Participants MUST receive appropriate care and treatment for HIV infection, including antiretroviral medications when clinically indicated, and should be under the care of a physician experienced in HIV management; participants will be eligible regardless of antiretroviral medication (including no antiretroviral medication) provided there is no intention to initiate therapy or the regimen has been stable for at least 4 weeks with no intention to change the regimen within 12 weeks following enrollment
Supportive care and other medications that are considered necessary for the subject’s wellbeing may be given at the discretion of the investigator
Patients with porphyria or psoriasis are ineligible unless the disease is well controlled and they are under the care of a specialist for the disorder who agrees to monitor the patient for exacerbations
Patients who, in the judgment of their treating physician, have available standard of care therapies will be excluded
Patients who are women of childbearing potential must have a negative pregnancy test documented =< 14 days prior to registration; this is not specific to dose escalation and is mandatory for standard care for patients being treated with radiation therapy; the cost of this test will be covered by standard of care
Grade >1 gastrointestinal toxicity that cannot be managed with supportive care measures.
Progressed following all standard of care therapies for advanced breast cancer. OR
Received standard of care treatment for primary malignancy and standard of care treatment for relapsed cancer
History of two or more episodes of acute chest syndrome (ACS) in the 2-year period preceding enrollment despite the institution of supportive care measures (i.e. asthma therapy);
Demonstrated lack of compliance with prior medical care as determined by referring physician.
Histologically-diagnosed, advanced Gl tumors that have relapsed or are refractory to or are not considered medically suitable to receive standard of care treatment (Dose Expansion Phase)
Histologically-diagnosed advanced colorectal tumors that have relapsed or are refractory to or are not considered medically suitable to receive standard of care treatment (Phase 1b)
Demonstrated lack of compliance with prior medical care
Failure of, inability to, or refusal to receive standard of care.
Expansion cohort(s): Progression during or following at least 1, and up to 5, previous systemic therapies, consistent with the standard of care for the specific tumor type.
Patients must have histological diagnosis of melanoma or non-small cell lung cancer (biopsy will be done per standard of care, if needed to prove metastatic melanoma and/or NSCLC as well as for clinically relevant mutation analysis); additional biopsy will be per standard of care
All melanoma patients may be tested for BRAF as part of routine standard of care, but is not a requirement for the trial; all NSCLC patients may be tested for with EGFR and ALK as part of standard of care, but is not a requirement of the trial
Patients must have previously received and progressed on standard-of-care therapy(ies).
CMML that is refractory to, or progressed following treatment with a hypomethylating agent or other standard of care treatment
Subject has any evidence of metastatic disease (pre-operative staging will be undertake per urologic standard of care) as deemed by the Investigator
Must have received appropriate standard of care
Concomitant medication(s) that may cause QTc prolongation or induce Torsades de Pointes, with the exception of anti-microbials that are used as standard of care to prevent or treat infections and other such drugs that are considered by the Investigator to be essential for the care of the patient.
Any cancer-related therapy for the current disease within 2 weeks of screening (all supportive care measures are allowed)
Must have refused standard of care chemotherapy for metastatic disease
Surgically sub-total or unresectable tumors, i.e. in insula, including but not limited to the insula and received standard of care (SOC) radiation
ARM I INCLUSION CRITERIA: Subject is eligible for and agrees to receive standard of care stereotactic radio surgery with or without prior neuro-surgical intervention
ARM II INCLUSION CRITERIA: Subject is eligible for and agrees to receive standard of care radiation and temozolamide after biopsy or maximum safe surgical resection
Lack of insurance coverage or funding to support cost of care.
Prior treatment with sipuleucel-T (on clinical trial or as part of standard of care)
Demonstrated lack of compliance with prior medical care
The patient must have completed chemoradiation with radiation therapy and temozolomide of the primary tumor according to standards of care
Contra indication or intolerance to required supportive care medications (aspirin and acyclovir)
Subject meets standard of care eligibility criteria for consideration of treatment with immunotherapy using a checkpoint inhibitor following surgical resection
Any cancer-related therapy for the current disease within 2 weeks of screening (all supportive care measures are allowed)
Patients must have progressive tumor growth after having received established standard of care treatment for their disease
Must have a histological diagnosis of epithelial adenocarcinoma of ovarian, tubal or peritoneal origin that is persistent or progressive following multiple rounds of prior standard of care and experimental therapy.
Meets standard of care to undergo embolization
Follow standard of care donor eligibility procedure, outlined in the standard operation procedure (SOP)
Completion of at least one standard of care IV chemotherapy course; hematologic recovery must be confirmed prior to study entry;
Being considered for trabectedin as standard of care
Planning to undergo additional treatment for the brain tumor other than standard of care
Patients must be willing to undergo endotracheal intubation, mechanical ventilation, dialysis, cardiopulmonary resuscitation (CPR), and electrical defibrillation; patients must be willing to receive vasopressor drugs and all other standard intensive care unit interventions; any living will must be amended to allow these interventions or the patient will not eligible
Patients with psoriasis are ineligible unless the disease is well controlled, and they are under the care of a specialist for the disorder who agrees to monitor the patient for exacerbations
Any candidate eligible for standard of care Y90 radioembolization for treatment of their primary or metastatic liver tumors
Must be eligible for treatment with nivolumab as standard of care
Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care. Participants should consent and enter the study within a maximum of 8 weeks of their last dose of ixazomib in the parent study or as agreed by the Millennium clinician/designee.
Recurrence or progression of disease (confirmed by MRI and measurable by RANO criteria) following receipt of standard of care therapy, which includes maximum safe surgical resection, standard adjuvant radiation/temozolomide treatment. Participants must have completed at least 21 days of temozolomide treatment in combination with radiation therapy to be considered to have received standard of care therapy.
Concomitant medication(s) that may cause QTc prolongation or induce Torsades de Pointes, with the exception of anti-microbials that are used as standard of care to prevent or treat infections and other such drugs that are considered by the Investigator to be essential for patient care
Subjects must be planning to start standard of care radiation therapy and chemotherapy
Karnofsky score of 60% or better (“requires occasional assistance, but is able to care for most of his/her needs”)
Failed any previous front line standard of care therapy that is currently used for the patient’s initial diagnosis
Patients who are refusing first line standard of care chemotherapy
EGFR wt as per patient standard of care by a validated test
AND ALK-negative rearrangement as part of the patient standard of care by a validated test
Cancer treatment other than radiation therapy, including investigational or standard of care, within 30 days prior to treatment with REGN2810
Vaccinations initiated between 3 weeks and 3 months from completion of SoC multi-modality cancer care
Carboplatin and/or paclitaxel defined by the Investigator based on the Food and Drug Administration (FDA) approved labeling or institutional standard of care (SOC)
Anticoagulants < 7 days prior to Day 1. Aspirin is permitted in Phase 1b per standard of care with lenalidomide-based therapy.
Completed all standard of care therapy (surgery + radiation as clinically necessary) prior to vaccination
EXCLUSION CRITERIA FOR ENROLLMENT: The patient’s life expectancy is =< 90 days even with aggressive treatment and/or supportive care, as determined by the treating hematologist/oncologist
EXCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: The patient’s life expectancy is =< 90 days even with aggressive treatment and/or supportive care, as determined by the treating hematologist/oncologist
Documented progression of disease according to RECIST v1.1 following primary standard of care (e.g. erlotinib, gefitinib) Group 2 patients:
Documented progression of disease according to RECIST v1.1 following standard of care (e.g. platinum doublet).
Patients with psoriasis are ineligible unless the disease is well controlled, and they are under the care of a specialist for the disorder who agrees to monitor the patient for exacerbations
Received transplant care locally and will remain in the Houston area for at least 6 weeks post Viralym-A infusion.
Have failed, or could not tolerate, other standard of care therapies
Have an active systemic bacterial or fungal infection requiring antimicrobial therapy (prophylactic antimicrobial therapy administered as standard of care is allowed)
MAIN STUDY COHORT EXCLUSION CRITERIA: Pregnancy (as determined by point of care test administered in accordance with the policies of the Department of Nuclear Medicine)
RENAL CELL CARCINOMA (RCC) COHORT EXCLUSION CRITERIA: Pregnancy (as determined by point of care test administered in accordance with the policies of the Department of Nuclear Medicine)
Patients who have completed standard of care and recovered with mild to no residual toxicity from recent therapy
Patients with psoriasis are ineligible unless the disease is well controlled and they are under the care of a specialist who agrees to monitor the patient for exacerbations
Planned stereotactic biopsy as standard of care (i.e., for confirmation of disease progression)
Unresponsive to currently available therapy and there is no standard-of-care therapy available in the judgment of the investigator.
History of grade 3 or higher radiation induced pneumonitis (severe, limiting self care activities of daily living [ADL], requiring oxygen)
Uncontrolled infections not responding to antimicrobial therapy or requiring intensive critical care or vasopressors
Intensive care unit (ICU) care, life expectancy of less than 28 days, ongoing or unresolved hepatic sinusoidal obstruction syndrome, unstable hemodynamics, or evidence of current or previous clinically significant disease, medical condition or finding (including vital signs and ECG) that in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data
Health care coverage.
Patient has a desire to preserve organ, understanding the risks of delaying standard of care
For stratum A, patients must have local recurrent disease (defined as negative spine magnetic resonance imaging [MRI] and negative cytology within 21 days prior to study registration) and undergo resection of local recurrence as part of their standard of care; children must have undergone what is considered the standard of care as upfront therapy including either surgery followed by high dose chemotherapy with stem cell rescue or multi-modality therapy of surgery, radiation and chemotherapy
ARM A: Child Pugh Score A (patients with ascites must have paracentesis performed within scope of standard of care, to be able to successfully perform intratumoral injection procedure)
Uncontrolled infections not responsive to antimicrobial therapy requiring intensive critical care
Subjects must be within 4 to 6 weeks of standard of care treatment for their particular stage of disease
Subjects must not be more than 6 weeks from standard of care treatment for their particular stage of disease
Demonstrated lack of compliance with prior medical care
Both patients who will and will not receive standard of care concomitant mitomycin C are eligible to enroll in this study
Eligibility for brachytherapy is determined per clinical standard of care
Unable to perform self-care during radiation isolation
Antiviral therapy per local standard of care if active hepatitis B (HBV) infection.
Contraindications to the planned second line standard-of-care chemotherapy regimen
Subjects who are eligible for further standard of care endocrine treatment.
Any evidence of metastatic disease; pre-operative staging will be undertaken per urologic standard of care
Patients in expansion cohort A will have a biopsy (which is standard of care) at the time of progression that shows evidence of MET positivity
Complete supportive and palliative care will continue to be provided to ameliorate signs and symptoms that were pre-existing or may arise while on study and which do not interfere with the objectives of the study
Patients with psoriasis are ineligible unless the disease is well controlled and they are under the care of a specialist for the disorder who agrees to monitor the patient for exacerbations
Eligible to receive standard of care chemotherapy and/or surgery based upon standard practices or institutional guidelines
Failure of at least one prior standard of care chemotherapy for advanced stage disease
Subject must be receiving treatment in an ICU, or in an acute care setting (e.g., ER, RR)
In countries where continuous anti-HER2 therapy is considered standard of care for HER-2 positive metastatic disease, HER-2 positive subjects are not eligible.
Patients undergoing Surefire DEB-TACE procedure as clinically determined to be part of their standard of care treatment plan
Ability to elect radiotherapy care in conjunction with their physician
Must have failed at least 1 standard of care systemic therapy for their malignancy
Patients will have cytoreductive surgery as part of their routine care for recurrent tumor
Prior to randomization, patients with metastatic disease must have been treated with established standard-of-care therapy, or physicians have determined that such established therapy is not sufficiently efficacious, or patients have declined to receive standard-of-care therapy
Any standard contraindications to myeloablative HSCT per standard of care practices at COH
Subjects have already undergone all standard of care surgery appropriate for stage of disease.
Patients must be on standard of care lenalidomide maintenance therapy for at least 6 months at the time of study enrollment.
Patient must require a new pre-treatment biopsy as part of their standard of care work-up
Patient does not require a pre-treatment biopsy as part of their standard of care work- up
Due to risk of disease exacerbation patients with psoriasis are ineligible unless the disease is well controlled and they are under the care of a specialist for the disorder who agrees to monitor the patient for exacerbations
Must have established relationship with primary care physician and provide contact information
Karnofsky score of 60% or better (requires occasional assistance, but is able to care for most of his/her needs)
Use of concomitant drugs that prolong QT/QTc interval are prohibited with the exception of antibiotics, antifungals, and other antimicrobials that are used as standard of care to prevent or treat infections and other such drugs that are considered absolutely essential for the care of the patient, but only if clinically indicated and must be fully documented.
All prospective participants must have an Ommaya reservoir (or equivalent ventricular access device) inserted as part of their standard clinical care prior to initiation of study treatment
Written informed consent obtained from the patient prior to performing any study-related procedures, including screening visits; available computed tomography (CT) scans, bone scans, and labs performed as standard of care prior to signing consent can be used to fulfill eligibility requirements if they were performed within 4 weeks of the first dose of AVX901; available multi gated acquisition scan (MUGA), echocardiogram, and electrocardiogram (EKG) performed as standard of care prior to signing consent can be used to fulfill eligibility requirements if they were performed within 8 weeks of the first dose of AVX901
Patients in whom surgical excision of the tumor is part of standard of care management
Been treated for early breast cancer with standard of care duration of trastuzumab.
Patients who have demonstrated relapse to 3 or more prior regimens of SM treatment (not including those given for supportive care)
Patients must be planning to undergo standard of care treatment with surgery and radiation therapy.
ELIGIBILITY CRITERIA – RECIPIENT ON STANDARD CARE THERAPY
EXCLUSION CRITERIA – RECIPIENT ON STANDARD CARE THERAPY
Patient is expected to undergo autologous HPC transplantation that is consistent with standard of care
Demonstrated lack of compliance with prior medical care
Uncontrolled infections not responsive to antimicrobial therapy requiring intensive critical care
Dose Escalation Phase: Have a documented diagnosis of a lymphoid hematological malignancy as described by the 2008 World Health Organization (WHO) classification that requires therapy and for which there is no standard of care or standard of care is not expected to be effective. Subjects must not be candidates for anti-tumor regimens known to provide clinical benefit. MM Dose Expansion Cohort:
Patients currently on other protease inhibitors; patients can be switched to an alternative combination antiretroviral therapy regimen, as deemed appropriate by their HIV care provider
Pathologically proven diagnosis of breast cancer with clinical evidence of recurrent disease on the chest wall following treatment that included radiotherapy, and for which there is no current standard of care or curative resection able to be performed
Has had within the past 6 months the occurrence or persistence of one or more of the following medical conditions that could not be controlled with usual medical care (e.g., required emergency care or hospitalization): hypertension, angina, congestive heart failure, diabetes, seizure disorder.
Participants for whom no further standard of care therapy exists, must have received standard of care chemotherapy in the adjuvant or advanced/metastatic setting
Standard (i.e., includes at least taxane + anthracycline) NAC and definitive surgery planned; (NOTE: NAC chemotherapy will be per standard of care, and not dictated by this clinical trial)
No standard care available
PLD at the dose and schedule being used might be considered standard of care
Received transplant care locally and will remain in the Houston area for at least 6 weeks post Viralym-C infusion
Subjects scheduled for VATS lobectomy in accordance with their institution's Standard Of Care;
Hemodynamically stable, consistent with standard of care values for patients undergoing elective tumor resection
Patient willing to undergo scheduled standard of care TRUS guided biopsy
Must have undergone biopsy after development of acquired resistance to erlotinib (which is performed as standard of care) with adequate tissue to determine EGFR T790M and tumor histology; slides from an outside institution may be used
- The remaining standard available therapy as recommended by investigator is best supportive care (note: previous treatment with regorafenib and TAS 102 are allowed and these agents should be administered before study if available to patient according to local standards)
PART II: ECOG performance status of 3-4\r\n* Grade 3 = Capable of only limited self care, confined to bed or chair more than 50% of waking hours\r\n* Grade 4 = Completely disabled; cannot carry on any self care; totally confined to bed or chair and in terminal stages of disease
Arm 2 only: Histologically or cytologically confirmed diagnosis of metastatic adenocarcinoma of the colon or rectum which is refractory to or has failed standard treatments, or participant is not considered medically suitable to receive standard of care treatment or refuses standard of care treatment
Patients with histologically confirmed diagnosis of MB, who have experienced relapse or progression after standard-of-care therapy including radiotherapy. Patients currently receiving steroids must have been on a stable (or decreasing) dose for at least 5 days before initiating study therapy.
Severity of any medical illness that, in the Investigator's judgement, justifies hospitalization of the subject for treatment and supportive care
Approval for allogenic regimen given at Patient Care Conference
All patients in both group 1 and 2 will also be referred to radiation and medical oncology for standard of care adjuvant therapy with or without PDT therapy
The patient received induction and consolidation therapy according to the Institution's standard of care.
Patients with bilateral pulmonary metastases from sarcomas, melanomas, germ cell tumors, or epithelial malignancies metastatic to the lungs, mediastinum, or pleura who can be rendered no clinical evidence of active disease (NED) or minimal residual disease (MRD) by standard of care metastasectomy where NED refers to diagnostic tests failing to detect presence of disease and MRD refers to low-volume, subclinical disease which is not amenable to standard of care biopsy for histologic confirmation and poses no immediate threat to patient health and would not otherwise warrant standard of care treatment but surveillance instead
Zubrod performance status > 2, or self-reports either not being up and about more than 50% of waking hours or unable to provide self-care
In phase 2, subjects are also required on accrual to be referred to palliative care
Designated by the patient as a person closely involved in their care
CLINICAL STAFF: Nurses, physicians, physician assistants, or support staff and perform direct patient care in the thoracic oncology clinic
Had their cancer care primarily managed by either Johns Hopkins Medical Institution (JHMI) or Peninsula Regional Medical Center (PRMC), with JHMI or PRMC primarily responsible for the patients’ survivorship care
Did not have cancer care primarily managed within one of the 4 participating clinics, or JHMI or PRMC is not primarily responsible for the patients’ survivorship care
Children in foster care or with unclear custody (i.e. children admitted with non-accidental trauma)
COHORT C SPECIFIC INCLUSION: Histologically confirmed IDH mutant glioma, meningioma, or ependymoma that has recurred despite previous standard of care therapy; because this cohort is, in part, meant to allow patients access to therapy who might not otherwise be eligible for other clinical trials - deviations from standard of care treatment can be presented to and approved by the principal investigator for inclusion in the study
on maintenance standard-of-care chemotherapies or on treatment holiday
Patients not receiving care at Massachusetts General Hospital (MGH)
Patients receiving supportive care alone
(Patient participation) First outpatient consultation visit with a palliative care specialist
Diagnosis of glioblastoma requiring standard care chemoradiation of concurrent Temozolomide and 60 gray (Gy) of radiation given over 30 treatments
Are unable to walk or to complete the 6-minute walk test\r\n* According to our current standard of care, those participants will be referred to physical therapy for evaluation and treatment and will be excluded from the study as unsupervised exercise would not be safe
Has a primary care provider at Columbia University Medical Center (CUMC)/New York Presbyterian (NYP)
PATIENTS: Admitted to the acute palliative care unit
PATIENTS: Patients with hematologic cancer receiving care at a participating clinic.
HSCT CLINICIANS: Member of MSKCC BMT patient care team for at least one year
Patients in the intensive care units will not be eligible
Patients already seeing pharmacy as a part of their care
Palliative Care Clinician: Current MGH palliative care clinician (board-certified physicians or mid-level practitioners)
Phase II: Patients will be excluded from participating in this research study if they:\r\n* Are already receiving palliative care in the outpatient setting\r\n* Need immediate palliative care and/or hospice care (as determined by their oncology team)\r\n* Have active, untreated, unstable, serious mental illness (e.g., active, untreated psychotic, bipolar, or substance-dependence disorder) interfering with ability to participate\r\n* Have a cognitive impairment (e.g., delirium, dementia) interfering with ability to participate
ECOG PS of 3 (capable of limited self-care; confined to a bed or chair > 50 % of waking hours) or 4 (cannot carry on any self-care; totally confined to bed or chair)
PHASE 2: PATIENT ELIGIBILITY: Currently does not independently self-manage follow-up care according to self-report (i.e., reports low readiness to assume total responsibility for care [score of 1 or 2 out of 4 on overall readiness item OR scores < 3 on any of the 10-item responsibility scale) using the Readiness for Transition Questionnaire)
PHASE 3B: PATIENT ELIGIBILITY: Currently does not independently self-manage follow-up care according to self- report (i.e., reports low readiness to assume total responsibility for care [score of 1 or 2 out of 4 on overall readiness item OR scores < 3 on any of the 10-item responsibility scale) using the Readiness for Transition Questionnaire)
Receives ongoing care from a medical oncologist at the Seidman Cancer Center (SCC)
Identifies a DCG involved in his/her care, support, or care planning
The patient sample is limited to patients with advanced cancer and/or patients receiving ongoing care from a medical oncologist
Willing to be randomized to either standard care or intervention group
Unwilling to be randomized to either standard care or intervention group
Actively receiving care at the Duke Cancer Center, Durham Regional Hospital, or Duke Raleigh Hospital
Seen at Supportive Care, cardiopulmonary center, thoracic radiation oncology or thoracic medical oncology
Involved in direct patient care
Research nurses, nurses without direct patient care, and nurse managers/directors (i.e. not involved in direct patient care)
Admitted to Burke Services (WBG 5th floor) with plans for inpatient myelosuppressive chemotherapy (with standard of care or protocol regimens) (this will include induction for patients with low risk APL)
Patients undergoing a cord blood or haploidentical transplantation on any protocol or standard of care treatment plan
Known allergy to the standard of care or ingredients in KeraStat Cream
Patients seen in the outpatient palliative care clinic or inpatients seen by the palliative care consult team or the fatigue clinic
Patients with disposition to be transitioned to inpatient hospice or inpatient palliative care unit
Patients admitted to the intensive care unit
PATIENTS: In hospice care
Providing the majority of the informal (unpaid) care during RT for a patient meeting inclusion criteria
CARE-RECIPIENTS
CARE-RECIPIENTS: Has an additional cancer diagnosis
Have already made a decision to not undergo any cancer treatment (e.g., being followed in best supportive care or hospice)
CARE RECIPIENT:
Admission to intensive care unit on enrollment
Primary cancer care at the Massachusetts General Hospital (MGH) Cancer Center
Patients treated as outpatients by the supportive and palliative care team.
Previous psychological counseling received in supportive care department.
Score of >= 3 on Patient Care Monitor Sexual Concerns screening item
Be under the care of a MCC physician
ONCOLOGIST: Be willing to attend the 5-session MODEL Care program for providers at the specified location, date, and time
ONCOLOGY NURSE: Be willing to attend the 5-session MODEL Care intervention for providers at the specified location, date, and time
PATIENT: Be receiving care from a medical oncologist enrolled in the study
PATIENT: Have a family member or friend eligible and interested in participating in the MODEL Care study
PATIENT: Participants must be under the care of an oncologist (who does not practice as a palliative care physician for that patient), but their current plan may or may not include chemotherapy or other forms of tumor-directed therapies
Prior visit to a survivorship clinic or previously provided with a treatment summary and care plan
Currently on hospice care
Histologic proof of HCC reviewed and confirmed per the local standard of care
Participants in the expansion cohorts must have histological confirmation of AML, Multiple Myeloma, breast cancer, NSCLC, prostate cancer, SCLC, or NHL that is either refractory after standard of care therapy or for which standard of care therapy does not exist.
Caregivers: The person in the patient’s life who is primarily responsible for care decisions, emotionally invested in the patient’s care, provides instrumental care such as transportation, and available if randomized to the fPER group to participate in the majority of intervention sessions
Patient is receiving hospice care
Admitted to Acute Palliative Care Unit (APCU)
Receiving hospice care
Participation in the study must be approved by the physician directly responsible for the patient’s care while at University of North Carolina (UNC)-Hospitals
Patients who qualify for pulmonary rehabilitation as part of the standard of care and are covered by medical insurance
Caregivers will be eligible for enrollment if they identify as the person in the patient’s life who is primarily responsible for care decisions
Caregivers will be eligible for enrollment if they identify as the person emotionally invested in the patient’s care
Caregivers will be eligible for enrollment if they identify as the person who provides instrumental care such as transportation for a patient who is receiving HSCT
Receiving care at University of Michigan Comprehensive Cancer Center Gynecologic Oncology Clinic or at St. Joseph Mercy Hospital, Alexander Cancer Care Center
Planned greater than one night admission to the intensive care unit (ICU)
Scheduled to undergo bronchoscopy for malignant airway obstruction as standard medical care
Hospice care at enrollment
Elect to undergo transrectal ultrasound (TRUS)-guided prostate biopsy as part of routine clinical care
Is pregnant (confirmed by the patient as imaging clinic standard of care) or nursing mother
Health care centers
Health care centers serving low-income, Medicaid, and uninsured patients in Missouri and Illinois
Patients seen at the health care center (HC) in the preceding 2 years
Providers at selected primary care practices in the Cleveland Clinic Health System
Referral from a primary care physician for colonoscopy (either diagnostic or screening)
FOCUS GROUP: Who are enrolled at Group Health at least one year prior to mammogram, receive care in the greater Seattle area and have had a negative mammogram (breast imaging-reporting and data system [BIRADS] 1 or 2 assessment) as part of their routine care within the past 6 months
BETA/USABILITY TESTING: Who are enrolled at Group Health, receive care in the greater Seattle area and have had a negative mammogram (BIRADS assessment of 1 or 2) as part of their routine care
RANDOMIZED CONTROLLED TRIAL: Who are enrolled at Group Health, and have had a negative mammogram as part of their routine care
Participants must consent to two standard of care lower gastro-intestinal GI endoscopy (flexible sigmoidoscopy or colonoscopy) with biopsies that will be 12 months (+/-21 days) apart.
Participants must consent to one standard of care lower gastrointestinal (GI) endoscopy (flexible sigmoidoscopy or colonoscopy) with biopsies and one flexible sigmoidoscopy with biopsies that will be 6 months (+14 days) apart
Plan to initiate systemic cancer therapy within plus or minus (+-) 1 week of receiving the first dose of study drug with the intention of receiving systemic cancer therapy during the double-blind treatment period for an intended duration determined by the treating oncologist according to standard protocols of clinical care
Patients will be included in the study based on the following criteria:\n\n          -  Women 18 years or older\n\n          -  Node-positive breast cancer (AJCC N1, N2, or N3)\n\n          -  Node-negative breast cancer if negative for both estrogen (ER) and progesterone (PR)\n             receptors and have received chemotherapy as standard of care\n\n          -  Clinically cancer-free (no evidence of disease) after standard of care therapy\n             (surgery, chemotherapy, radiation therapy as directed by NCCN guidelines). Hormonal\n             therapy will continue per standard of care. Neoadjuvant chemotherapy is allowed.\n\n          -  Recovery from any toxicity(ies) associated with prior adjuvant therapy.\n\n          -  HER2 expression of 1+ or 2+ by IHC. FISH or Dual-ISH testing must be performed on IHC\n             2+ tumors and shown to be non-amplified by FISH (?2.0) or by Dual-ISH (?2.0).\n\n          -  HLA-A2, A3, A24, or A26 positive\n\n          -  LVEF >50%, or an LVEF within the normal limits of the institution's specific testing\n             (MUGA or Echo)\n\n          -  ECOG 0,1\n\n          -  Signed informed consent\n\n          -  Adequate birth control (abstinence, hysterectomy, bilateral oophorectomy, bilateral\n             tubal ligation, oral contraception, IUD, or use of condoms or diaphragms)\n\n          -  Must start study treatment (receive first Herceptin infusion) 15between 3-12 weeks\n             from completion of standard of care therapy.\n\n        4.1.3 Exclusion Criteria\n\n        Patients will be excluded from the study based on the following criteria:\n\n          -  Node-negative breast cancer (AJCC N0 or N0(i+)) unless negative for both estrogen (ER)\n             and progesterone (PR) receptors and has received chemotherapy as standard of care\n\n          -  Clinical or radiographic evidence of distant or residual breast cancer\n\n          -  HER2 negative (IHC 0) or HER2 3+ or FISHDual-ISH amplified (FISH >2.0); Dual-ISH >2.0\n\n          -  HLA-A2, A3, A24, A26 negative\n\n          -  History of prior Herceptin therapy\n\n          -  NYHA stage 3 or 4 cardiac disease\n\n          -  LVEF <50%, or less than the normal limits of the institution's specific testing (MUGA\n             or Echo)\n\n          -  Immune deficiency disease or HIV, HBV, HCV\n\n          -  Receiving immunosuppressive therapy including chemotherapy, chronic steroids,\n             methotrexate, or other known immunosuppressive agents\n\n          -  ECOG ?2\n\n          -  Tbili >1.8, creatinine>2, hemoglobin<10, platelets<50,000, WBC<2,000\n\n          -  Pregnancy (assessed by urine HCG)\n\n          -  Breast feeding\n\n          -  Any active autoimmune disease requiring treatment, with the exception of vitiligo\n\n          -  Active pulmonary disease requiring medication to include multiple inhalers\n\n          -  Involved in other experimental protocols (except with permission of the other study\n             PI)
Agrees to Loop Electrosurgical Excision Procedure (LEEP), Cold Knife Conization (CKC) or Hysterectomy being performed at the end of study according to the standard-of-care
Participants who plan to relocate outside of their provider’s service area or who plan to leave their primary care clinic in the next two years will be excluded
Previous standard of care anti-tumor treatment including surgery and/or biopsy and chemoradiation. The washout periods from prior therapies are intended as follows:
Must have a primary care provider (PCP)
Completion of primary standard of care breast cancer therapies (i.e., surgery, chemotherapy, immunotherapy and radiation therapy as appropriate per standard of care for patients' specific cancer)
Established prenatal care
Patients who have a short term CVC that have been placed in Intensive Care Unit (ICU) (mainly rigid wall CVCs placed for acute care in ICU)
It is encouraged that standard of care vaccinations are not offered during the 2 weeks preceding plasma HIV-1 RNA measurements, and that standard of care vaccinations are not administered at the same time as the study vaccine; routine vaccinations other than influenza vaccine that are administered after enrollment in the study should be given 1 month before or after HPV vaccination (or any visit where antibody titers are measured) during the study period. Influenza vaccination may be given within 1 week before or after HPV vaccination visits
Surgery/biopsy planned as part of clinical care that is anticipated to yield sufficient material to meet the minimum requirements for profiling; OR
Is pregnant (confirmed by the patient as imaging clinic standard of care) or nursing mother
Radiation to the recurrent or metastatic site is clinically indicated and would be considered standard care for palliation or for locoregional control
Women who have already had their standard of care post-NAT mammogram and/or breast MRI
Lung cancer patients receiving definitive radiation therapy defined as 45-75 Gy as part of  standard of care for their disease
Patient must be expected to undergo therapy with bevacizumab in combination with paclitaxel at recommended standard of care doses if suspected recurrence is confirmed with imaging
Patients under the care of a St. Jude Children's Research Hospital (SJCRH) physician
Planned standard of care surgery
Must be patients undergoing standard of care EGD for the confirmation of dysplasia in Barrett's esophagus (BE) or endoscopic eradication therapy (EET) for dysplasia in BE
Patients scheduled for 90Y radioembolization for HCC as part of their standard of care
Suspicion of gynecological malignancies that requires a standard of care surgical resection in the operating room
Inadequate tumor sites or volume to allow for biopsy per standard of care
Eligible for anti-EGFR monoclonal antibody (mAb) therapy as standard-of-care (SOC), either as a single agent or in combination with approved irinotecan-containing regimens
Subjects for whom participating would significantly delay the scheduled standard of care therapy
Subjects for whom participating would significantly delay the scheduled standard of care therapy
Standard of care CT abdomen examination planned with intravenous (IV) contrast.
Have standard of care biopsy or resection planned or tumors amenable to serial biopsies.
Participating would significantly delay the scheduled standard of care therapy
Scheduled for contrast CT (standard of care)
Any condition that excludes SLN biopsy as the standard of care (e.g. lymphadenectomy indicated)
Participants whose clinical care plan includes treatment with anti-angiogenic treatment-based therapy
Is in an intensive care setting
Multiparametric MRI of the pelvis (performed or planned) as routine care
Subject is hospitalized in the intensive care unit
Is pregnant (confirmed by the patient as imaging clinic standard of care) or nursing mother
fMRI and/or DTI required for preoperative imaging as part of the standard of care
All participants under the care of St. Jude physicians with known or suspected neoplastic disease are eligible for participation
INCLUSION CRITERIA FOR OPEN-ACCESS: All participants under the care of St. Jude physicians with known or suspected neoplastic disease are eligible for participation
Scheduled to receive therapy with trastuzumab plus chemotherapy as part of standard care
Scheduled to receive pre-operative therapy with trastuzumab plus chemotherapy as part of standard care
Presently planned for ongoing octreotide according to current standard of care for at least 12 months (i.e. throughout the study follow-up period)
Presently planned for restaging using contrast-enhanced computed tomography (CT) scans at baseline and at least every 6 months, as a part of their standard of care assessments
Under the care of a surgical attending
Patient scheduled for TRUS-guided prostrate biopsy with or without MR TRUS Fusion determined based on standard of care requirements
Known lung lesion(s) based on standard of care (SOC) non-contrast CT
Participants enrolled in other therapeutic protocols are eligible, except protocols involving a VEGF-receptor (R) inhibitor or radiation therapy outside the standard of care
Relapsed or refractory disease after a systemic standard of care treatment regimen and, if available, at least one standard of care salvage regimen
Progressive disease following or intolerant of or refuses standard of care systemic therapy
Patients on life support or in a critical care unit
Patients must have been referred for repeat tumor biopsy as part of standard care and the biopsy must have been approved by the appropriate biopsy service (interventional radiology or surgery); such approval includes review of medical history and laboratory parameters as per standard care
Patients who will undergo IVU using digital tomosynthesis and staging abdomino-pelvic CT as part of their routine care, will be invited to participate in this study
Planned standard of care surgery
Receiving care in the Breast Surgery Department at Columbia
Patients must be scheduled to receive a 3-Tesla (3T) MRI exam as part of their standard of care (this exam will be\r\nmodified to also include pulse sequences which are for research only)
Subjects for whom participating would significantly delay the scheduled standard of care therapy
Participation would significantly delay the scheduled standard of care therapy
Participants must be scheduled to undergo an Eovist-enhanced MRI of the liver as a part of their standard of care
Physicians determine that OCT investigation will not alter standard of care for the patient
Patient who will undergo standard of care clinical staging for UTUC
Plan to begin trabectedin as standard of care
Currently in hospice care
Receiving care at the Massachusetts General Hospital (MGH) Cancer Center
Nurse: Involved in the perioperative care of patients with breast cancer
Patients presenting as follow-ups only at the outpatient Supportive Care Center
Patient must have ongoing oncologic needs and plan to receive all care at the study institution and not already be in hospice or home-care
PATIENTS: Admitted to the Intensive Care Unit (ICU) during their hospitalization
Patients receiving care from these oncologists who are willing to complete an anonymous survey
Patients receiving care from these oncologists who are willing to be audio recorded
Eligible caregivers who will be recorded are those present in the room with the enrolled oncologist and the patient participant receiving oncology care during the audio-recorded clinic visit
Patient samples will be identified from among those receiving care in one of 28 Henry Ford Health System (HFHS) primary care clinics
All participants will be recruited from patients receiving care at the HFHS
Does not have a usual primary care provider (PCP) at baseline
Eastern Cooperative Oncology Group (ECOG) status of 0 - 2, or self-reports being up and about more than 50% of waking hours and able to provide self-care (Arm 1)
Zubrod performance status > 2, or self-reports either not being up and about more than 50% of waking hours or unable to provide self-care (Arms 2 and 3)
Nurses covering patients on Seidman 6 under the care of the Gynecologic Oncology service
PHASE I: Have been registered in 1209 Clinic for at least two years and assigned a primary care physician
USABILITY PHASE: Have been registered in 1209 Clinic for at least two years and assigned a primary care physician
PHASE II: Have been registered at a University of New Mexico (UNM) Clinic for six months and assigned a primary care provider
Patient of the Internal Medicine Clinic at University of North Carolina (UNC) Health Care
Scheduled to see a primary care provider for a routine (i.e., non-urgent care) visit
Patients referred for consultation to the Supportive Care team
Outpatients (either new referrals or follow ups) seen in the supportive care clinic
Follow up patients seen in the outpatient Supportive Care Center
Any health care provider (physician, advanced practice clinician) at a study site (Fox Chase Cancer Center [FCCC] and Fox Chase Cancer Center Partners [FCCCP]) who provides care for NSCLC and/or CRC survivors
Undergoing routine oncology care and surveillance at the chosen site (defined as receiving follow-up care with FCCC or FCCCP site health care providers and have an active medical chart)
Patients who do not undergo routine oncologic care at the chosen Partners site or Fox Chase Cancer Center
Any Grady patient who has been consented to receive chemotherapy on trial or as standard of care; there is no restriction by disease site or stage of disease
Had their cancer care primarily managed by a participating clinician
Patient is willing and able to undergo standard of care imaging studies (same\n             imaging/staging modality being used at each evaluation), which are anticipated to be\n             performed prior to the initiation of therapy and subsequently every 3 months.
Willingness to have close follow-up and treatment at the Clinic at the Seattle Cancer Care Alliance (SCCA) or at a local facility; typically, patients will be seen at least 3 times per week as per standard practice, including at least once weekly at the SCCA
Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
Inability to complete the needed investigational due to other reasons (severe claustrophobia, radiation phobia, etc.)
Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (e.g. severe claustrophobia)
Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons
Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational; prior therapy with bisphosphonates is allowed; prior radiation therapy to a solitary plasmacytoma is allowed
Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational; prior therapy with bisphosphonate is allowed; prior radiation therapy to a solitary plasmacytoma is allowed
Other concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational\r\n* NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
Other concurrent chemotherapy, or any ancillary therapy considered investigational; NOTE: bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
Other concurrent chemotherapy, or any ancillary therapy considered investigational ? 14 days prior to study registration; NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm; NOTE: Bisphosphonates are considered to be supportive care rather than therapy and are allowed while on protocol treatment
Other concurrent chemotherapy, or any ancillary therapy considered investigational; NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
Other concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational; Note: bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
Concurrent chemotherapy, radiotherapy, or any ancillary therapy for treatment of multiple myeloma; NOTE: bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
Other concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational\r\n* NOTE: bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
Other concurrent chemotherapy or any ancillary therapy considered investigational\r\n* NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
Other concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational; NOTE: bisphosphonates are allowed while on protocol treatment
Other concurrent chemotherapy or any ancillary therapy considered investigational\r\n* NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
Concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational; NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
Other concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational; NOTE: bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
Other concurrent chemotherapy, immunotherapy, radiotherapy, or an ancillary therapy considered investigational
Other concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational; NOTE: bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
Other concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational; NOTE: bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
Neuroblastoma- Patients that have relapsed following standard of care therapy (such as high risk patients, patient presenting after age 15 months or MYCN amplified, and only following (for eligible patients) high-dose chemotherapy followed by hematopoietic stem cell transplantation and maintenance therapy with retinoic acid and antibody therapy) or having progressed during standard of care therapy and non-responsive/progressive to accepted curative chemotherapy.
Medulloblastomas (At relapse after standard of care therapy [surgery, chemotherapy and/or radiation] and/or non-responsive/progressive on accepted curative therapy)
Gliomas (At relapse after standard of care therapy [surgery and/or radiation and/or chemotherapy] and/or non-responsive/progressive on accepted curative therapy)
Ependymomas (At relapse after standard of care therapy [surgery with or without radiation] and/or non-responsive/progressive on accepted curative therapy)
Choroid plexus tumors (At relapse after standard of care therapy [surgery] and/or non-responsive/progressive on accepted curative therapy)
Craniopharyngiomas (At relapse after standard of care therapy [surgery or suppressive therapy] and/or non-responsive/progressive on accepted curative therapy)
Dysembryoplastic neuroepithelial tumors (DNETs) (At relapse after standard of care therapy [surgery] and/or non-responsive/progressive on accepted curative therapy)
Meningiomas (At relapse after standard of care therapy [surgery] and/or non-responsive/progressive on accepted curative therapy)
Primitive Neuroectodermal Tumors (PNETs) (At relapse after standard of care therapy [surgery, chemotherapy, and/or radiation] and/or non-responsive/progressive on accepted curative therapy)
Germ cell tumors (At relapse after standard of care therapy [surgery, and/or radiation and/or chemotherapy] and/or non-responsive/progressive on accepted curative therapy)
Soft tissue sarcoma Rhabdomyosarcoma (At relapse after standard of care therapy [surgery, and/or radiation, chemotherapy] and/or non-responsive/progressive to accepted curative chemotherapy) Non-rhabdomyosarcoma (At relapse after standard of care therapy [surgery, and/or radiation, chemotherapy] and/or non-responsive/progressive to accepted curative chemotherapy)
Bone Ewings sarcoma (At relapse after standard of care therapy [surgery, and/or radiation, chemotherapy] and/or non- responsive/progressive to accepted curative chemotherapy) Osteosarcoma (At relapse after standard of care therapy [surgery, chemotherapy] and/or non- responsive/progressive to accepted curative chemotherapy)
Renal Wilms tumor (At relapse after standard of care therapy [surgery, and/or radiation, chemotherapy] and/or non- responsive/progressive to accepted chemotherapy) Renal cell carcinoma (At relapse after standard of care therapy [surgery, chemotherapy] and/or non- responsive/progressive to accepted curative chemotherapy) Malignant rhabdoid tumor (At diagnosis, as there is no known curative therapy) Clear Cell Sarcoma- (At relapse after standard of care therapy [radiation, chemotherapy] and/or non- responsive/progressive to accepted curative chemotherapy) Germ Cell tumors (At relapse after standard of care therapy [surgery, chemotherapy] and/or non-responsive/progressive to accepted curative chemotherapy)
Liver Tumors (At relapse after standard of care therapy [surgery, chemotherapy] and/or non- responsive/progressive to accepted curative chemotherapy)