FOLFIRI therapy is appropriate for the patient and is recommended by the Investigator.
For inclusion into optional exploratory genetic and biomarker research, patients must fulfill the following criteria:\r\n* Provision of informed consent for genetic research\r\n* Provision of informed consent for biomarker research\r\n** If a patient declines to participate in the optional exploratory genetic research or the optional biomarker research, there will be no penalty or loss of benefit to the patient; the patient will not be excluded from other parts of the study
The patient must have undergone either a mastectomy (total, skin-sparing, or nipple-sparing) or lumpectomy
Patient has undergone total resection of the primary tumor with curative intent\r\n* NOTE: Patient is to be pre-registered to screening (Step 0) and tissue submitted to Foundation Medicine as soon as possible after surgery in order to meet the 8 week deadline to register the patient to Step 1 after surgery; full assay minimum turn-around time is 17-24 days
Surgical formalin-fixed paraffin-embedded (FFPE) specimen must be available for submission to GenomeDx for genomic analysis on DECIPHER GRID platform\r\n* Please note: If a patient already has a Decipher risk score and meets all of the other eligibility criteria, the patient is eligible to be registered; however, the Decipher risk report will need to be submitted to GenomeDx for validation
Although they will not be considered formal eligibility (exclusion) criteria, physicians should recognize that the following may seriously increase the risk to the patient entering this protocol:\r\n* Psychiatric illness which would prevent the patient from giving informed consent\r\n* Medical condition such as uncontrolled infection (including human immunodeficiency virus [HIV]), uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient\r\n* Patients with a “currently active” second malignancy other than non-melanoma skin cancers; patients are not considered to have a “currently active” malignancy if they have completed therapy and are free of disease for >= 3 years; there is an exception for patients with a history of well differentiated thyroid cancer that has progressed to anaplastic thyroid cancer\r\n* Patients who cannot swallow oral formulations of the agent(s)\r\n* Women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study ; appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives or double barrier method (diaphragm plus condom)\r\n* Efatutazone is metabolized by cytochrome P450, family 3, subfamily A, polypeptide 4/5 (CYP3A4/5), and inhibits CYP2C8, 2C9, 2C19, and 3A4, and is a substrate of P-glycoprotein (PgP) and breast cancer resistance protein (BCRP)
Patient must have chemosensitive disease as defined by at least a partial response to salvage therapy at their latest assessment
As of Amendment 2, if the registering site is a photon center (registering patients to group I), the patient must agree to participate in the advanced imaging sub-study
Patient must have undergone extended surgical staging including mediastinoscopy or endobronchial ultrasound; at minimum, samples must be obtained from the mediastinal stations 4R, 7 (subcarinal), and 4L; this surgical staging must be performed within 42 days prior to step 1 registration; patient must be T1-3 and N0-N2 (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 AHEP1531 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 AHEP1531 eligibility criteria at the time of emergent treatment\r\n** Patient must be enrolled on AHEP1531 prior to initiating protocol therapy; a patient will be ineligible if any chemotherapy is administered prior to AHEP1531 enrollment\r\n* Note: If the patient receives AHEP1531 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
Relevant diseases or clinical situations which may increase the patient's risk
For sites with the B1931022 pharmaceutical trial open, precursor B-cell ALL patients from that site may be eligible for S1312 providing they meet the following criteria:\r\n* Patient is in second salvage or more and B1931022 has been considered and ruled out as a treatment option; OR\r\n* Patient was treated on the standard of care arm of B1931022 and failed therapy
Hospitalization for an acute medical issue within 4 weeks prior to screening visit that would otherwise not be managed in an infusion center or outpatient clinic setting (i.e., a patient admitted to complete a transfusion would not be ineligible)
Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements
Patient with angina not well-controlled by medication;
Patient declines participation in NANT 2004-05, 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 male, patient must:
The patient and/or the patient’s legally authorized guardian must acknowledge in writing that consent to become a study subject has been obtained, in accordance with institutional policies approved by the U.S. Department of Health and Human Services
PIK3CA WILD TYPE COHORT (closed 03/17/2016): If premenopausal, patient must be willing to comply with pregnancy requirements
Patient intolerant to imatinib
Post randomization exclusion will occur if the patient is found to have unresectable disease at laparotomy and therefore will not have the potential for the same post-operative complications
Non-cooperative behavior or non-compliance of the patient and/or of his/her family
Patients with leiomyosarcoma must have tumors with intact Rb as documented by protein expression by immunohistochemistry (IHC) for study entry; patients without sufficient archival tissue for testing will not be eligible; in the event that a patient has prior sequencing information (i.e. through commercial testing) suggestive of intact Rb, the patient may be included into the study on a case by case basis as determined by the principle investigators; the patient will still be required to submit tissue for Rb determination by IHC, but will not need to wait for these results for study entry
Patient is pregnant or breastfeeding, or plans to become pregnant or father children from time of signing consent and lasting until 6 months after the last dose of trial treatment
Patients will be strongly encouraged to participate in 10-C-0086; if a patient does not agree to enroll on 10-C-0086, germline genetic analysis will not be performed
Confirmation that the patient’s 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 patient’s 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-S6 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
For inclusion in optional genetic research, the patient must provide a written informed consent for genetic research.
Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
Patient selected to undergo Whipple procedure or distal pancreatectomy
Any patient with an open oral ulceration(s) should avoid dosing with AZD4635 oral suspension.
Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and/or requirements.
Other medical or surgical conditions, especially involving the cardiac, respiratory, renal or hepatic organ systems that would either be unsafe for the patient, would limit study participation, or that would impede the determination of causality of any adverse events experienced during the conduct of this study.
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
Other co-morbidity which would interfere with patient's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease
General poor health, multiple co-morbidities placing the patient at risk or otherwise unsuitable for trial participation
Patients who have a history of another primary malignancy from which the patient has been disease free for < 3 years at the time of enrollment, with the exceptions of: a patient with a familial cancer syndrome-associated NETs including MEN1, VHL, NF-1, and thymidylate synthetase (TS)
Patients with a \currently active\ second malignancy that, in the opinion of the principal investigator, will interfere with patient participation, increase patient risk, shorten survival to < 1 year, or confound data interpretation
Symptomatic coronary artery disease (CAD), e.g., angina Canadian class II-IV; in any patient in whom there is doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present
Other co-morbidity which would interfere with patient's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease
Patient is more than 6 months since the last dose of FOLFIRI
Post exploratory thoracotomy must be done > 3 weeks prior to study registration or patient did not have post exploratory thoracotomy.
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.
Patient must not have any active infection or concurrent illness obscuring toxicity or dangerously altering drug metabolism
For Cohorts 1, 3 and 4, 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 must have a primary medical or surgical oncologist in the community or at NCI who is willing to collaborate with the ROB staff in the clinical management of the patient
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
At time of registration and within 4 weeks prior to initiating on-protocol treatment: Absolute neutrophil count (ANC) >= 1.5 x 10^9 /L\r\n* May be waived on a case-by-case basis for patient populations recognized to have normal baseline values below this level.
Other co-morbidity which would interfere with patient's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease
Psychiatric disorder or a mental deficiency of the patient that is sufficiently severe to make compliance with the treatment unlikely, and making informed consent impossible.
If a patient engages in sexual intercourse with a woman of childbearing potential, a condom and another form of birth control must be used during and for 100 days after completing treatment with CORT125281 or enzalutamide. A condom is required during and for 100 days after completing treatment with enzalutamide if a patient is engaged in sexual activity with a pregnant woman. Patients must also agree to avoid sperm donation during the study and for at least 100 days after the final treatment administration.
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.
Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirement
The patient has untreated concurrent urothelial cancer in other locations other than the target area (unless treated during screening)
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's indication is commercially available and reimbursed in the local country.
Patient has participated in a combination trial where dabrafenib and/or trametinib was dispensed in combination with another study medication.
Patient currently has unresolved toxicities for which dabrafenib and/or trametinib dosing has been interrupted in the parent study.
Patient must receive the following medical regimen as part of standard of care immunoprophylaxis for GvHD in either study arm at doses and regimen determined by local institutional guidelines, physician preference, and patient need: MTX or MMF + calcineurin inhibitor (CSA or TAC) +/- ATG (ATG use is limited to 30% of patients).
Any other condition that would cause a risk to the patient if he/she participated in the trial.
Provision of informed consent for genetic research. If a patient declines to participate in the genetic research, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study described in this clinical study protocol, so long as they consent to that part.
Patient has poorly controlled hypertension and on multiple antihypertensives
Patient has a history of interstitial cystitis
Mental condition that prevents patient from performing the study activities and requirements
Patients must not have current evidence of any condition, therapy, or laboratory abnormality (including active or uncontrolled myelosuppression [ie, anemia, leukopenia, neutropenia, thrombocytopenia]) that might confound the results of the study or interfere with the patient's participation for the full duration of the study treatment or that makes it not in the best interest of the patient to participate
Patient is or will be enrolled on protocol 00-CH-0093, Diagnosis, Pathophysiology, and Molecular Biology of Pheochromocytoma and Paraganglioma
Must have outside endocrinologist/medical oncologist who can follow the patient after receiving peptide receptor radionuclide therapy (PRRT) at the NIH
Patient must have no active major medical or psychosocial problems that could be complicated by study participation
Patient has sufficient stored T cell product to manufacture appropriate doses of T-APCs
Patient with a history of genetic prothrombotic state
Availability of and patient acceptance of curative therapy
Non-English speakers will be excluded from participating in the patient-reported outcomes component of the study.
Patient on Coumadin and not willing to change to LMWH or oral Factor II or Xa inhibitor with half-life of less than 24 hours.
If a patient declines to participate in genetics research, there will be no penalty or loss of benefit to the patient; a patient who declines genetics research participation will not be excluded from any other aspect of the main study
Availability of and patient acceptance of curative therapy
Prior treatment with everolimus is allowed, if the patient was able to tolerate 10 mg daily everolimus with acceptable side effects, and if everolimus was not given in combination with fosbretabulin; a 1 week washout period will be required if patient was previously on everolimus
Any reason, at the investigator’s discretion, that the participation of the patient in this protocol would not be in patient’s best interest, or where the patient would be unable to adhere to the study requirements
The patient must have received a boost immunization with trivalent inactivated poliomyelitis (IPOL) (Sanofi-Pasteur) at least 1 week prior to administration of the study agent
Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements
Patient on anti-retroviral medications
Psychiatric disorder or a mental deficiency of the patient that is sufficiently severe to make compliance with the treatment unlikely, and making informed consent impossible
No known infection with HIV. Due to the mechanism of action of ipilimumab, activity and side effects in an immune compromised patient are unknown.
Patients on concurrent anti-cancer therapy, unless specifically agreed to by the patient's medical oncologist and consenting professional
Patient is receiving any azole.
Patient is currently participating in an Immunocore-sponsored study of IMCgp100 and is actively receiving IMCgp100. 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 IMCgp100 study or from IMCgp100 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 0.5 or greater
Confirmed availability of production capacities for the patient's ACTolog products.
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
In accordance with National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) policy, protocol treatment is to begin within 2 working days of patient registration
Patient on anti-retroviral medication (as these medications may alter patient metabolism)
The expression of WT1 in the patient’s peripheral blood and/or bone marrow will be determined; if WT1 expression in the patient specimen is within the normal physiologic range or is not detected, the patient will be ineligible for treatment with WT1-specific T cells (and will not be included in the observation cohort)
Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements
The patient has radiologically documented evidence of major blood vessel invasion or encasement by cancer
Inoperable disease because of patient refusal, neurosurgical evaluation, or any other medical reasons
Multidisciplinary evaluation of the patient must be performed with a consensus recommendation for reirradiation
Other co-morbidity which would interfere with patient's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease
Patient must be able to maintain a 30 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 may have been pretreated with intermediate to high dose cytarabine (more than 1000mg/m2/d over 5d) if the day of the last infusion was at least 90 days before inclusion in the study
psychiatric conditions e.g. patients unlikely to comply with the protocol, e.g. mental condition rendering the patient unable to understand the nature, scope, and possible consequences of participating in the study
Patient has received intervening therapy for lymphoma after CTL019 infusion
Patients have unresectable MPM or the patient refuses surgery for resectable MPM
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 and partner are willing to use condoms for 12 months after receiving Toca 511 or until there is no evidence of the virus in his/her blood, whichever is longer.
Any other disease, either metabolic or psychological, that as per Investigator assessment may affect the patient's compliance or place the patient at an increased risk of potential treatment complications.
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
Localized EAC and its baseline clinical stage determined as: T2-T3N0 or T1-3N positive (+); imaging studies suspicious for metastases must be followed with a negative biopsy before a patient can enter the study
Symptomatic coronary artery disease (CAD), e.g., angina Canadian class II-IV; in any patient in whom there is doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present
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 12 – 15 could be included in only 6 centers (Bordeaux, Lyon, Villejuif, Lille, Marseille and Paris)
Willingness to take varenicline OR nicotine patch (patient choice)
Patient is mentally or legally incapacitated at the time of the study
Patient eligible for SABR to the IVC tumor thrombus as decided by the treating radiation oncologist
Patient eligible for IVC tumor thrombectomy as decided by the treating urologist
Patient must have injectable disease (direct injection or ultrasound guided)
Patient must have no active major medical or psychosocial problems that could be complicated by study participation
Patient must have no active major medical or psychosocial problems that could be complicated by study participation
Patient has completed participation in one of the ONC201 protocol, has not shown tumor progression while on study treatment, and has tolerated the study drug without unacceptable toxicities
Patient has not met criteria for withdrawal from the base protocol
Confirmation by a surgeon that the patient is able to undergo a low anterior resection with total mesorectal excision =< 28 days prior to registration
Patient will have opted for SBRT among definitive treatment choices
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
Unreliable for follow-up (drug use, planning to move out of region ,etc.); any patient that lives more than 100 miles away will be excluded
Imaging studies show evidence of recurrent tumor(s); if a patient is going to be enrolled to dose level two or higher, the patient must have a component of supratentorial disease (so as to enable placement of a Rickham reservoir/catheter) that is amenable to resection or biopsy
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
Other co-morbidity, which would interfere with patient's ability to participate in the trial, e.g. uncontrolled infection, uncompensated lung disease
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 allergic to naproxen or ibuprofen
If younger than 40, there must be comorbidities which preclude the patient to undergo cyclophosphamide (Cy) TBI conditioning regimen
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 4, 5, or 6/6 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 2 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 >60\n\n          -  Absolute neutrophil count (ANC) greater than 500/ul.\n\n          -  No evidence of GVHD > Grade II at time of enrollment.\n\n          -  Life expectancy > 30 days\n\n          -  Absence of severe renal disease (Creatinine > x 3 normal for age)\n\n          -  Absence of severe hepatic disease. Direct bilirubin must be < 3 mg/dl and AST < 5x\n             upper limit of normal.\n\n          -  Patient must be at least 30 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 Fi02 of >60%\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 <70%\n\n          -  Patients with grade 3 or 4 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 ?0.5 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 50% donor chimerism in either peripheral blood or bone marrow\n             or patients with relapse of original disease.
Patient must be eligible for HD IL-2 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 is currently benefiting from the treatment with pasireotide, as determined by the investigator
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
Patient has participated in a Novartis sponsored combination trial where pasireotide was dispensed in combination with another study medication and is still receiving combination therapy. (only patients receiving pasireotide monotherapy can be included)
Subjects who experience a significant flare after discontinuation of a tumor necrosis factor (TNF) inhibitor as part of this study that requires urgent medical management or hospitalization, or in the estimation of the principal investigator poses excessive risk to the patient to enter the study
Must be a patient to be treated with SBRT only at Johns Hopkins Hospital
Patient must be able to have fiducials placed; 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
Patient must be able to drink and eat more than 75% of their usual daily meals
Patient has signed the informed consent document agreeing to the use of the study drug, domperidone
Patient refusal
Patient agrees that intravenous (IV) bisphosphonates will be withheld for the first 8 weeks of dasatinib therapy due to risk of hypocalcemia
Patient has any disease that will obscure toxicity or dangerously alter drug metabolism
Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements
Other co-morbidity which would interfere with patient's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease
Patient must live within 30 minutes of the treating physician’s 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
Patient must be able to swallow enteral medications; patient must not require a feeding tube; patient must not have intractable nausea or vomiting, gastrointestinal (GI) tract disease resulting in an inability to take oral medication, malabsorption syndrome, or uncontrolled inflammatory bowel disease (Chron’s, ulcerative colitis)
For clinically stage II patients, the patient must have been evaluated by a thoracic surgeon, and deemed medically or technically inoperable, or the patient must refuse surgery
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
Patients should have uncontrolled intercurrent illness, which in the opinion of the attending medical oncologist, would render the patient unsuitable for the study (i.e., preclude safe administration of the prescribed chemotherapy treatment).
The donor and the patient and/or the patient’s legally authorized guardian must acknowledge in writing that consent to become a study subject has been obtained in accordance with the institutional policy approved by the United States (U.S.) Department of Health and Human Services
Patient who is otherwise considered unsuitable for transplant at the discretion of the principal investigator
The patient and/or the patient's legally authorized guardian must acknowledge in writing that consent to become a study subject has been obtained in accordance with the institutional policies approved by the United States (U.S.) Department of Health and Human Services; informed consent must be signed prior to registration on study
Presence of the t(9;22) (q34;q11) or bcr-abl fusion in the leukemic cells (if data are not known, patient still may be eligible)
Patient is unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator that the patient is not suitable for participation in the study.
Other co-morbidity which would interfere with patient's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease
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 5 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 demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.
Patient is currently benefiting from treatment with everolimus, as determined by the guidelines of the parent protocol.
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. 2.Patient is currently benefiting from the treatment with imatinib, as determined by the investigator. 3. Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.4. Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures. 5. 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 30 days after the final\n        dose of nilotinib.
Patient refractory to dacarbazine defined as patient presenting a disease progression after 3 months of dacarbazine therapy.
Patient presenting with at least one of the following feature: ischemic heart disease, cardiac failure, conduction disorders or arrythmia
Naïve patient or patient previously treated with imatinib as neoadjuvant/adjuvant who relapsed after imatinib discontinuation
Patient who are receiving concurrent combination with sorafenib (Nexavar) and TACE (transarterial chemoembolization) in their originating study will be eligible.
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 ? 3 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 18 and 90 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 ? 1cm 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 2004-05, the NANT Biology Study
Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements
Patient is anticipated to continue for at least 28 days with an EGFR inhibitor or restart ? 14 days of registration and continue for at least 28 days
Patient has no significant valvular heart disease (trace or mild valvular stenosis or regurgitation is allowed)
Patient has a foreign body which in the opinion of the treating investigator could be difficult to manage in case of infection
The patient has a prior or concurrent malignancy that in the opinion of the investigator, presents a greater risk to the patient’s health and survival, than of the MCL, within the subsequent 6 months at the time of consent.
FOR TISSUE COLLECTION TO ESTABLISH PDX (PART 1): Reasonable expectation that the patient can wait 3-6 months for generation of data for subsequent treatment selection.
FOR PDX-GUIDED THERAPY THROUGH ONGOING TRIALS AT MD ANDERSON OR OFF-PROTOCOL WITH STANDARD OF CARE (PART 2): 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 1 found this agent to be effective in a combination, the patient remains eligible for this combination that includes agent X.
THE PATIENT IS INELIGIBLE TO PARTICIPATE IN PART 2 IF ANY OF THE FOLLOWING OCCUR: PDX data are non-informative.
THE PATIENT IS INELIGIBLE TO PARTICIPATE IN PART 2 IF ANY OF THE FOLLOWING OCCUR: Part 1 data contradict clinical judgment. The investigator should discuss with the principal investigator (PI) and use the best discretion.
It will be at the Principal Investigator's (PIs) discretion to enroll a patient who has a small, asymptomatic brain hemorrhage, but patients who have had symptomatic hemorrhages will be excluded
Patient is premenopausal defined as either:
Patient had last menstrual period within the last 12 months or
Patient must have:
Respiratory illness requiring hospitalization at the time of step 1 registration\r\n* Note: if the respiratory illness is resolved and the patient meets the eligibility status above, then the patient can be considered for the trial
Other co-morbidity which would interfere with patient's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease
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
Patients who speak English (or read one of the languages for which a translation is available must consent to complete the mandatory dysphagia-related patient reported instrument (MDADI); if the patient cannot understand spoken English and reads only languages not available in the MDADI translations, the patient can still participate in the trial, as this has been factored into the trial statistics; for all other patients, the MDADI is mandatory as it is included in the primary endpoint to be studied
Patient is allergic to 5-FC, leucovorin, or 5-FU
Patient has had prior therapy with neural stem cells
Patient must be tolerating oral intake
Patient agrees that intravenous (IV) bisphosphonates will be withheld during the first 8 weeks of dasatinib therapy due to risk of hypocalcemia
Patient must not be receiving any medication that may markedly affect renal function (e.g., vancomycin, amphotericin, pentamidine)
Donors: If a patient is homozygous at a particular loci, mismatching at that loci is not allowed due to an isolated graft rejection vector, i.e., patient A*0101 and the donor is A*0101, A*0201; such a mismatch may increase the risk of graft rejection; if patient and donor pairs are both homozygous at a mismatched loci, they are considered a two-HLA antigen mismatch, i.e., the patient is A*0101 and the donor is A*0201, and this type of mismatch is not allowed
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 CD4 cell cut-off of 100 cells per microliter required for cohort 3 therapy (or, absolute lymphocyte count [ALC] value of < 300); in such cases, standard care chemotherapy regimens may be administered for the specific goal of reducing the CD4 count (that is, immune depleting regimens such as the pentostatin plus cyclophosphamide combination, administered similar to the manner that we have developed on protocol 08-C-0088); 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
Any other concurrent illness which in investigator’s opinion puts the patient at excessive risk of treatment related toxicities
Patients with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy
Operative report or other source documentation in the patient record
Patient has identified PIK3CA 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
No or minimal disease-related symptoms not affecting patient daily activities.
Before starting therapy the patient should be able to maintain adequate oral nutrition of >= 1500 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 (LEE011) in the parent protocol for any reason.
Patient meets all sub-protocol specific criteria of each applicable sub-protocol
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 1 (absence of deep tendon reflexes as the sole neurological abnormality does not render the patient ineligible)
Main inclusion criteria:\n\n          1. 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          2. Patient has recovered of all acute toxic side effects of prior therapy or surgical\n             procedures to grade ?1 National Cancer Institute-Common Toxicity Criteria (NCI-CTCAE\n             v4.02), except for the laboratory values\n\n          3. 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          4. ECOG Performance status ? 2\n\n          5. Patient with adequate organ function per laboratory tests evaluations\n\n          6. Patient with life expectancy > 3 months\n\n          7. Patient weight > 40 kg and BMI > 18\n\n          8. Female patient ? 18 years\n\n          9. Patient with nutritional risk index (NRI) ? 83.5, i.e. with no or moderate\n             malnutrition;\n\n         10. 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 3 months after the last treatment intake.\n\n        Main exclusion criteria:\n\n          1. Patient intolerant to gemcitabine\n\n          2. Patient who has not recovered from any significant treatment toxicities prior to\n             baseline (?Grade 2)\n\n          3. Patient presenting with serious cardiac disorders defined in the protocol\n\n          4. Pregnant or nursing female patient\n\n          5. Patient with active central nervous system (CNS) metastasis or with history of CNS\n             metastasis\n\n          6. Patient treated for a cancer other than epithelial ovarian cancer within 5 years\n             before enrolment, with the exception of basal cell carcinoma or cervical cancer in\n             situ\n\n        WASH-OUT:\n\n          1. Patient is at least 4 weeks from any major surgery (at baseline/W0)\n\n          2. Patient treated with any investigational agent within 4 weeks prior baseline\n\n          3. Patient who had systemic chemotherapy within 4 weeks before baseline\n\n          4. Patient who had radiotherapy within 4 weeks before baseline
Any reason that, in the opinion of the Investigator, contraindicates that the patient participates in the study
A signed Patient Authorization Form (HIPAA) has been obtained prior to registration
Patient with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator's best judgment.
All infections must be resolved and the patient must remain afebrile for seven days without antibiotics prior to being placed on study
household contact with hepatitis B infected patient(s),
household contact of hepatitis C infected patient(s),
Active hepatitis B, unless patient has been on antiviral agents for at least 2 months (baseline testing not required)
Patient with baseline symptoms of incontinence defined as urine leak in any of the following circumstances: 20.1. Before the patient can get to the toilet 20.2. When coughing or sneezing 20.3. While being asleep 20.4. While being physically active/exercising 20.5. After finishing urinating and being dressed 20.6. Leaking for no obvious reason
Patient with baseline impotence scoring 17 or below in the IIEF-5 (SHIM) questionnaire
The participating urologist judges that the standard next therapy, based on present urologic guidelines for this patient, is radical cystectomy
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 AHEP0731 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 AHEP0731 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 AHEP0731 eligibility criteria at the time of emergent treatment\r\n** Patient must be enrolled on AHEP0731 prior to initiating protocol therapy; a patient will be ineligible if any chemotherapy is administered prior to AHEP0731 enrollment\r\n** If the patient receives AHEP0731 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
Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements; Note: Patients who are likely to require surgery or radiation for NF2-related tumors during the first year of treatment in the investigator’s opinion should not be enrolled on this clinical trial
Patient has score of 0 or 1 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)
Patients with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy.
The patient has a prior or concurrent malignancy that in the opinion of the investigator, presents a greater risk to the patient’s health and survival, than of the MCL, within the subsequent 6 months at the time of consent; investigator discretion is allowed
Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements
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)
Symptomatic coronary artery disease (CAD), e.g., angina Canadian class II-IV; in any patient in whom there is doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present
Patient has evidence of uncontrolled malabsorptive diarrhea that would prevent adequate absorption of PBI 05204.
Patients with SCNSL actively receiving treatment for extra-CNS disease are excluded; patient should have complete resolution of their systemic disease not requiring additional systemic therapy (e.g. maintenance rituximab or Decadron)
Patient is mentally or legally incapacitated at the time of the study
The patient has a prior or concurrent malignancy that in the opinion of the investigator, presents a greater risk to the patient’s health and survival, than of the MCL, within the subsequent 6 months at the time of consent; investigator discretion is allowed
Patient has valvular heart disease that requires antibiotic prophylaxis for prevention of endocarditis
As judged by the investigator, the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions, and requirements
Patients who cannot undergo staging laparoscopy; for example, this may include patients with a prior history of multiple abdominal operations in which laparoscopy may not be technically feasible or potentially harmful; the patient is eligible if they have a common bile duct stent adjacent to the tumor that may be used as an internal marker, or if the patient has already had a staging laparoscopy without marker implantation and the markers can be implanted (by interventional radiology) prior to the beginning of radiation therapy
Patient has up to 6 local pulmonary metastases targetable by cryoablation.
Genetic disorder predisposing patient to skin cancers or radiation sensitivity (basal cell nevus syndrome, xeroderma pigmentosum, ataxia telangiectasia mutans)
Patients must have been surgically or medically castrated; if the patient is being treated with medical castration, he must be willing to continue this treatment for the duration of the study; ADT should not be initiated, terminated, or dose-adjusted during the study
The patient must be discussed at GI Tumor Board, NCI and suitability for the interventional procedure (TACE or RFA) re-affirmed
Other co-morbidity, which would interfere with patient's ability to participate in the trial, e.g. uncontrolled infection, uncompensated lung disease
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
For subjected enrolled in the United States, no coverage or not-acceptable by patient co-pay for lenalidomide
Patient is eligible for Low-Dose Cytarabine (LDAC) treatment.
Patient has achieved MR4.5 (local laboratory assessment) during nilotinib treatment, and determined by a Novartis designated central PCR lab assessment at screening
Patient has documented MR4.5 at the time when switched from imatinib to nilotinib
Patient ever attempted to permanently discontinue imatinib or nilotinib treatment
Patient must not have a true unknown primary in which permanent section results are negative for malignancy in completely excised ipsilateral oropharyngeal tissue (palatine and lingual tonsil)
In the opinion of the investigator, the patient is felt not to be appropriate for the study
Patients must have progressive disease based on RECIST Criteria, Version 1.1 while receiving an uninterrupted fixed dose of Octreotide LAR (20-30 mg/3-4 weeks). Disease progression must be centrally confirmed. In order to make the assessment, two CT (or MRI) scans are required. The oldest scan must not be older than 3 years from the date of randomization. The most recent scan must not be older than 4 weeks from the date of randomization. Both scans must be obtained while the patient is receiving the same fixed dose of Octreotide LAR (20-30 mg/3-4 weeks) with the following exceptions; 1) it is acceptable if the oldest scan is obtained within 12 weeks of the patient receiving a fixed dose regimen of Octreotide LAR (20-30 mg/3-4 weeks); AND 2) it is acceptable for either scan to be obtained before or during the time a patient receiving a fixed dose of Octreotide LAR has switched to an equivalent dose of short acting Octreotide for up to 6 weeks in order to obtain an OctreoScan®, provided the patient returns to the Octreotide LAR fixed dose after the OctreoScan® has been obtained.
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
Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the trial
If radiotherapy is required in a given patient, that patient should be withdrawn from the study
Have one or more symptoms that the Investigator believes to be related to the patient's MTC.
Other co-morbidity which would interfere with patient's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease
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 ADXS11-001 therapy
Patient has poorly controlled hypertension and on multiple antihypertensives
Extensive (invasive) loco-regional tumor mass and/or metastatic spread, rendering patient inoperable
If a patient has any serious medical problems which may preclude receiving this type of treatment
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 =< 125,000 cells/ul (blood work will be repeated within 2 weeks and if still abnormal, patient will be excluded)
Platelets >= 20,000/mm^3; this requirement may be waived if patient has hematologic relapse of disease or if patient has not yet recovered counts from chemotherapy
DONOR EXCLUSION: New health conditions which would exclude a transplant donor from a second blood donation are limited, but include:\r\n* New onset of an human immunodeficiency virus (HIV) infection\r\n* Other uncontrolled infection which could be transmitted to the patient by blood cells and would place the patient at significant increased risk of severe morbidity or death\r\n* Significant anemia with hemoglobin (Hgb) =< 10 gm/dl, persisting since the time of the original transplant donation\r\n* History of myocardial infarction or stroke since the time of hematopoietic stem cell transplant (HSCT) donation which might increase the risk of blood donation
Patients with acute leukemia or myelodysplastic syndrome or chronic myelomonocytic leukemia must be in a hematologic remission, defined as < 5% blasts present in both blood and marrow to be referred for evaluation; should a patient have > 5% 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 Hodgkin’s and Non-Hodgkin’s 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 8 weeks if chemo/radiotherapy or within 12 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 must meet the organ function requirements as stated in the protocol.
Patient declines participation in NANT 2004-05, the NANT Biology Study.
Patient meets the FDA-approved indication for Atezolizumab treatment in NSCLC.
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 1 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 v1.1 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 < 50,000/mm3\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 4 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 may not be receiving any other antineoplastic agents
Historical control data will be derived from patient medical records at the Ohio State University Medical Center (OSUMC)
Patient medication lists will be reviewed by a member of the study team for possible interactions with the nelfinavir; a patient may be deemed ineligible for the study if he/she is taking an essential medication that is known to interact with nelfinavir
The patient has a prior or concurrent malignancy that in the opinion of the investigator, presents a greater risk to the patient’s health and survival, than of the MCL, within the subsequent 6 months at the time of consent; investigator discretion is allowed
The patient has an uncontrolled and active infection that would preclude study conduct and assessment
Any condition that, in the clinical judgment of the treating physician, is likely to prevent the patient from complying with any aspect of the protocol or that may put the patient at unacceptable risk.
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:
No patient may be entered onto the study without consultation with the principal investigator or his designee
Patient with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator's best judgment.
As judged by the investigator, the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions, and requirements
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 7 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 28 days from when patient signs consent
Patient must have a palpable femoral/radial pulse in the affected extremity
Patient has Grade B aGvHD with skin-only involvement.
Patient has had prior treatment with mesenchymal stem cells (MSCs), including remestemcel-L.
Patient shows evidence of encephalopathy as defined by a change in mental status since the onset of aGVHD.
Patient has no significant valvular heart disease (trace or mild valvular stenosis or regurgitation is allowed).
Patient has a foreign body which in the opinion of the treating investigator could be difficult to manage in case of infection (e.g. prosthetic hip).
AST and ALT < 10 x ULN AND decreasing at two timepoints if patient is status/post (s/p) biliary stenting
Patient has received 6 cycles of DI-Leu16-IL2 on Protocol AO-101
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.
Inappropriate risk to the patient such as cardiorespiratory compromise such that safe conscious sedation or prone decubitus cannot be obtained
Any condition that will put the patient at undue risk or discomfort as a result of adherence to study procedures. For example, consider requirement to take mocetinostat with water and recommendation to avoid agents that increase gastric pH
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
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
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 ?18 years.\n\n          -  Patient has an ECOG performance status of 0 (fully active, able to carry out all\n             pre-disease activities without restriction) or 1 (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 C1D1, before the first dose of TVB 2640.\n\n          -  Patient has adequate renal function (creatinine ?1.5 times the upper limit of normal\n             [ULN]) or a glomerular filtration rate (GFR) of ?50 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             6 months before the first dose of TVB 2640 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 1.1 (1).\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-2640,\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 4 weeks before the first dose of TVB 2640 or\n             received cancer-directed therapy or an investigational drug or device within 4 weeks\n             (6 weeks for mitomycin C and nitrosoureas) or 5 half-lives of that agent (whichever is\n             shorter) before the first dose of TVB 2640.\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 5 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 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 demonstated compliance
Symptomatic coronary artery disease (CAD), e.g., angina Canadian class II-IV; in any patient in whom there is doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present
Patients with diabetes or in risk for hyperglycemia should not be excluded from trials with MK-2206, but the hyperglycemia should be well controlled on oral agents before the patient enters the trial
Other co-morbidity which would interfere with patient's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease
Other co-morbidity which would interfere with patient's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease
Patient has a GAD-7 mood scale score ? 15.
Males must agree to use condoms during sex to prevent spillage of semen for the duration of the study and for 3 months after the patient leaves the study
Inclusion Criteria:\n\n        Patients are eligible if they:\n\n          1. have undergone noncardiac surgery;\n\n          2. are ?45 years of age;\n\n          3. have suffered MINS based upon fulfilling one of the following criteria: A. Elevated\n             troponin or CK-MB measurement with one or more of the following defining features i.\n             ischemic signs or symptoms (i.e., chest, arm, neck, or jaw discomfort; shortness of\n             breath, pulmonary edema); ii. development of pathologic Q waves present in any two\n             contiguous leads that are ?30 milliseconds; iii. electrocardiogram (ECG) changes\n             indicative of ischemia (i.e., ST segment elevation [?2 mm in leads V1, V2, or V3 OR ?1\n             mm in the other leads], ST segment depression [?1 mm], OR symmetric inversion of T\n             waves ?1 mm) in at least two contiguous leads; iv. new LBBB; or v. new or presumed new\n             cardiac wall motion abnormality on echocardiography or new or presumed new fixed\n             defect on radionuclide imaging B. Elevated troponin measurement after surgery with no\n             alternative explanation (e.g., pulmonary embolism, sepsis) to myocardial injury; AND\n\n          4. provide written informed consent to participate within 35 days of suffering their\n             MINS.\n\n        Exclusion Criteria:\n\n        Patients meeting any of the following criteria will be excluded:\n\n          1. hypersensitivity or known allergy to dabigatran;\n\n          2. history of intracranial, intraocular, or spinal bleeding;\n\n          3. hemorrhagic disorder or bleeding diathesis;\n\n          4. known hepatic impairment or liver disease expected to have an impact on survival;\n\n          5. condition that requires therapeutic dose anticoagulation (e.g., prosthetic heart\n             valve, venous thromboembolism, atrial fibrillation);\n\n          6. currently using or plan to initiate rifampicin, cyclosporine, itraconazole,\n             tacrolimus, ketoconazole, or dronedarone;\n\n          7. women who are pregnant, breastfeeding, or of childbearing potential who refuse to use\n             a medically acceptable form of contraception throughout the study;\n\n          8. investigator considers the patient unreliable regarding requirement for study\n             follow-up or study drug compliance; OR\n\n          9. previously enrolled in the MANAGE Trial.\n\n        Also excluded will be patients in whom any of the following criteria persist beyond 35 days\n        of their suffering MINS:\n\n          1. the attending surgeon believes it is not safe to initiate therapeutic dose\n             anticoagulation therapy;\n\n          2. the attending physician believes ASA, intermittent pneumatic compression, or elastic\n             stockings are not sufficient for venous thromboembolism (VTE) prophylaxis and that the\n             patient requires a prophylactic-dose anticoagulant;\n\n          3. the patient has an indwelling epidural or spinal catheter that cannot be removed, or\n             the first dose of dabigatran will occur within 4 hours of epidural catheter removal;\n             OR\n\n          4. estimated glomerular filtration rate (eGFR) <35 ml/min as estimated by calculated\n             creatinine clearance.\n\n          5. it is expected that the patient will undergo cardiac catheterization for MINS.\n\n        Exclusion Criteria Specific to Patients in the Omeprazole Factorial Component of the Trial:\n\n        Patients meeting any of the following criteria:\n\n          1. hypersensitivity or known allergy to omeprazole;\n\n          2. requirement for a proton pump inhibitor, an H2-receptor antagonist, sucralfate,\n             atazanavir, clopidogrel, or misoprostol;\n\n          3. esophageal or gastric variceal disease; OR\n\n          4. patient declines participation in the omeprazole arm of MANAGE.
Other co-morbidity which would interfere with patient's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease
Any significant finding in the patient's medical history or physical examination that, in the opinion of the investigator, would affect patient safety or compliance with the dosing schedule.
Patient declines participation in NANT 04-05. (Neuroblastoma Biology Study)
If a patient has any serious medical problems which may preclude receiving this type of treatment
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 group’s procedures
Patient has a QT interval prolongation > 480 ms at screening. If a patient has a prolonged QT interval and the prolongation is deemed to be due to a pacemaker upon Investigator evaluation (ie, the patient otherwise has no cardiac abnormalities), then the patient may be eligible to participate in the study following discussion with the Medical Monitor.
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 18 years old and 80 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 12 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 ? 5 cm in its\n             greatest dimension?\n\n          -  Based on the pre-operative evaluation, is the tumor recurrence/progression a candidate\n             for ? 80% 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 ? 70?\n\n          -  Does the patient have an absolute neutrophil count (ANC) ? 1500/mm3?\n\n          -  Does the patient have an absolute lymphocyte count ? 500/mm3?\n\n          -  Does the patient have a platelet count ? 100,000/mm3?\n\n          -  Does the patient have a Hgb ? 10 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 50 mL/min\n             (inclusive) by the Cockcroft-Gault formula?\n\n          -  Does the patient have an ALT < 3 times the upper limit of the laboratory reference\n             range and total bilirubin < 1.5 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 21 days?\n\n          -  Is the patient willing to use condoms for contraception for 6 months after receiving\n             Toca 511 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 12 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 3 weeks (6 weeks for\n             nitrosoureas) of the planned surgery date?\n\n          -  Does the patient have, or has the subject had, within the past 4 weeks any infection\n             requiring antibiotic, antifungal or antiviral therapy?\n\n          -  Has the patient had a surgical procedure in the last 28 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 30 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 5 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's blasts cells show expression of WT1 transcript, detected by quantitative Reverse Transcription-Polymerase Chain Reaction (qRT-PCR).The patient received the following therapy according to the Institution's standard of care.
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's blasts cells show expression of WT1 tran-script, detected by quantitative RT-PCR.
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 14 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.
Has any other clinically important abnormalities such that risk to patient of participation outweighs the potential benefit of therapy as determined by the investigator
Other patient eligibility requirements\r\n * Human immunodeficiency virus (HIV) 1 and HIV 2 negative\r\n * Not pregnant or at risk for pregnancy and willing to use acceptable birth control methods\r\n * No uncontrolled drug of alcohol abuse; patients will be screened for drug and alcohol abuse by a pediatric psychologist who is a member of the HSCT team; this information will not be recorded in the patients’ hospital chart\r\n * Signed informed consent by patient or legal guardian in accordance with research ethics board guidelines or institutional review board (IRB)\r\n * Lansky or Karnofsky performance score of 0, 1 or 2\r\n * Suitable haploidentical donor available\r\n * Cryopreserved autologous stem cells (minimum 1 x 10^6 cluster of differentiation [CD]34+ cells/kg) available for infusion for patient with solid tumors; subjects with solid tumors who have not had stem cells collected for clinical purposes prior to enrolling in the study will undergo autologous stem cell harvest following standard clinical procedures before beginning the study conditioning regimen
Patient is either ineligible for or declines radical cystectomy; the investigator must explain that a delay in cystectomy may increase the patient’s chance of disease progression
Patient is considered a poor surgical candidate for removal of a renal mass as determined by pre-operative assessment due to the following factors or various combinations thereof:\r\n* Significant comorbidity precluding ability to deliver anesthesia, without compromised ability to undergo systemic chemotherapy with pazopanib as deemed by the Urologist and Medical Oncologist \r\n* Medically documented contraindication for surgery due to religion or risk of blood transfusion\r\n* Size or location of tumor deemed high risk for surgical intervention by Urologist\r\n* Unacceptable risk for anesthesia, such as history of malignant hyperthermia\r\n* Any one of these factors may or may not constitute unresectability, but for consideration for this trial, the surgical and medical oncologist must agree that the particular constellation of findings for the patient under consideration would likely entail a low probability (< 50%) that the tumor would be resectable (with negative margins) or that the potential morbidity associated with an attempt at surgical resection would not be clinically acceptable\r\n* The numerical thresholds noted above are only a guideline and the clinical judgment of the surgeon and medical oncologist will determine unresectability or if patient refuses surgery or other forms of local therapy; the histopathology for this cohort is limited to clear cell carcinoma of the kidney
Patient must have undergone immediate reconstruction at the time of mastectomy or be planning to undergo reconstruction within 8 months after radiation
Patient must be premenopausal at breast cancer diagnosis, as determined locally and documented in patient record; (Note: it is understood that patients’ menopausal status may be unclear at the time of study enrollment)
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
The patient has been informed of and agrees to data transfer and handling, in accordance with national data protection guidelines
Plan to be on chemotherapy or other allowable treatment for at least 3 months (minimum 70 days) and be willing to come in for study visits\r\n* The plan for treatment should be for at least 3 months at time of study enrollment; the treatment can stop earlier during the study at the discretion of the physician and patient (e.g., due to progression as noted through imaging, toxicity, or patient preference)
PATIENT: Lives in a state where their institutions’ PC clinicians are licensed to practice
PATIENT: They are already receiving PC or hospice services
Patient and partner are married or cohabitating and relationship duration >= 1 year
Patient with a history of a thrombotic event within 12 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 participants will have an appointment in the Thoracic Oncology Program at the Brigham and Women’s Hospital
Patient lives with a partner (spouse/significant other – includes homo- and heterosexual couples)
PHASE I: Significant developmental delay per patient, parent, or physician report
Patient receiving antiplatelet agents
Patient has had no clinically significant change in renal status within 3 months prior to screening, according to Investigator's review of clinical patient records.
One of the below criteria must be met based on patient's therapy:
Patient cannot be on the following medications: GABA analogues (such as Neurontin, Lyrica), tricyclic antidepressants (such as amitriptyline or nortriptyline)
A relative or a friend upon whom the patient relies for help and who likely to be present during hospitalizations or clinic appointments, or willing to participate by phone
(Patient participation) Normal cognitive status, defined as a normal state of arousal and an absence of obvious clinical findings of confusion, memory deficits or concentration deficits, as determined by the patient's physician
Patient’s attending medical oncologist would not be surprised if the patient died in the next 12 months
Patient has not completed a Physician Orders for Scope of Treatment (POST) form
Patient is willing and able to consent and travel to the class location for 6 weekly 2-hour sessions
Patient has a family member or close friend eligible and interested in participating in the study
Patient reports a score of > 2 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 ONLY: Regularly (self-defined) participation in psychotherapy or a formal cancer support group
Patient on stable analgesic regimen for > 7 days without escalation during study period with rescue or immediate release medication every 3 hours or longer
Does not complete baseline patient-reported outcome (PRO) assessment items required to determine stratification or whether the survivor meets inclusion and exclusion criteria
The patient and/or the patient's legally authorized guardian must acknowledge in writing that consent to become a study subject has been obtained in accordance with the institutional policies approved by the United States (U.S.) Department of Health and Human Services; informed consent must be signed prior to registration on study
Patient has bradyarrhythmia
Workshop A (2017 - 10 weeks- City of Hope)\r\n* Either one of the following:\r\n* City of Hope (COH) cancer patient (all types and at any time point of their disease) OR\r\n* Caretaker/friend family member of the cancer patient
FAMILY CAREGIVERS: Patient’s spouse, adult child, sibling, parent, other relative, or significant other (defined by the patient as a partner)
CAREGIVERS: Family member or friend of an eligible patient.
PATIENTS: Lacks decision-making capacity, as determined by the patient's oncologist.
Patient receiving active intravenous, intraperitoneal or oral chemotherapy
Patient at University of Michigan Gynecologic Oncology Clinic
The oncologist \would not be surprised if the patient died in the next year\
Patient is self-identified as African-American
Patient is anticipating leaving the area within the next 12 months
DCG: Identifies himself/herself as a DCG for the patient
DCG: Lives > 1 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
Any patient who is unable to comprehend and operate the activity tracker at the discretion of the enrolling provider
Participants will be recruited by BMT registered nurse (RN) coordinators and physicians prior to patient admission to the Pediatric BMT Unit; caregiver (age 18 years or older) of any patient eligible to undergo autologous or allogeneic BMT and any patient (age 10 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
Has unstable suicidal ideation as determined by the patient's treating psychiatrist
Patient should describe fatigue as being present for a minimum of four days
Patient who eats yogurt equal or more than once a day in the last 3 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
Coming with the patient at the Seidman Comprehensive Cancer Center at University Hospitals Case Medical Center (UHCMC)
Planned treatment for stages I – III cancer at VICC or at MMC (patient)
Treatment expected to last longer than 12 months since this will make it impossible to deliver the end of therapy survivorship care planning session within the study timelines (patient)
Patient expresses inability or unfamiliarity with using SMS/MMS messaging on their phone and is unwilling to be trained in the use of this technology
Caregivers do not need to reside with the patient
Patient with known tracheobronchial anatomical anomalies
Patient requiring sizes not available in DLT or VDLT
The patient has a cell phone capable of receiving text messages
PATIENT: Be those whose attending medical oncologist would not be surprised if the patient died in the next 12 months
PATIENT: Be willing and able to travel to the class location for 6 weekly 2-hour sessions
PATIENT: Not have completed a Physician Orders for Scope of Treatment (POST) form
CANCER PATIENT GROUP: Caucasian or African-American/Black
NON-CANCER PATIENT GROUP: Caucasian or African-American/Black
NON-CANCER PATIENT GROUP: Sedentary defined as < 60 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
Patient unable or not willing to perform all study related biopsies and blood draws for exploratory endpoints will not be enrolled on study as all study related procedures are mandatory
The patient must be less than 6’ 6” in height
The patient must feel comfortable in the prone position
Patient is allergic to components of the study drug; for arms A and B only, patient has perviously taken ibrutinib
Patient has a Patient Generated Subjective Global Assessment (PG-SGA; the patient-reported version of the Eastern Cooperative Oncology Group score) > 2
Patient does not have working phone service
Patient’s 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
Permission from the attending medical oncologist if the patient is currently on an interventional cancer therapy trial
Neutropenia (absolute neutrophil count < 1.0) (bloodwork is not required if patient did not have recent chemotherapy within last 2 weeks)
Relative or friend of patient participant who will likely accompany the patient to clinic visits
Patient on psychiatric hold
Insomnia present for >= 30 days per patient report
Severe marital maladjustment that prevents a patient from benefiting from the proposed intervention (< 85 on the Locke-Wallace Marital Adjustment Test)
Patient must have adequate kidney function as measured by eGFR greater than or equal to 50 calculated from a standard care serum creatinine performed within 30 days prior to the PN; patient must be able to give written informed consent
Patient has a single functioning kidney
Radiation oncology and medical oncology consults must deem patient suitable for protocol treatment
Patient being treated at St. Jude Children's Research Hospital
Pre-morbid condition that prevents patient from ambulating
Patient participating in another biomedical/oral health interventional research study
Patient deprived of freedom, under supervision or guardianship
Patient being treated at St. Jude Children’s Research Hospital
Patient currently residing in a skilled nursing facility
CAREGIVERS ONLY: Able to attend the last two days of the retreat with patient
Bothersome hot flashes (defined by their occurrence >= 28 times per week [about 4 per day]) and of sufficient severity to make the patient desire therapeutic intervention
Patient with poor bowel preparation
INHALATION: Patient has known respiration problems (i.e., emphysema)
Medical comorbidities making surgery unsafe as determined by the patient's surgeon
PATIENT (AS PER SELF-REPORT)
Patient has taken phenothiazines (prochlorperazine, fluphenazine, perphenazine, thiethylperazine, chlorpromazine, etc.) for any indication within the last 48 hours prior to the start of treatment with study drug
Patient elects to undergo active surveillance
Patient has taken finasteride or dutasteride during the prior 6 months
Patient or the patient's legally authorized guardian must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible side effects), and must sign an informed consent in accordance with the institutional policies approved by the U.S. Department of Health and Human Services
Patient is enrolled on an investigational nonmyeloablative HCT protocol or a nonmyeloablative treatment plan with postgrafting CSP that does not use acute GVHD as its primary endpoint (protocol 2546 serves as adjunct protocol); OR
Patient is not enrolled on an investigational nonmyeloablative HCT protocol, in which case protocol 2546 serves as an independent primary treatment protocol and the patient must meet the following inclusion and exclusion criteria:
Patients < 12 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 30 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
Patient not already seen by UKanQuit staff as part of the hospital based clinical service
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          1. Patient, male or female, is at least 18 years of age.\n\n          2. 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          3. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n\n          4. Patient is able to take oral medications.\n\n          5. Female patient, if of childbearing potential, has a negative serum pregnancy test\n             within 72 hours prior to taking study drug and agrees to abstain from activities that\n             could result in pregnancy from enrollment through 120 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               -  ?45 years of age and has not had menses for > 1 year.\n\n               -  Amenorrheic for < 2 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          6. Male patient agrees to use an adequate method of contraception starting with the first\n             dose of study treatment through 120 days after the last dose of study treatment..\n\n          7. 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 1):\n\n        Patients screened for the normal hepatic function group must meet the following additional\n        criteria to be eligible for enrollment:\n\n          1. Patient has no history of hepatic impairment.\n\n          2. Patient has liver function test (LFT) results within normal range:\n\n               -  Total bilirubin ? ULN\n\n               -  Aspartate aminotransferase (AST) ? ULN.\n\n               -  INR ?1.5 X ULN unless the patient is receiving anticoagulant therapy and the INR\n                  is within therapeutic range of intended use of anticoagulants.\n\n          3. Patient has adequate hematologic and renal function as defined below:\n\n               -  Absolute neutrophil count ?1500/µL\n\n               -  Platelets ?100,000/µL\n\n               -  Hemoglobin ?9 g/dL\n\n               -  Serum creatinine ?1.5 × ULN or a calculated creatinine clearance ?60 mL/min using\n                  the Cockcroft-Gault equation.\n\n        Patients with moderate hepatic impairment (Group 2):\n\n        Patients screened for the moderate hepatic impairment group must meet the following\n        additional criteria to be eligible for enrollment:\n\n          1. Patient has stable, moderate hepatic impairment, defined as:\n\n               -  BILI: >1.5 × to 3 × ULN, for at least 2 weeks prior to Day 1\n\n               -  AST: Any value\n\n               -  INR less than 1.8 unless the patient is receiving anticoagulant therapy and the\n                  INR is within therapeutic range of intended use of anticoagulants.\n\n          2. Patient has hematologic and renal function as defined below:\n\n               -  Absolute neutrophil count ?1000/µL\n\n               -  Platelets ?75,000/µL\n\n               -  Hemoglobin ?8 g/dL\n\n               -  Serum creatinine ?1.5 × ULN or a calculated creatinine clearance ?60 mL/min using\n                  the Cockcroft-Gault equation.\n\n          3. 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          1. Patient has undergone palliative radiotherapy within 1 week of study drug\n             administration, encompassing >20% of the bone marrow.\n\n          2. Patient is starting chemotherapy within 3 weeks of study drug administration.\n\n          3. Patient has a known hypersensitivity to the components of niraparib or excipients\n\n          4. Patients who received colony-stimulating factors within 2 weeks prior to the first\n             dose of study treatment are not eligible.\n\n          5. Patient has persistent chemotherapy associated Grade 2 or greater toxicity except for\n             neuropathy, alopecia or fatigue.\n\n          6. Patient has symptomatic uncontrolled brain or leptomeningeal metastases.\n\n          7. Patient has undergone major surgery within 3 weeks of starting the study or patient\n             has not recovered from any effects of any major surgery.\n\n          8. 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          9. Patient has received a transfusion (platelets or red blood cells) within 3 weeks of\n             receiving niraparib.\n\n         10. Patient is pregnant, breastfeeding, or expecting to conceive children while receiving\n             study treatment or for 3 months after the last dose of study treatment.\n\n         11. Patient has a known history of myelodysplastic syndrome (MDS) or acute myeloid\n             leukemia (AML).\n\n             NOTE: Exclusion Criteria 12-16 apply patients participating in the PK phase of the\n             study.\n\n         12. Patient is currently receiving, or unable to refrain from taking from 4 days prior to\n             dosing until the time of the last PK blood draw, any of the following cytochrome (CYP)\n             1A2 substrates: alosetron, duloxetine, melatonin, ramelteon, tacrine, tizanidine, and\n             theophylline.\n\n         13. Patient is unable to refrain from any intake of grapefruit or grapefruit juice within\n             4 days of the first administration of niraparib until the final PK sample collection.\n\n         14. Patient is currently receiving, or unable to refrain from taking from 4 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         15. Patient is taking proton pump inhibitors, antacids, or histamine 2 (H2) blockers\n             within 48 hours prior to niraparib administration, and/or within 6 hours after\n             niraparib administration.\n\n         16. 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 2):\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          1. Patient has hepatic encephalopathy, severe portal hypertension and/or porto-systemic\n             shunt.\n\n          2. Patient has fluctuating or rapidly deteriorating hepatic function as determined by the\n             investigator within the screening period.\n\n          3. Patient has acute liver disease caused by drug toxicity or by an infection.\n\n          4. Patient has biliary obstruction or other causes of hepatic impairment not related to\n             parenchymal disorder and/or disease of the liver.\n\n          5. Patient has esophageal variceal bleeding within the past 2 months.\n\n          6. Patient is receiving anticoagulant therapy with warfarin or related coumarins.\n\n          7. 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 (< 15 days from initial surgical patient evaluation)
HIV-positive patient at Thomas Street Health Center
The patient must be willing to provide blood, urine, stool and saliva samples as required by the study
Patient must be cleared for bevacizumab administration with respect to any recent surgeries, and post-surgical scans must confirm the presence of measurable residual disease
The patient has diagnosed cancer of the cervix, vulva, or endometrium
The patient has an intermediate risk of malignancy (5-65% per the Mayo Model) and is in need of diagnosis for alternative treatment, OR The patient has a high probability of cancer (>65%) 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 18F-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, < 2 months on these medications or a change in the prescribed dose in the past 2 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 18 for this study.
The patient is found to have unfavorable anatomy to indicate that stereotactic biopsy could not be safely performed.
Patient may be of any race/ethnicity
Patient girth exceeds the bore of the PET/MRI scanner
Patient with metastatic disease (from primaries other than lung) who have suspicious mediastinal or hilar LN that require sampling
Presence of visual impairment to an extent that the patient is unable to complete the computer testing
Inability to adequately oxygenate the patient during the procedure
Acute respiratory failure with hypercapnia (unless the patient is intubated and ventilated)
Patient is being considered for SBRT
PATIENT: Patients with congenital heart defects
Patient must be seen at the St. Louis Children’s 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 6 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 2 months washout period is needed if the patient was treated with tamoxifen) who are going to be treated with ET
Any patient with tachycardia defined as heart rate (HR) of 100 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 50 Gy in 25 fractions)
The patient has an orbital mass which needs further diagnostic evaluation before treatment or for monitoring
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
The patient and/or the patient’s legally authorized guardian must acknowledge in writing that consent to become a study subject has been obtained, in accordance with institutional policies approved by the US Department of Health and Human Service
Any patient with permanent braces, permanent retainers or nonferrous implant that, in the judgement of the principal investigator, would interfere with obtaining spectroscopy in the area of the tumor
Patient is ? 18 years old at the time of the drug administration (Patient may be male or female of any race / ethnicity.)
Patient declines procedures that might be necessary for optimal primary cytoreduction (i.e. colostomy or splenectomy)
The protocol nurse will check with the patient that there is no history of (h/o) kidney disease
Patient is participating in other research protocols at the time of the NaF/FDG PETMRI scan
Patient with sinonasal carcinoma
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 10 weeks after the MRI or patient is diagnosed with invasive disease, the patient should register to Step 2, 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 3, 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 3
Patient may be part of other clinical trials (as long as no other local treatments beyond GK such as WBRT or other local therapy are indicated to the brain) or imaging studies
Patient must not require sedation for imaging purposes
Surgeon and medical oncologist agree one week window trial is appropriate/safe for the patient and that surgery appointment/initiation of therapeutic systemic therapy can accommodate treatment schedule as outlined in the study schema
Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements
The patient has hepatic dysfunction confirmed by bilirubin > 2 x normal (based on reference values from the laboratory used by the patient)
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
The principal investigator determines that the patient is acting in ways that would lessen their chances of completing the study
Patient must have selected mastectomy for surgical option of treatment
Patient has two separate same histology lung tumors (where the question of two separate primaries or metastatic disease makes definitive clinical staging inaccurate)
Patient gives informed or surrogate consent
Patient will have vocal fold leukoplakia or other abnormal epithelial changes
As judged by the investigator, the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions, and requirements
* Patient volunteers for the DW- and DCE-MRI sequence parameter optimization portion of the study are exempt from these criteria
* Patient volunteers for the DW- and DCE-MRI sequence parameter optimization portion are exempt from these criteria
In the opinion of the investigator, the patient is felt not to be appropriate for the study
As judged by the investigator, the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions, and requirements
A member of the patient’s 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 S1316 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: Willingness to be audio-recorded as per self-report
CAREGIVERS: A relative or a friend upon whom the patient relies for help and who will be likely to be present during hospitalization, or willing to participate by phone
Patient on the gynecologic oncology service
A referring physicians estimate of patient life expectancy must be between 1-12 months
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.
The patient is receiving colony stimulating factors (CSFs) that cannot be held during the monitoring period for dose-limiting toxicities (DLT).
Inclusion criteria:\n\n        1)15-29 year olds receiving treatment for any type of cancer, either primary or\n        recurrent/relapsed disease.\n\n        2) Patient has completed at least one month of therapy\n\n        3)Patient is expected to remain on therapy for 3 month duration of study\n\n        4) Patient has an iPhone, iPad, or iTouch running iOS 4.0 or later\n\n        5) Patient is willing to use a smart-phone medication reminder application-\n\n        Exclusion Criteria:\n\n        1)Patients who are unable to speak/read/write English as required for use of smart-phone\n        medication reminder application and completion of study measures.
Inclusion criteria:\n\n        1)15-29 year olds receiving treatment for any type of cancer, either primary or\n        recurrent/relapsed disease.\n\n        2) Patient has completed at least one month of therapy\n\n        3)Patient is expected to remain on therapy for 3 month duration of study\n\n        4) Patient has an iPhone, iPad, or iTouch running iOS 4.0 or later\n\n        5) Patient is willing to use a smart-phone medication reminder application-\n\n        Exclusion Criteria:\n\n        1)Patients who are unable to speak/read/write English as required for use of smart-phone\n        medication reminder application and completion of study measures.
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