Have synchronous primary endometrial cancer
Have a prior history of primary endometrial cancer, except: Stage IA cancer; superficial myometrial invasion, without lymphovascular invasion; grade less than (<) 3 or poorly differentiated subtypes, and this includes papillary serous, clear cell or other International Federation of Gynecological Oncologists (FIGO) Grade 3 lesions
Patients that are determined to have a rare cancer with unknown primary site are eligible under cohort #32 (tumor of unknown primary [cancer of unknown primary; CuP]), provided that there is histologic documentation of metastatic malignancy with no discernible primary site identified from histopathologic review, physical exam and associated cross-sectional imaging of the chest, abdomen, and pelvis
Primary surgeon indicates need for abdominoperineal (APR) at baseline
Patients cannot have:\r\n* Central nerve system involvement\r\n* Primary refractory multiple myeloma, where primary refractory multiple myeloma is defined as disease that is nonresponsive – patients who have never achieved a minimal response (MR) or better – with any therapy over the course of their disease; it includes patients who never achieve MR or better in whom there is no significant change in M-protein and no evidence of clinical progression as well as patients who meet criteria for true progressive disease (PD)\r\n* Primary or secondary plasma cell leukemia\r\n* Light-chain (AL) amyloidosis or polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome\r\n* Known active hepatitis C based on:\r\n** +hepatitis C virus (HCV) antibody (confirmed)\r\n** +HCV RNA\r\n** Liver disease with history of positive serology\r\n** Note: patients with a prior history of hepatitis C that has been successfully eradicated with antiviral therapy are eligible\r\n* Known hepatitis B surface antigen positivity\r\n* Previous hypersensitivity to any of the components of the study treatment\r\n* Prior history of erythema multiforme with thalidomide or lenalidomide treatment
For de novo stage IV NSCLC patients (patients with metastatic disease at first presentation), primary disease must be treatable with local therapy in the form of SBRT or hypofractionated radiation. If the primary disease is found in the peripheral or central lung parenchyma without nodal disease, for instance, SBRT may be employed at the discretion of the treating institution. If primary disease is more advanced with involvement of the mediastinum (T4 tumor, N1-N3 disease, etc.), these volumes should be technically treatable with hypofractionated radiation; surgery should only be used for metastatic tumors that can be completely resected by lobectomy, segmentectomy, or wide wedge resection.
The primary tumor site must be controlled prior to registration\r\n* For those who present with synchronous primary and oligometastatic disease, primary must be controlled prior to registration\r\n* The definition of control is definitive surgery by excision or mastectomy (+/- radiotherapy) per institution preference\r\nFor those who present with local recurrence and oligometastatic disease, local recurrence must be controlled prior to registration\r\n* The definition of control is definitive surgery by excision or mastectomy (+/- radiotherapy) per institution preference
Patient has an extensively disseminated primary glioblastoma
Histologically confirmed locally advanced gastric (primary endpoint includes proximal and mid-body stomach) or esophagogastric adenocarcinoma; distal gastric (antral) adenocarcinomas are eligible for enrollment but will not be included in the primary analysis
Has histologically-confirmed cSCC as the primary site of malignancy (metastatic skin involvement from another primary cancer or from an unknown primary cancer is not permitted).
primary refractory myeloma (PRMM): subjects who have never achieved the minimal response or better to prior therapy OR
Patients who have had more than 12 months of prior therapy; patients outside of this window may be considered for inclusion; please contact the sponsor’s representative in Poland or the lead primary investigator as appropriate on a case-by-case basis
De novo recipients of a primary orthotopic liver transplant from a deceased or living donor
Can have recurrent disease from the primary disease (this is definition of oligorecurrent disease) but cannot have any other primary cancer diagnosed or treated within the last 3 years other than cutaneous skin cancer
Patients with history of primary idiopathic myelofibrosis or any severe marrow fibrosis.
Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, unless all of the following conditions are met: stage not greater than I-A, grade 1 or 2, no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including serous, clear cell or other FIGO grade 3 lesions
primary refractory myeloma
Patients who are primary English or French speakers are eligible
Patients who have an intact unresected primary tumor should be considered for radical nephrectomy and primary resection prior to enrollment in the study; if the patient is not eligible for surgical resection, the primary tumor must be amenable to SBRT or request for applications (RFA); generally, this will be defined as a primary tumor < 10 cm in size or a primary lesion which can be treated to a dose of >= 8 Gy x 5 without excessive perceived risk of toxicity
Patients with any psychiatric or social condition that leads them to be unlikely to adhere to the study schedule and contribute to the primary objectives
Patients may have had multiple primary melanomas.
Planned treatment with the LR-IUD for CAH or grade 1 EC by primary physician
Participation in other clinical trials with the same primary endpoint
AUTOLOGOUS APHERESIS: Known primary immunodeficiency
TREATMENT WITH SJCAR19: Known primary immunodeficiency
Primary refractory disease
Autoimmune disease or history of primary immunodeficiency (excluding Hashimoto’s thyroiditis, vitiligo, or DM type I)
Primary nasopharyngeal carcinoma
Has a known history of a hematologic malignancy, primary brain tumor or sarcoma, or of another primary solid tumor, unless the patient has undergone potentially curative therapy with no evidence of that disease for five years
Direct invasion of the duodenum by the primary tumor
Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, are excluded, unless all of the following conditions are met: stage not greater than I-B; no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell or other Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions
History of diseases with influence on bone metabolism, such as Paget’s disease, osteogenesis imperfecta, active primary or secondary hyperparathyroidism, and primary or secondary hyperthyroidism within 12 months prior to study entry
Patients will be eligible regardless of whether they have had prior nephrectomy or still have their primary tumor in-situ.
Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, unless all of the following conditions are met: stage not greater than I-A, grade 1 or 2, no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including serous, clear cell or other FIGO grade 3 lesions
Simultaneous primary cancers or separate bilateral primary tumor sites
Both metastatic and inoperable primary-only patients are eligible
Patients with metastatic disease are allowed, if indication to remove primary tumor
Patients who have undergone resection of primary disease.
Patient has salivary gland primary
All primary cutaneous T-cell lymphomas
Diagnosis of primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis
Patients must have histologic or radiographic proof of a primary liver malignancy suitable for radiation therapy
Primary tumor of the nasopharynx (nasopharyngeal carcinoma)
Hepatitis B or C seropositivity with evidence of ongoing liver damage; if there is a positive result in the infectious disease testing that was not previously known, the patient will be referred to their primary physician and/or infectious disease specialist
Meet criteria for neoadjuvant chemotherapy or primary breast surgery, as determined by primary oncologist and surgeon
Resectable primary lesion (patients with pre-existing metastasis will be included if their primary is still going to be resected)
Patients must have histologically or cytologically confirmed diagnosis of mycosis fungoides (MF), Sezary syndrome (SS) or primary cutaneous CD30-positive lymphoproliferative disorder, including lymphomatoid papulosis and primary cutaneous anaplastic large cell lymphoma (ALCL) (pc-ALCL) as defined by the World Health Organization (WHO) classification of tumors of hematopoietic and lymphoid tissue
Patient must have cholangiocarcinoma, gallbladder cancer or adenocarcinoma on liver biopsy with clinical features consistent with biliary primary/cholangiocarcinoma
Patients with a history of primary endometrial cancer are excluded unless the following conditions are met:\r\n* Stage not greater than IA\r\n* Not a poorly differentiated subtype (including papillary serous, clear cell or other International Federation of Gynecology and Obstetrics [FIGO] grade 3 lesions)
Primary surgeon indicates the need for an abdominal perineal resection (APR) at baseline
For patients undergoing SABR, both early stage primary lung cancer patients and those with limited metastatic disease to the lungs are eligible; however, patients with oligometastatic disease should have a controlled primary and no more than one other involved organ system
Perineural invasion (PNI) on transoral robotic surgery (TORS) resection of the primary cancer
Lymphovascular invasion (LVI) on TORS resection of the primary cancer
For patients with a new diagnosis of melanoma treated in cohort 2 who have a cutaneous primary, the primary site may be addressed surgically (wide local excision; skin grafting) prior to the initiation of ipilimumab and radiation at the discretion of the treating surgeon
Patients with primary ampullary, biliary or duodenal cancer would be excluded
Primary melanoma arises from the eye or mucus membranes
Patients with primary or secondary immunodeficiencies
Primary HLH patients
Untreated primary uveal melanoma except in cases where metastatic disease is diagnosed at the time of primary disease
Patients with primary idiopathic myelofibrosis
Patient must have achieved MR or better with any anti-myeloma therapy (ie, primary refractory disease is not eligible).
Patients with Primary Hepatic Cancer have not recently been treated with antivirals.
Primary arising in testis, ovary, retro-peritoneum, or mediastinum
Metastatic disease or non-testicular primary
Gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease. Patients with RECIST, v. 1.1 evaluable remaining cancer either in the neck or primary site remain eligible.
Simultaneous primary cancers or separate bilateral primary tumor sites.
Patients with primary refractory disease with progression of the primary tumor on initial therapy
Subject has a primary pneumothorax
Primary nasopharyngeal carcinoma
If present, primary disease in the prostate must be stable for > 6 months (defined as no growth > 5 mm)
Patients with unknown primary melanoma (Tx) who present with cutaneous, subcutaneous, nodal and/or lung metastases that are completely surgically resected with free margins are allowed; these patients are allowed even if they don’t fit the strict staging criteria; for stage IV patients LDH within the institutional ULN must be documented within 4 weeks prior to randomization (M1c is not eligible) \r\n* NOTE: all subjects should be classified as IIIB, IIIC, M1a or M1b including subjects with disease recurrence after adequate surgical excision of the original primary melanoma; that is the treating team/physician investigator should review an overall TNM status (that includes primary tumor presentation and disease recurrence status) and provide a designation of IIIB, IIIC, M1a or M1b
Patients with synchronous primary endometrial cancer or a past history of endometrial cancer, unless all of the following conditions are met:\r\n* Stage not greater than IB\r\n* No more than superficial myometrial invasion\r\n* No vascular or lymphatic invasion\r\n* No poorly differentiated subtypes, including papillary serous, clear cell, or other International Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions
Participants with synchronous primary endometrial cancer, or a past history of endometrial cancer unless all of the following conditions are met: endometrial cancer stage not greater than IA, no vascular or lymphatic invasion, no poorly differentiated subtypes including serous, clear cell, or other FIGO grade 3 lesions.
Patients with T1 disease accompanied by the presence of hydronephrosis secondary to the primary tumor
Requirement of re-transplantation for primary non function
Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, are excluded, unless all of the following conditions are met: stage not greater than I-B; no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell or other International Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions
Or known cases of hepatobiliary diseases (e.g., primary biliary cholangitis, primary sclerosing cholangitis, history of immune-mediated cholangitis);
Recovery from primary local surgical treatment, radiotherapy or orchiectomy
Carcinoma of the nasopharynx, salivary gland, unknown primary origin, or nonsquamous histologies as primary tumors.
Patient must have undergone nephrectomy or partial nephrectomy to remove primary renal cell carcinoma (at any time in the past)
Participants with documented diagnosis of primary Myelofibrosis, post polycythemia Vera Myelofibrosis or post-essential thrombocythemia myelofibrosis
Subject must not have primary refractory disease
No evidence of any systemic autoimmune disease (e.g. Hashimoto’s thyroiditis) and/or any history of primary or secondary immunodeficiency, and no immunosuppressant therapy (with the exception of dexamethasone as noted below) for any reason
Need for urgent palliative intervention for primary disease (e.g., rapidly increasing intracranial pressure, impending herniation, uncontrolled seizures).
Requires urgent palliative intervention for primary disease.
Progesterone only oral contraception, where inhibition of ovulation is not the primary mode of action.
Patients with synchronous colon cancers are eligible and staging for stratification will be based on higher N stage of the more advanced primary tumor; however, patients with synchronous colon and rectal primary tumors are not eligible
Primary refractory patients will be eligible if, on day 14 of their previous chemotherapy regimen, they have significant residual disease; patients who received only hypomethylating agent or low dose therapy for Induction are not considered primary refractory for purposes of this study and are not eligible
Patients < 12 yrs of age must be discussed on a case by case basis with the primary investigator (PI) of the protocol prior to registration
Subject must not have primary refractory disease
Concurrent participation in other studies that could affect the primary endpoint
History of a hematologic malignancy, primary brain tumor or sarcoma, or of another primary solid tumor, unless the participant has undergone potentially curative therapy with no evidence of that disease for 5 years
The trial is open only to women with primary endometrioid adenocarcinoma of the uterine corpus (all histologic grades and stages) who are planned and appropriate for primary surgical treatment
Phase II expansion: biopsy proven RMHNSCC, of any primary site (including unknown primary) and RMSGC will be eligible
Patients with a history of obstructive jaundice due to the primary tumor must have a metal biliary stent in place
Patient is < 3 years free of another primary malignancy except: if the other primary malignancy is not currently clinically neither significant nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ; existence of any other malignant disease is not allowed
History of primary idiopathic myelofibrosis
Primary refractory disease
Need for urgent palliative intervention for primary disease (e.g., impending herniation).
Patients who have undergone resection of primary disease
Cleared by the primary medical doctor for surgery
Deemed a poor surgical risk per primary medical doctor
Systemic disease must be well-controlled or no evidence of disease (NED) in the opinion of the patient’s primary oncologist
History of previous or concurrent (i.e., second primary) invasive melanoma.
Patient has carcinoma primary to the intra- or extra-hepatic biliary system or gall bladder.
Immunosuppression including primary, secondary, iatrogenic and idiopathic
Multiple myeloma which has relapsed following primary therapy or is not responsive to primary therapy. For this study, stable disease following ASCT will be considered nonresponsive to primary therapy.
Patients with synchronous primary endometrial cancer or a past history of endometrial cancer, unless all of the following conditions are met: \r\n* Stage not greater than IB \r\n* No more than superficial myometrial invasion \r\n* No vascular or lymphatic invasion \r\n* No poorly differentiated subtypes, including serous, clear cell or other International Federation of Gynecologists and Obstetricians (FIGO) grade 3 lesions
AT THE TIME OF INFUSION: Nasopharyngeal carcinoma in first or subsequent relapse or with primary refractory disease
Participants with primary refractory disease
Patients with resected primary must be active participants of the NSABP Patient Registry and Biospecimen Profiling Repository (MPR-1) study. Patients with intact primary and metastatic KRAS wild-type disease at presentation (treatment naive), must have signed consent for quadruple wild-type central testing for treatment-naive tumor sample submission
Patient has uncontrollable primary or metastatic disease outside of the lung.
Treatment with systemic therapy for the primary disease within 14 days (except for hydroxyurea or isolated doses of cytarabine or decitabine for white blood cell control)
Stable primary malignancy for previous 3 months
Patients with a history of obstructive jaundice due to the primary tumor must have a metal biliary stent in place (or a percutaneous biliary drain)
Patients with primary disease arising in the posterior elements of the VB in question
Patients with a known synchronous primary endometrial cancer, or a past history of primary endometrial cancer, are excluded, unless all of the following conditions are met: stage not greater than IA, no more than superficial myometrial invasion, without vascular or lymphatic invasion, no poorly differentiated subtypes (including papillary serous, clear cell or other FIGO grade 3 lesions)
Patients with a synchronous primary endometrial cancer, or a past history of primary endometrial cancer are excluded unless all of the following conditions are met: stage not greater than stage IA; no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell, or other International Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions
Primary ocular and mucosal melanomas are allowed
Primary myelofibrosis, post-PV MF, or post-ET MF that requires therapy
Women with planned treatment of primary definitive chemoradiation therapy
Patients with a history of other primary cancers are eligible if the pathology report confirming the diagnosis of primary breast cancer is available and the other primary cancer was curatively treated with a 5-year disease-free interval\r\n* Patients with non-melanoma skin cancer are eligible; however, patients with squamous cell carcinoma of other sites (except in-situ cervix) are not eligible
Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, are excluded, unless all of the following conditions are met: Stage not greater than IB; no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell or other FIGO Grade 3 lesions.
T stage 1, 2, 3; surgery of the primary tumor is limited to incisional or excisional biopsies (i.e., tonsillectomy) even without macroscopic disease left; positive resection margins and/or gross residual disease at the primary site are allowed; evaluation of primary tumor extent may require the use of a flexible fibroscope if deemed clinically necessary by the treating physician
Patients with a history of one of the following myeloproliferative neoplasms: essential thrombocythemia, polycythemia vera, and primary myelofibrosis
History of one of the following myeloproliferative neoplasms: essential thrombocythemia, polycythemia vera, and primary myelofibrosis.
The patient has a history of another primary cancer, with the exception of:
Have a primary or other severe immunodeficiency which predisposes to rapid progression to disseminated AdV disease
Patient with an extensively disseminated primary glioblastoma.
Patient has an extensively disseminated primary glioblastoma.
Primary resistance or acquired resistance (i.e., acquired resistance will be defined as disease progression following a period of response defined as >= 50% decline in PSA within 12 weeks of starting therapy and not otherwise meeting criteria for primary resistance) to any of the following agents/combinations of therapy:
History of another primary cancer, with the exception of:
Patients who have a history of primary malignancy other than that being treated in this study, and currently requires active clinical intervention.
Cancer patients greater than 18 years of age who have completed all assessments required to meet the primary objectives of a parental phase 1, 2 or 3 clinical study of iniparib as monotherapy or in a combination regimen.
Primary refractory patients
Primary melanoma with the following Breslow thickness and stage:\r\n* =< 2 mm\r\n* Patients with recent (within 12 weeks) biopsy of primary melanoma that has not been widely resected will be eligible for study according to the above-specified criteria for tumor thickness and stage; if more than one biopsy was done for the primary melanoma, the window of 12 weeks will be counted from the date of the last surgery
Primary refractory MM
Disease status\r\n* Tumors must have NOT been completely resected, or must be locoregionally recurrent if previously resected; tumor must be deemed potentially resectable by local surgeon\r\n* MM arising from the head/neck, genitourinary, or gastrointestinal tract\r\n* Disease meets any 1 of 4 characteristics:\r\n** Regional lymph node (LN) involvement; OR\r\n** Multifocal/satellite primary disease; OR\r\n** Single localized, primary disease meeting one of the following site-specific requirements:\r\n*** Head/neck – any primary lesion if sinonasal; pT4a or above for nasal or oral cavity\r\n*** Anorectal – any primary lesion\r\n*** Conjunctiva – any primary lesion T2 or T3 stage by American Joint Committee on Cancer (AJCC)\r\n*** Vaginal/cervical – any primary\r\n*** Vulvar (hair bearing surface, labia majora) – AJCC cutaneous stage IIB or higher\r\n*** Esophageal – any primary\r\n** Locoregionally recurrent following prior resection\r\n* No evidence of metastatic disease at the time of registration
The study population will consist of patients who have undergone primary therapy (prostatectomy or primary radiation) for biopsy-proven adenocarcinoma of the prostate and now have biochemical-only recurrence
Primary closure of wound
Patients with advanced prostate cancer suitable for systemic treatment defined as: having metastatic disease, a biochemical relapse after primary therapy, or patients in whom primary therapy is not appropriate or feasible; patients without metastatic disease will need evaluation for local therapy and deemed inappropriate or have refused this treatment option
Patients with known diagnosis of a primary mast cell disease (ie. mastocytosis)
Hereditary metabolic bone disease or skeletal dysplasia (e.g., osteopetrosis or osteogenesis imperfecta [OI]) or primary hyperparathyroidism
Phase I: Not serving as the primary decision maker for their health-related decisions
Cirrhotic patients; when incidentally discovered intra-operatively, patients will be excluded from the study and replaced, but will be followed for primary and secondary endpoints
Evidence of active intrathoracic malignancy (primary or metastatic) in the lungs or pleural space that is a significant cause of respiratory insufficiency
Primary treatment is active surveillance (AS) with planned annual surveillance biopsies
Age >= 40 (to reduce the likelihood of enrolling patients with obstruction due to primary sclerosing cholangitis).
Known diagnosis of primary sclerosing cholangitis without suspicion of dominant hilar stricture.
Post HNC primary treatment
Primary family caregivers of cancer patients with > 6 months prognosis
Patient with a secondary malignancy who would be otherwise eligible for study, but for whom remission from the primary disease cannot be conclusively confirmed or for whom the chance of relapse of the primary disease is significant
Patients who are primary English or French speakers are eligible
Patients with history of primary idiopathic myelofibrosis or any severe marrow fibrosis
Prior participation in clinical studies that include durvalumab alone or in combination, where the study has registrational intent and the analyses for the primary endpoint have not yet been completed
Patients with symptoms and signs of clinically unacceptable deterioration of primary disease at time of screening
Patients with aplastic anemia or primary myelofibrosis; patients with marrow fibrosis secondary to myelodysplastic syndrome (MDS), AML or a myeloproliferative disorder other than primary myelofibrosis are eligible
Primary or secondary tumor in the oral cavity
Surgical intervention is planned primary mechanism of local control
Post HNC primary treatment
PARENTS/PRIMARY CAREGIVERS
Subjects with a history of primary idiopathic myelofibrosis.
Primary or secondary myelofibrosis
T1, T2, T3, or T4 primary
History of cardiovascular disease that may adversely affect patient participation at the discretion of the primary investigator
Patients with acute serious illnesses at the discretion of the primary investigator
Patients who have had primary surgical excision
Patients with synchronous primary endometrial cancer or a past history of endometrial cancer, unless all of the following conditions are met:\r\n* Stage not greater than IB\r\n* No more than superficial myometrial invasion\r\n* No vascular or lymphatic invasion\r\n* No poorly differentiated subtypes, including serous, clear cell, or other International Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions
Primary refractory disease
(STEP 1) - PRIMARY INTERVENTION STUDY (RANDOMIZED CONTROLLED TRIAL [RCT]):
Unable to undergo the informed consent process and the study interview in English per the judgment of the primary urologist.
Primary nasopharyngeal carcinoma.
Only measureable disease (primary or metastatic) is located in or near the thyroid gland, liver, kidney, or urinary bladder.
Have a primary diagnosis, or at high clinical suspicion, of primary ovarian cancer (of epithelial type), planned for primary debulking or interval debulking surgery, and: