Has extensive pleural effusion which occupies greater than 50% of the total lung volume observed on screening imaging
Evidence of fluid retention at Screening (including, for example, peripheral edema, pleural effusion, or ascites on physical or radiological examination) or history of severe capillary leak syndrome
Has symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible.
Participants (all indications) with confirmed bilateral pleural effusion and NSCLC participants with confirmed uni- or bilateral pleural effusion by X-ray are not eligible
Patients with active extra-abdominal disease including active malignant pleural effusion; patients who have been successfully treated with neoadjuvant chemotherapy and no longer have (malignant) pleural effusions may be included
No clinically significant pleural effusion
Participants with confirmed bilateral pleural effusion
Patients with non-malignant pleural effusion are eligible\r\n* If a pleural effusion is present, the following criteria must be met to exclude malignant involvement:\r\n** When pleural fluid is visible on both the CT scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative\r\n** Exudative pleural effusions are excluded, regardless of cytology\r\n** Effusions that are minimal (i.e, not visible on chest x-ray) that are too small to safely tap are eligible
Evident symptomatic pulmonary fibrosis or interstitial pneumonitis, pleural or cardiac effusion rapidly increasing and/or necessitating prompt local treatment within seven days.
For NSCLC, patients with clinical stage IIB-IV patients (American Joint Committee on Cancer [AJCC], 7th edition [ed.]) are eligible, and for SCLC, limited-stage patients are eligible, if documented to be a candidate for definitive radiation and concurrent chemotherapy in the radiation oncologist or medical oncologist clinic note\r\n* Stage IV NSCLC patients are eligible only if they have a solitary brain metastasis\r\n* Patients with non-malignant pleural effusion are eligible,\r\n** If a pleural effusion is present, the following criteria must be met to exclude malignant involvement:\r\n*** When pleural fluid is visible on both the computed tomography (CT) scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative\r\n*** Exudative pleural effusions are excluded, regardless of cytology\r\n*** Effusions that are minimal (i.e., not visible on chest x-ray) that are too small to safely tap are eligible
Evidence of measurable disease (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1]) outside of the peritoneal cavity (ex: mediastinal lymphadenopathy, parenchymal liver metastasis, or symptomatic pleural effusion proven or suspected to be due to cancer)\r\n* Note: Asymptomatic pleural effusion with or without minimal pleural involvement as long as there is no measurable disease outside the peritoneum/retroperitoneum is allowed
Participants with bilateral pleural effusion and NSCLC participants with uni- or bilateral effusion confirmed at screening by X-ray are not eligible
Pleural or pericardial effusion\r\n* A patient with pleural effusion may be enrolled the effusion is sampled by thoracentesis and cytology is negative or the effusion is seen on axial imaging but not on chest x-ray and deemed too small to tap under CT or ultrasound guidance
Pleural or pericardial effusion\r\n *Pleural effusions allowed if one of the following conditions are met: 1) negative cytology after adequate sampling by thoracentesis 2) effusion seen on CT scan but not on chest x-ray and deemed too small to tap under CT or ultrasound guidance
Patients with pleural effusion or abdominal/peritoneal ascites, except the finding of physiological levels of fluid.
Pleural effusion as the only evidence of metastatic disease
Presence of a significant pleural effusion by chest x-ray
A pleural effusion of moderate severity or worse.
No clinically significant pleural effusion
Pleural effusion: when pleural fluid is visible on both CT scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative; patients with effusions that are minimal (i.e. not visible on chest x-ray) or that are too small to safely tap are eligible
Patients with known extrathoracic metastases, including brain metastases, or known malignant pleural or pericardial effusion
A pleural effusion of moderate severity or worse.
No clinically significant pleural effusion
No pleural or peritoneal serous effusion.
DASATINIB\r\n* Any history of second or third degree heart block (may be eligible if the subject currently has a pacemaker)\r\n* Known pulmonary arterial hypertension\r\n* Patients may not have clinically significant pleural or pericardial effusion per provider discretion
Presence of third space fluid which cannot be controlled by drainage; for patients who develop or have baseline clinically significant pleural or peritoneal effusions (on the basis of symptoms or clinical examination) before or during initiation of pemetrexed therapy, consideration should be given to draining the effusion prior to dosing; however, if, in the investigator's opinion, the effusion represents progression of disease, the patient should be discontinued from study therapy
Presence of pleural effusion
Patients with symptomatic ascites or pleural effusion; a patient who is clinically stable following treatment for these conditions is eligible
Patients with evidence of a malignant pleural or pericardial effusion
If a pleural effusion is present and visible on both CT scan AND chest x-ray, the investigator should exclude malignant disease by pleurocentesis to confirm cytologically-negative pleural fluid; if fluid is exudative or cytologically positive for tumor cells, patient is excluded\r\n* Patients with effusions that are minimal (i.e. not visible on chest x-ray) and that are too small to safely tap are eligible
If the patient has received pre-operative neoadjuvant chemotherapy, evidence of response must be documented by at least one of the following: decline in serum carcinoma antigen (CA)125 level, at least a 30% decrease in the sum of the longest diameter of target lesions on radiographic imaging, or resolution of ascites or pleural effusion(s)
Dasatinib \r\n* Known pulmonary arterial hypertension\r\n* Patients may not have pleural or pericardial effusion of any grade\r\n* Patients may not have clinically significant pleural or pericardial effusion per provider discretion\r\n* Uncontrolled hypertension: inability to maintain blood pressure below the limit of 140/90 mgHg\r\n* Any history of second or third degree heart block (may be eligible of the subject currently has a pacemaker)
Patients with known, clinically significant pericardial or pleural effusion
Subjects with significant fluid retention, including ascites or pleural effusion, may be allowed at the discretion of the Principal Investigator (PI)
Measurable disease as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria or non-measurable disease with symptomatic malignant pleural effusion or malignant ascites; if only site of disease is a pleural effusion, cytologic confirmation of recurrence should be obtained
Clinically significant pleural effusion that either required pleurocentesis or is associated with shortness of breath.
Symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible.
Clinically significant pleural effusion
Exudative pleural effusion, regardless of cytology
Pleural effusion that cannot be controlled with appropriate interventions
Presence of a pleural effusion with the ability to safely place an intrapleural catheter or have pre-existing intrapleural catheter
Pleural effusion requiring active medical management
Cytologically positive pleural effusion
Pleural effusion that cannot be controlled despite appropriate interventions
If a pleural effusion is present, the following criteria must be met at registration to exclude malignant involvement (incurable M1a disease):\r\n* When pleural fluid is visible on both the CT scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative\r\n* Effusions that are minimal (i.e. not visible under ultrasound guidance) and that are too small to safely tap are eligible
Patients with evidence of a malignant pleural or pericardial effusion are excluded
If a pleural effusion is present, the following criteria must be met to exclude malignant involvement (incurable M1a disease):\r\n* When pleural fluid is visible on both the CT scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative\r\n* Exudative pleural effusions are excluded, regardless of cytology\r\n* Effusions that are minimal (i.e. not visible under ultrasound guidance) that are too small to safely tap are eligible
For Cohort B: Has ascites and/or clinically significant pleural effusion
Grade 3-4 ascites or pleural effusion\r\n* Note: The following will NOT be exclusionary: A participant who is clinically stable following treatment for ascites or pleural effusion (including therapeutic thoracentesis or paracentesis)
Malignant pleural effusion
Patients must have histologically or cytologically-proven new diagnosis of unresectable stage IIIA/IIIB*, non-small cell lung cancer (adenocarcinoma, bronchioloalveolar cell carcinoma, large cell carcinoma, squamous cell carcinoma, or mixed)\r\n* Per the American Joint Committee on Cancer (AJCC) 7th edition, pleural and pericardial are now considered stage M1a disease; when pleural fluid is visible on the computed tomography (CT) scan or on a chest x-ray, a thoracentesis is required to confirm that the pleural fluid is cytologically negative; patients with exudative pleural effusions are excluded, regardless of cytology; patients with effusions that are minimal (i.e. not visible on chest x-ray) that are too small to safely tap are eligible; a small effusion that has positive fludeoxyglucose F 18 (FDG) uptake on positron emission tomography (PET) has to be proven to be malignant per standard of care diagnostic procedures for the patient to be excluded
Stage IIIB with malignant pleural effusion/pleural seeding or stage IV histologically confirmed NSCLC
Patients with a pleural effusion that is a transudate, cytologically negative and non-bloody are eligible if the radiation oncologists feel the tumor can still be encompassed within a reasonable field of radiotherapy; if a pleural effusion can be seen on the chest computed tomography (CT) but is too small to tap, the patient is eligible
Any clinically significant pleural or peritoneal effusion that cannot be drained with standard approaches; an indwelling drainage device placed prior to enrollment is acceptable
Diagnosis of histologically or cytologically documented, malignant pleural effusions (primary non-small cell lung carcinoma, mesothelioma, and other histologies), who have free pleural space (partial or total) that permits the intrapleural drug instillation; this includes cytologically negative pleural effusion in conjunction with histologically proven malignancy involving the pleura
Patients with symptomatic ascites or pleural effusion; a patient who is clinically stable following treatment for these conditions is eligible
Have clinically significant and/or malignant pleural effusion (pleural effusions that are not clinically significant are allowed, defined as no more than 25% fluid level of the corresponding hemithorax and stable fluid level [non-progressive] over at least 6 weeks documented radiographically)
No clinically significant evidence of pleural effusion or ascites
Documented extensive disease, defined as any tumor beyond the above limited disease definition, including ipsilateral lung metastases and malignant pleural effusion.
Have clinically significant and/or malignant pleural effusion
Pleural effusion large enough to be detectable on chest x-ray
Has symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible.
Patients with a pleural effusion which is a transudate, cytologically negative and non-bloody are eligible if the radiation oncologist feels the tumor can be encompassed within a reasonable field of radiotherapy; patients with exudative, bloody, or cytologically malignant effusions are not eligible; if a pleural effusion can be seen on the chest CT but not on CXR and is too small to tap, the patient will be eligible
Patients with any pulmonary infiltrate including those suspected to be of infectious origin. Exception: Patients with a pleural effusion related to the disease under study as confirmed by the investigator are permitted to enter the study
Subject's with significant fluid retention, including ascites or pleural effusion, may be allowed at the discretion of the principal investigator (PI)
Patients with stage I or stage IV disease, including malignant pleural or pericardial effusion
Malignant pleural, pericardial, or peritoneal effusion if it is the only site of disease activity; i.e., if no other measurable tumor lesions exist
Clinically significant (in the opinion of the Investigator) ascites or pleural effusion requiring chronic medical intervention
Patients with a pleural effusion, which is a transudate, cytologically negative and non-bloody, are eligible if the radiation oncologist feels the tumor can be encompassed within a reasonable field of radiotherapy
If a pleural effusion can be seen on the chest CT but not on chest x-ray and is too small to tap, the patient will be eligible; patients who develop a new pleural effusion after thoracotomy or other invasive thoracic procedure will be eligible
Stage IV cancer according to TNM classification (7th edition - UICC, December 2009; includes tumor with malignant pleural or pericardial effusion
Pleural effusion large enough to be detectable on chest x-ray (CXR)
Free flowing pleural effusion requiring management by placement of a pleural catheter; patients with a functional pleural catheter already in place are eligible for the study, as long as there are no clinical concerns of infection
No free-flowing pleural effusion
Cardiac ejection fraction >50%, no evidence of pericardial effusion as determined by an ECHO, and no clinically significant pleural effusion
Clinically significant pleural effusion.
Clinically significant pleural effusion
Presence of tumor metastases causing significant pleural disease/effusion unilaterally or bilaterally (significant pleural effusion is defined by need for thoracentesis more frequently than once every 21 days)
Malignant pleural effusion or pleural disease
Pleural effusion requiring repetitive drainage, i.e., an indwelling catheter or 2 thoracenteses with 6 weeks of the first dose of mogamulizumab;
Malignant pleural effusion that is recurrent
Clinically significant and/or malignant pleural effusion
Any cause of dyspnea that is determined by the investigators as readily reversible by other means (e.g. pleural effusion, pulmonary embolism, acute infection, anemia hemoglobin [Hb] < 9.0, etc.)
Pleural effusion or clinically evident (visible or palpable) ascites
Have clinically significant and/or malignant pleural effusion
Pre-existing ascites (abdominal fluid collection) and/or clinically significant pleural effusion ( fluid collection between the lung and chest wall)
Pleural effusion requiring thoracentesis within 1 week of study enrollment or scheduled during the study period
Subject has a symptomatic malignant pleural effusion requiring intervention; for an effusion to be defined as malignant, at least one of the following must be true\r\n* There is cytological confirmation of pleural malignancy\r\n* The effusion is an exudate (per Light’s criteria) in the context of histocytologically proven malignancy elsewhere, with no other clear cause for fluid identified
Subject has sufficient pleural fluid to allow safe insertion of an indwelling tunneled pleural catheter as determined by the principal investigator (PI)
Radiographic evidence of brain metastases and/or ipsilateral lung metastases/malignant pleural effusion
Patients with minimal pleural effusion evident on chest X-ray (CXR); minimal pleural effusion visible on chest CT is allowed
Presence of a symptomatic moderate or large free-flowing pleural effusion on the basis of:\r\n* Chest radiograph: effusion filling >= 1/3 the hemithorax, OR\r\n* Computed tomography (CT)-scan: maximum anteroposterior (AP) depth of the effusion >= 1/3 of the AP dimension on the axial image superior to the hemidiaphragm, including atelectatic lung completely surrounded by effusion, OR\r\n* Ultrasound: effusion spanning at least three rib spaces with depth of 3 cm or greater in at least one interspace, while the patient sits upright
Pleural effusion is smaller than expected on bedside pre-procedure ultrasound
More than 1 biopsy on the same side requiring more than 1 pleural puncture
There is histocytological confirmation of pleural malignancy
A CXR shows ?20% of the affected hemithorax to be occupied with pleural fluid AFTER a pleural aspiration which resulted in symptoms suggestive of trapped lung (e.g., chest pain or cough).
Patients with symptomatic pleural effusion requiring placement of an indwelling pleural catheter (IPC) or new placement of an IPC.
Positive effusion cytology
Patients with a pleural effusion that is a transudate, cytologically negative and non-bloody are eligible if the radiation oncologists feel the tumor can still be encompassed within a reasonable field of radiotherapy; patients with exudative, bloody, or cytologically malignant effusions are ineligible; if a pleural effusion can be seen on the chest computed tomography (CT) but not on chest x-ray (CXR) and is too small to tap, the patient will be eligible
Tumor with pleural contact.
Patients with non-measurable non-evaluable lesions such as pleural effusion are not eligible to participate
No clinically significant pleural effusion
Clinically significant ascites, defined as ascites that is symptomatic or has resulted in a paracentesis in the past 3 months
Uncontrolled ascites requiring weekly large-volume paracentesis for 2 consecutive weeks prior to initiation of study treatment
Patients who had therapeutic paracentesis of ascites (> 1L) within the 3 months prior to starting study treatment or who, in the opinion of the investigator, will likely need therapeutic paracentesis of ascites (> 1L) within 3 months of starting study treatment.
Refractory encephalopathy or ascites
Fluctuating ascites
Ascites that your doctor will manage by increasing your medications or by performing non-invasive methods (eg, paracentesis) to control, within 6 months prior to the first scheduled dose.
Clinical evidence of ascites (trace ascites on imaging acceptable)
No evidence of clinically apparent ascites or active encephalopathy, and/or varices that have not been treated; subjects with controlled ascites or encephalopathy are eligible so long as they meet Childs-Pugh score criterion; please note that controlled ascites and encephalopathy require scores of 2 each when calculating the C-P score
Clinical ascites or metastatic pleural fluid
Ascites refractory to medical therapy (mild to moderate ascites is allowed)
No clinical evident ascites that required therapeutic paracentesis
Malignant ascites that is clinically detectable by physical examination or is symptomatic; evidence of radiographic ascites that is not clinically significant will not be an exclusion criterion
Clinically apparent ascites on physical examination, ascites present on imaging studies is allowed
Presence of symptomatic liver failure including ascites and hepatic encephalopathy
Requirement for diuretics, paracentesis, or other medications or procedures to control ascites or hepatic encephalopathy within 6 months before enrollment\r\n* Diuretics or medications such as lactulose used for other indications (e.g. edema, constipation) are allowed
Decompensated liver disease as evidenced by clinically significant ascites refractory to diuretic therapy, hepatic encephalopathy, or coagulopathy
Moderate or severe ascites
Has clinically relevant ascites at baseline (defined as requiring paracentesis) or with moderate radiographic ascites; a minimal amount of radiographic ascites is allowed
Participants with uncontrolled gross ascites or encephalopathy; assessment of ascites will be determined by the treating physician
Patients with any clinically apparent ascites or who have undergone a paracentesis within 7 days of enrollment
Evidence of severe portal hypertension with evidence of decompensation either with bleeding varices, large volume ascites, or hepatic encephalopathy
If present, clinically significant or symptomatic amounts of ascites should be drained prior to Day 1.
Clinical ascites
Patients with malignant small bowel obstruction within the last 6 months, on parenteral nutrition, clinically significant ascites (palpable on physical exam and/or causing symptoms) or ascites requiring fluid removal more than twice in the last 6 weeks
Subjects with clinically apparent ascites or encephalopathy, or untreated varices are not eligible for enrollment
Moderate to large volume ascites.
Significant ascites that require therapeutic paracentesis
At risk for hepatic or renal failure\r\n* Serum creatinine > 1.5 mg/dl\r\n* Serum bilirubin > 1.3 mg/ml\r\n* Albumin < 2.0 g/dL\r\n* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times upper normal limit\r\n* Any history of hepatic encephalopathy\r\n* Cirrhosis or portal hypertension\r\n* Clinically evident ascites (trace ascites on imaging is acceptable)
Presence of ascites (as determined by clinician)
Ascites refractory to medical therapy
Ascites refractory to medical therapy
Any evidence of ascites (beyond trace)
No clinical evidence of hepatic failure (e.g. coagulopathy, ascites)
Patients with current cirrhotic status of Child-Pugh class A only (5-6 points with total bilirubin < 2 mg/dL for dose-escalation) with no encephalopathy and no clinical ascites (ascites controlled by diuretics is also excluded in this study).
Evidence of significant ascites as determined by the investigator
Hepatic blood flow abnormalities and/or large-volume ascites
Presence of ascites that is not medically controlled or that required a therapeutic paracentesis within the last 3 months prior to initiation of study therapy
Patients must be willing and able to undergo ascites fluid collection pre- and post-study treatment if adequate ascites is present; patients without adequate ascites may also participate in the trial
Has clinically apparent ascites on physical examination. Note: ascites detectable on imaging studies only ARE allowed.
Moderate or severe ascites.
Clinically evident ascites (trace ascites on imaging is acceptable)
Any prior (within 1 year) or current clinically significant ascites as measured by physical examination and that requires paracentesis for control;
Clinically significant ascites
Decompensated liver disease as evidenced by clinically significant ascites refractory to diuretic therapy, hepatic encephalopathy, or coagulopathy
Have greater than grade 2 ascites at time of enrollment.
Have presence of clinically relevant ascites.
Any prior or current clinically significant ascites
Significant or symptomatic amount of ascites should be drained prior to first dose of BBI608.
Clinically evident ascites (trace ascites on imaging is acceptable)
Has clinically apparent ascites on physical examination
No clinical ascites (mild ascites on scans permissible)
Ascites requiring intervention
Subject has uncontrolled symptomatic ascites.
Uncontrolled or clinically relevant ascites
Histologically confirmed metastatic ovarian or GI malignancy with malignant ascites amenable for paracentesis; adjudication of malignant ascites can be made on clinical grounds e.g. in the absence of cirrhosis or other non-malignant causes of ascites
Presence of clinically significant ascites
Decompensated liver disease as evidenced by clinically significant ascites refractory to diuretic therapy, hepatic encephalopathy, or coagulopathy
Moderate or severe ascites
No moderate-to-severe ascites (subjects with ascites restricted to the perihepatic space or pelvic cavity)
Clinical ascites
Clinically evident ascites (trace ascites on imaging is acceptable)
Uncontrolled ascites defined as not easily controlled by stable doses of diuretics
Uncontrolled ascites (defined as not easily controlled with diuretic or paracentesis treatment).
Ascites detected by CT, ultrasound (US) or MRI; (trace ascites will not be an exclusion)
Presence of symptomatic liver failure including ascites and hepatic encephalopathy
Patients cannot have active ascites
Subjects with refractory ascites, defined as ascites needing drainage catheter or therapeutic paracentesis more often than every 4 weeks
Recurrent symptomatic malignant ascites having required at least 2 paracenteses within a 45-day interval prior to baseline paracentesis
Compensated cirrhosis defined as a Child-Pugh score of 5 or 6 at Screening • A minimal rim of ascites if detected at imaging is acceptable. Exclude ascites that requires the need to apply diuretic treatment to control ascites
Significant or symptomatic amounts of ascites should be drained prior to Cycle 1 Day
Clinically significant ascites or clinical evidence or history of portosystemic hypertension or cirrhosis.
No signs of decompensated liver cirrhosis or ascites requiring therapeutic paracentesis
Uncontrolled ascites requiring weekly large volume paracentesis for 3 consecutive weeks prior to enrollment
Poorly controlled ascites and/or requirement for therapeutic paracentesis more frequently than once every 3 months.
Clinically significant ascites
Unwilling to allow removal of tumor biological samples for analysis, i.e., biopsies of tumor lesions, and/or collection of ascites fluid from abdominal ascites (if present)
Presence of ascites that requires paracentesis more frequently than once every 21 days.
Presence of ascites that preclude biopsy of liver lesions.
Subjects with sensory neuropathy, ascites, or plastic biliary stent.
Subjects with clinically significant ascites
Clinically evident ascites
Active infection, ascites, hepatic encephalopathy
Evidence of ascites on imaging study, or the use of diuretics for ascites
Patients with clinically significant ascites requiring paracentesis on 2 or more occasions within 4 weeks prior to start of study treatment
Significant peri-hepatic ascites interfering with safe/effective PTBD.
Patients presenting with ascites
Presence of ascites
Moderate or severe ascites
History of or current hepatic encephalopathy or clinically meaningful ascites.
Ascites absent
Uncontrolled large ascites
Clinically or radiographically detectable ascites (beyond trace/rim of ascites) or ascites requiring medication
Minimal or non-symptomatic ascites
Ascites or other clinical or radiographical signs of portal hypertension
Uncontrolled ascites that is not stable with medical management (i.e., on diuretics and salt restriction) as defined by requiring therapeutic paracentesis more than once every 4 weeks.
Uncontrolled ascites requiring weekly large volume paracentesis for 3 consecutive weeks prior to enrollment
Patients with malignant pleural effusions that do not resolve after first-line systemic therapy. Patients with pleural effusions that have become too small for thoracentesis at the time of registration would be permitted on study, indicating a significant response to first-line systemic therapy.
Exudative, bloody, or cytological proven malignant effusions
Uncontrolled symptomatic ascites or pleural effusions within 6 months.
Patients with significant visceral fluid collections including ascites, pericardial effusions, pleural effusions or others may experience delayed clearance of methotrexate and inability tolerate the proposed study treatment; while these are not absolute exclusions the Study Chair or co-Chairs should be contacted to discuss possible enrollment; patients with significant ascites defined as European Association for the Study of the Liver >= grade 2, or with asymptomatic pleural effusions with an estimated size > 200 mL, or with symptomatic pleural effusion of any size will be excluded
Patients with clinically significant ascites or pleural effusions.
Greater than minimal, exudative, or cytologically positive pleural effusions
Chylous effusions associated with malignant disease
The presence of lung, liver, or known brain metastases, malignant pleural effusions, or malignant ascites
Patients with documented significant pleural or pericardial effusions unless they are thought to be secondary to their leukemia.
Symptomatic pleural effusions or ascites (requiring constant or intermittent drainage)
Clinically significant and/or rapidly accumulating ascites, pericardial and/or pleural effusions; mild ascites that does not preclude safe tumor biopsy as protocol specified is allowed at the discretion of the treating physician
Pleural effusions or ascites.
Patients with documented significant pleural or pericardial effusions unless they are thought to be secondary to their leukemia.
High volume peritoneal or pleural effusions requiring a tap more frequently than every 14 days; moderate to severe ascites
Uncontrolled effusion e.g., presence of third space fluid that, in the opinion of the investigator, cannot be successfully controlled by drainage\r\n* Note: Patients with small effusions remaining after pleurodesis are eligible; determination of eligibility based on pleural size will be determined by the principal investigator
Any clinical or radiological ascites or pleural effusions
Patients with large and recurrent pleural or peritoneal effusions requiring frequent drainage (e.g. weekly)
Subjects with malignant pleural effusions and malignant ascites
Patients with clinically significant pleural or pericardial effusions
Patients with documented significant pleural or pericardial effusions unless they are thought to be secondary to their leukemia
History of moderate or severe ascites, bleeding esophageal varices, hepatic encephalopathy or pleural effusions related to liver insufficiency within 6 months of screening
Presence of third space fluid that cannot be controlled by drainage\r\n* For patients who develop or have baseline clinically significant pleural effusions before or during initiation of pemetrexed therapy; consideration should be given to drain the effusion prior to chemotherapy administration
Presence of pleural effusions > 5 mm as measured by treating physician using standard radiologic measuring tools
Recent history (within 6 months) of uncontrolled symptomatic ascites or pleural effusions.
Pleural effusions that are minimal (i.e. not visible on chest x-ray) that are too small to safely tap are eligible
Patients with symptomatic effusions (pleural, pericardial, or peritoneal) and/or those who have required a procedure for symptomatic effusions within 4 weeks of start of dasatinib are ineligible
The presence of liver, or known brain metastases, malignant pleural effusions, or malignant ascites
Symptomatic ascites or pleural effusions
Exudative, bloody, or cytologically malignant effusions
Uncontrolled pleural, pericardial effusions, or ascites requiring recurrent drainage procedures
If pleural fluid is visible on CT scan thoracentesis to exclude malignancy should be obtained. Patients with effusions that are too small to tap are eligible.
Greater than minimal, exudative, or cytologically positive pleural effusions
History of ascites or pleural effusions, unless successfully treated.
Symptomatic effusions due to pleural, pericardial, or peritoneal metastasis of epithelial ovarian cancer
Patients with known moderate/severe pleural effusions that are unrelated to malignancy or established diagnosis of pulmonary arterial hypertension
The presence of known brain metastases, malignant pleural effusions, or malignant ascites; brain MRI is required at screening only if clinically indicated
Patients with clinically significant pleural or pericardial effusions
Patients with symptomatic effusions on account of pleural, pericardial or peritoneal metastases of melanoma
Known presence of central nervous system metastases, pleural effusions or ascites
Patients with a history of malignant pleural effusions are not eligible; pleural effusions considered by the investigator too small for a diagnostic thoracentesis are permissible
For metastatic solid tumors with documented malignant pleural and/or peritoneal effusions, patients must not be receiving specific therapy for the effusion or have an indwelling drain.
Patients with documented significant pleural or pericardial effusions unless they are thought to be secondary to their leukemia
Exudative, bloody, or cytologically malignant effusions
Patients with malignant pleural effusions or significant pericardial effusions
Patients with symptomatic effusions on account of pleural, pericardial or peritoneal metastases of melanoma
The participant has clinically significant third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry.
Ascites, pleural effusions, or osteoblastic bone metastases as the only site of disease.
Presence of large accumulation of ascites or pleural effusions, which would be a contraindication to the administration of methotrexate for GVHD prophylaxis
Recent history (within 6 months) of uncontrolled symptomatic ascites or pleural effusions.
All patients whom do not have malignant pleural effusions
Subject has bilateral pleural effusions, with both being at least moderate in size (greater than one-third of the hemithorax on CXR).
Chylous effusions associated with malignant disease
Epithelial ovarian cancer outside of the peritoneal cavity, with the exception of pleural effusions
Body cavity effusions not caused by primary effusion lymphoma nor chylous effusions directly related to lymphatic infiltration by KS
Patients with any pulmonary infiltrate including those suspected to be of infectious origin; in particular, patients with resolution of clinical symptoms of pulmonary infection but with residual pulmonary infiltrates on chest x-ray are not eligible until pulmonary infiltrates have completely resolved
New or progressive pulmonary infiltrates on screening chest x-ray or chest CT scan that has not been cleared by Pulmonary. Infiltrates attributed to infection must be stable/improving (with associated clinical improvement) after 1 week of appropriate therapy (4 weeks for presumed or documented fungal infections)
No evidence of acute pulmonary infiltrates on chest radiograph
New or progressive pulmonary infiltrates on screening chest X-ray or chest CT scan unless cleared for study by pulmonary; infiltrates attributed to infection must be stable/improving (with associated clinical improvement) after 1 week of appropriate therapy (4 weeks for presumed or documented fungal infections)
New or progressive pulmonary infiltrates on screening chest X-ray or chest computed tomography (CT) scan unless cleared for study by Pulmonary; infiltrates attributed to infection must be stable/improving (with associated clinical improvement) after 1 week of appropriate therapy (4 weeks for presumed or documented fungal infections)
New or progressive pulmonary infiltrates on screening chest X-ray or chest computed tomography (CT) scan unless cleared for study by pulmonary; infiltrates attributed to infection must be stable/improving (with associated clinical improvement) after 1 week of appropriate therapy (4 weeks for presumed or documented fungal infections)
New or progressive pulmonary infiltrates on screening chest x-ray or chest computed tomography (CT) scan unless cleared for study by pulmonary; infiltrates attributed to infection must be stable/improving (with associated clinical improvement) after 1 week of appropriate therapy (4 weeks for presumed or documented fungal infections)
New or progressive pulmonary infiltrates; progressive pulmonary infiltrate is defined as an increase of 20% or greater from prior radiologic exam; radiologic assessment methods may be computed tomography (CT) or posterioranterior (PA)/lateral (L) x-ray imaging; infiltrates attributed to infection must be stable or improving after 1 week of appropriate therapy, or 4 weeks for presumed or proven fungal infections to be eligible
New progressive pulmonary infiltrates on screening chest x-ray or chest computed tomography (CT) scan that have not been evaluated with bronchoscopy; infiltrates attributed to infection must be stable/improving after 1 week of appropriate therapy (4 weeks for presumed or proven fungal infections)
New or progressive pulmonary infiltrates on screening chest x-ray or chest computed tomography (CT) scan unless cleared for study by pulmonary. Infiltrates attributed to infection must be stable/improving (with associated clinical improvement) after 1 week of appropriate therapy (4 weeks for presumed or documented fungal infections).
New or progressive pulmonary infiltrates on screening chest x-ray or chest computed tomography (CT) scan that has not been evaluated with bronchoscopy; infiltrates attributed to infection must be stable/improving (with associated clinical improvement) after 1 week of appropriate therapy (4 weeks for presumed or documented fungal infections); surgical resection waives any waiting requirements
New progressive pulmonary infiltrates on screening chest x-ray or chest computed tomography (CT) scan for which evaluation with bronchoscopy is not feasible; infiltrates attributed to infection must be stable/improving (with associated clinical improvement) after 1 week of appropriate therapy (4 weeks for presumed or documented fungal infections)
Patients with an abnormal chest X-ray and/or any pulmonary infiltrate including those suspected to be of infectious origin; in particular, patients with resolution of clinical symptoms of pulmonary infection but with residual pulmonary infiltrates on chest x-ray are not eligible until pulmonary infiltrates have completely resolved
New or progressive pulmonary infiltrates on screening chest x-ray or chest computed tomography (CT) scan that has not been evaluated with bronchoscopy, if feasible; infiltrates attributed to infection must be stable/improving (with associated clinical improvement) after 1 week of appropriate therapy (4 weeks for presumed or documented fungal infections); surgical resection waives any waiting requirements
New or progressive pulmonary infiltrates on screening chest x-ray or chest computed tomography (CT) scan that has not been evaluated with bronchoscopy, if feasible; infiltrates attributed to infection must be stable/improving (with associated clinical improvement) after 1 week of appropriate therapy (4 weeks for presumed or documented fungal infections)
Ascites or pleural effusion requiring intervention or that required intervention or recurred within three months prior to randomization
Pericardial effusion (except trace effusion identified by echocardiogram) within three months prior to randomization
No history of the following:\r\n* Class III or IV congestive heart failure (CHF)\r\n* Grade 3 or 4 thromboembolic event =< 6 months\r\n* Pericardial effusion =< 12 months (any grade)\r\n* Pericardial involvement with tumor\r\n* Grade 2 or higher pleural effusion =< 6 months
Patients must not have active pericardial effusion, ascites or pleural effusion of any grade based on chest x-ray and echocardiogram within 28 days prior to registration; exception: if the effusion is suspected to be related to the leukemia, the patient may have pericardial effusion =< grade 2 or pleural effusion =< grade 1
Patient has pleural effusion, ascites, or pericardial fluid requiring drainage Note: Patient who had drain removal ? 14 days prior to planned first dose of study drug and has no sign of worsening is eligible
Have symptomatic ascites or pleural effusion.
Symptomatic ascites or pleural effusion.
Uncontrolled pleural effusion, pericardial effusion, or ascites
Symptomatic ascites or pleural effusion
Has ascites or pleural effusion by physical exam
Has symptomatic ascites or pleural effusion.
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage more than once every 28 days
Presence of fluid collection (ascites, pleural, or pericardial effusion) that interferes with methotrexate clearance or makes methotrexate use contraindicated.
Pleural or pericardial effusions of any grade at study entry; subjects previously diagnosed with pleural/pericardial effusion of any grade resolved at the time of study entry are allowed
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
Concurrent medical condition that would increase drug toxicity: pleural or pericardial effusion, coagulation or platelet function disorder, ongoing or recent (less than 3 months gastrointestinal bleeding)
Presence of medically significant third space fluid (symptomatic pericardial effusion, ascites or pleural effusion requiring repetitive paracentesis)
Current, or history of a pericardial effusion, and/or hemodynamic compromise due to pericardial effusion of any size; minimal pericardial effusion < 50 cc is not excluded
Uncontrolled tumor-related pain; pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures; or, hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab.
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage more than once every 28 days
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) (patients with indwelling catheters such as PleurX® are allowed)
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
Symptomatic ascites or pleural effusion.
Ascites, pleural effusion, or pericardial fluid requiring drainage in the last 4 weeks prior to registration
Grade 2 or higher ascites, pleural, or pericardial effusion within 4 weeks of study enrollment or any history of recurrent grade 2 or higher effusions requiring ongoing drainage.
Ascites or pericardial effusion that required intervention within 3 months prior to study treatment
Uncontrolled pleural or pericardial effusion or ascites that would require recurrent drainage
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)\r\n* Subjects with indwelling drainage catheters are allowed
Marked pleural effusion or ascites above Grade 2, based on NCI-CTCAE v4.03 criteria
No pleural or pericardial effusion of any grade
Patients with large and recurrent pleural or peritoneal effusions requiring frequent drainage (e.g. weekly); patients with any amount of clinically significant pericardial effusion
Uncontrolled pleural or pericardial effusion or ascites that would require recurrent drainage
Symptomatic ascites or pleural effusion
Patients with any amount of clinically significant pericardial effusion
Pleural/pericardial effusion or ascites > 1 L
Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage
Presence of fluid collection (ascites, pleural or pericardial effusion) that interferes with methotrexate clearance or makes methotrexate use contraindicated
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures >/=1 time per month
Has symptomatic ascites or pleural effusion
Patients with large and recurrent pleural or peritoneal effusions requiring frequent drainage (e.g. weekly); patients with any amount of clinically significant pericardial effusion
Clinically significant pericardial effusion, circumferential pericardial effusion, or any effusion greater than 1.0 cm at any location around the heart
Has significant ascites or pleural effusion requiring drainage for symptom relief
Clinically detectable (by physical exam) third?space fluid collections (e.g. ascites or pleural effusion) that cannot be controlled by drainage or other procedures prior to study entry
Uncontrolled effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
Ascites, pleural effusion or pericardial fluid requiring drainage in the last 4 weeks
Patients with pre-existing interstitial lung disease (ILD), or pericardial/pleural effusion of grade 2 or higher; trace pericardial or pleural effusion is acceptable
Patients with large and recurrent pleural or peritoneal effusions requiring frequent drainage (e.g. weekly); patients with any amount of clinically significant pericardial effusion
Exclusion at the discretion of the principal investigator (PI) or delegate if participation to the study is deemed too risky (e.g. clinically significant pleural or pericardial effusion or ascites with possibly increased radio-toxicity)
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage at least once monthly.
Significant ascites or pericardial or pleural effusion
Has symptomatic ascites or pleural effusion.
Cardiopulmonary dysfunction, symptomatic pleural effusion, pericardial effusion, or ascites
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently); participants with indwelling catheters are eligible
Subjects with ascites or pleural effusion requiring drainage within the last 28 days.
Symptomatic ascites or pleural effusion
Presence of a small (or greater size) pericardial effusion
No history of the following:\r\n* Class III or IV congestive heart failure (CHF)\r\n* Pericardial effusion =< 12 months (grade 3 or 4)\r\n* Pericardial involvement with tumor\r\n* Grade 2 or higher pleural effusion =< 6 months
Patients with only non-measurable lesions other than bone metastasis (e.g. pleural effusion, ascites, etc).
Uncontrolled pleural effusion, pericardial effusion, or ascites (indwelling drainage catheters allowed)
Symptomatic ascites or pleural effusion
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
Uncontrolled tumor-related pain or uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent (once monthly or more frequently) drainage procedures
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
Presence of symptomatic pleural and/or pericardial effusion not appropriately treated
Presence of symptomatic pleural and/or pericardial effusion not appropriated treated
Patients with only non-measurable lesions other than bone metastases (e.g., pleural effusion, ascites, etc)
Patients with a pleural effusion requiring continuous drainage
Concurrent medical condition which may increase the risk of toxicity, including:\r\n* Pleural or pericardial effusion of any grade
Has symptomatic ascites or pleural effusion
Symptomatic pleural effusion (> CTCAE Grade 1 dyspnea) that is not amenable to drainage
Pleural effusion or ascites > 1 liter
Prior history of pericarditis or pericardial effusion
Clinically significant third-space fluid collections (e.g. ascites or pleural effusion) that cannot be controlled by drainage or other procedures prior to study entry
Patients require regular ascites/pleural effusion drainage
Clinically significant pericardial effusion, circumferential pericardial effusion, or any effusion greater than 1.0 cm at any location around the heart.
Uncontrolled pleural effusion, pericardial effusion, or ascites
Patient with pleural effusion, ascites, or pericardial fluid requiring drainage.
Patient has pleural effusion, ascites, or pericardial fluid requiring drainage. Note: Patient who had drain removal ? 14 days prior to planned first dose of study drug and has no sign of worsening is eligible.
Pleural effusion, pericardial fluid, or ascites requiring drainage every other week or more frequently
Uncontrolled clinical symptoms including pleural effusion, pericardial effusion, or ascites, tumor-related pain, hypercalcemia (or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy)
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
No effusion or ascites > 1 L prior to drainage
Uncontrolled pleural effusion or ascites
Signs of third spacing as determined by the treating physician (e.g., pedal edema, pleural effusion, ascites)
Uncontrolled pleural effusion, pericardial effusion, or ascites
Presence of fluid collection (ascites, pleural or pericardial effusion) that interferes with methotrexate clearance or makes methotrexate use contraindicated
Uncontrolled pleural effusion, pericardial effusion or ascites requiring recurrent drainage procedures
Presence of fluid collection (ascites, pleural or pericardial effusion) that interferes with methotrexate clearance or makes methotrexate use contraindicated
Malignant pleural effusion or pericardial effusion
Has symptomatic ascites or pleural effusion
Subjects with prior history of pericardial effusion or pleural effusion that required thoracentesis are excluded. Subjects with prior history of pericardial or pleural effusion that was clinically manageable and a maintained CMR for ? 1 year on a stable dose of dasatinib are allowed.
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
Significant pericardial effusion, pleural effusion, or ascites