Tumor verified by a thoracic surgeon to be in a location that will permit sublobar resection
Stage T3 or T4a, histologically-confirmed NPNSCC requiring orbital or skull base resection:\r\n* Stages T3 and T4a disease will be included regardless of nodal status (N0 or N1-3), provided that surgical therapy would require orbital or skull base resection\r\n* The surgical oncologist in each institution will determine the need for resection of the orbit OR base of skull at baseline for patients on both Arms A and B and following neo-adjuvant chemotherapy for patients on Arm B\r\n** Resection of skull base will be deemed necessary according to skull base bone erosion by CT or marrow involvement by MRI is noted; for any disease abutting the skull base\r\n** Resection of orbital contents will be deemed necessary according to skull base society guidelines, based on involvement of periorbital fat documented by MRI imaging
Unsuitable for resection or transplant or radiofrequency ablation (RFA)
Patients with complete surgical resection of disease are not eligible
Patient must fit into one of the following three categories:\r\n* Patients who received neoadjuvant chemotherapy and pathologic stage at surgical resection is >= pT2 and/or N+ OR\r\n* Patients who are not cisplatin-eligible (according to >= 1 of the following criteria: Eastern Cooperative Oncology Group [ECOG] performance status of 2, creatinine clearance < 60 mL/min, grade >= 2 hearing loss, grade >= 2 neuropathy, or New York Heart Association class III heart failure and pathologic stage at surgical resection is >= pT3 or pN+) OR\r\n* Patients that decline adjuvant cisplatin-based or other systemic chemotherapy based on an informed discussion with the physician and pathologic stage at surgical resection is >= pT3 or pN+
Patient must have had radical surgical resection of their bladder cancer >= 4 weeks but =< 16 weeks prior to pre-registration
Patients who have undergone complete surgical resection of the recurrent tumor and have no evidence of residual disease evaluable clinically and by CT or MRI imaging, following resection
No prior treatment other than surgical intervention and corticosteroids; patients are allowed to have had more than one attempt at resection prior to enrollment
Patients with codeleted low grade gliomas must also be considered “high risk” by exhibiting one or more of the following characteristics:\r\n* Age >= 40 and any surgical therapy\r\n* Age < 40 with prior and subtotal resection or biopsy (i.e., anything less than gross total resection)\r\n* Documented growth following prior surgery (NOTE: patients with prior surgery cannot have received prior radiation, chemotherapy or targeted therapy)\r\n* Intractable seizures
A diagnostic contrast-enhanced magnetic resonance imaging (MRI) (no other scan type allowed) of the brain must be performed postoperatively; the residual enhancing tumor and/or resection cavity must have a maximal diameter of 5 cm or less; the tumor diameter will be the greatest diameter as measured on the contrast-enhanced postoperative MRI and will include residual disease and/or the postoperative surgical cavity as appropriate\r\n* The postoperative brain MRI should be obtained within 72 hours of resection; if it is not obtained within 72 hours post-resection, then an MRI obtained 2 weeks or longer after surgery is required and can be utilized to ensure maximal diameter of residual tumor and/or resection cavity is 5 cm or less\r\n* For cases where a gross total resection of enhancing tumor is performed, but postoperative surgical cavity is NOT identifiable, the patient will be excluded from the trial
Patients with T2 or T3 primary tumors (N0-3, M0) not amenable to surgical resection by standard radical vulvectomy
All patients with T1 urothelial carcinoma must undergo re-transurethral resection of bladder tumor (TURBT) within 60 days prior to registration, and must have uninvolved muscularis propria in the pathologic specimen from either the first or the second TURBT; tissue from the re-resection must be submitted; the TURBT that identified the recurrent T1 disease may have taken place more than 60 days prior to registration
Patients may have had surgical resection of the hepatic malignancy prior to enrollment; all other anti-cancer therapy for the current liver lesion is prohibited
Patients must have histologically confirmed well-differentiated islet cell carcinoma (PNET) not amenable to surgical resection
Not scheduled to start radiation within 42 days of surgical resection of tumor;
SURGICAL STUDY (STRATUM 2): Patients for whom surgical intervention is clinically indicated (gross total resection or sub-total resection) at recurrence and are amenable to receiving ribociclib for 7 – 10 days prior to resection\r\n* Note: patients with DIPG are excluded from the surgical study
Patients who are otherwise deemed clinically unsuitable for surgical resection (applicable for surgical study only)
Participant has a history of >= grade 3 AST, ALT, or bilirubin increase or has extensive liver resection (i.e., left lobe resection).
Absence of resectable disease after transurethral resection (TURBT) procedures (residual carcinoma in situ (CIS) acceptable; patients with T1 tumors must undergo repeat resection and biopsy [inclusive of muscularis propria] if initial biopsy did not include muscularis propria). Patients with high-grade Ta and/or T1 disease should have complete resection before study treatment.
Cutaneous, subcutaneous soft tissue, or superficial lymphatic metastasis not suitable for surgical resection
Sub-optimal resection as their surgical outcome
There must be a commitment by the surgical team to resect the primary tumor within 3 days following the 4 weeks of sirolimus unless the clinical situation at the time of resection suggests that these interventions are not in the patient's best interest
Not eligible for surgical resection or liver transplant or have refused such procedures
Adjuvant chemotherapy or radiation therapy for UC following surgical resection
Patients with no evidence of metastatic disease as well as patients with a local recurrence following surgical resection of primary lesion.
Inclusion Criteria:\n\n        Patients must meet all of the following inclusion criteria to be eligible for participation\n        in this study:\n\n          -  Surgical or biopsy-proven diagnosis of WHO grade 3 AA.\n\n          -  Unequivocal evidence of first AA tumor progression or recurrence ? 3 months prior to\n             randomization based on MRI criteria for tumor progression using enlarging Gd-contrast\n             enhancement and/or T2 hyperintensity. Patients with non-measurable Gd contrast\n             enhancing tumors will only be eligible if there is no necrosis seen on MRI and/or\n             histopathological confirmation of AA per standard of care procedures is obtained.\n\n          -  First tumor progression or recurrence following surgical resection or biopsy, if\n             resection is not feasible, EBRT and temozolomide chemotherapy.\n\n          -  Completion of EBRT ? 6 months prior to randomization.\n\n          -  A patient whose AA tumor has progressed or recurred and has had another surgical\n             resection prior to randomization will be eligible if a) pathology review confirms AA,\n             and b) post-surgical MRI demonstrates measurable tumor on T2/FLAIR.\n\n          -  Karnofsky Performance Status (KPS) score of ? 70.\n\n        Exclusion Criteria:\n\n        Patients who meet any of the following exclusion criteria are not eligible for study\n        participation:\n\n          -  MRI defining progression is consistent with a diagnosis of glioblastoma or radiation\n             necrosis.\n\n          -  Patients who are considered to be refractory to EBRT and temozolomide but who have not\n             progressed.\n\n          -  Prior systemic therapy for recurrence of AA.\n\n          -  Presence of extracranial or leptomeningeal disease.\n\n          -  Prior lomustine use.\n\n          -  Any other clinical condition or prior therapy that, in the opinion of the\n             Investigator, would make the patient unsuitable for the study.\n\n          -  Pregnant or breastfeeding.
Before enrollment, patients must show non-enhancing T2-fluid-attenuated inversion recovery (FLAIR) lesions that are amenable to surgical resection; surgical resection of at least 0.5 grams of tumor is expected to ensure adequate evaluation of the study endpoints
All patients must have developed recurrent disease/progression (evidence of recurrence to be established by MRI or CT scan with contrast; there is no limit to the number of relapses) after receiving all standard treatments, which must include the following: \r\n* Surgical resection, if possible;\r\n* Definitive radiation therapy for unresectable meningioma, or for recurrent meningioma after resection\r\n* (Note: At registration, patients must be at least 28 days post-surgery, and must be at least 28 days post-radiation therapy, with resolution of related cytotoxicities down to grade 2)
Patients eligible for resection with one or more of the following
Before enrollment, patients must show supratentorial, non-enhancing T2-FLAIR lesions that are amenable to surgical resection and are likely WHO grade II glioma; surgical resection of at least 500 mg tumor tissue to ensure adequate evaluation of the study endpoints
Candidate for MLA based on the size, location, and shape of the recurrent tumor as determined by the performing neurosurgeon; surgical resection/debulking prior to MLA is allowed per standard of care, but is not required; if the patient undergoes resection or debulking, it must have occurred at least 3 weeks prior to the first dose of MK-3475
Initiation of chemotherapy is planned within 6 weeks (42 days) of the definitive biopsy or surgical resection
Complete macroscopic resection of all known disease
Treatment directed against the melanoma (eg, chemotherapy, targeted agents, biotherapy, limb perfusion) that is administered after a prior complete resection other than adjuvant radiation after neurosurgical resection and IFN for resected melanoma
No prior therapy to primary tumor prior to surgical resection (no induction therapy or recurrent disease).
Prior surgical castration
An interval of >= 28 days and full recovery (i.e., no ongoing safety issues) from surgical resection prior to randomization.
An interval of ? 21 days since surgical resection prior to treatment on the trial
Maximal tumor resection has been performed as feasible
Subjects with disease that is amenable to surgical resection
Criteria for surgical resection of at least one metastasis per neurosurgeon discretion
Surgical resection able to be performed within 1 – 3 days after radiosurgery
Patients who received anti-VEGF therapy within 6 weeks prior to enrollment, as there is increased risk of fatal brain hemorrhage with surgical resection
Patients on the Intratumoral Studies surgical arm must be undergoing repeat surgery that is clinically indicated as determined by their care providers, where a significant debulking or a gross total surgical resection of the contrast-enhancing area is intended
An interval of at least 2 weeks for surgical resection and 1 week for stereotactic biopsy from the start of study treatment
Subjects deemed surgically unresectable or subjects unwilling to undergo surgical resection
Prior surgical resection of pancreatic tumor
Plan for next therapeutic intervention to be surgical resection of metastatic disease.
Patients must have disease determined to be surgically resectable and candidates for upfront surgery as agreed upon by a multidisciplinary consensus (Surgical Oncology, Medical Oncology, Radiation Oncology) after presentation at sarcoma multidisciplinary conference. Resectable tumors are defined as having no significant vascular, neural or bony involvement. Only cases where a complete surgical resection can safely be achieved are defined as resectable.
Disease that is considered surgically unresectable, including, but not limited to significant vascular, neural, or bone involvement, and in cases where a complete surgical resection cannot be safely performed.
Disease amenable to surgical resection in the opinion of the treating surgeon
Patients must have stage IIIB, IIIC, or IVM1a (equivalent staging at time of enrollment) metastatic melanoma which is eligible for complete surgical resection
Unfit to receive study treatment or subsequent surgical resection
All disease should be deemed resectable based on imaging studies e.g.:\r\n* Hepatic metastases (unilateral or bilateral =< 5 lesions, =< 15 cm total diameter)\r\n** Note: Hepatic lesions must be amenable to complete resection\r\n* Primary peritoneal metastases (small disease load =< P2 disease) without intestinal obstruction\r\n* Lung metastases (=< 3 unilateral/bilateral, 9 cm total diameter)\r\n** Note: lung lesions must be amenable to complete resection\r\n* Note: Patients with both pulmonary and hepatic metastases will be enrolled at the discretion of the principal investigator (PI)\r\n* Note: In situations where resection to completeness of cytoreduction score (CC) 0 or 1 is uncertain, patients may undergo diagnostic laparoscopy prior to enrollment to determine feasibility of resection
Completed an R0 or R1 surgical resection as determined by pathology
Evidence of disease recurrence or metastasis following surgical resection at any time prior to the first vaccination administration; most patients will undergo restaging midway through adjuvant chemotherapy and at the completion of therapy; however, timing of imaging is at the discretion of the patient’s medical oncologist
Patient must have stage I NSCLC and is not undergoing surgical resection
Patients are only eligible if complete resection of a plexiform neurofibroma with acceptable morbidity is not feasible, or if a patient with surgical option refuses surgery
An interval of at least 4 weeks (to registration) between prior surgical resection or one week for stereotactic biopsy
Patients must be undergoing surgery that is clinically indicated as determined by their care providers; patients must be eligible for surgical resection with the expectation that the surgeon is able to resect at least 400 mg of tumor with low risk of inducing neurological injury
prior surgical procedures affecting absorption including total gastric resection;
Scheduled date of surgical resection that would limit the amount of time taking the intervention to less than 21 days
Patients must have undergone prior standard therapy for their primary disease; for patients with glioblastoma, this would include surgical resection or biopsy, if safe resection was not permitted due to the tumor location, radiation and adjuvant temozolomide; for patients with anaplastic astrocytoma, this would include surgical resection, radiation and adjuvant chemotherapy (procarbazine, lomustine and vincristine [PCV] or temozolomide)
Patients must be registered within 6 weeks of most recent resection
Patient may have had prior therapy for brain metastasis, including radiosurgery and surgical resection however must have completed prior resection and radiosurgery at least 90 days before enrollment and not received further active treatment
Patients must have clinical indication for standard-of-care surgical resection of relapsed PFEPN tumor for enrollment in Stratum 1
Surgical consultation at enrolling site to confirm that patient will be able to undergo curative resection after completion of chemoradiation =< 56 days prior to registration\r\n* Tumor is amenable to standard resection and reconstruction
Have disease amenable to surgical resection
For patients who will participate in the optional DSF pharmacokinetic study, they should be eligible for surgical resection for which at least 0.2 cubic cm or approximately 200 mg of tumor will be removed in additional to tumor specimen required for pathology evaluation; patients enrolled after undergoing surgical resection or biopsy with histologically confirmed GBM are not required to meet this point of inclusion
Willing to defer definitive surgery for one week while taking DSF and Cu; patients who declined the optional pre-operative pharmacokinetic study or enrolled after undergoing surgical resection or biopsy with histologically confirmed GBM are not required to meet this point of inclusion
Prior therapy < than 2 weeks since surgical re-resection or biopsy
The patient is not eligible for a complete surgical resection of their disease as evaluated by a radiologist and/or surgeon.
Patient may undergo surgical resection prior to reirradiation
Patients with brain metastases for whom complete surgical resection is clinically appropriate
Patient has undergone major surgical resection within 4 weeks prior to enrollment
PHASE II DOSE EXPANSION IN RECURRENT GBM UNDERGOING RESECTION: Be at first relapse; Note: relapse is defined as progression following initial therapy (i.e., radiation, chemotherapy, or radiation plus (+) chemotherapy); if the participant had a surgical resection for relapsed disease and no antitumor therapy instituted for up to 12 weeks, this is considered one relapse; for participants who had prior therapy for a lower grade glioma, the surgical diagnosis of glioblastoma or gliosarcoma will be considered first relapse
PHASE I: A baseline brain MRI must be obtained no more than 14 days (+ 3 working days) prior to study enrollment; the patient must either be on no steroids or a stable dose of dexamethasone no greater than 2 mg a day for at least 5 days prior to entrance onto the study; patients having undergone recent surgery are eligible as long as they are at least 3 weeks from resection or 1 week from stereotactic biopsy, and recovering from any operative or perioperative complications; no measurable disease post resection will be required
PHASE 1: Patients having undergone recent surgery are eligible as long as they are at least 3 weeks from resection or 1 week from stereotactic biopsy, and recovering from any operative or perioperative complications; no measurable disease post resection will be required
Subjects must have had a definitive resection with residual radiographic contrast enhancement on post-resection CT or MRI of less than or equal to 2 cm in any two perpendicular planes on any images
Prior history of surgical resection, chemotherapy, transarterial chemoembolization (TACE), and/or radiofrequency ablation are allowed
Local surgical resection is not possible due to tumor or patient factors
Patients with solid tumors or lymphoma must have 1 or more tumors accessible to biopsy or resection, including biopsy allowing multiple cores from at least 1 lesion (fine needle aspiration is excluded), incisional or excisional biopsy, and/or resection. Note: Patients with resectable brain metastases must be undergoing planned resection. Patients with rHGG must be undergoing planned subtotal or gross total resection.
For patients with rHGG, the patient intends to undergo treatment with the Gliadel® wafer at the time of planned resection (ie, on-study surgery) or has received the Gliadel wafer < 30 days from the date of planned resection.
Complete surgical resection of the primary NSCLC is mandatory. All gross disease must have been removed at the end of surgery. All surgical margins of resection must be negative for tumour.
Patients who are not eligible for resection and are chemotherapy naïve
Patients must be eligible for surgical resection of their breast cancer or repeat biopsy after completing 14 days of treatment
Resection: at least 3 weeks from the last surgical resection, prior to start study drug
Complete surgical resection of the primary NSCLC is also mandatory. All gross disease must have been removed at the end of surgery. All surgical margins of resection must be negative for tumour. Resection may be accomplished by open or VATS techniques Note: Patients with synchronous primary tumours will not be eligible due to the potential uncertainty regarding their appropriate PD-L1 status. Prior Systemic Therapy:
Patients must have histologically or cytologically confirmed stage IIIB/C melanoma; the definition of resectability can be determined by the patient’s surgical oncologist and verified via discussion at multidisciplinary tumor conference attended by melanoma medical and surgical oncology staff; resectable tumors are defined as having no significant vascular, neural or bony involvement; only cases where a complete surgical resection with tumor-free margins can safely be achieved are defined as resectable
Patient must have undergone gross total resection, subtotal resection, or biopsy with the extent of resection determined by the treating neurosurgeon, and must begin radiation within 12 weeks of this procedure
HCC not amenable to surgical resection, liver transplantation, chemoembolization, or ablation therapy
Not a candidate for surgical resection according to the local guidelines for resection and in the Investigator's judgment.
Symptomatic brain metastases; symptoms may be present from the surgical lesion prior to resection or LITT but must have resolved by the time of administration of study drug
Patients with brain metastases for whom complete surgical resection is clinically appropriate
Ineligible for surgical resection
Prior surgical resection of targeted tumor
Able to get a Whipple resection per surgeon assessment performed within 4 weeks of registration
Subjects deemed surgically unresectable or subjects unwilling to undergo surgical resection
Recurrent disease/progression after receiving all standard treatments, which must include the following:\r\n* Surgical resection, if possible\r\n* Definitive radiation therapy for unresectable meningioma, or for recurrent meningioma after resection
Previous treatment for glioblastoma must include surgery (biopsy, partial resection, or full surgical resection), conventional radiation therapy and temozolomide (TMZ)
Patient deemed medically unfit to undergo surgical resection of brain metastasis
Histologically confirmed adenocarcinoma of the rectum in patients with no prior therapy who are candidate for surgical resection
Subjects must be able and willing to schedule surgical resection of their tumor 2 or more weeks following the start of the study agent
Tumor types – tumor type/location:\r\n* Stratum A: Patients with a recurrent ependymoma with the primary site in the posterior fossa; patients may have non-bulky asymptomatic, metastatic disease; patients may have undergone surgical resection or debulking prior to enrollment\r\nStratum B: Patients with a recurrent ependymoma with the primary site outside the posterior fossa; patients may have non-bulky asymptomatic, metastatic disease; patients may have undergone surgical resection or debulking prior to enrollment
Patients must have a life expectancy of at least 12 weeks, a Zubrod performance status of =< 1 and be willing and medically able to undergo surgical resection
Patients will be excluded if they have had prior surgical resection of metastatic cancer from the brain
Patients must have been previously treated with surgical resection (any extent okay) and radiation therapy plus temozolomide
Participants must plan to begin radiation therapy 14-42 days after surgical resection
Patients with brain metastases for whom complete surgical resection is clinically appropriate
For Part C (surgical): Have metastatic brain lesion(s) for which surgical resection is clinically indicated.
Initial surgical resection of the paranasal sinuses or nasal cavity region rendering the patient clinically and radiologically disease free.
Surgical procedure may have been complete resection, partial resection, or biopsy
Patient has to start gefitinib within 6 weeks of hepatic resection with full recovery
Tumor accessible for injection that is classified as borderline-resectable or locally advanced but considered potentially resectable after central review by surgical investigators. Resection may include major vascular resection with reconstruction as needed.
Microscopically complete resection, defined as no evidence of microscopic residual disease based on surgical reports, histopathology and post-operative imaging. Detailed pathological and surgical reports prepared according to guidelines detailed in appendix x and y should be available for assessment.
Scheduled to undergo surgical resection in 2 weeks or longer
Pathological diagnosis of DCIS requiring surgical resection
Undergone complete resection of primary tumour
Has a known clinically significant GI disorder(s) including, but not limited to, inflammatory bowel disease or a history of extensive gastric resection and/or small intestinal resection.
Patients who are eligible for surgical resection of the primary breast cancer and targeted dissection of the axilla
Surgical resection must be planned as primary therapy with expected adjuvant radiation therapy. Patients are eligible with previous surgical intervention if they have residual or recurrent disease, and it is greater than 4 weeks since surgery and they have fully recovered from surgery.
Must have undergone a surgical resection with definitive intent, either by open or laparoscopic resection of the primary gastric or GE junction cancer. Patients must have undergone a total gastrectomy, subtotal gastrectomy, or distal gastrectomy (depending on the location of primary gastric lesion) with at least a modified D2 lymphadenectomy.
Patients must be treated within 6 weeks of most recent resection.
Patients must be eligible for surgical resection of their breast cancer or repeat biopsy after completing treatment
Participants must be at first relapse of GBM; relapse is defined as progression following initial therapy (i.e. radiation+/- chemo if that was used as initial therapy); the intent therefore is that patients had no more than 1 prior therapy (initial treatment); if the patient had a surgical resection for relapsed disease and no anti-cancer therapy was instituted for up to 12 weeks, and the patient undergoes another surgical resection, this is considered to constitute 1 relapse
Tumor recurrence or progression documented after previously failing surgical resection, chemotherapy or radiation
Patients with oral cavity cancer are excluded from participation if the patient is medically operable and resection of the primary tumor is considered technically feasible by an oral or head and neck cancers surgical subspecialist;(please consult the surgical oncology co-principal investigator [PI], Steven Chang, Doctor of Medicine [MD], if clarification is needed on an individual case)
Patients must have a primary tumor that are determined by multidisciplinary team (medical oncology, orthopedic/surgical oncology, and radiation oncology) to require radiation therapy for optimal management prior to surgical resection
Patients must have at least one of the following high risk pathologic features:\r\n* Extracapsular nodal extension\r\n* Invasive cancer at the primary tumor resection margin (tumor on ink); Note: Patients who have a positive margin and undergo re-resection with final negative margin are eligible only if they can be enrolled within 63 days of initial gross total resection AND extracapsular nodal extension was also present; patients who have a positive margin and undergo re-resection with final negative margin and do not have extracapsular nodal extension, are NOT eligible
ARM A: Patient for whom surgical resection or liver transplantation would be more appropriate
ARM B: Patient for whom surgical resection or liver transplantation would be more appropriate
An interval of >= 4 weeks since surgical resection prior to study treatment
Patients must not be eligible for curative liver resection or has refused resection
Stereotactic biopsy (without further resection)
Complete surgical resection of metastatic disease (lymph node, in transit, satellite lesion[s], distant metastases) with negative margins on resected specimens as confirmed by pathologic review has not been performed, but is deemed feasible by the treating surgical oncologist; surgical resection of the primary melanoma may or may not have been performed
Prior resection of lung cancer is allowed, if at least five years have elapsed between previous resection and registration
More than 8 weeks between resection and radiosurgical procedure
Patients must not have received any adjuvant treatment (chemotherapy, biotherapy, or limb perfusion) after the resection(s) that make(s) them eligible for this trial\r\n* NOTE: previous radiation therapy, including after the surgical resection, is allowed as long as 21 days have elapsed between the radiation and initiation of this adjuvant systemic therapy
Patients who may benefit from surgical resection
All disease should be deemed resectable based on imaging studies e.g.:\r\n* Hepatic metastases (unilateral or bilateral =< 5 lesions, =< 15 cm total diameter)\r\n** Note: Hepatic lesions must be amenable to complete resection\r\n* Primary peritoneal metastases (small disease load =< P2 disease) without massive ascites or intestinal obstruction\r\n* Lung metastases (=< 3 unilateral/bilateral, 9 cm total diameter)\r\n** Note: lung lesions must be amenable to complete resection\r\n** Note: Patients with both pulmonary and hepatic metastases will be enrolled at the discretion of the principal investigator (PI)\r\n** Note: In situations where resection to completeness of cytoreduction score (CC) 0 or 1 is uncertain, patients may undergo diagnostic laparoscopy prior to enrollment to determine feasibility of resection
Inoperable tumor or residual disease after resection
Patients must have had surgical resection at University of California, Los Angeles (UCLA), for which a separate informed consent was signed for the collection of their tumor prior to surgery
Surgical consultation to confirm that patient will be able to undergo curative resection after completion of chemoradiation within 56 days prior to step 2 registration
Patients must have undergone surgical resection with curative intent within 6 months of enrollment; neoadjuvant or adjuvant chemotherapy, radiation, and/or chemoradiation will be allowed as long as no more than 6 months have passed between surgical resection and enrollment; if patients receive sequential chemotherapy and radiation, they are allowed 9 months between surgical resection and enrollment
Clinical staged III or IV HNSCC that is not amenable to surgical resection
Patients who are receiving adjuvant chemoradiation after surgical resection of the primary site of disease
The recurrent or the second primary tumor is unresectable, the patient elects against surgical resection; patients who underwent surgery who has indications for postoperative radiation therapy is also eligible
Histological diagnosis of ATC made through surgical resection is also acceptable.
Histologically confirmed diagnosis of stage IIIB, IIIC or IVM1a melanoma eligible for complete surgical resection.
Post resection serum cancer antigen (CA)19-9 =< 180 units/mL AND prior to any systemic treatment
The patient must have had an en bloc complete gross resection of tumor (curative resection) by open laparotomy or laparoscopically-assisted colectomy. The distal extent of the tumor must have been greater than or equal to 12 cm from the anal verge. (Patients who have had a two-stage surgical procedure to first provide a decompression colostomy and then in a later procedure to have a surgical resection are eligible.)
Measurable disease or non-measurable disease; extent of resection: patients with complete resection, partial resection, or biopsy are eligible
Planned resection of primary tumor
An interval of >= 4 weeks since surgical resection prior to entry in to the trial
Patients must be able to undergo surgical resection of their tumor as determined by the treating surgeon
Surgical resection or major surgery within 4 weeks or stereotactic biopsy within 1 week of first G-202 treatment
Patients who underwent an R2 resection are not eligible
Stage IIIB, IIIC, IVM1a, IVM1b, or IVM1c disease that is not suitable for surgical resection
Surgical resection within 90 days of first dosing
Patients may have had surgical resection of some or all sites of hepatoblastoma prior to enrollment
Patients must begin radiation therapy within 30 days of surgery or radiographic diagnosis, whichever is the later date; date of surgery or radiographic diagnosis is considered day 1 (radiation treatment must start no later than day 31); if a patient has a biopsy followed by a surgical resection then the date of the surgical resection is considered day 1
Circumferential resection margin: CRM+ (Positive)
Prior surgical resection and radiation therapy for the progressive meningioma are not required for study enrollment
Diagnosis must be made by surgical excision, either partial or complete; stereotactic biopsy will not be allowed; maximal safe surgical resection is required
Current diagnosis of histological or cytopathological HNSCC malignancy borderline resectable stage III up to stage IVb (T1-4, N0-2, M0) or unresectable stage IV with high nodal status defined as >= N2b (by the American Joint Committee on Cancer [AJCC] 7th Edition Staging) that is amenable or appropriate for curative treatment; borderline resectability is assessed; NOTE: surgical unresectability will be defined as the combination of the treating surgeon’s judgment of unresectability plus one of the following objective criteria:\r\n* Encasement of tumor or nodes to the carotid artery or 3/4 encasement of the carotid artery\r\n* Involvement of prevertebral musculature\r\n* Need for glossectomy or extensive glossal resection where functional outcome is considered unacceptable to surgeon or patient\r\n* Involvement of the cervical spine\r\n* Severe, unacceptable functional deficit that would result from any proposed definitive surgical resection\r\n** NOTE: the principal investigator (PI) of the study, Dr. Mendez, is a surgical ear, nose and throat (ENT) (head and neck) oncologist and all HNSCC cases will be discussed at the University of Washington/Seattle Cancer Care Alliance weekly tumor conference where two other ENT surgical oncologists, and co-investigators in this study, will help assess resectability; as surgical unresectability may vary from patient to patient based on individual anatomy, treating physicians may, with the approval of the surgical team, declare a tumor not meeting the above criteria to be unresectable; in this case, the reason for unresectability should be documented in the medical record; medical co-morbidity and poor performance status may not be used to declare a patient unresectable
Cohort 2 patients must have had a complete resection of all sites of metastatic disease within 30 days prior to enrollment\r\n* Patients will only be eligible after they have undergone complete surgical resection of suspected metastatic disease that is histopathologically confirmed to be osteosarcoma prior to enrollment\r\n** Note: the definition of complete resections is: gross resection of all disease as per the operating surgeon; post-operative imaging is not required for confirmation of complete resection\r\n* Patients must undergo resection of any lung lesion meeting criteria for likely metastatic disease, defined as: \r\n** 3 or more lesions > 5 mm in diameter OR a single lesion > 1 cm\r\n* Patients with lung as the only site of resected metastatic disease must have refused participation in protocol AOST1421\r\n** Note: this applies if AOST1421 is open to enrollment at the enrolling institution on the day the patient consents
An interval of at least 4 weeks (to start of study agent) between prior surgical resection or one week for stereotactic biopsy
R1 or R2 resection
Documented tumor recurrence or progression after failing prior surgical resection, chemotherapy, or radiation
Subjects are only eligible if complete resection of a plexiform neurofibroma with acceptable morbidity is not feasible, or if a subject with surgical option refuses surgery
at least 4 weeks since craniotomy and resection or stereotactic radiosurgery
No plans for surgical resection
Patient must not have an intercurrent illness likely to interfere with protocol therapy or prevent surgical resection
Cohorts 1 and 2: In addition, patients have to meet one of the following high risk conditions: \r\n* Age >= 40 with any extent resection \r\n* Age 16-39 with incomplete resection (post-op MRI showing > 1 cm residual disease, based on the maximum dimension of residual T2 or fluid-attenuated inversion recovery [FLAIR] abnormality from the edge of the surgical cavity either laterally, anteroposteriorly, or superoinferiorly)\r\n* Age 16-39 with neurosurgeon-defined gross total resection (GTR) but the tumor size is >= 4 cm (the maximum preoperative tumor diameter, based on the axial and/or coronal T2 or FLAIR magnetic resonance [MR] images)
Have histologically confirmed epithelial or biphasic MPM not amenable to potentially curative surgical resection (subjects with biphasic tumors that have a predominantly (?50%) sarcomatoid component will be excluded)
Has failed prior standard therapy including maximal safe surgical resection, radiation therapy (when appropriate for the specific cancer type), and systemic therapy\r\n* For diagnosis of GBM: has undergone maximal safe surgical resection, a course of postoperative radiation therapy with concurrent temozolomide, and maintenance temozolomide\r\n* For diagnosis of meningioma: has no other option of standard therapy such as surgical resection (partial or total resection) or radiation
Prior surgical resection allowed
Any previous radiation to sites of planned SRS; a patient may be deemed eligible in this case if a non-radiation mode of local ablation such as surgical resection is deemed safe and feasible by the principal investigator (PI)
Resection cavity must measure < 5.0 cm in maximal extent on the post-operative MRI or CT brain scan obtained =< 35 days prior to pre-registration; Note: it is permissible for the resection of a dominant brain metastasis to include a smaller “satellite” metastasis as long as the single resection cavity is less than the maximum size requirements
Local failure after surgical resection will be considered a metastatic lesion for purposes of protocol inclusion
There is a planned definitive surgical resection of the primary tumor
Patients must meet the following criteria for unresectability as determined by two hepatobiliary surgeons and one radiologist:\r\n* When a margin negative resection would require resection of all three hepatic veins, both portal veins, or the retrohepatic vena cava\r\n* Requiring a resection that leaves less than 2 hepatic segments (not including the caudate lobe) behind with adequate arterial/portal inflow, venous outflow and biliary drainage\r\n** A patient is considered resectable if the procedure includes a minor wedge or thermo-ablation encompassing 10% or less of the volume of the remaining 2 segments\r\n* Patient’s liver metastases must comprise < 70% of the liver parenchyma; all patients must be clinically fit to undergo surgery as determined by the pre-operative evaluation
Patients should not be candidates for further surgical resection or definitive tumor-directed radiation therapy (XRT) based upon prior therapies and/or extent of disease at recurrence
“Failure” of prior therapy is defined as:\r\n* A > 25% increase in the products of perpendicular diameters of measurable tumor masses during prior therapy which are not amenable to surgical resection\r\n* The presence of new tumors which are not amenable to surgical resection\r\n* An increase in AFP or beta-hCG (two separate determinations at least one week apart are required if rising tumor markers are the only evidence of failure)\r\nNOTE: subjects with clinically growing “teratoma” (normal declining tumor markers and radiographic or clinical progression) should be considered for surgery
Patients with tumors whose resection would necessitate a free-tissue transfer for reconstruction of the surgical defect
R0 or R1 resection
No plans for surgical resection
Metastatic CRC not amenable to surgical resection
Brain biopsy or resection;
Previously undergone surgical resection of the cholangiocarcinoma
Patients must be those for whom surgical resection is clinically indicated; the intent of surgical resection may include debulking or attempt to resect as much of the tumor as safely feasible; if a gross total or near total resection is not feasible, HSV1716 injection into the wall of the resection cavity, encompassing residual tumor, is permissible
Resection declined by surgical staff based on designation of LAPC
Patients in the surgical arm only: patients with recurrent glioblastoma must be eligible for surgical resection as deemed by the site Investigator.
Received maximal, safe, surgical resection
Patients must not have other concurrent uncontrolled malignancies, defined as a malignancy that currently requires therapy or other intervention. Patients with suspected cuSCCs should have them excised prior to study registration. Surgical resection should not be performed within 7 days of starting protocol therapy.
TREATMENT: Patients who were initially rendered NED by surgical resection must remain NED at the time of treatment
Resection of all pTa/pT1 papillary disease
Any major thoracic (thoracotomy with lung or esophageal resection) or abdominal (laparotomy with organ resection) operation must have occurred at least 28 days before study enrollment; patients who have undergone diagnostic video assisted thoracoscopy (VATS) or laparoscopy can be included in the study
Greater than 3 months since melanoma resection;
CNS disease requiring immediate neurosurgery intervention (e.g., resection, shunt placement, etc.)
Eligible patients are expected to have a complete resection based on preoperative imaging; any patient not found to be able to have complete resection will not be eligible for this study
Treatment directed against the melanoma (eg, chemotherapy, targeted agents, biotherapy, limb perfusion) that is administered after a prior complete resection other than adjuvant radiation after neurosurgical resection and IFN for resected melanoma.
Patient will undergo surgical resection as per consultation with their thoracic surgeon and medical oncologist
Macroscopic complete resection of the primary tumor must be planned
Patients enrolling in the retreatment cohort may have experienced localized disease progression that was treated with definitive therapy to return the patient to a state of stable disease. Examples include localized disease progression treated with complete surgical resection, a solitary brain metastasis treated with complete surgical resection or curative intent stereotactic radiosurgery, or a solitary bone metastasis that is treated with curative-dose radiation therapy.
If the patient had a surgical resection for relapsed disease and no anti-cancer therapy was instituted for up to 12 weeks, and the patient undergoes another surgical resection, this is considered one relapse; for patients who had prior therapy for a low-grade glioma, the surgical diagnosis of the recurrent tumor as GBM will be considered the first relapse
Require hepatic resection due to trauma.
Medically or technically inoperable as per thoracic surgeon or patient's preference not to undergo surgical resection
breast carcinoma in situ with full surgical resection
HCC patients only: Cancer potentially amenable to local modalities of therapy or surgical resection (phase I)
Cancer potentially amenable to local modalities of therapy or surgical resection
Single brain metastasis status post surgical resection with =< 1 cc of residual enhancing tumor
Resection cavity volume on planning scan of =< 35 cc
Post-operative MRI within 72 hours of surgical resection
Resection cavity volume > 35 cc
More than 8 weeks between resection and radiosurgical procedure
Completion of multimodality therapy; this must include surgical resection by either pleurectomy/decortication or extrapleural pneumonectomy; the surgery should be performed with the intent of complete resection, though patients with an R1 resection will still be eligible; patients should have also received treatment with chemotherapy and/or radiation; patients with an R2 resection are also eligible as long as the site of residual disease is treated post-operatively with radiotherapy
Randomization must occur ? 6 weeks after complete surgical resection.
Unequivocal and measurable CT evidence of liver metastases which are not treatable by surgical resection or local ablation.
Patients who have undergone stereotactic radiosurgery prior to or following surgical resection, or the placement of Gliadel® Wafers.
Surgical resection of all gross disease\r\n* This assessment will be made by the local investigator based on review of the operative report, pathology results, and/or radiology reports; microscopically positive margins (e.g. R1 resection) are permitted
Has received prior chemotherapy for any malignant disorder, thoracic radiation therapy or prior surgical resection of an esophagogastric tumor
Tumor verified by a thoracic surgeon to be in a location that will permit a sublobar resection
Treatment with bevacizumab may not be initiated until 4 weeks after surgical resection or radiation therapy completion
Prior surgical resection for brain metastases
Patients scheduled for surgical resection
Patients can receive chemoradiotherapy preoperatively prior to surgical resection or as definitive/primary chemoradiotherapy
COHORT B SPECIFIC INCLUSION: Patients must have relapsed/progressed following therapy (consisting of at least maximum feasible surgical resection and radiation therapy)
A minimum of 2 months post-surgical resection or biopsy (if applicable) and/or a minimum 1 month post radiation treatment (if applicable)
Planning to receive surgical resection at MGH (including both curative and palliative resections)
Undergoing surgical resection with pancreaticoduodenectomy (Whipple)
An interval of at least 6 weeks between prior surgical resection and study enrollment
Patients may have had prior therapy for brain metastasis, including radiosurgery and surgical resection; patients must have completed prior therapy by at least 14 days prior to Step 2 for surgical resection and 7 days for radiosurgery
Need for vascular resection/reconstruction
Patient without chemotherapy and/or radiation therapy as part of cancer treatment (e.g., surgical resection only patients are not-eligible)
Incomplete tumor resection (R2 resection, grossly positive resection margin)
Surgery for bowel resection (including esophagus to rectum), pancreatic resection, or peritoneal surface malignancy resection
No prior systemic chemotherapy, radiation therapy to the thorax, or total surgical resection
Newly diagnosed with a primary invasive colorectal adenocarcinoma (all stages) and have a resection at any hospital in Ohio between 1/1/2013 and 12/31/2015\r\n* For individuals who have neoadjuvant treatment and show a complete response at resection, the tumor screening will be attempted on their original biopsy (even if it occurred in 2012) as long as their resection occurred between 1/1/2013 and 12/31/2015\r\n* Many individuals with stage IV CRC will not have a resection; therefore, the tumor screening will be attempted on their original biopsy as long as their primary diagnosis occurred between 1/1/2013 and 12/31/2015; if only metastatic CRC is available on a biopsy, tumor screening will be attempted on the metastatic tissue
Newly diagnosed with a primary invasive endometrial cancer (any histology except sarcoma) and have a resection between 1/1/2013 and 12/31/2015 exclusively at Ohio State University (OSU)\r\n* For individuals who have neoadjuvant treatment and show a complete response at resection, the tumor screening will be attempted on their original biopsy (even if it occurred in 2012) as long as their resection occurred between 1/1/2013 and 12/31/2015
Not planned for surgical intervention
Patients must be registered between 180 days and 465 days (inclusive) of primary resection; patients must show no evidence of disease (NED) based on post-operative colonoscopy (performed at least 180 days after the colon resection date or at least 120 days after the rectal resection date and prior to registration) and computed tomography (CT) scans* of chest, abdomen and pelvis (performed at least 180 days after the colon resection date or at least 120 days after the rectal resection date and prior to registration); patients with adenomas detected at the one-year postoperative colonoscopy are eligible if all adenomas have been completely removed\r\n* CT scan is for high risk patients, as per National Comprehensive Cancer Network (NCCN) guidelines and at the discretion of the treating physician\r\n* NOTE: magnetic resonance imaging (MRI) evaluation is an acceptable alternative to CT scans for eligibility purposes
Patient treated with neoadjuvant chemotherapy with or without radiation therapy prior to surgical resection, AND/OR placement of a biliary stent and/or drain for biliary tree decompression
Individuals with a history of colon resection or colectomy due to any reason
Patient has evidence of current mucositis, mucosal ulceration, or unhealed surgical wounds from surgical resection or biopsy
Patients who have received a single dose of mitomycin C following staging trans-urethral resection (TUR)
The lesion plus the resection margin should not exceed 4.0 cm circumferentially; planned to undergo surgical treatment by resection without flap reconstruction and without neck dissection
Patients with lung lesions undergoing anatomic resection (lobectomy/segmentectomy/bilobectomy/pulmonary sleeve resection/pneumonectomy) OR
Subject has a presence of mucosal ulceration or oral mucositis at screening or develops this prior to randomization, and/or has unhealed wounds remaining from surgical resection and/or excisional biopsy procedure.
Patients who are medically unfit to undergo surgical resection
Subjects who do not wish to have subsequent surgical resection
Suspected malignancy scheduled to be treated with surgical resection at the sarcoma or cancer center of participating sites
Prior thoracic radiotherapy directed to the ipsilateral lung or prior surgical wedge resection in the involved lobe
Resection: tumor must be judged suitable for resection on the basis of imaging studies
Subjects must be eligible for resection as determined by the operating surgeon
Patients getting a planned wedge resection as the only thoracic resectional procedure
Participation in this trial will not significantly alter pre-surgical, surgical or post-surgical care
Patients who require and agree to surgical resection of their evolving post-treatment brain lesion (a clinical decision made prior to and independent of enrollment in this study)
Kinetic Studies Arm only:\r\n* Participant with a suspected or confirmed cancer diagnosis who is scheduled for surgical resection, biopsy, or chemotherapy treatment\r\n* One or more tumor sites measuring >= 1 cm in the shortest transaxial diameter by CT
Subject has a tumor that will undergo upfront resection
Standard of care surgical resection and/or stereotactic biopsy of the brain tumor planned using the FDOPA-PET/MRI study
Planned craniotomy and resection or biopsy
Is being evaluated for surgical resection of the mass
Medical contraindications to low anterior resection or abdominoperineal resection
Surgical resection, chemotherapy, radiation therapy, or biologic therapy since last Octreoscan + CT; continuation of the same dose of Sandostatin–LAR or subcutaneous Sandostatin is allowed
Subjects must be deemed eligible for resection by a surgeon who is listed as an Investigator in this study
Patients must have received prior surgical resection and radiation therapy for the progressive meningioma
An interval of at least 2 weeks (to start of study agent) between prior surgical resection or one week for stereotactic biopsy
Subjects must be eligible for resection as determined by the operating surgeon
Planned for treatment with radiation, chemotherapy and surgical resection or any of these treatment strategies combined
OR a brain lesion that is concerning for malignancy for which histopathological confirmation is anticipated following enrollment (e.g., biopsy or surgical resection of the tumor is scheduled)
Tumor must be determined to be surgically resectable; surgical resection is planned to take place at University of California, San Francisco (UCSF)
For patients who have undergone surgical resection prior to joining the study, in whom baseline magnetic resonance (MR) images exhibit enough signal degradation (due to susceptibility artifact in the region of the surgical bed) such that the data are uninterpretable will be excluded
Subjects must be planned for resection (this includes localized resectable disease or patients with metastatic disease with planned palliative resection) and scheduled to begin neoadjuvant chemotherapy
Patients are not required to have measurable disease; post-operative patients (patients who have had surgical resection of the lung) are eligible
Patients must have a planned surgical resection of the rectum
Participants must have histologically confirmed adenocarcinoma of the colon that is localized, with no evidence of distant metastasis (stage I, II, or III), and for which surgical resection of the primary tumor is being planned; OR participants must have histologically or cytologically confirmed adenocarcinoma of the colon with resectable liver metastases for which liver resection is being planned; OR participants may have a colon biopsy that is suspicious for adenocarcinoma if clinical and/or endoscopic findings strongly support the presence of malignancy, and if surgical resection is being planned; NOTE: in the unlikely event that the final pathology of the surgical resection specimen is consistent with high-grade adenoma or dysplasia, the patient will not be considered ineligible and collected research samples will still be utilized
Prior surgical evaluation and plan for surgical biopsy or surgery to remove the tumor being injected.
Patients must have a previous diagnosis of a recurrent or progressive glioblastoma for which surgical resection is now indicated
Planned surgical resection
Scheduled date of surgical resection that would limit the amount of time taking the intervention to less than 21 days
Patients who are seen by members of the Thoracic Surgical oncology Group at Vanderbilt Ingram Cancer Center for their initial surgical consultation
the OSCC treatment plan includes surgical resection
No history of colon cancer or colon resection
History of colon cancer or colon resection
Subjects must have histologically or cytologically confirmed esophageal, colorectal or pancreatic adenocarcinoma (inclusive of high grade dysplasia) on a biopsy prior to surgery and must be scheduled for surgical resection, inclusive of endoscopic mucosal resection, of the primary tumor. Subjects at any cancer stage will be enrolled.
Per the operative report, the gross total resection of the primary tumor with curative intent was completed within 8 weeks prior to randomization
Patients with gross total resection of the primary tumor prior to enrollment on ARST1321 are NOT eligible; patients who have experienced tumor recurrence after a gross total tumor resection are NOT eligible
Primary surgical debulking before protocol therapy is permissible; this would include removal of gross symptomatic disease in the pelvis and/or vagina\r\n* Exenterative surgery is not permissible; patients with complete resection of gross recurrent disease are eligible
Patients who have gross residual disease or distant metastatic disease
Gross total resection (GTR) will be interpreted as modified Simpson grade 1-3 without gross residual dural-based or extradural tumor; GTR must be confirmed both by modified Simpson grade and by post-operative magnetic resonance imaging (MRI) findings
Status post gross total resection with curative intent
Any evidence of hematemesis, melena, hematochezia, ? grade 2 hemoptysis, or gross hematuria
History of gross hemoptysis.
Surgery achieves either no gross residual disease (R0) or optimal cytoreductive status defined as no single lesion measuring more than 5.0 mm in its greatest diameter
The only surgical consideration is biopsy. Subjects who had gross total resection, partial resection and/or debulking are excluded.
Subjects who had gross total tumor resection, partial resection, and/or debulking surgery.
Participant has symptoms of gross hematuria or gross hemoptysis
Patients must have received no previous therapy for the tumor with the exception of corticosteroids and surgery; patients with a gross total resection will not be eligible
Gross total surgical resection with curative intent of the primary tumor and at least unilateral neck dissection within 7 weeks of registration
Have evidence of active clinically significant bleed (e.g., gastrointestinal bleed, hemoptysis, or gross hematuria) at screening
Uncontrolled cystitis, significant bladder pain or spasms, or gross hematuria that in the opinion of the treating investigator, should preclude study entry
Patients who have undergone a gross total resection for recurrence will be eligible, and MLA will be directed at treating a peritumoral margin of 0.5-1 cm surrounding the resection cavity to disrupt the blood brain barrier (BBB) and potentially increase access of MK-3475 to the peritumoral infiltrating glioma cells
On-going gross hematuria associated with clots
Gross total excision of both the primary and nodal disease
The patient must be a candidate for surgical debulking (either subtotal or gross total resection); biopsy-only candidates will not be eligible
Patients must have undergone gross total surgical resection within 42 days prior to registration and beginning of therapy under the clinical trial. Note: Patients may have biopsy under general anesthesia in an operating room followed by definitive ablative cancer surgery representing gross total resection.
Presence of metastatic disease or gross orbital involvement
No evidence of gross hematuria
Gross (visible) hematuria
Gross disease within the breast must be unifocal; (patients with microscopic multifocality are eligible as long as the total extent of tumor, gross and microscopic, occupies a volume with greatest dimension 3 cm or less)
Macroscopic complete salvage surgery with curative intent (surgery was not performed only for biopsy or palliation); final pathology and imaging must indicate a R0 or R1 resection (no gross disease remaining)
Any patient with gross residual disease following salvage surgery
Patients with gross residual tumor after surgical resection
COHORT II: Gross disease must be unifocal on Mammo/ MRI imaging
Evidence of gross duodenal invasion, gastric outlet obstruction
Current evidence of hematemesis, melena or gross hematuria
Presence of metastatic disease or gross (residual) orbital involvement
Absence of residual or disseminated disease as defined by the following criteria:\r\n* Minimal residual disease as determined by post-operative imaging preferably performed within 48 hours of resection (and at most 28 days post-surgery), i.e. gross total resection or residual disease of < 1.5 cm^2 on post-operative imaging
Patient’s will have no evidence of gross vascular invasion
Patients who had craniotomy with biopsy, subtotal resection, total gross resection, or re-resection will be permitted.
Prior craniotomy and gross total or sub-total resection of tumor at this recurrence
Gross total or partial tumor resection is not possible or not planned
Patients with gross total resection of the primary tumor prior to enrollment are not eligible; patients who have experienced tumor recurrence after gross total tumor resection are not eligible
Patients must have undergone gross total surgical resection of high-risk oral cavity, oropharynx (p16 negative), larynx, or hypopharynx squamous cell carcinoma (SCC) within 63 days prior to registration; note: patients may have a biopsy under general anesthesia in an operating room followed by definitive ablative cancer surgery representing gross total resection; the gross total resection has to be done within 63 days prior to registration; if, however, patients have ablative resection but demonstrate rapid gross recurrence or are determined to have gross persisting disease requiring re-resection to achieve gross total resection, then the patient is not eligible
Patients must have undergone gross total surgical resection of high-risk oral cavity, oropharynx (p16 negative), larynx, or hypopharynx within 63 days prior to registration; Note: patients may have biopsy under general anesthesia in an operating room followed by definitive ablative cancer surgery representing gross total resection; the gross total resection has to be done within 63 days prior to registration; if, however, patients have ablative resection but shortly recur or are determined to have persisting disease requiring re-resection to achieve gross total resection, then the patient is not eligible
Candidate for gross total or subtotal resection
Gross total excision of both primary and nodal disease with curative intent; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease; in other words, to participate in this protocol, the patient must have clinically or radiographically evident gross disease for which disease response can be assessed
Previous radiosurgery to any currently progressive gross metastatic disease
Total (aggregate) gross tumor volume > 500 cm^3 (500 cc’s or 0.5 liters)
Active untreated gross hematuria for any cause
Patients with gross residual or metastatic tumor findings following complete surgical treatment for uterine LMS
Histologic proof of primary head of pancreas invasive adenocarcinoma managed with a potentially curative resection (i.e., removal of all gross tumor) involving a classic pancreaticoduodenectomy (Whipple) or a pylorus preserving pancreaticoduodenectomy; patients with invasive adenocarcinoma that also contains a component of intraductal papillary mucinous neoplasm (IPMN) are eligible\r\n* The operating surgeon must document in the operative note that a complete gross excision of the primary tumor was achieved; the pathology report must include documentation of the margin status and the size of the tumor; the pathology report must also include the status of the three major margins—bile duct, pancreatic parenchyma, and retroperitoneal (uncinate)
Resected tumor: No evidence of gross tumor at the surgical resection margin noted in the final surgery report. No evidence of gross residual adenopathy
Patients who have had gross total excision of the primary tumor.
gross extension of tumor to the skull base;
Patients who had craniotomy with biopsy, subtotal resection, total gross resection, or re-resection will be permitted
The tumor must be unifocal, confined to the supratentorial compartment and have undergone a gross total or near gross total resection; this will increase the likelihood that the patient will not require corticosteroids or develop pseudoprogression
History of gross hemoptysis within 2 months of study entry.
Patients must have had all gross disease resected (R0 or R1 resection)
Not undergoing surgical resection or for whom gross total resection is not possible
Patient should have surgery (biopsy, partial resection or gross total resection) and no additional anti-cancer therapy except the chemoradiation as specified in the protocol
Achieved a gross total or sub-total resection at time of surgery
Gross total surgical resection with curative intent of the primary tumor and at least unilateral neck dissection within 7 weeks of registration
Evidence of clinically evident gross residual or recurrent disease following preoperative therapy and surgery
The patient must have undergone surgical resection (gross total, subtotal, or biopsy) of the spinal lesion(s) no more than 16 weeks prior to SRS treatment
Patient must not have gross residual and/or microscopic disease present after surgery including re-resection(s), per the operative and pathology report
Participants with gross hematuria are not eligible; patients with microscopic hematuria are eligible
Participants with gross hematuria are ineligible
Patients with more than 2 (i.e., 3 or greater) uncontrolled or untreated extracranial sites of gross disease
Gross extension of tumor into the lumen of the duodenum
Subjects must have undergone primary gross total resection (no re-resected patients are allowed) with fulfillment of at least 1 of the following histologic criteria for high-risk disease:
Participants may have had a gross total resection, sub-total resection or biopsy\r\nonly
Patients with tumors adjacent to a vertebral body are eligible, unless there is demonstrable bone invasion, as long as all gross disease can be covered to the total radiation dose while respecting spinal cord tolerance
Patients who have undergone gross total resection and have no detectable residual disease are eligible
Gross total resection as determined by the intraoperative observations of the neurosurgeon of record and confirmed by postoperative MR imaging; gross total resection is defined as residual tumor or imaging abnormality (not definitive for residual tumor) whose size is < 1 cm^2 on postoperative computed tomography (CT) or MR images
Histologic diagnosis of nodular desmoplastic medulloblastoma with less than gross total resection, but with no evidence of metastasis
Prior cancer treatment for this cancer, including gross total tumor excision
Participants with a history of gross hemoptysis within 2 months prior to study treatment
Pulmonary hemorrhage or gross hemoptysis within 12 months
Pulmonary hemorrhage or gross hemoptysis within 6 months prior to enrollment
Gross total resection followed by conventional chemoradiation therapy without progression of disease.
Patients with gross disease involving only the posterior elements
Patients with both pedicles involved with gross disease at the level of potential cement augmentation
Symptoms of gross hematuria or gross hemoptysis.
Patients with clinical evidence of gross disease
Gross nodal or metastatic disease at presentation (>= N1, M1)
Patients with gross tumor involvement of the oral cavity or oral mucosa
No gross disease visible on imaging at the start of radiotherapy
Definitive/gross total lesion resection
No gross disease visible on imaging at the start of radiotherapy
Subtotal, gross total or biopsy patients will be eligible
Gross tumor volume (GTV) or resection cavity must be visible on CT such that it can be delineated as a target for radiotherapy
Histologically-confirmed angiosarcoma that is not amenable to curative intent surgery (e.g., metastatic or bulky disease and disease for which surgical resection would carry an unacceptable risk to the patient). Pathology report will be reviewed by sponsor prior to randomization.
For this patient, the standard treatment recommendation in the absence of a clinical trial would be combined modality, neoadjuvant chemoradiation followed by curative intent surgical resection
Disease that is currently not amenable to surgery, radiation, or combined modality therapy with curative intent
Patient must have no prior history of RCC that was resected with curative intent within the past 5 years
Surgical resection with curative intent within 8 weeks prior to registration
Eligible for surgery with curative intent
Have received only one prior radiation treatment course; prior radiation course must have been with curative intent
Histologically or cytologically proven diagnosis of advanced stage angiosarcoma that is not amenable to treatment with curative intent; specify site of origin as cutaneous vs. non-cutaneous
Other prior malignancy active within the previous 2 years except for local or organ-confined early stage cancer that has been definitively treated with curative intent or does not require treatment, does not require ongoing treatment, has no evidence of active disease, and has a negligible risk of recurrence and is therefore unlikely to interfere with the endpoints of the study.
Evaluation by an attending thoracic surgeon to confirm eligibility for an R0 resection with curative intent
Received at least 2 cycles of one prior regimen administered with curative intent and one of the following:
Localized prostate cancer that has been treated surgically with curative intent and presumed cured
Patient has histologically/cytologically confirmed, non-keratinizing/undifferentiated, EBV-related nasopharyngeal carcinoma, not amenable to curative intent therapy; EBV testing may be completed per institutional standards
Subjects have no known curative treatment.
Are eligible for a curative treatment option.
Other prior malignancy active within the previous 3 years except for local or organ confined early stage cancer that has been definitively treated with curative intent, does not require ongoing treatment, has no evidence of residual disease and has a negligible risk of recurrence and is therefore unlikely to interfere with the primary and secondary endpoints of the study, including response rate and safety
Primary disease site must be able to be treated with curative intent
Another active malignancy requiring therapy such as radiation, chemotherapy, or immunotherapy; exceptions to this are as follows: localized non-melanotic skin cancer and any cancer that in the judgment of the investigator has been treated with curative intent and will not interfere with the study treatment plan and response assessment; patients with >= 25% of the bone marrow radiated for other diseases are not eligible
The subject is a candidate for surgery or loco-regional treatment with curative intent.
Must have esophageal cancer that cannot be operated on, or treated with definitive chemoradiation with curative intent, that is advanced, reoccurring or has spread out
Disease that is currently not amenable to surgical resection with curative intent as determined by the treating investigator
Possibility of a curative local treatment (surgery and/or radiotherapy)
Patients who have a standard curative option for their lymphoid malignancy at current state of disease are excluded; for eligibility on this trial, allogeneic stem cell transplantation is not considered a standard curative option
Malignancy treated with curative intent and with no known active disease > 5 years prior to the start of CMP-001 dosing on W1D1 and of low potential risk for recurrence.
Recurrent/metastatic disease, fulfilling at least one of the criteria defined below:\r\n* Incurable disease as assessed by surgical or radiation oncology\r\n* Metastatic (M1) disease\r\n* Persistent or progressive disease following curative-intent radiation, and not a candidate for surgical salvage due to incurability or morbidity; patients who decline radical surgery are eligible
Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent; requires discussion with TA MD.
Has not achieved disease-free status after completion of CCRT administered with curative intent.
Documented disease progression occurring within 12 months from the last treatment with curative intent
Has newly diagnosed disease (no prior chemotherapy, radiation or surgery with curative intent for this sarcoma diagnosis – prior surgery for diagnostic purposes are allowable)
Plans to undergo neo-adjuvant radiation and surgery with curative intent
Have evidence of persistent, recurrent, or progressive disease for which there is no known or established treatment available with curative intent, after failing at least one course of community standard systemic treatment with chemotherapy (and endocrine therapy if appropriate)
Participants must have disease that has progressed on prior treatment and is not amenable to surgical resection or other approved therapeutic options with curative intent. Participants must not be eligible for further therapy that is likely to provide a survival benefit
Deemed ineligible for curative intent therapy with surgical resection or liver transplantation
Availability of curative treatment option for the patient’s cancer, whether surgery, chemotherapy, radiation, or combination thereof, unless the patient has documented refusal of curative treatment
Histologically documented differentiated thyroid cancer with or without metastases, not amenable to curative treatment; or the patient has documented refusal of curative treatment
Have evidence of persistent, recurrent, or progressive disease for which there is no known or established treatment available with curative intent, after failing at least one course of community standard systemic treatment with chemotherapy (and endocrine therapy if appropriate)
Patients must not be eligible for therapy with curative intent (i.e. surgery, radiation, etc)
For patients undergoing curative intent resection the following criteria are required:
If a curative treatment option in the form of chemoradiation exists in a patient with unresectable disease, this has to be attempted first and must have failed, unless the patient has documented refusal of curative treatment
Availability of curative treatment option for the patient’s cancer, whether surgery, chemotherapy, radiation, or combination thereof, unless the patient has documented refusal of curative treatment
ALL patients who have relapsed or have residual disease following treatment with curative intent; ALL patients must have ROR1 expressed on > 90% of the leukemia blasts to be eligible
Be eligible for curative-intent concurrent chemoradiation therapy
Patients will not have any other curative therapeutic option, such as radiation or surgery
In the absence of a being treated on a clinical trial, the patient would be recommended to receive neoadjuvant chemoradiation followed by curative intent surgery
Patients with prior malignancies are allowed, provided they have been treated with curative intent and have no evidence of active disease
Patients will not have any other curative therapeutic option, such as radiation or surgery
Surgery intent within 4 weeks
Fit to receive chemotherapy and radiotherapy with curative intent.
Subjects must not be candidates for hepatic surgery or locoregional therapy of liver tumors with curative intent.
ORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Disease is surgically resectable with curative intent
Has current NSCLC disease that can be treated with curative intent with surgical resection, localized radiotherapy, or chemoradiation
Brain metastases unless treated with curative intent (gamma knife or surgical resection) and without evidence of progression for ? 2 months.
Be appropriate candidates for resection and curative intent therapy in general
Patients who have had prior chemotherapy, radiotherapy, or surgery with curative intent for HNSCC
Patients with a history of prior malignancy are eligible provided they were treated with curative intent and have been disease free for the time period considered appropriate to not interfere with the outcome of this study
Prior cytotoxic chemotherapy for another condition treated with curative intent is allowed provided at least 18 months has elapsed between last treatment and enrollment on protocol
Patients with a history of prior malignancy are eligible provided they were treated with curative intent and have been free of disease for the time period considered appropriate for cure of the specific cancer; for most diseases this time frame is 5 years
At least 6 months since prior treatment with curative intent and recurrence
Histologically confirmed hepatocellular carcinoma not amenable for management with curative intent by surgery or local therapeutic measure;
No other active malignancy requiring therapy such as radiation, chemotherapy, or immunotherapy; exceptions to this are as follows: localized non-melanotic skin cancer and any cancer that in the judgment of the investigator has been treated with curative intent and will not interfere with the study treatment plan and response assessment
Prior systemic chemotherapy unless it was part of definitive-intent (curative intent) treatment more than 6 months before study entry
Eligible for curative treatment (ablation or transplantation)
Disease surgically resectable with curative intent
Participant completed all prior radiotherapy with curative intent ? 3 weeks prior to randomization
Prior curative-intent surgery at least 3 months prior to the nodal recurrence.
Surgically eligible for tumor resection with curative intent
Has a history of prior cancers not included in this study that were either not treated with curative intent or have been active within the past 5 years
Active malignancy requiring therapy such as radiation, chemotherapy, or immunotherapy; exceptions to this are as follows: localized nonmelanotic skin cancer and any cancer that in the judgment of the investigator has been treated with curative intent and will not interfere with the study treatment plan and response assessment
Patients who have a standard curative option for their lymphoid malignancy at current state of disease are excluded; for eligibility on this trial, allogeneic stem cell transplantation is not to be considered a standard curative option
Recurrent/metastatic disease, fulfilling at least one of the criteria defined below:\r\n* Incurable disease as assessed by surgical or radiation oncology\r\n* Metastatic (M1) disease\r\n* Persistent or progressive disease following curative-intent radiation, and not a candidate for surgical salvage due to incurability or morbidity; patients who decline radical surgery are eligible
Subject must have NSCLC that is not amenable to surgical resection or radiation with curative intent at time of screening.
Subjects with recurrent squamous NSCLC after surgical treatment that is not amenable to surgical resection or radiation with curative intent are eligible.
Patients who are eligible for curative treatment (ablation or resection or transplantation)
Recurrent or persistent measurable disease that has progressed (defined as radiological and/or clinical progression; an increase in cancer antigen [CA]-125 alone is not sufficient) on or after last therapy (i.e., chemotherapy, hormonal therapy, surgery) and is not amenable to potentially curative intent surgery, as determined by the patient's treating physician.
Patients who have a standard curative option for their lymphoid malignancy at current state of disease are excluded; for eligibility on this trial, allogeneic stem cell transplantation is not to be considered a standard curative option
Recurrent NSCLC, who relapse less than one year after completing curative intent therapy
Completed all acceptable therapies with curative intent that are the current standard of care for their respective diseases. If no conventional therapy available, patient may participate after review by sponsor.
The patient has progressed within 6 months after completion of curative intent (definitive) treatment for localized/locoregionally advanced disease.
For subjects receiving adjuvant therapy only, subjects with node positive disease must have undergone treatment of axillary LN with curative intent, or subjects must be scheduled for further treatment of regional lymph nodes with curative intent. Definitive treatment must be planned to be completed within approximately 9 months of randomization
Patients must be eligible for curative intent surgical resection
Patient must continue to be eligible for curative intent surgical resection
Prior radiotherapy with curative intent
Prior chemo-radiotherapy with curative intent
Newly diagnosed inoperable cervical cancer treated with chemoradiation therapy with curative intent and life expectancy of at least 12 months as assessed by the investigator o No CNS/spinal metastases
Patient is receiving concurrent radiation therapy to treat primary disease with curative intent. (Note that palliative radiotherapy is allowed as long as there is no evidence of progressive disease.)
Inability to start study treatment within 12 weeks following the completion of curative intent therapy for rectal adenocarcinoma
Disease that is currently not amenable to surgery, radiation, or combined modality therapy with curative intent
Active suicidal ideation with plan and intent
Treated with intent to cure
Not treated with intent to cure
Completed curative intent therapy, without additional standard of care curative intent therapy feasible within 20 weeks prior to study enrollment
After prior curative intent treatment for HNC have estimated risk of recurrence >= 40-50% and fall into one of the below categories (A, OR B, OR C, OR D, OR E, OR F); while exact estimation of the risk of recurrence can be difficult the following categories will be included reflecting patients at substantial risk for tumor recurrence or already with early evidence of recurrence:\r\n* A: Any of the below HNC patients are eligible for treatment on this protocol AFTER completion of curative intent therapy:\r\n** HPV(-) HNC: N2C, N3, bulky N2B disease (>= 5 cm LN/tumor conglomerate)\r\n** HPV(+) HNC: N2C, N3, AND >= 10 pack years of tobacco use\r\n** HPV(+) HNC with multilevel nodal involvement, AND bulky N2B disease (>= 5 cm LN/tumor conglomerate), AND >= 10 pack years of tobacco use\r\n** EBV(+) nasopharyngeal carcinoma (NPC) may be eligible if other criteria under A, or alternative criteria B, or C, or D, or E are met\r\n** HNC with supraclavicular or mediastinal nodal involvement (either HPV+/- or EBV+/-) at the time of curative intent treatment and were treated as part of curative intent therapy (e.g. inclusion in the radiation field)\r\n** Residual mass in area of prior tumor that on biopsy does not show residual tumor, is equivocal/not highly-suspicious on imaging (e.g. positron emission tomography/ computed tomography/magnetic resonance imaging [PET/CT/MRI]), but remains of concern, requires close follow-up AND is not resected/amenable to resection OR immediate palliative treatment\r\n** Non-responders to induction chemotherapy (progressive disease [PD] on induction, or lack of tumor shrinkage (< 15% per Response Evaluation Criteria in Solid Tumors [RECIST])\r\n** Interrupted treatment course or lower than intended radiation dose – i.e. interruption of radiation by >= 3 weeks (cumulative), or delivery of =< 50 Gy as part of a radiation based treatment (that was NOT a de-escalation approach)\r\n* B: Patient treated with salvage treatment (i.e. salvage surgery or re-irradiation) for residual or recurrent tumor after prior radiation based therapy (either HPV+ or HPV- or EBV+) AND not a candidate for additional curative intent therapy (for various reasons including poor performance status, comorbidities, refusal of patient, prior radiation or re-irradiation, etc); positive margins or residual tumor may still be acceptable); patients should also not be appropriate for systemic palliative therapy (e.g. in the case of overt disease)\r\n* C: Mx or indeterminate distant lesions that are not appropriate for either local radiation/stereotactic body radiation therapy (SBRT) treatment and also not appropriate for initiation of palliative system therapy (e.g. in the setting of overt metastatic disease); such lesions should be negative/equivocal by PET imaging and if amenable negative by biopsy, but remain of concern and require close follow-up\r\n* D: Oligometastatic disease treated with SBRT or other curative-intent therapy (e.g. surgery or radiofrequency ablation (RFA), etc) for oligometastatic disease\r\n* E: Microscopic or very low volume residual tumor after surgery or radiation based treatment (including salvage treatment or SBRT for oligometastatic disease), AND not a candidate for either additional curative intent therapy (for various reasons including feasibility, poor performance status, comorbidities, refusal of patient, prior radiation or re-irradiation, etc) AND also not a candidate for systemic palliative therapy (for various reasons including microscopic/non-[RECIST] measurable low volume disease); very low volume disease is defined as non-RECIST measurable)\r\n* F: Patients with multiple recurrences or multiple primaries: specifically patients who had malignant or pre-malignant tumors/changes (with severe dysplasia present), who have undergone surgery >= 2 times, and currently do not have an indication for additional (adjuvant) treatment such as radiation, or surgery, or other treatment; this may include multiple recurrences/incidences of early stage tumors or premalignant lesions, however at least one lesion needs to show squamous cell carcinoma on pathology\r\n* There may be additional scenarios for patients that are considered very high risk for disease recurrence and not appropriate for either curative or standard of care palliative therapy; such patients can be considered for enrollment after discussion and approval by the principal investigator (PI) and/or co-PI
Not amenable to treatment with curative intent
Patients scheduled to undergo surgical resection for curative intent during study participation
Patients to be treated with RT for curative intent
Patient undergoing any resection requiring an anastomosis to the esophagus for curative intent; including but not limited to esophagectomy or total gastrectomy
Completed cancer treatment with curative intent
Patient has histologically proven colorectal cancer or polyp(s) that is planned to be treated by surgical resection performed with curative intent
Other prior malignancy active within the previous 2 years except for local or organ confined early stage cancer that has been definitively treated with curative intent or does not require treatment, does not require ongoing treatment, has no evidence of active disease and has a negligible risk of recurrence and is therefore unlikely to interfere with the endpoints of the study
Patients who are receiving a course of radiation therapy for curative or adjuvant intent
Patients who have been diagnosed with locally advanced unresectable NSCLC undergoing definite chemo-radiation with curative intent
Macroscopic resection of the tumor via TORS must be planned with curative intent
Eligible for at least 2 cycles of standard of care AML chemotherapy that will result in moderate to severe myelosuppression and have curative intent
Patients may be enrolled between 3 months and 5 years AFTER completion of curative-intent therapy (including surgery, radiotherapy, and/or chemotherapy)
Planned curative intent chemotherapy, delivered either concurrently or sequentially in combination with radiotherapy
Planned standard of care surgery with curative intent for pancreatic adenocarcinoma
Histologically confirmed cancer that is advanced; metastatic; or otherwise not suitable for surgical resection with curative intent
Must be in acceptable health to undergo radiation therapy and curative intent surgery as assessed by UNC surgeons and radiation oncologist
Must receive their neoadjuvant radiation therapy and curative intent surgery at UNC Hospitals – Chapel Hill location
Medical conditions precluding radiation therapy or curative intent surgery
Planned standard of care surgery with curative intent for squamous cell carcinoma
Planned standard of care surgery with curative intent for pancreatic adenocarcinoma
Planned standard of care surgery with curative intent for squamous cell carcinoma
History of malignancy that is in complete remission after treatment with curative intent is allowed.
Patients with known, active (i.e. not adequately treated with curative intent) malignancies other than melanoma
Patients who underwent, currently undergoing or planned to start radiation treatment with curative, adjuvant or palliative intent, who have not yet had their first post-treatment visit
Patients must have completed all therapy for curative intent at least six months prior to chart audit
Criteria 1, Participant is a candidate for hepatic surgery or local regional therapy of liver metastases with curative intent
Disease that is not amenable to surgery, radiation, or combined modality therapy with curative intent.
For phase Ib only: Pretreated patients, and not amenable to further therapy with curative intent. This part is open to pretreated patients regardless of the number of previous treatment lines. For phase II only: Patients who received a maximum of two prior systemic regimens for recurrent and/or metastatic disease and not amenable to further therapy with curative intent.
No prior curative attempts for this cancer, (i.e., surgery, radiation and/or other)