\n* Patient refusal for high dose cisplatin