Women who are pregnant or breastfeeding. Women should not breastfeed while taking study treatment and for 4 weeks after the last dose of napabucasin or while undergoing treatment with FOLFIRI and for 180 days after the last dose of FOLFIRI.
Patients undergoing primary systemic treatment (hormones or chemotherapy) as initial treatment with neoadjuvant reducing tumor size
After undergoing surgery, patients may be optimally or sub optimally debulked
Patients undergoing elective pancreatoduodenectomy (PD) for any diagnosis/indication
Hematologic parameters for patients undergoing biopsy only: patients should have international normalized ratio (INR) =< 1.4 and partial thromboplastin time (PTT) =< 40 seconds (unless due to lupus anticoagulant); in patients not meeting these parameters, clearance by hematology will be required prior to undergoing a biopsy
Patient capable of undergoing anesthesia
Eligible for otherwise curative treatment or undergoing concurrent therapy
Rochester patients: Willing to sign consent onto Evaluation of cardiac function in patients undergoing proton beam or photon radiotherapy, IRB number 15-007443
Hematologic parameters for patients undergoing biopsy only: patients should have international normalized ratio (INR) =< 1.4 and partial thromboplastin time (PTT) =< 40 seconds (unless due to lupus anticoagulant); in patients not meeting these parameters, clearance by hematology will be required prior to undergoing a biopsy
Patients undergoing primary medical treatment (hormone or chemotherapy) as initial treatment with neoadjuvant intent of reducing tumor size
Outpatients with MPE undergoing IPC placement
Patients undergoing pleurodesis for benign disease (e.g., spontaneous pneumothorax)
Patients who are concomitantly undergoing systemic therapy for more advanced stage disease are eligible.
Planned for multidisciplinary evaluation by a breast surgical oncologist and breast radiation oncologist. For patients undergoing mastectomy and desirous of reconstruction or those undergoing breast conservation in whom oncoplastic local tissue rearrangement or reduction mammoplasty is being considered, this multidisciplinary evaluation will also include a plastic surgeon
Any condition or history of illness or surgery that might pose an additional risk to men undergoing the VTP procedure;
Undergoing or have plans to undergo changes to current cancer treatment.
Patients who are currently undergoing other anti-tumor therapies or have concurrent active cancer
Patients must be willing to and medically capable of undergoing the surgical operation
Patients undergoing prior surgery or laser interstitial thermotherapy are allowed
Histologically confirmed prostate cancer of any stage undergoing RP
Patients undergoing an extrapleural pneumonectomy (EPP); lung sparing surgeries, such as pleurectomy/decortication, are acceptable
Hematologic parameters for patients undergoing biopsy only: patients should have international normalized ratio (INR) =< 1.4 and prothrombin time (PT) =< 40 seconds (unless due to lupus anticoagulant); in patients not meeting these parameters, clearance by hematology will be required prior to undergoing a biopsy
localized prostate cancer undergoing surveillance or surgery;
For patients undergoing definitive CFRT, patients with distant metastatic disease are not eligible
Patient undergoing yellow fever vaccination.
Patients with resectable primary NSCLC who are undergoing surgery to resect T3 to T4 lesions OR any patients with clinical NI or N2 disease regardless of T-stage
Patients can be undergoing concurrent systemic therapy, such as temozolomide, at the discretion of their treating oncologist
Patients undergoing preoperative chemoradiotherapy
Patients undergoing extrapleural pneumonectomy
Recent use of photosensitizing agents such as fluoroquinolones and retinoids or patients undergoing phototherapy.
Patients can be undergoing concurrent systemic therapy, such as temozolomide, at the discretion of their treating oncologist.
Undergoing autologous breast reconstruction
Undergoing delayed reconstruction
Subject is undergoing robotic partial nephrectomy being performed by participating surgeon
Patients undergoing haploidentical allogeneic hematopoietic stem cell transplants are not eligible; patients undergoing < 10/10 HLA allele matched allogeneic transplant are not eligible
Patients undergoing any other experimental intervention for oral mucositis
Part 1 patients must be undergoing repeat surgery that is clinically indicated as determined by their care providers
Patients undergoing pre-treatment secondary cytoreduction will undergo therapy with bevacizumab on cycle #2
Patients undergoing breast conservation therapy (i.e. lumpectomy) must not have any contraindications to radiation therapy
Patients undergoing current treatments for other cancers
• Subject is undergoing an elective open cardiothoracic, abdominal, or orthopedic lower extremity surgery;
Subject undergoing cardiothoracic surgery is not allergic to protamine; and
• Subject is undergoing a laparoscopic, thoracoscopic, or robotic surgical procedure;
Subject is undergoing a neurologic surgical procedure;
Subject is undergoing a spinal surgical procedure;
Patients who are undergoing concomitant radiotherapy are NOT eligible for participation
Concurrent active malignancy under treatment except prostate or breast cancer undergoing treatment with hormonal therapy
Willing and capable of undergoing apheresis for collection of mononuclear cells
Undergoing laparoscopic or minimally invasive surgery
Patients undergoing breast conservation therapy (i.e. lumpectomy) must not have any contraindications to radiation therapy
Patients who are undergoing concomitant radiotherapy are NOT eligible for participation
Same as above and patients undergoing single fraction spinal SBRT
Patients with uncontrolled hypertension (i.e., persistent grade 3 while undergoing treatment)
Undergoing concurrent neoadjuvant therapies for breast cancer
Patients undergoing either a Type II or III radical hysterectomy (Piver Classification)
Undergoing stapled anastomosis with the use of an experimental or non-FDA approved stapler.
Patients undergoing preoperative or adjuvant chemotherapy
Patients must have potentially resectable non-small cell lung cancer (NSCLC) by VATS as determined by a multidisciplinary team review; this primary should not have undergone any neoadjuvant chemotherapy (chemo-) or radiation therapy; only those patients undergoing surgery by conventional VATS will be included; (robotic procedures will not be eligible for inclusion in this study)
Currently undergoing treatment with photodynamic therapy, topical chemotherapy agents including imiquimod, fluorouracil, ingenol mebutate (picato) to the selected treatment lesion sites
Active malignancy currently undergoing chemo or radiation therapy; hormone therapy is acceptable
Undergoing unilateral or bilateral, two-stage, tissue expander-assisted breast reconstruction
Patients must be undergoing repeat surgery that is clinically indicated as determined by their care providers
Patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs after chronic use
Women who are morbidly obese (BMI >= 40) undergoing laparotomy for any indication
Women undergoing panniculectomy at the time of laparotomy
Patients undergoing RC and IC formation in an elective setting for non-metastatic cancer
Undergoing treatment with surgery, chemotherapy, radiation, or combined modalities
Undergoing surgical procedures of expected length =< 6 hours requiring NMB
Undergoing lumpectomy (partial mastectomy) procedure
Are undergoing cancer treatment for another malignancy
Esophageal carcinoma, undergoing minimally invasive esophagectomy with intrathoracic anastomosis
Eligible patients must not be currently undergoing standard cytotoxic chemotherapy
Individuals who are actively undergoing standard cytotoxic chemotherapy
Undergoing radiation therapy or chemotherapy
Currently undergoing phase I complete decongestive therapy (CDT)
Undergoing primary resection of esophageal cancer and resultant esophagectomy
Patients undergoing reconstruction after mastectomy (either implant or tissue based)
INCLUSION - STUDY 1: Cancer adult patients undergoing neurotoxic chemotherapy (agents including platinums, vinca alkaloids, taxanes, proteasome inhibitors and interferons) will be eligible to participate
Patients undergoing penile prosthesis surgery
Undergoing pancreatic resection
Undergoing or initiating active surveillance
Patients undergoing gynecologic surgery via midline vertical laparotomy at University of Wisconsin Hospital and Clinics (UWHC)
Patients undergoing any resection requiring an anastomosis to the esophagus for palliative intent
Participant is undergoing chemotherapy
Patients undergoing diagnostic laparoscopy
Bladder cancer, undergoing radical cystectomy and ileal conduit diversion
Undergoing elective open radical cystectomy
Undergoing chemotherapy or radiation therapy at any time during the study
Undergoing an exploratory laparotomy for suspected gynecologic cancer, which includes metastatic disease from neoplasia originating in other organs
Patients undergoing anterior abdominal wall hernia repairs
Subjects with malignant dysphagia due to esophageal cancer or esophagogastric junction cancer who are undergoing upper endoscopic ultrasound or upper endoscopy for pre-treatment staging or symptom evaluation
Patients with BMI greater than or equal to 30 kg/m^2 who are undergoing hormonal treatment of endometrial cancer
Caregivers of patients undergoing HCT at Massachusetts General Hospital (MGH)
Caregivers of patients who are receiving hospice care will be excluded; caregivers who are themselves undergoing active cancer treatment will be excluded (hormonal treatment allowed)
Additionally, at time of enrollment, participants must be post-treatment (with the exception of adjuvant therapy) for their primary cancer and not actively undergoing treatment for a secondary, metastatic, or recurrence of cancer (local or distant)
Evaluation of Web-based Program: HNSCC patients who are currently undergoing or have recently completed radiation treatment (< 2 years)
Patients who have seen an oncologist after undergoing first line treatment imaging
The patient is undergoing Mohs surgery
Adult caregivers (> 18 years) of patients undergoing HSCT at MGH who agreed to participate in study
Patients undergoing concomitant colectomy
PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Undergoing chemotherapy
Patients with gynecologic cancer who are undergoing vaginal brachytherapy as part of their treatment
All women, undergoing surgery, via a midline laparotomy
Undergoing chemotherapy or radiation
Patients with airway stents undergoing bronchoscopy
Patients with newly diagnosed or recurrent gynecologic cancer (ovarian, uterine, cervical, vaginal, vulvar) actively undergoing treatment (chemotherapy, surgery, or radiation therapy) at COH (including Duarte and South Pasadena campuses)
Peer mentors will be past gynecologic cancer patients not currently undergoing treatment for their cancer, and considered without evidence of disease
Currently undergoing treatment for active gynecologic cancer
Outpatients with MPE undergoing IPC placement
Patients undergoing pleurodesis for benign disease (e.g., spontaneous pneumothorax)
Undergoing definitive treatment with either radiation alone or in combination with systemic therapy
undergoing a procedure other than laparotomy
Undergoing active treatment or in remission and undergoing active surveillance
Has active infectious disease undergoing systemic treatment excluding oral candidiasis
Actively undergoing any chemotherapy treatment at Maroone Cancer Center
Patients not actively undergoing chemotherapy at Maroone Cancer Center
Patients are undergoing other cancer treatments
Patients will be undergoing initial therapy for their disease or undergoing first salvage treatment, i.e. patients who fail therapy, or respond and relapse after initial therapy
Undergoing a procedure other than laparotomy
Any condition that would exclude women from undergoing regional anesthesia
Patients undergoing immediate tissue expander reconstruction following mastectomy by any of the surgeon co-investigators are eligible for the study
Patients undergoing skin-sparing mastectomy utilizing bioprosthetic mesh are eligible for the study
May include patients undergoing ileostomy or colostomy reversal
Patients who are undergoing colonoscopy for screening or surveillance purposes
Participants will be undergoing surgical excision to remove the ADH.
Patient must be asymptomatic for breast disease and undergoing routine screening
Patients are undergoing clinically indicated EGD
Patients are not undergoing clinically indicated EGD
Women actively undergoing in-vitro fertilization or fertility treatments are excluded
Undergoing salvage therapy
Patients undergoing other interventions to prevent CLABSI (e.g. Children's Oncology Group [COG] ACCL1034 with chromogranin [CHG], antimicrobial lock therapy, etc.) are ineligible
STUDY I: Smoked at least one cigarette per week prior to undergoing the CT scan
Currently undergoing treatment with photodynamic therapy, topical chemotherapy agents including imiquimod, fluorouracil
Patients must be undergoing surgery that is clinically indicated as determined by their care providers
Women currently undergoing cancer treatment or with a known active cancer; history of malignancy is allowed as long as the patient has completed treatment > 3 months prior to enrollment
Patients undergoing esophageal resection
Not currently undergoing or planning to initiate chemotherapy
Patients undergoing cervicography OR colposcopy OR visual inspection with acetic acid (VIA) OR patients undergoing loop electrosurgical excision procedure (LEEP) for the treatment of cervical cancer
Patients undergoing a reduction mammoplasty OR
Undergoing colposcopy for the diagnosis of cervical cancer and LEEP or cervical biopsy for the treatment of premalignant cervical dysplasia
Patients with known or suspected pancreatic or ovarian carcinoma who will be undergoing clinically appropriate laparoscopic evaluation or treatment; patients will not undergo laparoscopy solely for the purpose of participation in this trial
Undergoing diagnostic breast MRI ordered by the referring clinician for staging and extent of disease
Participants must be undergoing a surgical procedure with the intention of removing more tissue than what would be taken for a biopsy
Men undergoing a first-time prostate biopsy driven by PSA elevation to rule out cancer
Anyone who would be normally excluded from undergoing an MRI examination as per Memorial Hospital for Cancer and Allied Diseases Screening Questionnaire
CHILD: Pediatrics patients aged 2-17 years undergoing myelosuppressive therapies for acute leukemias and other childhood cancers
Patients who would be normally excluded from undergoing an MRI examination as per Memorial Hospital for Cancer and Allied Disease Screening Questionnaire for MRI
Patients with unresectable HCC undergoing systemic therapy based on clinical indication or approved drug trial; and/or undergoing clinically indicated Y90 radioembolization
Is experiencing photo-toxicity or photo-sensitivity or is undergoing treatment for a photo-sensitive condition such as porphyria or lupus erythematosus;
Patients must be undergoing ovarian resection
Subjects undergoing MRI evaluation of the brain
Participants undergoing active treatment, or who have completed treatment, will have radiographic abnormalities that may or may not be recurrent tumor
Patients not undergoing radioembolization to the liver
Patients who have gynecologic malignancies involving the upper, middle and/or lower third of the vagina or are undergoing pelvic exenteration
Contraindication for undergoing EUS/FNA procedure (such as unwilling or medically unstable patients, patients with severe coagulopathy, patients with poor visualization on EUS for various reasons, etc)
Patients undergoing an upper endoscopy for BE surveillance with prior biopsy-confirmed BE with dysplasia (at least LGD).
Subject must be a patient undergoing diagnostic bronchoscopy and/or thoracoscopy at University of California Irvine Medical Center (UCIMC)
No prior radiation therapy or systemic treatment is allowed for patients undergoing resection of stage I, II, or III colon cancer
Undergoing salvage therapy
Patients undergoing bilateral neck dissection
Patients undergoing neck skin defect reconstruction
concurrent NSAID treatments while undergoing treatment
PATIENT: Undergoing treatment for cancer by one of the consented HCPs as per the HCP and/or EMR
Radiation oncology patients undergoing shorter courses of radiation or undergoing palliative courses of radiation
Men undergoing TRUS-guided prostate biopsy in the OR under anesthesia
No prior intra-thoracic radiation therapy; NOTE: previous radiotherapy as part of treatment for head and neck, breast, or other non-thoracic cancer is permitted so long as possible radiation fields would not overlap; previous chemotherapy or surgical resection specifically for the lung cancer being treated on this protocol is NOT permitted; no prior lung resection on the ipsilateral side
Patients planning to undergo radiation therapy for primary or recurrent carcinomas of the lung or oligo-metastatic carcinoma to the lung; Note: this may be delivered by SBRT or standard fractionation, based on the discretion of the treating physician
Any prior therapy for lung cancer
Prior chemotherapy, adjuvant therapy, or radiotherapy for lung cancer other than standard concurrent chemoradiation or up to 2 cycles of consolidation as described above
Any CT imaging findings indicating radiation or drug-induced lung disorders at the time of screening
Any prior therapy for lung cancer
Prior (within last 6 months) or future planned therapeutic surgery for the treatment of the existing lung cancer
Received radiation therapy to the lung that is > 30 Gy within 6 months of the first dose of study drug.
Patient must not have received prior radiation for this lung cancer
No prior chemotherapy or thoracic radiotherapy for lung cancer
No prior chemotherapy or radiation for lung cancer
Lung cancer\r\n* Patients with an endobronchial component causing symptoms\r\n* Patients who cannot undergo resection because of poor lung function or distant lung metastasis
No prior hormonal therapy for lung cancer
Central or necrotic lung metastases
The patient has a biopsy-proven radio-opaque (visible by computed tomography [CT]) lung cancer or secondary metastasis to the lung.
Previous radiation therapy to the lung per investigator discretion
Diagnosis of primary lung cancer stage I, II, or IIIa OR secondary lung cancer
Received chemotherapy for lung cancer within 6 months of registration
Patients with isolated lung parenchymal recurrent/persistent NSCLC (histology as defined in eligibility criterion 1) after prior definitive surgery or radiotherapy/chemotherapy, when the lesion or lesions are suitable for SABR, are also eligible. Patients with a single metastatic focus in the lung parenchyma with no other lesions are also eligible, because this presentation is challenging to distinguish from recurrent disease. Recurrent disease can be in the same lobe or a different lobe but should not invade critical structures (esophagus, brachial plexus, major vessels, heart, spinal cord); should not involve any lymph node; and should not include any other suspicious lesions in the lung or any other locations. Any prior therapy (surgery, radiotherapy, or systemic) must have been completed at least 12 weeks before administration of the study drug. Tumors should be =< 7 cm (measured by computed tomography [CT] imaging in the lung window setting) with N0M0; positron emission tomography (PET) imaging is required for restaging (per eligibility criterion) and any lymph node suspected of harboring tumor should be confirmed by biopsy (per eligibility criterion)
Patients with direct evidence of regional or distant metastases after appropriate staging studies, or with synchronous non-lung primary or prior non-lung malignancy (other than nonmelanomatous skin cancer or in situ cancer) diagnosed within the past 3 years are not eligible. Patients with a history of curable non-lung cancer up to 3 years before registration and have been cancer-free for 2 years are eligible
Patients must not have elevated lung shunting precluding treatment with Y-90
Symptomatic lung disease
Pre-operative or post-operative or planned radiation therapy for the current lung cancer
> 5 sites of visceral disease in lung or liver (nonspecific lung nodules =< 1 cm in diameter are permitted)
Lung function capacity capable of tolerating the proposed lung surgery
Previous radiotherapy to the lung or mediastinum
Previous surgery for this lung or mediastinum tumor
Patients diagnosed with another lung cancer subtype
Lung cancer
Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map)
Peripheral lung nodule =< 2 cm on preoperative CT scan and presumed to be lung cancer; the center of the tumor, as seen on CT, must be located in the outer third of the lung in either the transverse, coronal or sagittal plane; patients with pure ground glass opacities or pathologically confirmed N1 or N2 disease are not eligible
Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map)
Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map)
Prior history of lung cancer
Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map)
Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map)
Symptomatic intrinsic lung disease or lung involvement
History of lung inflammation or disease.
Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map)
Received radiation therapy to the lung that is >30 Gy within 6 months of the first dose of study medication.
Radiation therapy to lung >30 Gy within 6 months of first dose of study medication
Prior systemic chemotherapy (for lung cancer) and/or thoracic/neck radiotherapy for any reason and/or surgical resection of present cancer
Previous lung or mediastinal radiotherapy
Metastatic breast cancer (MBC) OR metastatic non-small cell lung cancer (NSCLC) OR metastatic adenocarcinoma of the prostate; the sites of allowed metastases are: peripheral lung, central lung, mediastinal/cervical lymph node, liver, spinal/paraspinal, osseous, and abdominal-pelvic\r\n* NOTE: after the required number of evaluable patients have been accrued for a given dose level, the accrual for that metastatic location will be temporarily suspended while the safety of that dose level is assessed; a patient can only be entered onto the trial if all of their metastatic locations are open to accrual (e.g. if central lung is temporarily suspended for safety assessment and the patient has a central lung metastases, regardless of other metastases, they cannot enroll until the safety of dose to central lung is determined)
No prior chemotherapy or radiation for this lung cancer.
No previous lung or mediastinal radiation therapy
Prior Therapy: Platinum doublet chemotherapy for current diagnosis of advanced lung cancer. Only one prior line of chemotherapy for advanced lung cancer allowed. Adjuvant chemotherapy, neoadjuvant chemotherapy, or chemoradiotherapy given for early stage lung cancer at least 6 months prior to diagnosis of recurrent/metastatic disease is not counted as a line of therapy for advanced lung cancer. Patients who received platinum doublet therapy with or without radiotherapy as part of treatment for early stage non-small cell lung cancer less than 6 months after developing stage 4 or recurrent incurable disease will be considered study eligible by the criterion of having received one line of chemotherapy for non-small cell lung cancer.
Participant has received radiation therapy to the lung that is > 30 Gy within 6 months of the first dose of trial treatment
Prior chemotherapy, adjuvant therapy, or radiotherapy for lung cancer, other than standard concurrent chemoradiation as described above
Patients with single or multiple lung metastases at diagnosis or that develop over the course of treatment
Patient's index tumor(s) is primary lung cancer.
Subjects must have a clinically indicated need for systemic chemotherapy for adenocarcinoma of the lung based on the investigator's assessment
NO prior chemotherapy for current diagnosis of lung cancer
NIH lung score 3
Patients with diagnosis of advanced cancer with lung metastases; patients with no prior therapy are eligible if there is no known superior alternative medical therapy; for phase Ib expansion cohort diagnosis of osteosarcoma, lung metastases will be required
Patients with advanced cancer with resectable lung metastases
LUNG (ONLY APPLIES TO PATIENTS WITH PRIMARY OR METASTATIC LUNG LESIONS NOT PREVIOUSLY TREATED WITH RT):
Patients cannot have more than 3 lung lesions\r\n* Patients with a single lung lesion other than the primary tumor and no other thoracic or extra-thoracic disease will not be eligible
Patients with suspected lung cancer with nodules in the lung or liver (1-2 cm in diameter) will be eligible for this study.
Restrictive lung diseases due to parenchymal damage (eg idiopathic lung fibrosis) or pleural adhesions. Patients with lung resection, scoliosis or thorax malformations can be included provided adequate spirometry testing during screening (eg FEV-Forced expiratory volume 1 ? 70%; age, sex and height adapted vital capacity)
Patients who have had prior radiation to the lung will be excluded from the study, although mediastinal irradiation will be permitted if minimal lung is in the treatment volume
Patients with surgery for a prior ipslilateral lung cancer are excluded
V20 =< 40% of total lung volume
Atelectasis of the entire lung
Patient must have a completed 3D plan and the attending physician must have reviewed and approved the dose volume histograms as follows: total lung volume percentage receiving at least 20 Gy (V20) =< 35%, and mean lung dose =< 20 Gy
Prior systemic anticancer therapy for metastatic squamous cell lung cancer
Prior radiation to lung fields
Lung disease unrelated to underlying malignancy.
No prior history of VAT or open lung surgery (on the lung in which the procedure will be performed);
Significant symptomatic deterioration of lung function.
If diagnosed with lung cancer, must have completed definitive treatment more than 6 months prior
Prior surgery or chemotherapy for this presentation of lung cancer (history of prior lung cancer that has been treated and deemed inactive by the clinician is acceptable; recurrent tumors may be treated on protocol as long as SBRT will be the definitive treatment)
Prior surgery for the current or another lung cancer is allowed as is prior radiation therapy
Prior systemic therapy for lung cancer
Prior therapy, with the intent to treat, the current diagnosis of lung cancer
Patients that undergo bronchoscopy and are found to have endobronchial lung cancer that is obstructive or hemorrhagic as evident by inspection or CT scan are eligible
Patients that have endobronchial lung cancer that is obstructive or hemorrhagic, but do not wish to undergo PDT therapy will be eligible to participate in the non-treatment group
Presence of metastatic disease in other locations in addition to the lung.
Disruption of the lung pleura by tumor.
Subjects must have melanoma or lung cancer or renal cell carcinoma and received ipilimumab or nivolumab as a single treatment or in combination
Any current smoker who meets the Centers for Medicare and Medicaid Services (CMS) eligibility criteria for lung cancer screening will be eligible for our intervention; thus, patients with a history of lung and/or other cancer(s) (who do not have current signs or symptoms of lung cancer) will be eligible
Past history of any lung cancer
Patients who have had more than 2 weeks of chemotherapy or radiation for this diagnosis of lung cancer
NIH lung score 3
Diagnosis of cancer, with evidence of primary or secondary lung involvement
Are receiving active treatment (e.g., radiation, hormone, or chemotherapy) or have been receiving treatment in the past 6 months for prostate, breast, lung, lymphoma, or gynecological cancer
Patients need lung isolation for purposed surgery
History of lung cancer
Subject has significant trapped lung, or a proximal bronchial obstruction which is likely to lead to trapped lung. For a subject to be eligible for this study, 2 separate study center clinicians must agree that there is no significant trapped lung on the same CXR using visual estimation (reference guide). The CXR used to make this decision must have been performed ?30 days preceding the consent form being signed, and must have been performed preferably on the same day, but no more than 7 calendar days after a pleural drainage. Significant trapped lung is deemed present if any 1 of the following criteria is met:
Cancer care continuum points are defined as follows:\r\n* Diagnosis: A lung cancer patient who has received diagnosis within the last 45 days but has not yet started treatment\r\n* Treatment: A lung cancer patients who has started initial treatment (chemotherapy, radiation, surgery) for diagnosis within the last 30 days, is actively receiving treatment, and has a prognosis of more than one year\r\n* Survivorship: A lung cancer patient who has completed treatment and who is clinically disease free at the time of caregiver enrollment to study\r\n* End of Life: A lung cancer patient who is estimated to have 6 months or less to live
PATIENTS: Scheduled to undergo surgery with lung resection for treatment of primary or secondary neoplasms of the lung
No patients who have received neoadjuvant therapy (chemo- or radio-therapy) for this lung cancer
No patients with recurrence of lung cancer after prior resection
Patients who are or become ineligible as defined by USPSTF guidelines for lung cancer screening.
Reports at least one year of lung cancer screening experience
Seeking baseline or annual follow-up low dose computed tomography (LDCT) lung cancer screening
Any prior investigational immune therapy, such as for lung cancer prevention or treatment or for CIS of the cervix
Meets guidelines for lung cancer screening, as determined by radiology team.
Individuals who have registered to undergo lung cancer screening and who agree to be called for possible participation
Lung carcinoma:
Have heart disease, lung disease, or mental illness
Patients must have histologically confirmed, newly diagnosed or recurrent from a previously treated early stage lung cancers that are locally confined, non-small cell lung cancers that are considered unresectable and for which chemoradiation will be considered definitive therapy; patients with recurrent cancer that is amendable for chemoradiation can be eligible only if patients with prior lobectomy for stage I cancer had not had adjuvant chemotherapy, and more than 8 weeks have elapsed from surgery to allow for wound healing; patients who recur from prior X-ray therapy (XRT) or stereotactic body radiation therapy (SBRT) will not be eligible
Not received radiation to the lung fields within the past 8 weeks.
Confirmed diagnosis of adenocarcinoma lung cancer OR,
Known Folate Receptor-negative lung nodules
Lung function assessment required for pre-surgical evaluation at the discretion of the cardiothoracic surgeon
Patients receiving SBRT lung treatment and who have any one of the following high risk features:\r\n* Lung lesion > 5 cm\r\n* Diffusing capacity of the lungs for carbon monoxide (DLCO) < 35%\r\n* Forced expiratory volume, first second (FEV1) < 0.5 L\r\n* Central lung tumors (defined as within 2 cm from the proximal bronchial tree)\r\n* Tumors that abut the great vessels, trachea, spinal cord, or esophagus\r\n* Prior lobectomy or pneumonectomy\r\n* Prior lung radiation (SBRT or conventional definitive lung radiation)
Patients undergoing guided-bronchoscopy for diagnosis of peripheral lung lesion/s > 1 and < 3 cm in diameter located in the outer 2/3 of the lung fields
Prior thoracic surgery on the same side of the lung as the SPN.
Patients undergoing SABR for the treatment of a lung tumor, inclusive of non-small cell lung cancer or lung metastases
Patient is planning to undergo radiation therapy for primary or recurrent carcinomas of the lung or oligo-metastatic carcinoma of the lung
Histologically confirmed lung cancer, or clinically diagnosed lung cancer
Adult (age ? 18 years) subjects with peripheral lung lesions that are <1.5 cm in size who are planning to undergo percutaneous image guided lung biopsy as part of their routine medical care.
Participant must have histologically confirmed lung cancer and be deemed an appropriate surgical candidate for thoracoscopic lung resection and will have consent for a sentinel lymph node mapping by their oncologic surgeon; these patients will have invasive non-small cell lung cancers for which thoracoscopic mediastinal lymph node dissection at the time of thoracoscopic lung resection is standard of care; the extent of lung resections in potential trial patients could span from sublobar resection (i.e. wedge resection) to pneumonectomy, though it is anticipated that most patients will be undergoing the most common anatomic operation for lung cancer which is lobectomy; all stages of lung cancer that would otherwise be undergoing thoracoscopic lung resection and mediastinal lymph node dissection would be eligible
Patients who have had a prior lung cancer within the last five years from the current diagnosis
Patients with any prior systemic therapy for the current diagnosis of lung cancer
Patients must not be planned for lung resection after radiation therapy
Bronchoscopy or any other lung procedure for any reason within the previous year
Previous history of lung cancer
Ever diagnosed with lung cancer
Primary or metastatic lung tumor located in central lung or near vertebral body
Patients planning to undergo radiation therapy for primary or recurrent carcinomas of the lung or cancer that is metastatic to the lung.
Uncontrolled lung disease
If a patient is currently receiving denosumab, this must be discontinued prior to enrollment. Substitution with biphosphonates are acceptable.
Subjects with known metastases that are currently involving the lumen of the gastrointestinal tract.
Currently receiving experimental treatment with non-approved drugs at the time of enrolment. Patients must undergo a 28-day washout between last dose and screening CPET.
Patients currently receiving and unable to stop high doses of supplemental vitamin E
Patients currently receiving active treatment for melanoma
Currently receiving exogenous estrogen replacement therapy (topical vaginal estrogen therapy is allowed)
Patients who are currently receiving belimumab (a monoclonal antibody for systemic lupus erythematosus) are not eligible
Are currently receiving other medications intended for the treatment of their malignancy.
Currently using or planning to use:
Currently receiving progestin therapy (local, topical, or systemic)
History of hypertriglyceridemia or hypercholesterolemia and currently on medication(s)
Subject currently receiving abiraterone and prednisone for CRPC.
Patients currently receiving cancer therapy.
Patient is currently receiving treatment with dabrafenib/trametinib monotherapy or combination within a Novartis or former GSK sponsored study which has fulfilled the requirements for the primary objective.
Currently receiving or likely to require systemic immunosuppressive therapy from Day -7 to Day 29.
Is currently receiving and able to discontinue erlotinib, gefinitib, or afatinib.
Patients who are currently receiving an anti-IGF-IR monoclonal antibody as part of their treatment regimen
As per self report, currently engaged in ongoing acupuncture
Currently receiving radiation or chemotherapy
Are currently receiving other medications or radiation intended for the treatment of their malignancy
Currently using aluminum-containing antacid products
Patient is currently receiving clinical benefit from the treatment with IMCgp100, as determined by the principal investigator from the parent study
Currently receiving or ever received immunosuppressive therapy for an autoimmune disorder or an organ transplant
Patients currently receiving chemotherapy/biologic/immunotherapy as these need to be held during FFSRT
PART 2 GROUP 1 EXCLUSION CRITERIA: Subjects who are currently receiving treatment with agents that are known to cause QTc prolongation in humans; agents causing a strong signal will be prohibited
PART 2 GROUP 1 EXCLUSION CRITERIA: Subjects who are currently receiving treatment with drugs or herbal medications that can impact drug metabolism
PART 2 GROUP 2A EXCLUSION CRITERIA: Subjects who are currently receiving treatment with agents that are known to cause QTc prolongation in humans; agents causing a strong signal will be prohibited
PART 2 GROUP 2A EXCLUSION CRITERIA: Subjects who are currently receiving treatment with drugs or herbal medications that can impact drug metabolism
PART 2 GROUP 3 EXCLUSION CRITERIA: Subjects who are currently receiving treatment with agents that are known to cause QTc prolongation in humans; agents causing a strong signal will be prohibited
PART 2 GROUP 3 EXCLUSION CRITERIA: Subjects who are currently receiving treatment with drugs or herbal medications that can impact drug metabolism
Currently using hormone replacement therapy (oral or patch) or/and phytoestrogen supplements (i.e. black cohosh)
Currently receiving active therapy for other neoplastic disorders
Patients currently receiving active therapy for other neoplastic disorders
Patients who are currently receiving treatment with cidofovir, leflunomide, or other antiviral therapy with no response, will be eligible for CTL infusion
Patients who are currently receiving and responding to a different course of anti-neoplastic therapy, within the limits of acceptable toxicity per standard clinical practice, may not be enrolled to this study
Subjects with a diagnosis of metastatic disease who are currently receiving treatment or who have not been deemed in remission
HER2 therapy naive or currently receiving non-lapatinib HER2 targeted therapy
Patient is currently participating in a Novartis Oncology sponsored study receiving pasireotide (LAR and/or s.c.) and has fulfilled all required assessments in the parent study (unless the study is being terminated) and patients that are benefiting from the study drug have no other alternatives
Patient is currently receiving treatment with ceritinib within a Novartis-sponsored study which has fulfilled the requirements for the primary objective and, in the opinion of the Investigator, would benefit from continued treatment.
Patient is currently enrolled in a Novartis-sponsored, CD&MA study receiving everolimus or everolimus plus Sandostatin LAR Depot and has fulfilled all their requirements in the parent study
Patient currently requires systemic therapy.
Patient is currently receiving medication(s) that are principally metabolized via the cytochrome P450 3A4 enzyme pathway.
Currently tolerating treatment in the parent protocol.
Currently receiving or has received treatment with systemic steroids in the following dosages within 30 days prior to administration of the first study vaccination.
Currently receiving active therapy for other neoplastic disorders
Part 2: currently receiving anticoagulants, anticonvulsants (phenobarbital, diphenylhydantoin, primidone), phenylbutazone, and/or tricyclic drugs (imipramine, clomipramine, or desipramine)
Patients currently being treated with quinacrine or drugs related to quinacrine
Patients currently receiving any medication known to induce central serous chorioretinopathy which in the opinion of the principal investigator, would make the administration of study drug hazardous
Receiving phenytoin
Women who are currently or planning to breastfeed during protocol treatment
Not currently receiving therapy
Patients must not be currently receiving immunosuppressive drugs such as corticosteroids, tacrolimus or cyclosporine
A 7-day washout period is required if patients are currently using another oral topical treatment for mouth lesions; patients currently using clobetasol oral topical treatment are not eligible for this study
Subject is currently using or use within 6 months of illicit drugs.
Currently receiving chemotherapy, radiation therapy, immunotherapy, or biotherapy for breast cancer
Currently receiving nivolumab and considered by Investigator to have the potential to derive clinical benefit from continuing treatment with nivolumab.
Currently receiving therapy with a UDP-glucuronosyltransferase 1A9 inhibitor including diclofenac, imipramine, ketoconazole, mefenamic acid, and probenecid
Currently receiving hormone replacement therapy, unless discontinued prior to screening
Patient is currently enrolled in an eligible Novartis-sponsored study and receiving ribociclib (LEE011) as single agent or in combination with other investigational treatment.
Patients who are currently receiving treatment with agents that are known to cause QTc prolongation in humans (Refer to Appendix 3)
Patient is currently receiving any of the following medications and cannot be discontinued 7 days prior to starting study drug Ribociclib:
Patient is currently receiving any of the following substances and cannot be discontinued 7 days prior to start the treatment:
Patient is currently using other antineoplastic agents
Currently receiving cancer therapy. Hydroxyurea will be allowed.
Currently receiving or less than 28 days since ending systemic anticancer treatment for unresected stage IIIB to IV melanoma
Patients who are currently receiving angiotensin-converting enzymes (ACE) inhibitors are not eligible
May not be currently prescribed ritonavir, cobacistat and/or zidovudine
Patients who are currently receiving treatment with agents that are known to cause QTc prolongation or inducing Torsade de Pointes in humans and are unable to discontinue or switch to an alternate medication
Concomitant medications:\r\n* Growth factors that support platelet or white cell number or function must not have been administered within the 7 days prior to enrollment (14 days if pegfilgrastim)\r\n* Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for the 7 days prior to enrollment are not eligible\r\n* Patients who are currently receiving another investigational drug are not eligible\r\n* Patients who are currently receiving other anti-cancer agents are not eligible\r\n* Patients who are currently receiving the enzyme inducing anticonvulsants: phenytoin, phenobarbital, carbamazepine, oxcarbazepine are not eligible; patients who are currently taking rifampin, voriconazole, itraconazole, ketoconazole, aprepitant, or St. John’s Wort are not eligible\r\n* Use of warfarin is not allowed while on study; patients already on warfarin should use alternative anticoagulants while on this study; warfarin must not have been administered within 7 days of starting protocol therapy\r\n* Patients receiving medications that prolong the QTc
Patients who have an uncontrolled infection, or who are currently receiving treatment for Clostridium (C) difficile infection
Patient currently receiving lithium, steroid, chemotherapy or radiotherapy treatment
Currently progressing, resistance to or with a suboptimal response to their most recent therapy
Currently receiving treatment in a different clinical study in which investigational procedures are performed or investigational therapies are administered
Patient is currently receiving any of the following medications and cannot be discontinued 7 days prior start if the treatment:
Active second malignancy, i.e., patient known to have potentially fatal cancer present for which she may be (but not necessarily) currently receiving treatment a. Patients with a history of malignancy that has been completely treated, with no evidence of that cancer currently, are permitted to enroll in the trial provided all chemotherapy was completed >6 months prior and/or bone marrow transplant (BMT) >2 years prior to first dose of rucaparib
Patients who are currently receiving treatment with medications that meet one of the following criteria and that cannot be discontinued at least one week prior to the start of treatment with LGH447:
Is currently participating in GSK1120212 study and is receiving treatment with GSK1120212.
Is currently receiving clinical benefit as determined by the investigator from previous treatment with GSK1120212 either as monotherapy or as part of a combination treatment regimen.
Is currently participating in a GSK-sponsored study of GSK2118436
Patients who are currently participating or planning to participate in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study or who are receiving other investigational agents.
Patients currently receiving chemotherapy or radiation therapy.
Currently receiving vismodegib, biologics or chemotherapy
Subjects who are currently receiving or have had previous hormonal, chemotherapy, or radiotherapy for prostate cancer
Patients currently entered on Alopexx Oncology Protocol AO-101
patient was currently enrolled in Novartis sponsored study, which had met its endpoint and was receiving single agent oral dovitinib or dovitinib and fulvestrant coadministration
Patients currently receiving active therapy for other neoplastic disorders
PART II: Currently receiving chemotherapy or radiation therapy
Patients who are currently receiving treatment with agents that are known to cause QTc prolongation in humans.
Patients who are currently receiving active therapy for other neoplastic disorders will not be eligible
Patients who are currently receiving lithium chloride (LiCl)
Patients who are currently receiving active therapy for other neoplastic disorders will not be eligible
Subjects must not be currently using other tobacco or nicotine products.
Active diagnosis of psoriasis or currently receiving treatment for psoriasis.
Currently receiving other GCTB specific treatment (eg, radiation, chemotherapy, or embolization)
Currently using an opioid antagonist or partial antagonist.
NOTE: patients currently receiving warfarin must have approval from an oncologist or their designee to participate in this study
Currently receiving (or scheduled to receive) radiation treatment for a cancer listed in the inclusion criteria
Patient's household is currently receiving or applying for Supplemental Nutrition Assistance Program (SNAP) benefits (formerly known as food stamps)
Currently receiving or expected to start cytotoxic chemotherapy or immunotherapy within 1 week of study enrollment and additional dexamethasone cannot be used concurrently as per attending oncologist.
Patients who are currently receiving physical therapy or practicing yoga for any reason
Currently employed in night shift work
Currently receiving palliative or hospice care
Currently receiving reflexology or meditative practices
Subject must currently be receiving enzalutamide for prostate cancer in a study sponsored by Astellas or Medivation and, based on the investigator's assessment, benefit from continued treatment. Subjects participating in investigator-initiated trials are not eligible.
Subject is currently participating in an investigator-initiated interventional trial and receiving enzalutamide.
Patients currently receiving anti-convulsants (such as gabapentinoids, e.g. gabapentin (Neurontin) or pregabalin (Lyrica) will be tapered off these medications over 7 days; the study team will provide instructions on how to do this
Currently receiving acupuncture for any condition or if they have ever used acupuncture before
As per self-report, currently engaged in ongoing psychotherapy
Currently on gabapentin
Currently residing in nursing or assisted living facility
Currently practicing nurse
Subjects currently participating in a RT program
Currently on gabapentin or pregabalin; note: (all patients on these medications will be weaned off of them prior to study initiation; the study team will provide instructions on how to do this)
Patient is currently on antibiotics
Currently receiving rehabilitation
At the time of recruitment the patient is on active treatment defined as either currently receiving chemotherapy or radiation or less than 6 months post-cancer surgery
Currently walking =< 30 minutes/day for < 5 days a week (via self-report)
Currently walking, on average, more than 150 minutes per week
Currently receiving or have plans for adjuvant radiation or chemotherapy
Currently receiving gabapentin or pregabalin and not willing to be weaned off of these medications prior to Scrambler therapy initiation\r\n* Note: it is OK to continue these medications in patients who are receiving TENS
Currently receiving anti-convulsants (such as gabapentinoids, e.g. gabapentin [Neurontin] or pregabalin [Lyrica]); all patients on these medications will be weaned off them prior to study initiation
Currently receiving other alternative treatment for CDI (e.g. antibiotics other than metronidazole or vancomycin; probiotics; immunoglobulin therapy; fecal transplant)
Patients currently using a wearable activity tracker
Currently participating in couple/marital therapy
PATIENT: Currently receiving hospice care
INTERVENTION PHASE: Currently receiving acupuncture treatment for CIPN
Patients who are currently receiving acupuncture for any condition or if they have ever had acupuncture before
CANCER PATIENT GROUP: Currently receiving ADT treatment for at least 6 months (and continue to receive treatment during the duration of the study)
Currently receiving other intravesical chemotherapy.
Currently receiving Dilantin (phenytoin) or auranofin or another gold-containing compound
Currently receiving immune-modulating therapies
Patients currently receiving therapy for mucositis
Participant is currently receiving treatment with fluvoxamine
Participant is currently receiving treatment with immunosuppressants or corticosteroids
Participant is currently receiving treatment with nifedipine (Procardia XL)
Currently receiving anticonvulsants (phenobarbital, diphenylhydantoin, primidone), phenylbutazone, clonidine, and/or tricyclic drugs (imipramine, clomipramine, or desipramine)
Be currently receiving anticoagulants, anticonvulsants (phenobarbital, diphenylhydantoin, primidone), phenylbutazone, and/or tricyclic drugs (imipramine, clomipramine, or desipramine)
Patients who are currently receiving acupuncture for any condition or if they have ever had acupuncture before
Currently receiving chemotherapy or radiation
Subjects may be currently prescribed hormone treatment or Herceptin therapy
Patients currently participating in a meditation practice for more than 1 hour per week prior to preoperative visit
Currently receiving chemotherapy
Currently prescribed plavix (clopidogrel)
Currently weighs > 350 pounds
Currently receiving anticoagulant therapy
Currently receiving therapeutic anticoagulant therapy or dual antiplatelet therapy (e.g. aspirin and clopidogrel)
Currently on the wait list for a new garden
Currently participating in a smokeless tobacco cessation study
Participants must not be currently receiving or have previously received thiazolidinedione treatment unless sputum atypia or endobronchial dysplasia are documented again after thiazolidinedione treatment and within 12 months of entry
PILOTS II and III: Currently receiving radiation therapy or cytotoxic chemotherapy
For nicotine replacement therapy (NRT) (patch, gum, lozenge):\r\n* History of severe eczema or any serious skin problem if requested nicotine patch\r\n* History of severe allergic reaction to the nicotine patch or other skin adhesives\r\n* History of heart attack in the last 2 months\r\n* Currently experiencing frequent angina or chest pain related to heart\r\n* Currently experiencing signs and symptoms of peptic ulcer\r\n* Currently receiving medications for rapid or irregular heart beat\r\n* Currently experiencing signs and symptoms of severe, uncontrolled high blood pressure
Presence of at least 1 CV risk factor:\r\n* Currently on medication for hypertension, or\r\n* Currently on medication for cholesterol or triglyceride, or\r\n* Currently on medication for diabetes, or\r\n* Currently not physically active (self-reported average < 20 minutes/day), or\r\n* Currently smoking.
Currently institutionalized
Currently on the wait list for a new garden
Not currently using immunosuppressant medications
Pregnancy in the last 6 months/planned within the next 2 years or currently lactating
Currently receiving vismodegib, biologics or chemotherapy
Currently receiving or planning to receive other xerostomia treatment, including drugs, herbs or devices; all other treatments known to affect salivation should be stopped at least 14 days prior to enrollment
Currently receiving treatment for any malignancy
Patients who currently have stomatitis/oral mucositis/mouth ulcers;
Currently receiving immunosuppressive therapy to include chemotherapy, steroids, or methotrexate
Subject is currently receiving anticoagulation therapy other than acetylsalicylic acid
currently minimally active,
Not currently receiving cancer-directed therapy
Currently receiving immunotherapy
Not currently on ADT
Is currently receiving and able to discontinue erlotinib, gefinitib, afatinib, or osimertinib
Currently treated for hyperthyroidism
Presence of synchronous malignancy for which the patient is currently receiving active treatment
Not currently receiving radiation treatment for a cancer listed in the arm-specific inclusion criteria (Arms 2 and 3)
Currently receiving treatment for a cancer other than those listed in the arm-specific inclusion criteria (exception: the study does not exclude those receiving treatment for non-melanoma skin cancer) (Arms 2 and 3)
Patients currently receiving active therapy for any cancer, including CRC or NSCLC
Currently fasts 12 hours or more (on either of two 24 hour diet recalls, conducted during interim 1)
Criteria 4, Participant is currently receiving or has received liver metastatic-directed therapy ( eg: radiation, ablation, embolization) less than 4 wks prior to enrollment or hepatic surgery
Patient currently receiving or had prior treatment for the currently diagnosed breast cancer.
Are currently receiving other medications or radiation intended for the treatment of their malignancy
Participant must be previously untreated, (no more than 72 hours of steroids, one intrathecal chemotherapy treatment, and/or emergency radiation)
PARTICIPANTS FROM COLLABORATING SITES PARTICIPATING IN BIOLOGICAL OBJECTIVES ONLY: Participant must be previously untreated, (no more than 72 hours of steroids, one intrathecal chemotherapy treatment, and/or emergency radiation)
Patients requiring emergency radiation therapy are eligible for enrollment on this trial
Subjects undergoing emergency surgery
Emergency surgery
More than 10 VOCs within the past 12 months that required a hospital, emergency room or clinic visit
Patients who are receiving an emergency colonoscopy
No prior therapy, unless an emergency situation requires local tumor treatment (discuss with principal investigator [PI])
ORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Prior surgery, radiation therapy, or chemotherapy other than biopsy or emergency procedure required for supportive care
Patient is able to stay within 45 minutes driving time of an emergency room for 28 days after dosing with C. novyi-NT
Severe increased intracranial pressure, status epilepticus, or other serious complications from the brain tumor, requiring emergency or urgent intervention
Prior surgery, radiation therapy, or chemotherapy other than biopsy or emergency procedure required for supportive care of this oral cavity cancer.
Emergency leukapheresis
Emergency surgery for abdominal indications
Subject is undergoing an emergency surgical procedure;
Emergency leukapheresis;
Emergency treatment for hyperleukocytosis with hydroxyurea for ? 10 days;
Patient is able to stay within 45 minutes driving time of an emergency room for 28 days after doing.
Subject needs non-emergency cardiac surgery with cardiopulmonary bypass.
Subject needs emergency surgery.
Previously untreated AML (except: emergency leukopheresis and/or hydroxyurea during the screening phase to control hyperleukocytosis but must be discontinued at least one day prior to start of study therapy)
e. Unstable pulmonary disease requiring hospitalization or emergency room visit within the last 3 months.
Emergency case
Emergency craniotomies
Emergency surgery of any type that does not allow for proper time for protocol review by the patient
Patient requiring emergency operations
Patients requiring emergency surgical intervention that would be inappropriately delayed by FLT-PET imaging