Pathologically proven diagnosis of any of the following malignancies:
Patients with biopsy proven locoregional recurrence or second primary SCCHN which is unresectable or the patient is unwilling to undergo resection
Subjects must have proven pediatric cancer with confirmation at diagnosis or at the time of recurrence/progression and clinical determination of disease for which there is no known effective curative therapy or disease that is refractory to established proven therapies fitting into one of the following categories:
Histologically or cytologically proven diagnosis of prostate cancer, sqNSCLC, TNBC, or known PTEN-deficient solid malignancy, and is refractory to standard therapies.
Histologically proven recurrent or residual intracranial or metastatic meningioma or meningioma with extracranial spread
History of clinically significant glomerulonephritis, biopsy-proven tubulointerstitial nephritis, crystal nephropathy, or other renal insufficiencies.
Biopsy-proven advanced stage follicular lymphoma, that have failed at least two lines of therapy multi-agent chemotherapy, but responds to salvage therapy (i.e., chemosensitive disease) (timeline 8 months prior to enrollment)
Biopsy-proven advanced stage mantle cell lymphoma with proliferation-related Ki-67 antigen (Ki-67) > 10% in first complete remission (timeline 8 months prior to enrollment)
Must have biopsy-proven desmoid tumor (or aggressive fibromatosis). For patients with recurrent disease, a biopsy is not required at the time of recurrence
Participants must have a biopsy-proven tumor consistent with small cell lung cancer and intracranial lesions radiographically consistent with or pathologically proven to be brain metastases; patients who have undergone prior systemic therapy are eligible
Participants must have a biopsy proven solid malignancy with untreated (by radiation) intracranial lesions radiographically consistent with or pathologically proven to be brain metastases; patients who have undergone prior systemic therapy are eligible
Parts A-C only: Patients must have biopsy proven MF, clinical stage I, II, or III (excluding visceral or nodal involvement), and must be refractory to or intolerant of established therapies for their condition
Biopsy proven confirmation of relapsed disease.
biopsy-proven refractory disease after frontline chemo-immunotherapy
If the standard biopsy cores are positive, they must be from the same location in the prostate as MR lesion was biopsied and proven to be cancerous. (Left / Right, Base, Mid Gland, Apex).
Patients must have pathologically or cytologically proven transitional cell carcinoma (TCC) of the urothelium
Has biopsy-proven invasion of tracheobronchial tree or tracheo-esophageal fistula
Proven hypersensitivity to statins
Men with new or progressing lymphadenopathy clearly consistent with prostate metastasis on imaging or proven by pathologic biopsy at any time three months or later following their initial definitive therapy
Biopsy proven diagnosis of squamous cell carcinoma of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls). Clinical evidence should be documented, and may consist of imaging, endoscopic evaluation, palpation, and should be sufficient to estimate the size of the primary for purposes of T staging.
biopsy-proven refractory disease after frontline chemo-immunotherapy
Histologically proven diagnosis of grade 1, 2, or 3A FL
The diagnosis of relapsed FL must have been made within the last 6 months of screening if no other treatment is given for the FL in the interim; if an interim treatment is given within the last 6 month, re-biopsy will be required even if there is already a biopsy proven relapsed FL within the last 6 months
Any patient with a biopsy proven diagnosis of chondrosarcoma that is grade I, II or III or
Patients with biopsy proven dedifferentiated chondrosarcoma that chose not to pursue neoadjuvant chemotherapy
Biopsy proven T2 malignant melanoma
Oligometastatic disease or unresectable primary abdominal malignancy with biopsy-proven primary disease histology of solid tumor categorization; patients with a diagnosis of hepatocellular carcinoma do not require a biopsy
Diagnosis of localized breast, uterine or cervical cancer that is either biopsy proven or suspected based on history, physical, and/or radiographic findings, and who are planned for definitive resection of the tumor without the use of neoadjuvant chemotherapy or radiation therapy at Thomas Jefferson University Hospital (TJUH) are eligible to participate
Documented or pathologically-proven metastatic disease
Patients do not need a histologically proven diagnosis of brain mets
Histologically or genetically proven unilateral primary or metastatic active pleural malignancy
Histologically proven recurrent meningioma or aggressive meningioma; note: confirmation of ESO expression and pathology is not required in patients with definitive radiologic evidence of meningioma who are unresectable, and in whom radiation therapy without biopsy is the standard treatment
Pancreatic adenocarcinoma proven either by histology (surgical biopsy) or cytology (CT- or endoscopic-guided)
Patients with known (biopsy proven) invasive carcinoma in a potential study polyp
Diagnosis of secondary Haemophagocytic Lymphohistiocytosis consequent to a proven rheumatic or neoplastic disease.
Any clinical or radiographically suspicious nodes, unless biopsy proven benign.
Biopsy-proven, unresected stage IB-IVA invasive carcinoma of the cervix
Pathologically (histologically) proven diagnosis of prostatic adenocarcinoma
Histologically proven non-Hodgkin’s lymphoma
Patients with relapsed/refractory, biopsy-proven primary cutaneous T-cell lymphoma who have received at least two previous standard systemic therapies and, if MF/SS, is stage IB IVB at study entry.
Patients at least eighteen (18) years of age with histologically proven, progressive and/or refractory SM.
Biopsy proven ccRCC
Biopsy-proven KS involving skin (with or without visceral involvement) without need for urgent cytotoxic therapy; there should be no evidence of improvement in KS in the 4 weeks immediately prior to study enrollment
Patients must have biopsy-proven adenocarcinoma of the small bowel at any site (duodenum, jejunum, ileum), excluding ampullary and appendiceal tumors
Biopsy proven locally advanced breast cancer: IIB, IIIA and IIIB
Histologically proven adrenocortical carcinoma (ACC) with the majority of disease confined to the peritoneal cavity and resectable or amenable to radiofrequency ablation
Biopsy proven NSCLC
Pathologically proven diagnosis of endometrial or cervical cancer
Patients with histologically proven HL will be eligible for transplantation after failing prior therapy
Histologically proven MCC
Pathologically proven diagnosis of NSCLC
Histologically or cytologically proven metastatic breast cancer (metastases can be proven with imaging results in certain circumstances provided that the initial tumor was demonstrated histologically)
Patients with biopsy proven NRSTS or bone sarcoma
Biopsy-proven diagnosis of AL amyloidosis by immunohistochemistry or mass spectroscopy of a tissue biopsy excluding bone marrow
Patients must have biopsy-proven metastatic MCC or locoregional MCC that has recurred following standard locoregional therapy with surgery and/or radiation therapy
Patient has biopsy-proven diagnosis of cancer and radiographic evidence of bone metastasis to serve as target lesion(s)
Histologically proven colon carcinoma with serosal invasion or peritoneal disease or a history of tumor rupture, and/or ascites
Biopsy proven locally advanced stage cervical cancer (LACC, International Federation of Gynecology and Obstetrics [FIGO] IB2 – IVB)
The cancer that has no proven effective therapy
Group B:\r\n* Newly diagnosed patient with histologically proven Ewing sarcoma family of tumor involving the bone or soft tissue and at least one of the following:\r\n** Metastatic disease (must be biopsy proven)\r\n** Pelvic primary\r\n** Age >= 14 years at the time of diagnosis\r\n*** Patients with more than one pulmonary lesion > 1cm may be considered as having evidence of metastatic disease without biopsy, as long as there is no other clear medical reason for these lesions; these cases should be discussed with the principal investigator (PI) and if there is any doubt, a biopsy should be obtained\r\n* Newly diagnosed patients with intra-abdominal, unresectable or metastatic desmoplastic small round cell tumor; metastatic site must be biopsy proven
Histologically proven solid tumor malignancy with metastasis to the spine; diagnosis may be acquired from needle biopsy, cytology, or surgical biopsy or resection
Retinoblastoma-positive, histologically proven CRC with measurable disease
If patient has only one metastatic lesion/focus, this must be proven by biopsy and the pathology report confirming the diagnosis of primary breast cancer, as well as the metastatic site, must be available
Biopsy-proven squamous cell carcinoma (SCC) of the oropharynx (tonsil, base of tongue, pharyngeal wall or palate)
Histologically or cytologically proven diagnosis of unresectable B3 thymoma or thymic carcinoma recurrent or progressing after prior chemotherapy (only one prior systemic therapy allowed)
Histologically proven non-Hodgkin’s lymphoma
Biopsy-proven, invasive carcinoma of the cervix
Patients with proven TTP as per historical data (as defined by ADAMST13 activity test) and if already available results of ADAMST13 test done at screening.
The cancer has no proven effective therapy
Pathologically (histologically or cytologically) proven diagnosis of intrahepatic cholangiocarcinoma (IHC) without distant extrahepatic metastasis within 90 days of registration; patients with an adenocarcinoma suggestive of a pancreaticobiliary primary with radiographic findings consistent with an intrahepatic cholangio-carcinoma are eligible
Biopsy-proven KS involving skin, with or without visceral involvement, either newly diagnosed or refractory to or intolerant of one or more prior therapies
Biopsy proven plasmacytoma. Prior biopsy is acceptable.
Participants must have biopsy-proven KS involving skin with or without visceral involvement
Patients with a history of proven myocarditis, pericarditis, or endocarditis
Oligometastatic or unresectable primary disease planned for SBRT with biopsy-proven primary disease histology of solid tumor categorization with the exception of small cell cancers; hepatocellular carcinoma does not need to be biopsy proven if imaging and clinical findings are consistent with the diagnosis
Biopsy-proven well-differentiated, low-to-intermediate-grade PNET or GI-NET with elevated (> ULN) biomarkers (serotonin, 5-hydroxyindoleacetic acid (5-HIAA), chromogranin A (CgA), neurokinin A, and neuron-specific enolase (NSE))
An interval of at least 12 weeks after last dose of radiation and temozolomide is required, unless cancer progression is proven by diagnostic tumor biopsy. If temozolomide is being used in a maintenance phase, there must be a 28-day washout period prior to Randomization.
Biopsy-proven non-metastatic squamous cell carcinoma of the mouth or oropharynx and is planned to receive a standard course of concomitant CRT.
Has biopsy-proven invasion of tracheobronchial tree or tracheo-esophageal fistula
Patients with a known history of proven myocarditis, pericarditis, and/ or endocarditis
Histologically/cytologically proven primary thoracic or breast malignancy, lymphoma or lung metastases (which are not required to be biopsy-proven) treated with definitive intent
Biopsy-proven differentiated VIN;
Biopsy-proven tumor invasion of the tracheobronchial tree or presence of tracheoesophageal fistula; recurrent laryngeal or phrenic nerve paralysis
Pancreatic cancer of any type, biopsy-proven
Biopsy proven sarcoma located in the extremities
A probability of 60% or higher of a lung lesion being malignant as calculated by Bayesian analysis derived from clinical and radiographic criteria or, alternatively, biopsy proven disease
Biopsy-proven endometrial cancer
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.
Serum creatinine < 2.0 x ULN unless due to biopsy proven CLL kidney infiltration
Subjects with pathologically-proven gynecologic malignancies
Subjects with history of presumed or proven invasive fungal infection within 30 days of randomization
All consecutive outpatients with > 1 cm biopsy-proven Barrett’s esophagus who are undergoing standard of care endoscopic surveillance for metaplasia, dysplasia, or neoplasia
History of proven influenza disease after September 1, 2016
FOR THE 31 SUBJECTS ENROLLED IN YEAR 1: History of proven influenza disease after September 1, 2017
History of proven influenza disease after September 1, 2017
Proven, probable or possible IFI within the previous 30 days
Biopsy-proven Barrett’s esophagus that is non-dysplastic or with low grade dysplasia
Has a proven or probable invasive fungal infection
Participants with biopsy proven metastatic disease (M1)
Subject has biopsy-proven multifocal breast cancer
Biopsy proven diagnosis or clinical diagnosis of any benign oral cavity lesion; pre-surgical biopsy will not be required if lesion is suspected to be benign
Biopsy proven diagnosis or clinical diagnosis of premalignant oral cavity lesions (leukoplakia, erythroplakia, lichen planus, dysplasia); pre-surgical biopsy will not be required if lesion is suspected to be benign
Biopsy proven diagnosis of small superficial oral cavity squamous cell carcinoma (SCC) (stage T1N0) requiring resection without the need for neck dissection
Patients with biopsy-proven breast cancer
Patient with lung cancer (presumed or biopsy proven) undergoing evaluation for resection
Pathologically (histologically or cytologically) proven diagnosis of cervical, vulvar, esophageal and anal canal cancer
Diagnosis of histologically proven node-positive lung cancer (n=20) OR base of skull or brain tumor (n=20)
Diagnosis of biopsy-proven invasive breast cancer measuring at least 1.5 cm in diameter by any imaging modality
Biopsy-proven PR-positive (sample size [N]=23) or PR-negative (N=5) invasive breast cancer, as defined by University of Wisconsin (UW) Health Pathology
Patients who have had surgical intervention or radiation for the current biopsy-proven malignancy
Pre-operative adult (> 19 years of age) patients with biopsy proven (as opposed to being status post definitive surgical therapy) or highly suspected glioblastoma of the brain
History of biopsy proven or clinically documented castrate resistant prostate cancer which is metastatic to bone as assessed by medical record review
Have biopsy-proven breast cancer and decided to receive neoadjuvant chemotherapy
Patients with biopsy-proven extra-abdominal desmoid tumors
Biopsy proven HER2 negative primary breast cancer and biopsy proven metastatic disease
Suspected or known biopsy-proven malignancy (BI-RADS [R] category 4 & 5)
Adult, non-pregnant patients with biopsy-proven or clinically obvious primary, recurrent or metastatic breast cancer
Pathologically (histologically or cytologically) proven diagnosis of carcinoma
Primary tumor 2.0 cm or greater, and/or clinical evidence of axillary disease (palpable N1 or N2 or biopsy proven)
Biopsy proven Kaposi’s sarcoma involving the skin or mucosa
Participant must have either radiological (presumptive) or established (proven) histological diagnosis of a brain tumor or lesion
Patient must have biopsy-proven cervical cancer (International Federation of Gynecology and Obstetrics [FIGO] stage-Ib2-IVb)
Patients who have histologically proven transitional cell carcinoma (TCC); or
Biopsy proven or clinically suspected advanced parenchymal liver disease
Patients with biopsy-proven breast cancer and biopsy-proven axillary lymph node metastases at Beth Israel Deaconess Medical Center (BIDMC) who are candidates for neoadjuvant chemotherapy or neoadjuvant endocrine therapy
Ipsilateral biopsy-proven invasive breast cancer < 5 cm in maximal dimension by ultrasound or mammography
Recently diagnosed (i.e., within 70 days of enrollment) with clinically suspicious or biopsy-proven early stage (i.e., stage I-II) NSCLC; the inclusion criteria will be operationalized as follows:\r\n* Recently diagnosed (i.e., within 70 days of definitive tissue biopsy) biopsy-proven NSCLC\r\n* Recently diagnosed (i.e., within 70 days of clinical diagnosis) probable NSCLC where \probable NSCLC\ is defined as a suspicious lung nodule for which the patient was referred for\r\n** Invasive diagnostic procedure (i.e., bronchoscopy or image-guided biopsy), OR\r\n** Surgical or radiation oncology consultation and \date of clinical diagnosis\ is defined as (whichever comes first)\r\n** Date of referral for invasive diagnostic procedure (i.e., bronchoscopy or image-guided biopsy), OR\r\n** Date of referral for surgical or radiation oncology consultation\r\n* Study sites should enroll patients that meet either of the above inclusion criteria as early as possible during the diagnostic work-up (i.e., if the patient meets the criteria for recently diagnosed, clinically suspicious NSCLC, definitive tissue biopsy is not required for eligibility)
Status post-surgical resection or definitive radiotherapy for recently diagnosed clinically suspicious or biopsy-proven early stage NSCLC
Patients must have biopsy-proven bladder cancer