The subject has received bevacizumab for their disease unless in the context of primary therapy for newly diagnosed glioma
Patients with newly diagnosed RMS of any subtype, except adult-type pleomorphic, based upon institutional histopathologic classification, are eligible to enroll on the study based upon stage, group, and age, as below
Enrollment on ANBL00B1 or APEC14B1 is required for all newly diagnosed patients
Group C: patients < 18 months (< 547 days) of age with newly diagnosed INRG stage Ms neuroblastoma/ganglioneuroblastoma
Newly diagnosed patients with histologically proven ALCL (International Classification of Diseases for Oncology [ICD-0] code: 9714/3)
Subject with histologically or cytologically confirmed extensive-stage disease SCLC which is newly diagnosed and chemotherapy naive
Patients with CNS GCTs who are newly diagnosed are excluded from the study
Newly-diagnosed brain cancer with histopathological diagnosis of GBM;
Histologically confirmed newly diagnosed stage I-II HER2/neu positive breast cancer
Newly diagnosed mature B-lineage (CD20 positive) Leukemia/Lymphoma
Be newly diagnosed and previously untreated
Prior WBRT for newly diagnosed brain metastases
Newly diagnosed neuroblastoma or ganglioneuroblastoma as verified by histology and/or demonstration of tumor cells in bone marrow with elevated urinary catecholamine metabolites
Treatment naive for his or her newly diagnosed malignancy for enrollment to groups 1 or 2
newly diagnosed AML unsuitable for intensive chemotherapy
For the Phase II part of the study, newly diagnosed OR refractory/metastatic anaplastic thyroid cancer confirmed by histology, incurable by surgery, radiotherapy or chemoradiotherapy alone or in combination
Newly diagnosed, previously untreated participants with rhabdomyosarcoma (RMS)
Patients with biopsy proven newly diagnosed rhabdomyosarcoma
Have newly diagnosed localized or locally advanced (T1N1-3M0 or T2-3NanyM0), potentially resectable disease without any prior systemic chemotherapy
Group 1: Must have newly diagnosed, pathologically confirmed cHL at Stages IA, IB and IIA without bulky disease. Group 2: Must have newly diagnosed, pathologically confirmed cHL at Stages IIEB, IIIEA,IIIEB, IIIB, IVA and IVB
Elderly (> 60 year old) patients with newly diagnosed AML not eligible for intensive chemotherapy
Newly diagnosed patients who are ineligible or declined to receive intensive chemotherapy after discussion of risks and benefits of that approach or patients with primary refractory/relapsed AML
Newly diagnosed brain cancer or tumor called glioblastoma or GBM
Newly-diagnosed brain cancer or tumor called glioblastoma or GBM
Must have recurrent disease confirmed by MRI (Group 1) or completed SoC therapy such as surgery with adjuvant radiochemotherapy with or without maintenance temozolomide according to local standards for newly diagnosed disease (Group 2)
Patients with newly diagnosed, uncontrolled and or untreated cancer; related central nervous system diseases are excluded.
Newly diagnosed androgen-sensitive metastatic disease; or
Newly diagnosed, treatment naive, HNSCC suitable for surgical resection with planned radiotherapy and/or chemotherapy after surgery
Newly diagnosed histologically proven locoregional OCSCC (T-stage 2-4) without evidence of distant metastases; OCSCC includes the subsites of oral tongue, floor of mouth, gingiva, retromolar trigone, and buccal mucosa
Patients may have metastases, with newly identified peripheral metastases
Newly diagnosed, biopsy proven cancer of the endometrium, prostate or breast
Subjects must be newly diagnosed or suspected to have breast, uterine (endometrial cancer with histologies including endometrioid, serous, clear cell, and carcinosarcoma) or cervical cancer
Histopathologically proven newly-diagnosed primary glioblastoma with complete or partial surgical resection; biopsy not acceptable
Newly diagnosed de novo AML; or
Newly diagnosed (non-M3) AML patients
PHASE II DOSE EXPANSION IN NEWLY DIAGNOSED GBM: Is currently participating or has participated in any other newly diagnosed therapeutic trial before or after chemoradiation
PHASE II DOSE EXPANSION IN NEWLY DIAGNOSED GBM: Has known gliomatous meningitis, extracranial disease, or multifocal disease
Documented evidence of newly diagnosed, symptomatic MM, by IMWG criteria within five years of enrollment
Histologically or cytologically confirmed newly diagnosed treatment-naive metastatic adenocarcinoma of the pancreas with metastatic disease diagnosed no more than 8 weeks prior to enrollment
Newly diagnosed or relapsed participants are eligible to participate; this protocol is intended to enroll both previously treated and untreated patients
Patients must have histologically confirmed newly diagnosed or previously untreated (patients may be under no treatment “wait and watch” or have received two cycles of chemotherapy or localized radiation therapy before going on this study) non-Hodgkin’s lymphoma or CLL
Newly diagnosed, histologically confirmed breast cancer
Patients with newly diagnosed AT/RT
Patients with newly diagnosed AT/RT and synchronous extra-CNS MRT
HER-2+ (HER2 status is not required for women diagnosed with DCIS)
Patients with 1?10 newly diagnosed brain metastases deemed to be eligible for radiosurgery\r\n* Prior whole brain radiotherapy (RT) and radiosurgery (to areas outside of the newly diagnosed brain metastases requiring radiosurgery) is allowed
Patient has newly diagnosed disease with no prior therapy
Any prior treatment for the current, newly diagnosed breast cancer
Patients must have newly diagnosed (i.e., within 5 weeks), histologically or cytologically confirmed glioblastoma multiforme
Patient must have newly diagnosed, histologically confirmed GBM
Patients with newly diagnosed stage I and II nasal NK cell lymphoma
Four or more newly-diagnosed lesions
In the phase II portion, patients must be newly diagnosed or treatment naive, or have been off adjuvant imatinib therapy for at least 3 months; patients with newly diagnosed GIST and who had been on imatinib for up to 4 weeks prior to signing the consent are allowed to enroll in order to expedite accrual
Newly diagnosed MCL: Confirmed diagnosis of MCL with CD20 and cyclin D1 positivity in tissue\r\nbiopsy; patients must have never received any prior therapy for their disease
Newly diagnosed MCL: Ki67 protein (Ki67) < 50%
Newly diagnosed MCL: Patients must be willing to receive transfusions of blood products
Newly diagnosed MCL: The patient has a prior or concurrent malignancy that in the opinion of the investigator, presents a greater risk to the patient’s health and survival, than of the MCL, within the subsequent 6 months at the time of consent
Newly diagnosed MCL: Prior treatment with ibrutinib
Newly diagnosed MCL: Patients with blastoid and pleomorphic variants
Newly diagnosed MCL: Ki-67 to be equal or more than 50%
Newly diagnosed MCL: Central nervous system lymphoma
Patients with newly diagnosed brain metastases are eligible as long as they are not planned for WBRT upfront
Cohort A: newly diagnosed AML, no prior cytotoxic chemotherapy
Untreated, non-transplant eligible, newly diagnosed mantle cell lymphoma with measurable disease as determined by computed tomography (CT), and bone marrow biopsy
Elderly subjects (? 65 years) with newly diagnosed AML must be treatment naive and unfit for intensive chemotherapy.
Patients with ICGCTs who are newly diagnosed are excluded from the study
Newly diagnosed disease
Has a newly diagnosed tumor and a curative treatment option or approved therapy is available
newly diagnosed untreated AML in patients ? 65 years of age, if they are not candidates for standard available induction chemotherapy
Subjects with (newly diagnosed or recurrent) metastatic cancer for whom surgery, radiation, or radiosurgery has not been advised by the treating physician.
Newly diagnosed DIPG patients\r\n* Patients must have not received any prior therapy for treatment of their current CNS malignancy other than radiation therapy
PART 2 PATIENTS (NEWLY DIAGNOSED GBM)
Patients should be newly diagnosed HNSCC, with no prior therapy for this disease
Patients with newly diagnosed GCT
newly diagnosed advanced breast cancer, then relapsed with documented evidence of progression while on or after only one line of endocrine therapy
Subjects ? 60 years of age with newly diagnosed AML
Newly diagnosed, histologically confirmed de novo AML (bone marrow blasts ? 20%), or
Diagnosis of newly diagnosed lymphoblastic lymphoma (patients must have < 25% tumor cells in bone marrow by morphology)
newly diagnosed advanced/metastatic breast cancer, treatment naïve
Patients must either not be a candidate for docetaxel chemotherapy for newly diagnosed metastatic prostate cancer, as determined by their treating oncologist, or have declined this therapy
Diagnosed with PNH
Known newly diagnosed cardiac arrhythmia; patients with an arrhythmia that has been stable for at least 3 months will be allowed to participate
Patients must be newly diagnosed with de novo acute myelogenous leukemia
Patients must be newly diagnosed with histologically-proven hepatoblastoma
Newly diagnosed stage IIIA/B NSCLC, PS 0-1
Patients must not have received any prior treatment for current or newly diagnosed breast cancer
“High-risk SMM” per Mayo Clinic or Spanish PETHEMA (Treatment of Newly Diagnosed Patients with Acute Promyelocytic Leukemia) criteria
Newly diagnosed, biopsy-proven stage 0-II breast cancer
Is newly diagnosed with a curative treatment option available.
INCLUSION CRITERIA FOR NEWLY DIAGNOSED PATIENTS WITH DIPG
EXCLUSION CRITERIA FOR NEWLY DIAGNOSED PATIENTS WITH DIPG
Newly diagnosed elderly AML patients (> 60 years) unfit for intensive chemotherapy with cytarabine and anthracyclines are also eligible to this trial given that no clinically beneficial therapy exists for these patients
Newly diagnosed or uncontrolled cancer-related central nervous system disease
COHORT A: The subject must have newly diagnosed prostate cancer with a metastatic site(s)
Subjects must be newly diagnosed or previously diagnosed with CNL or aCML; all patients must have a bone marrow biopsy completed during the screening or baseline period if one has not been done within 90 days of day 1, cycle one
Patients with newly diagnosed, CD30-positive mature T-cell lymphomas
Patients must have newly diagnosed (i.e., within 5 weeks), histologically or cytologically confirmed glioblastoma multiforme
Patients with newly diagnosed PVNS with, at least, one measurable site of disease on MRI.
Pre- and post-menopausal women newly diagnosed with DCIS histologically confirmed on breast core biopsy
Newly diagnosed patients with no prior attempt at curative therapy
Newly diagnosed, previously untreated patients with histologically or molecularly confirmed DSRCT
Tumor: newly diagnosed non-disseminated diffuse intrinsic pontine glioma based on clinical AND radiographic finding
Histopathologically confirmed newly diagnosed glioblastoma multiforme; diagnosis must be made by surgical biopsy or excision
Patients must have 3 or fewer newly diagnosed metastatic lesions in the brain with a complete resection of at least one lesion as determined by the study neuroradiologist
Newly diagnosed, treatment naive CP-CML (Cohort 3)
Newly diagnosed disease
Subjects must have newly diagnosed (within 3 years), previously untreated prostate cancer without concurrent malignancy
Newly diagnosed untreated stage IV and/or recurrent after adjuvant therapy with metastatic disease
Newly diagnosed cGVHD defined by:
Have newly diagnosed or recurrent multi-focal Ta, large Ta, high grade Ta, carcinoma in situ (CIS) or T1 bladder cancer
Newly diagnosed cardiac arrhythmia; patients with an arrhythmia that has been stable for at least 3 months will be allowed to participate
Newly diagnosed patients with unilateral group D retinoblastoma
Patients must have newly diagnosed metastatic disease; note this may include non-measurable chest wall recurrence
Newly diagnosed, previously untreated patients with histologically or molecularly confirmed Ewing sarcoma
Patients must have newly diagnosed histologically proven invasive carcinoma of the breast with no evidence of metastases
Arm B: Patients with CML in AP or BP, either newly diagnosed or failing TKI therapy (i.e., Acute Group patients);
Newly diagnosed patients who have not received prior therapy, with the exception of one short course of emergent chemotherapy in newly presenting patients with neurological compromise per provider decision
Documented evidence of symptomatic MM, either newly diagnosed or relapsed/refractory
Newly diagnosed de novo GBM with documented EGFRvIII expression in tumor tissue.
Have newly diagnosed localized or locally advanced (T1N1-3M0 or T2-4NanyM0), potentially resectable disease without any prior systemic chemotherapy
Patients must have a biopsy proven newly diagnosed locally confined, stage T1a, T2a or T2b prostate cancer
Newly diagnosed cardiac arrhythmia; patients with an arrhythmia that has been stable for at least 6 months will be allowed to participate
Patients with 1-10 newly diagnosed brain metastases
The child must be a newly diagnosed patient with any type of malignant disease who will be or is receiving chemotherapy and/or radiation therapy
Patient must be newly diagnosed or relapsed/progressed with a brain tumor that has not previously been treated with CRT\r\n* Note: COG therapeutic study participation is not required for ACCL10P1 enrollment
Diagnosed with ALL
Individuals who have been diagnosed with lung cancer\r\n* Individuals are eligible regardless of date of diagnosis (newly diagnosed or long-term survivor), pathology type or stage of lung cancer, or history of other cancers
Newly diagnosed prostate cancer (PCa) (within 3-months).
The patient must not have received bevacizumab as an upfront treatment in newly diagnosed glioblastoma.
Patients diagnosed with T-cell Lymphomas.
Are newly diagnosed with prostate cancer
Newly diagnosed solid tumor or lymphoma with histological verification
A newly diagnosed, histologically proven cancer arising from the oral cavity and oropharynx
Newly diagnosed, in need of a new line or therapy, or at a treatment decision making timepoint.
PATIENTS: Newly diagnosed with any stage cancer
Patients who are newly diagnosed with acute leukemia and hospitalized to receive their initial 4 weeks of intensive induction chemotherapy for this disease
Newly diagnosed with stage 2 or higher cervical cancer within the past 6 months
Newly diagnosed with any stage of uterine cancer (both sarcoma and carcinosarcoma) in the past 6 months
Be diagnosed with cancer
Newly diagnosed adult cancer patients from VICC and MMC or a participating caregiver designated by the patient
Patient must be newly diagnosed (i.e., not relapsed) with any malignancy
newly diagnosed with I-III non-metastatic cancer
Newly diagnosed with acute leukemia by pathology report
Spouses of women with diagnosed within the past 8 months with stage III or IV ovarian cancer will be eligible to participate, as will the diagnosed wife/partner
Women who have been newly diagnosed with a first primary, epithelial ovarian cancer, have undergone surgical debulking and who will be treatment according to the Armstrong method
Newly diagnosed, primary, epithelial ovarian cancer
Newly diagnosed breast cancer patients
Patient must be a newly diagnosed ALL, in first remission
All patients with newly diagnosed lymphoma
Diagnosed with osteoporosis
Newly diagnosed stage I-III breast cancer (including inflammatory and newly diagnosed recurrent breast cancer) or lymphoma with a > 2 year life expectancy
Men newly diagnosed with prostate cancer who are scheduled for prostatectomy (stage T1 or T2)
Newly diagnosed tumors: patients with newly diagnosed grade IV glioma who have had not been previously treated with cranial radiation therapy
Be diagnosed with an adnexal mass
Newly diagnosed breast cancer patients
Newly diagnosed primary brain tumor of any location and any histology (Cohort 1)
Patients must have histologically or cytologically proven advanced non-squamous NSCLC; patients may have newly diagnosed recurrent progressive or refractory disease which may be localized or wide spread
Patients with histologically confirmed malignancy (local or metastatic, newly diagnosed or recurrent disease)
Diagnosed with hypotonia
An adult patient with a newly diagnosed, untreated primary lung cancer diameter 7 mm or more; AND
Have one of the following disease histories: \r\n* Newly-diagnosed or recurrent (local, regional, metastatic) malignant melanoma or breast cancer patients in whom SLN mapping is indicated \r\n** Residual clinically or radiographically evident tumor, including primary cutaneous and mucosal melanomas \r\n** Prior radiation therapy, chemotherapy, or surgery in patients requiring flap reconstruction in the head and neck region\r\n** Newly-diagnosed patients with previous excisional biopsy OR \r\n** Newly-diagnosed gynecologic cancer patients in whom SLN mapping and surgical excision is indicated
Newly diagnosed, untreated mass in posterior fossa, either benign or malignant
Newly-diagnosed or recurrent (local, regional, metastatic) metastatic melanoma or malignant brain tumor patients with:\r\n* Residual clinically or radiographically evident tumor, including primary cutaneous and mucosal melanomas, or malignant brain tumor\r\n* Prior radiation therapy, chemotherapy, or surgery in patients requiring flap reconstruction in the head and neck region\r\n* Newly diagnosed patients with previous excisional biopsy
Newly diagnosed with esophageal cancer.
Patient is diagnosed with cancer
Be diagnosed with T1 or greater LABC, any N and M0.
Patients with newly diagnosed and untreated stage II and II breast cancer scheduled to undergo neoadjuvant chemotherapy
Patients who will be undergoing surgery for newly-diagnosed glioblastoma
Women must have newly diagnosed histologically or cytologically confirmed endometrial cancer
Have newly diagnosed infiltrating ductal carcinoma of the breast
All cancer types and both newly diagnosed and previously treated patients will be included
Newly diagnosed with clinically node-negative breast cancer or melanoma being staged with SLN biopsy
Hospitalized for newly diagnosed acute leukemia
Be diagnosed with a neurodegenerative disease
Providing surgical treatment for newly diagnosed breast cancer patients
PHASE II: Women newly diagnosed with breast cancer on the day they meet with their surgeon for their initial consultation after the visit
Newly diagnosed breast cancer
Patients newly diagnosed with cancer referred from MGH community health centers in Revere, Chelsea, and Charlestown, or surrounding communities referred to receive cancer treatment at the MGH Cancer Center
Newly diagnosed suspected or proven clinical stage I NSCLC (T1 or T2, N0, M0) with no prior treatment for this disease
Histologically confirmed newly diagnosed G4 MG
Patients must have suspected refractory or relapsed pre-B cell ALL or mixed phenotype acute leukemia (MPAL), or if newly diagnosed, the patient must be 60 years of age or older
Newly diagnosed, de novo or secondary, previously untreated AML
Participants must have progressive, advanced cancer as defined by one of the following:\r\n* Newly diagnosed, untreated advanced disease\r\n* Newly diagnosed, untreated metastatic recurrence of earlier stage disease (previous treatment of early stage disease allowed)\r\n* Clinical determination of progressive disease on previous systemic therapy as evidenced by plan to change treatment; any number of prior therapies are acceptable excluding previous EGFR kinase inhibitors
Patients with Stage I or IV breast cancer are not eligible.
Any patient with inflammatory breast cancer or stage IV or confirmed metastatic disease
Stage IV or metastatic breast cancer
Patients with confirmed stage IV disease
Has stage III or stage IV disease that is not surgically resectable.
Stage IV metastatic breast cancer
Diagnosed with Stage IV resectable disease
Patients must have histologically or cytologically confirmed breast cancer with stage IV or unresectable stage III disease
Histologically-proven diagnosis of advanced (American Joint Committee on Cancer [AJCC], 7th addition: stage III or IV) or aggressive (published disease-specific survival rates less than 20% at 5 years following best currently available therapies) solid organ cancer; this includes but is not limit to: \r\n* Metastatic melanoma\r\n* Esophageal and gastric adenocarcinoma (stage III/IV)\r\n* Cholangiocarcinoma (any stage)\r\n* Pancreatic adenocarcinoma (any stage)\r\n* Gallbladder cancer (any stage)\r\n* Colorectal cancer (stage IV)\r\n* High-grade mucinous appendix cancer (any stage)\r\n* High-grade gastrointestinal neuroendocrine cancer (any stage)\r\n* Mesothelioma (any stage)\r\n* High-grade soft tissue sarcoma (any stage)
Has evidence of recurrent or metastatic (stage IV) breast cancer
Stage IV disease (metastatic or surgically unresectable, cT4b, N+, or M+ cancer)
Patients must have stage II-IV disease
Clinical stage IV cancer
Stage 0 or Stage IV BC
T2 (> 3.0 cm), T3, stage III, or stage IV breast cancer
Colon cancer stages I-II and IV or rectal cancer stage I or IV
Patients with a history of stage IV or metastatic disease
Patients with a diagnosis of cytologically or histologically documented adenocarcinoma of the lung with either metastatic disease (stage IV), Stage IIIB or Stage IIIC disease not amenable to surgery with curative intent
Clinical stage IV invasive mammary carcinoma
Stage IV metastatic disease (only during the phase II)
Has stage IV or recurrent disease that has been treated
T-2 (> 3.0 cm), T-3, stage III, or stage IV breast cancer
Patients with stage III-IV HER2 negative breast cancer treated with primary or salvage therapy and now have:\r\n* No evidence of disease (NED), or \r\n* Stable bone only disease
Patients may have advanced unresectable stage IV disease, resectable stave IV disease or recently resected stage IV disease (<10 weeks prior) with no apparent disease.
Diagnosed with stage I-IV breast cancer
T2 (> 3.0 cm), T3, stage III, or stage IV breast cancer
Patients must have measurable or evaluable Stage IV breast cancer
All stages (I-IV) of disease
Stage IV disease
Patients who have received previous treatment for metastatic or stage IV disease
Stage IV (metastatic) disease.
Stage IV disease
Significant medical disease other than Stage IV breast cancer
Subjects must have either stage IV breast or ovarian cancer in remission or with stable disease on trastuzumab monotherapy
Stage IV breast cancer
Stage IV (metastatic) disease
Stage IV disease
HER-2 negative breast cancer that at the time of study entry is either stage III (locally advanced) disease not amenable to curative therapy or stage IV disease; histological confirmation of recurrent/metastatic disease is encouraged but not required if clinical evidence of stage IV disease is available
Histologically confirmed MBC, current stage IV.
Centrally confirmed Stage IV/M1 mTNBC
Breast cancer, which at the time of study entry is either stage III (locally advanced) disease not amenable to curative therapy or stage IV disease; histological confirmation of recurrent/metastatic disease is encouraged but not required if clinical evidence of stage IV disease is available
Stage IIIb/C or Stage IV before complete resection
Patients with initial diagnoses of stage IV disease
Stage IV disease diagnosed within 6 weeks of randomization
Patients must have pathologically documented breast cancer which is stage IV
Stage IV (metastatic) breast cancer
Stage IV HER2/Neu positive breast cancer patients who failed previous anti-HER2 targeted therapies
Stage IV or recurrent pancreatic cancer by imaging
Stage IV breast cancer, stage IV non-small cell lung cancer (NSCLC), stage IV sarcoma
Stage IV disease (measurable disease NOT required)
Participant has received more than one line of therapy for stage IIIB or IV disease
Stage IV HER2 (+) breast cancer
Metastatic disease (Stage IV) or bilateral breast cancer
Have metastatic disease (stage IV) confirmed surgically, by imaging or pathologically
Histologically confirmed metastatic breast cancer (MBC), current stage IV
Must not have received prior systemic chemotherapy for Stage IV CRC
Patients with stage IV HER2+ breast cancer treated to:\r\n* No evidence of disease (NED), or \r\n* Stable bone only disease after definitive therapy
Patients must have locally advanced unresectable stage IIIC or metastatic stage IV cancer with either progression to prior therapy or a newly diagnosed cancer that does not have an available treatment with curative intent
Stage IV (metastatic) breast cancer
Patients must have stage IV breast cancer
Pathologically confirmed diagnosis of Stage IIIB / IV adenocarcinoma of the lung.
Stage IV breast cancer.
Stage IV disease
Stage IV (M1), Stage IA, and lymph node negative breast cancer.
Patients with known brain metastases should be excluded as this would qualify as stage IV/metastatic disease
Patients with histologically documented metastatic melanoma with:\r\n* (Metastatic disease cohort) measurable disease, stage IIIB, IIIC (in transit lesions with or without nodal metastases) that includes lesions accessible for biopsies or IV M1B\r\n* (Adjuvant cohort) subjects who are no evidence of disease (NED) and stage III or IV; this includes patients with stage IV disease resected to NED; stage IIB or IIC patients will be enrolled after review and approval by the PI
Stage IIIB, IIIC, or IV erbB2 (HER2) positive breast cancer
Pathologic diagnosis of breast cancer and current stage IIIB, IIIC, or IV
Histological or pathologically confirmed stage IV adenocarcinoma of the colon.
Has locally advanced or metastatic disease (Stage IIIb or Stage IV) with radiographically or clinically evaluable lesions.
Metastatic disease (Stage IV) OR
Histologically confirmed diagnosis of stage IV, HER2 negative breast cancer
Stage IV disease at the start of first-line chemotherapy
Patients with stage IV disease with no more than five metastases in no more than two visceral organ sites will be eligible; if a multidisciplinary tumor board determines trial entry for an individual patient with stage IV exceeding this number of metastases is appropriate, that patient can be enrolled
Metastatic (Stage IV) breast cancer
Participants must have clinical diagnosis of lung or bladder cancer; if the diagnosis of non-small cell lung cancer (NSCLC) or bladder cancer is confirmed, platinum-based chemotherapy must be planned either for neoadjuvant chemotherapy for stage II or above bladder cancer, or palliative therapy for stage III or IV bladder cancer or stage IV lung cancer regardless of patient participation in this study; stage II or above transitional cell carcinoma (TCC) patients and stage IV NSCLC patients that will receive platinum-based chemotherapy will be eligible for this study; patients with stage III or IV bladder cancer or stage IV lung cancer must have measurable lesion(s)
The patient has histologically or cytologically confirmed breast cancer which at the time of study entry is either Stage III disease not amenable to curative therapy or Stage IV disease
The participant has Stage IV disease at the time of study entry.
Treatment with investigational parenteral anti-influenza drugs (IV peramivir, IV zanamivir or IV oseltamivir) in the 4 weeks prior to Baseline.
Stage IV disease at the time of study entry
Initial presentation: stage IV or metastatic disease, enrolled prior to any cytoreductive therapy
Stage IV cancer
Diagnosed with in situ or metastatic breast, prostate or colorectal cancer (i.e. stage 0 or IV)
A diagnosis of stage IV breast cancer
Stage IV breast cancer
Stage IV and/or metastatic solid tumor cancer diagnosis, or stage III pancreatic or lung cancer diagnosis
Metastatic breast cancer (stage IV)
Mallampati IV
Metastatic breast cancer (MBC) diagnosis – Stage IV
Metastatic (stage IV) BCa
Advanced stage (stage IV) or metastatic breast cancer diagnosis (screening for metastases with scans only needed if there is clinical suspicion for metastases)
Confirmed diagnosis of metastatic or stage IV BC
Patients with stage IV breast cancer
Patients with advanced or stage IIIC or IV breast cancer or other cancers
Patients with stage IV disease will be excluded from the study
Patients must have stage III or IV cancer diagnosis
Primary family caregivers of cancer patients who are diagnosed with stage II-IV disease
Metastatic disease (Stage IV C)
Women diagnosed with stage I-IV ovarian cancer
Caregivers of patients who have been diagnosed with stage IV gastrointestinal (GI) cancer
Stage IV or stage IIIB cancer
History of endometrial cancer stage I-IV > 6 months < 5 years, not currently receiving cancer treatment
Stage IV breast cancer
PATIENT: Be diagnosed with an incurable and advanced-stage solid malignancy (stage IIIB, IIIC, or IV)
SCREENING PHASE: Known metastatic (stage IV) breast cancer involvement
INTERVENTION PHASE: Known metastatic (stage IV) breast cancer involvement
Diagnosed with stage IV disease
Stage III/IV cancer
Have diagnosis of breast cancer stage IV
Has metastatic disease (M1) Stage IV C
Women diagnosed with stage IV ovarian cancer and who are hospice eligible
Diagnosis of stage III or stage IV cancer
Patients diagnosed with GOLD Stage IV Emphysema.
Metastatic disease (Stage IV C)
Currently stage IV (metastatic) breast cancer on the basis of definitive imaging or biopsy with\r\nstable disease (scans within the past 2 months)
AJCC Stage IV breast cancer
Stage IV or distant metastatic disease
The patient has diagnosis of stage IV disease or is found to have stage IV disease prior to randomization
Subject has metastatic disease (M1) Stage IV-C.
Stage II-IV epidermoid cancer of the head and neck OR stage III-IV pancreatic cancer, with prognosis of at least three months, per oncologist
Stage IV breast cancer
Participants with known metastatic (stage IV) prostate cancer
Stage I-IV disease\r\n* For patients with stage I-IIIC disease:\r\n** Scheduled for lumpectomy or mastectomy or considered a candidate for therapeutic systemic treatment\r\n** No prior or current therapy for breast cancer \r\n* For patients with stage IV disease: \r\n** Previously untreated for breast cancer with breast mass intact
Patients with a diagnosis of advanced stage disease (stage III or IV)
For stage IV disease:\r\n* Scheduled for surgical resection of oligometastatic disease\r\n* Previously untreated for breast cancer
Stage IV breast cancer
Diagnosed with stage IV breast cancer within the past 3 years
Newly diagnosed patients for the following conditions\r\n* Colon cancer stage III and IV\r\n* Rectal cancer stage II, III, IV\r\n* Glioblastoma multiforme (brain) -- no stage\r\n* Non-small cell lung cancer stage IIIA, IIIB, IV\r\n* Small cell lung cancer, limited stage and extensive stage\r\n* Castration-resistant prostate cancer\r\n* Head and neck cancer stage III and IV\r\n* Gastric cancer stage III and IV\r\n* Esophageal cancer stage III and IV\r\n* Pancreatic cancer stage II, III, IV\r\n* Renal cell carcinoma, stage IV\r\n* Breast cancer, stage IV, if triple negative ER/PR/H2N negative or on systemic chemotherapy\r\n* Sarcoma, stage IV\r\n* Bladder carcinoma, stage IV\r\n* Acute myeloid leukemia\r\n* Melanoma, stage III and IV\r\n* Ovarian cancer, stage III and IV\r\n* High grade myelodysplastic syndrome (MDS)
Patients with in situ cancers (Stage 0) and those with metastatic disease (Stage IV);
Stage IV cancer or evidence of metastatic disease at any time point
Known Stage IV ovarian cancer with Brain Metastases
Must have a life expectancy of at least 10 years based on age and comorbidities but excluding diagnosis of breast cancer.
Histologically or cytologically proven diagnosis of breast cancer with evidence of metastasis.
Histological diagnosis of breast cancer
Pathologically proven diagnosis of breast cancer
Current diagnosis of bilateral breast cancer
History of radiotherapy for current breast cancer diagnosis
Diagnosis of breast malignancy
Stage at diagnosis T2 through T4a-c, N0 through N2, and M0; patients with inflammatory breast cancer or metastatic disease at diagnosis will be excluded; patients with multicentric, multifocal, and/or bilateral disease are allowed to participate so long as all tumors meet the histologic criteria of the study
Subjects with confirmed diagnosis of recurrent or metastatic breast cancer based on histopathology examination
Patients should have a life expectancy of at least 10 years, excluding their diagnosis of breast cancer; (comorbid conditions should be taken into consideration, but not the diagnosis of breast cancer)
diagnosis of HR+, HER2+ breast cancer (BC)
Confirmed diagnosis of HR+/HER2- breast cancer
Have a diagnosis of HR+, HER2- breast cancer.
Have a diagnosis of HR+, HER2- breast cancer
Pathologically confirmed diagnosis of breast cancer with documented progressive disease
Current diagnosis of bilateral breast cancer
Current diagnosis of any other active or clinically significant non-breast cancer
Pathologically confirmed diagnosis of breast cancer (central confirmation is not required)
Have a diagnosis of breast cancer and be chemotherapy naive; NOTE: prior methotrexate for non-cancerous conditions is allowed
Post-menopausal patients at breast cancer (BC) diagnosis, as determined locally
Diagnosis of other active malignancy; prior treated malignancies in addition to breast cancer are acceptable
PATIENT: Confirmed medical diagnosis of breast or thoracic cancer regardless of stage and followed at DCC for management
New breast cancer diagnosis
Stage IV breast cancer diagnosis (metastases remote from the breast)
Recent diagnosis of breast cancer with pending surgery as primary treatment for breast cancer
Confirmed first diagnosis of stage IV breast cancer or a recurrent diagnosis of metastatic breast cancer (MBC) (i.e., spread to distant organs), any time since diagnosis
Patient must be an Asian American who has had a breast cancer diagnosis in the past 5 years
Primary diagnosis of breast cancer (initial or recurrence) within the last two years
Have a diagnosis of stage I-III female breast cancer or colorectal cancer within the past 5 years; bilateral or multiple primary breast cancers are permitted; individuals who have had more than one type of cancer (e.g., both breast and melanoma) are permitted as long as the breast (or colorectal) diagnosis meets the other criteria and primary treatment for any cancer is not ongoing
YOUNG BREAST CANCER SURVIVORS (YBCS): Breast cancer (Stages 0-III) diagnosis
YBCS: Breast cancer diagnosis age ? 45 years
Patients who have a diagnosis of breast cancer
Patients with a recurrent breast cancer diagnosis
A diagnosis of local regional breast cancer (stage 0-IIIa)
Had a previous diagnosis of breast cancer (any type or stage) as confirmed by official medical records
Have a diagnosis of prostate, breast, lung, lymphoma, or gynecological cancer
Have a previous diagnosis of breast cancer
New diagnosis of breast cancer stage 1-2
Histologically confirmed stage I, II or III breast cancer (if the patient has had more than one breast cancer diagnosis, then the most recent diagnosis)
Primary diagnosis of breast cancer within the last three years
PHASE I: Has a first, primary diagnosis of unilateral stage 0, 1, 2, or 3a breast cancer (patients with bilateral breast cancer will be excluded from participation)
Diagnosis of stage IV breast cancer or recurrent metastatic breast cancer
Diagnosis of metastatic breast cancer
Diagnosis of recurrent breast cancer
Diagnosis of breast cancer with adjuvant chemotherapy treatment
Stage 1A – 2B breast cancer diagnosis
Diagnosis of breast cancer
Diagnosis of HER2-positive breast cancer
History of a diagnosis of breast cancer
Breast cancer diagnosis within past 5 years
Have a confirmed diagnosis of breast cancer; participants can have had more than one primary cancer diagnosis in the past
Have a diagnosis of breast cancer, any stage.
Women initially diagnosed with breast cancer by histological tissue diagnosis in 2003 or later
Prior breast cancer or DCIS diagnosis
Patients with known diagnosis of breast cancer
Have a prior diagnosis of T1 or T2 breast cancer diagnosed within the last 10 years
History of prior breast cancer treated within the past two years; patients completing all breast cancer-specific treatment over two years prior to the current diagnosis are eligible
COHORT B: No prior diagnosis of breast cancer but at high risk for development of breast cancer and participating in HSC 4601
Diagnosis of breast cancer
Pathologically confirmed diagnosis of HER2 positive breast cancer of any stage (previous treatment is allowed without limits on lines of prior therapy)
Previous history or current diagnosis of breast cancer
Patients with a previous diagnosis of invasive breast cancer who are less than 3 years from diagnosis
Life expectancy of at least 5 years, excluding diagnosis of breast cancer (comorbid conditions should be taken into consideration, but breast cancer diagnosis is not a consideration)
Diagnosis of stage I-IIIA breast cancer within past 5 years (confirmed by medical record review)
New diagnosis of breast cancer
The patient must have a histologically proven diagnosis of stage I through IIIC breast cancer
Pathologic diagnosis of invasive breast cancer or high suspicion of breast cancer based on imaging
with a suspicious lesion found in the breast and recommended for biopsy or have a confirmed diagnosis of cancer;
Women who have undergone open surgical (excisional) biopsy for breast cancer diagnosis
Patients must have a current diagnosis of sarcoma, lymphoma, or HER2(-) breast cancer
Patients with a prior breast cancer diagnosis
Pregnant at the time of diagnosis of their breast cancer.
Diagnosis of primary breast cancer.
Patients must have histologically or cytologically confirmed stage IV or unresectable stage III BRAF V600E or BRAF V600K mutant melanoma
Patients must have unresectable stage III or stage IV disease
Patients must have pathologically confirmed melanoma that is either stage IV or unresectable stage III; patients may have primaries of cutaneous, mucosal or unknown origin; patients with uveal (ocular) primary are not eligible
Patients with unresectable or metastatic stage III B/C or IV melanoma. Patients enrolled under this version of the protocol must also have progressed on prior anti-PD-1 therapy, according to RECIST 1.1 criteria. Patients who progressed within 3 months of treatment start are excluded.
Subjects must have histologically confirmed metastatic melanoma with measurable (by RECIST v1.1), stage III (lymph node or in transit lesions) or stage IVA, IVB, or IVC disease that is accessible for injection.
Stage IV melanoma for which surgery is not recommended.
Histologically-confirmed diagnosis of advanced (unresectable Stage III) or metastatic (Stage IV) melanoma excluding mucosal, or ocular melanoma (or a histologically or cytologically-documented locally-advanced or metastatic solid malignancy in Parts 4 and 5)
Participants must have histologically or cytologically confirmed stage IV melanoma or recurrent stage IIIc melanoma following primary treatment of surgery and prior treatment or consideration of adjuvant therapy
Participants must have a clinical indication for resection of metastatic melanoma; patients will be informed about other treatment options for stage IV melanoma including Braf inhibitors and antibodies to CTLA-4
Participants must have histologically or cytologically confirmed stage IV uveal melanoma
Has a histologically confirmed diagnosis of unresectable stage III or metastatic melanoma not amenable to local therapy
Have histologically- or cytologically-confirmed unresectable stage III or stage IV melanoma not amenable to local therapy
Histologically confirmed Stage IV (metastatic) or unresectable Stage IIIc (locally advanced) melanoma
Histologically confirmed unresectable stage III or stage IV melanoma (American Joint Committee on Cancer [AJCC] 7th edition classification); cutaneous melanoma and mucosal melanoma will be eligible
American Joint Committee on Cancer (AJCC) (2009) stage IV cutaneous melanoma or stage III cutaneous or acral melanoma that is judged inoperable; patients with a history of uveal or mucosal melanoma are not eligible
Histologic or cytologic diagnosis of cutaneous melanoma that is considered unresectable (stage III) or metastatic (stage IV); ocular and mucosal melanoma is excluded
Unresectable Stage III or Stage IV melanoma.
All patients must be either stage IIIb/c or stage IV melanoma according to the American Joint Committee on Cancer (AJCC) (7th edition) and have histologically confirmed melanoma that is felt to be surgically unresectable in order to be eligible\r\n* All melanomas, except ocular/uveal melanoma, regardless of primary site of disease will be allowed; mucosal melanomas are eligible\r\n* Patients must not have received prior anticancer treatment for metastatic disease (for example, but not limited to, systemic, local, radiation, radiopharmaceutical)\r\n* Exceptions: Surgery for melanoma and/or post-resection brain radiotherapy (RT) if central nervous system (CNS) metastases and/or prior treatment with adjuvant IFN\r\n* All patients must have their disease status documented by a complete physical examination and imaging studies within 4 weeks prior to the first dose of study drug; imaging studies must include computerized tomography (CT) scan of neck, chest, abdomen, pelvis, and all known sites of resected disease in the setting of stage IIIb/c or stage IV disease, and brain magnetic resonance imaging ([MRI], brain CT allowable if MRI is contraindicated)\r\n* The complete set of baseline radiographic images must be available before treatment initiation
Participants must have histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the AJCC staging system
Patients with histologically confirmed unresectable stage III or stage IV metastatic melanoma, who have not been previously treated with a SEMA4D antibody and have had prior anti-PD1/PDL1 inhibitors with documented progression; patient may have or not have prior anti-CTLA4 treatments
Participants must be newly diagnosed, treatment-naive with histologically confirmed stage IIIC unresectable melanoma or stage IV melanoma
Have a histologically or cytologically confirmed diagnosis of unresectable stage III or IV melanoma; patient may not have a diagnosis of uveal or mucosal melanoma
Histologically or cytologically confirmed diagnosis of unresectable stage III or metastatic melanoma (stage IV) not amenable to curative local therapy
Have unresectable (stage III) or advanced (stage IV) melanoma
Have unresectable stage III or stage IV melanoma
Histologically or cytologically confirmed malignant melanoma at Screeningthat is unresectable/unresected Stage IIIB, IIIC, IIID or IV. Patients with unresectable mucosal melanoma may be enrolled after consultation with the Medical Monitor.
Patients must have received and failed or refused available therapy for unresectable/unresected Stage III or IV melanoma.
Diagnosis of unresectable stage III or metastatic melanoma (stage IV) not amenable to local therapy
Histologic or cytologic confirmation of unresectable stage III or metastatic melanoma (stage IV) not amenable to local therapy
Failure to confirm histologically or cytologically unresectable stage III or metastatic melanoma (stage IV) not amenable to local therapy
Subjects who are ipilimumab naive with progressive unresectable stage III or stage IV melanoma; eligible patients may have had prior adjuvant therapy, but not including ipilimumab, and been treated with up to 3 prior treatments for metastatic melanoma (eg, chemotherapy, other biologic or targeted therapy or IL-2)
Histologic or cytologic confirmation of stage III or stage IV melanoma
Patients who have unresectable stage III through stage IV metastatic melanoma that have not received prior PD-1 directed therapy (Arm A) or that have progressed despite prior PD-1 directed therapy (Arm B)
CAPMATINIB INCLUSION CRITERIA: Unresectable stage III or stage IV melanoma by clinical or radiographic criteria
CERITINIB INCLUSION CRITERIA: Unresectable stage III or stage IV melanoma by clinical or radiographic criteria
REGORAFENIB INCLUSION CRITERIA: Unresectable stage III or stage IV melanoma by clinical or radiographic criteria
ENTRECTINIB INCLUSION CRITERIA: Unresectable stage III or stage IV melanoma by clinical or radiographic criteria
Subjects with metastatic or unresectable stage IIIb/c of IV melanoma for whom treatment with pembrolizumab is indicated and who have at least one cutaneous, subcutaneous tumor or palpable lymph node amenable to intratumoral injection.
AJCC stage III or IV completely resectable melanoma identified before surgery
Patients with metastatic, surgically unresectable melanoma or newly diagnosed melanoma patients of any stage unable to receive or complete standard therapy
The subject must have clinical stage III or resectable stage IV MEL; subject’s may not have a diagnosis of uveal or mucosal melanoma
Patient must have a histologically or cytologically confirmed diagnosis of unresectable stage III or IV melanoma; patient may not have a diagnosis of uveal melanoma
Histological/cytological diagnosis of melanoma. AJCC stage IV (any T, any N, M1), metastatic, progressive, refractory, melanoma.
Patients with stage IB or II cutaneous melanoma
A history of AJCC stage IIIB/C or stage IV melanoma but no current clinical evidence of metastatic disease
Participants must have histologically confirmed unresectable stage III or stage IV melanoma
Treatment of unresectable stage III or stage IV melanoma with a tyrosine kinase inhibitor within prior 4 months; sorafenib for purposes of eligibility will not be considered acceptable prior therapy
More than 3 prior systemic therapies for unresectable stage III or stage IV melanoma
Histologically confirmed locally advanced unresectable (stage III) or stage IV pancreatic ductal adenocarcinoma (PDAC)
Patients must have unresectable stage III or stage IV melanoma; patients must have histological or cytological confirmation of melanoma that is metastatic or unresectable and clearly progressive
Diagnosis of stage IV melanoma
Melanoma cohort only: histologic proof of surgically unresectable stage IV malignant melanoma
Pathologically confirmed, clinically evident (by physical examination or radiographic imaging) stage IIIB, IIIC, and IV M1a and b cutaneous melanoma (anatomic stages T1-4b N1a and T1-4b N2a not included); the current diagnosis may be the patient’s first diagnosis of melanoma or recurrent melanoma after previous diagnosis of an earlier stage melanoma
Histologic or cytologic diagnosis of cutaneous melanoma, mucosal melanoma, or melanoma of unknown primary that is considered unresectable (stage III) or metastatic (stage IV)
Patients must have primary cutaneous melanoma that belong to one of the following American Joint Commission on Cancer (AJCC) stages (2009 AJCC Melanoma Staging System):\r\n* Stage IIIB\r\n** T1-4b N1a M0\r\n** T1-4b N2a M0\r\n** T1-4b N1b M0\r\n** T1-4b N2b M0\r\n** T1-4b N2c M0\r\n* Stage IIIC\r\n** T1-4b N1b M0\r\n** T1-4b N2b M0\r\n** T1-4b N2c M0\r\n** Any T N3 M0\r\n* Stage IV \r\n** M1a\r\n** M1b\r\n** NOTE: patients with stage IV melanoma must have normal lactate dehydrogenase (LDH) and either distant skin, subcutaneous, lymph node, or lung metastases, but no other visceral metastases in order to be eligible; for patients with resected stage IV melanoma, LDH within the institutional upper limit of normal (ULN) must be documented within 4 weeks prior to randomization
Unresectable stage III or IV validated by clinical criteria (including recurrent melanoma), or patients with multiple skin/soft tissue metastases of melanoma that may be resectable but are judged to have a future recurrence risk exceeding 70% (e.g., large adenopathy, distant skin metastases or multiple in-transit melanoma metastases); tumor deemed amenable to biopsy (excisional, incisional, or core, with at least 100 mm^3 tumor volume per biopsy date) and fine-needle aspiration (FNA) biopsy\r\n* NOTE: optimally, patients will have tumor approachable for three serial biopsies during the trial; for patients with only one or two tumors approachable for biopsy, available tumor blocks from prior biopsies can serve as the pretreatment sample, but only if formalin-fixed tumor tissue is available and adequate to provide at least 20 unstained slides with sufficient tumor for analysis\r\n* NOTE: patients with unresectable advanced stage III or IV melanoma (including recurrent melanoma) are only eligible if they have failed at least one other first-line systemic therapy (other than adjuvant therapy); exceptions to this requirement are those patients who have refused and/or are ineligible for other systemic therapies\r\n* NOTE: v-raf murine sarcoma viral oncogene homolog B inhibitor (BRAFi) should be considered for all ‘unresectable” or metastatic melanoma with BRAFV600E mutation; for low burden in-transit disease patients may enter trial without prior systemic therapy\r\n** Stage IV no evidence of disease (NED) is excluded by this criterion
Patients must have unresectable stage III or stage IV melanoma, either initial presentation or recurrent, that is of cutaneous origin or unknown primary origin and that is histologically diagnosed
Patients must have unresectable metastatic stage IV melanoma or stage III intransit or regional nodal disease, and in the opinion of the institutional Principal Investigator (PI) is an acceptable candidate for ACT with high dose IL-2 (aldesleukin)
Patients must have unresectable metastatic stage IV melanoma or stage III in-transit or regional nodal disease and in the opinion of the principal investigator (PI) or treating co-investigator is an acceptable candidate for ACT
Histologic diagnosis of unresectable stage III or IV melanoma\r\n* All melanomas regardless of primary site of disease will be allowed
Completely surgically resected stage IIIb/c/d or stage IV melanoma within 12 weeks of participation in study.
Patients must have advanced (stage III-IV) or recurrent histologically confirmed USPC
Have unresectable Stage III or Stage IV melanoma, as per AJCC staging system not amenable to local therapy
Have advanced, unresectable (Stage III) or metastatic (Stage IV) melanoma;
Histologically-confirmed (1) NSCLC, (2) bladder cancer, (3) castrate-resistant prostate cancer which are metastatic, or (4) stage 3C or stage 4 melanoma.
Untreated or previously received one treatment regimen for measurable unresectable stage III or stage IV melanoma (American Joint Committee on Cancer [AJCC] 2010) (for BRAF wild-type, and regardless of human leukocyte antigen [HLA] type); untreated or previously received up to two treatment regimens for measurable unresectable stage III or stage IV melanoma (AJCC 2010) (for BRAF mutant, and regardless of HLA type; If 2 prior regimens, one should be a BRAF inhibitor); this does not include any therapies given in the adjuvant setting
Unresectable Stage III or Stage IV melanoma (AJCC 2010)
Subjects who are ipilimumab naïve with progressive unresectable stage III or stage IV melanoma who are either treatment naïve or may have been treated with up to 3 prior treatments for melanoma (e.g. chemotherapy, biologic or targeted therapy or interleukin [IL]-2)
Histologic or cytologic confirmation of stage III or stage IV melanoma
Stage IV melanoma or stage III melanoma that is unlikely to be cured by surgery
Participants with BRAFV600 mutation-positive, cutaneous melanoma (either pathologic Stage IIC or Stage III according to AJCC Staging Criteria version 7 that has been completely resected
Histologically confirmed Stage IIb, IIc, III melanoma
Histologically confirmed melanoma that is considered surgically incurable with either: \r\n* Stage IIIc melanoma including locally relapsed, satellite, in-transit lesions or bulky draining node metastasis\r\n* Stage IV melanoma (M1a, M1b, or M1c)
Histologic diagnosis of unresectable III or stage IV metastatic melanoma
The patient must have a pathologically confirmed (by histology or cytology) diagnosis of melanoma, which is currently Stage 3 (unresectable) or Stage 4 disease.
Patients must have histologically confirmed metastatic melanoma with measurable, stage III (lymph node or in transit lesions) or stage IVA, IVB, or IVC disease.
Naive or any number of prior systemic therapeutic regimens for unresectable stage III or stage IV melanoma, except prior BRAF or MEK inhibitor agents; this includes chemotherapy, immunotherapy, biochemotherapy, or investigational treatments; patients may also have received therapies in the adjuvant setting
Patients must have histologically or cytologically confirmed stage IIIB/C or stage IV oligometastatic melanoma; oligometastatic melanoma is defined as three or fewer areas of resectable disease excluding central nervous system and bone involvement; patients with cutaneous, mucosal, acral, ocular or unknown primary melanomas are eligible for enrollment; for patients with stage IV disease with distant lymph nodes (stage M1a), a maximum of three separate lymph node sites fit the definition of oligometastatic disease; 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
Subject with stage IIIB to IVM1c melanoma for whom surgery is not recommended
Completely resected Stage III melanoma
Patients must have Stage IIIB, IIIC or IV melanoma, which is unresectable/unresected or histologically confirmed diagnosis of metastatic malignant melanoma.
Histologic or cytologic proof of surgically unresectable stage IV malignant melanoma - including that of uveal and mucosal origin\r\n* Note: biopsy can be of locoregional disease in setting of clinically evident stage IV disease; a biopsy of the primary tumor alone does not fulfill this requirement
Diagnosis of locally advanced, unresectable or metastatic cutaneous melanoma or unknown primary melanoma (AJCC Stage IIIB, IIIC, or IV)
Patients must have histologically confirmed melanoma with BRAF^V600 mutation; patients must have stage IIIC or stage IV disease
Histologically confirmed stage III (unresectable) or stage IV melanoma
Patients with histologically documented diagnosis of advanced stage IV or unresectable stage III mucosal or cutaneous melanoma are eligible
Diagnosis of locally advanced, unresectable or metastatic cutaneous or melanoma of unknown primary AJCC Stage IIIC or IV (uveal and mucosal melanoma are excluded)
Unresectable stage III/IV melanoma
Histologically confirmed Stage III (unresectable)/Stage IV melanoma
Patients with a history of stage III melanoma (any primary melanoma with locoregional nodal/subcutaneous disease) treated with surgical resection who subsequently have disease recurrence meeting the criteria for stage IIIC disease
Completely resected histologically confirmed high-risk [Stage IIIa (LN metastasis more than 1 mm), IIIb or IIIc cutaneous melanoma determined to be V600E/K mutation positive by a central laboratory. Patients presenting with initial resectable lymph node recurrence after a diagnosis of Stage I or II melanoma are eligible.
Stage IIIc or Stage IV BRAF V600E/K cutaneous melanoma
Histologically confirmed stage IV melanoma including brain metastasis
Patients must have histologically or cytologically confirmed melanoma stage III/IV, unresectable
Histologic/cytologic proof of stage IV malignant melanoma not amenable to surgery
For Melanoma Subjects: Have histologically or cytologically confirmed diagnosis of unresectable Stage III or metastatic (Stage IV) melanoma not amenable to local therapy, and irrespective of PD-L1 status
Complete and adequate resection of Stage III melanoma with histologically confirmed melanoma metastatic to lymph node
Unresectable stage lll or IV, histologically confirmed diagnosis of one of the following solid tumors:
Patient must have histologically or cytologically confirmed diagnosis of stage III melanoma inoperable/not amenable to local treatment or stage IV melanoma.
Unresectable Stage III or IV disease
Histologically confirmed surgically incurable and unresectable Stage IIIC or Stage IV (AJCC) melanoma
Patients with histologically documented diagnosis of advanced stage IV or unresectable stage III melanoma are eligible
Patients must have a histologically confirmed diagnosis (by either primary surgical specimen or biopsy for recurrence) of advanced stage (stage III or IV) or recurrent endometrioid endometrial cancer
Patients with histologically proven melanoma with metastasis that is unresectable Stage III or Stage IV. This will include bulky stage III and M1-3. Patients with melanoma with documented metastases to the brain are eligible.
Previously treated or untreated, unresectable Stage III or Stage IV malignant melanoma
Histologically or cytologically documented advanced NSCLC who have Stage IIIB/Stage IV disease, or recurrent disease following radiation therapy or surgical resection or advanced, unresectable (Stage III) or metastatic (Stage IV) melanoma;
Histologically confirmed cutaneous melanoma that is either Stage IIIc (unresectable) or Stage IV (metastatic) and determined to be BRAF V600E or V600K mutation-positive (cohort A) or mutation-negative (cohorts B and C)
Patients must have histologically confirmed recurrent stage III or stage IV melanoma (AJCC 7th edition classification); cutaneous melanoma, ocular or mucosal melanoma will be eligible
Histologically confirmed stage IV or unresectable stage III melanoma with documented BRAF V600 mutation
Histologically confirmed cutaneous melanoma that is either Stage IIIc (unresectable) or Stage IV (metastatic), and determined to be BRAF V600E or V600K mutation-positive by the local laboratory. Subjects with ocular or mucosal melanoma are not eligible
Recurrent, satellite or in-transit locally advanced cutaneous or subcutaneous melanoma metastases (i.e., AJCC Stage IIIB, IIIC or Stage IV M1a with no active nodal metastases)
Unresectable Stage III or Stage IV melanoma
Histologic diagnosis of melanoma with in transit metastasis stage IIIB, IIIC, or IV
Unresectable stage III or stage IV M1a/M1b/M1c melanoma including patients with uveal melanoma
Histologic diagnosis of unresectable stage IIIC or stage IV melanoma that is BRAF V600 mutation positive
Patients must have pathologically confirmed stage IV or unresectable stage III melanoma; patients must not have disease that is suitable for local therapy, administered with curative intent
Phase I: Diagnosis of primary pathologic stage 0–III cutaneous malignant melanoma
Phase II: Diagnosis of primary pathologic stage 0–III cutaneous malignant melanoma
Have been diagnosed within one month with a pathologically confirmed advanced cancer who have an average of < 2 year (y) life expectancy (primary stage IV hepatobiliary, esophageal, colorectal, glioblastoma, gastric, pancreatic, melanoma, head and neck, or stage III or IV lung or pancreatic cancers) and are being treated at one of the participating hospital sites and speak English or Spanish
Participants must have histologically confirmed malignancy that is metastatic or currently unresectable; eligible malignancies include:\r\n* Adenocarcinoma of the pancreas (locally advanced or metastatic)\r\n* Colorectal (stage IV)\r\n* Non-small cell lung cancer (currently unresectable stage III or stage IV)
Patients must have histologically or cytologically confirmed diagnosis of unresectable, stage III or metastatic melanoma
Melanoma tumor that meets indications for a groin SLN biopsy with a >= 10% risk of having metastasis to the draining lymph node (i.e. stage IB to stage IIIC melanoma of the lower body below the umbilicus)
Subjects must be diagnosed with histologically proven stage IV (metastatic) melanoma or stage III with bulky disease which may or may not be amenable for surgery and are receiving therapy at present
Subjects with unresectable Stage III or IV melanoma who are either refractory or intolerant to, or have refused standard therapy for treatment of metastatic melanoma
Patients with pheochromocytoma
Patients with pheochromocytoma
Patients with pheochromocytoma
FOR ALL PHASES (Ib AND II): Concurrent diagnosis of pheochromocytoma
Concurrent diagnosis of pheochromocytoma
REGORAFENIB EXCLUSION CRITERIA: Patients with pheochromocytoma
Untreated or metastatic pheochromocytoma
Metastatic pheochromocytoma
Patients with pheochromocytoma
Concurrent diagnosis of pheochromocytoma
Patients with pheochromocytoma
Patients with pheochromocytoma
History of or current pheochromocytoma
Patients with pheochromocytoma
Patients with pheochromocytoma
Pheochromocytoma
Subjects with pheochromocytoma.
Patients with pheochromocytoma
Have pheochromocytoma.
Biochemically and/or radiologically confirmed pheochromocytoma, hyperaldosteronoma, or adrenocortical carcinoma
Pheochromocytoma
Patients with pheochromocytoma
Endocrine disorders (such as primary aldosteronism, pheochromocytoma, hyper- or hypothyroidism) not controlled with medication
Pre- and postmenopausal women or men with Stage II (Stage IIA limited to max. 1000 patients) or Stage III early invasive breast cancer
Metastatic breast cancer that is measurable (Stage 1) or early breast cancer with a primary tumor size greater than (>) 2 centimeter (cm) (Stage 2)
Unresected operable breast cancer stage II-III with primary tumor > 2.0 cm
Patients must be diagnosed with metastatic cytologically or histologically confirmed adenocarcinoma of the breast with HER2 over-expression or with newly diagnosed locally advanced (including inflammatory) breast cancer (LABC) with stage II-III disease; patients with metastatic (stage IV) disease (MBC) must have measurable lesions
Patients with stage II-III breast cancer are eligible if they are deemed appropriate for neoadjuvant endocrine therapy by the referring or treating medical oncologist. Patients with stage I disease are eligible if they are deemed borderline candidates for breast conservation and the treating surgeon recommends preoperative therapy to increase the chances of breast conservation.
Clinical stage I or II breast cancer for which there will be at least a 2 week period of time between diagnosis and definitive surgery
Clinical stage I-III breast cancer with any invasive residual disease in the breast or axillary nodes following neoadjuvant chemotherapy including HER-2 directed treatment
Early stage (curable) breast cancer
Patients must have a histologically confirmed HER2 positive breast cancer (by immunohistochemistry [IHC] 3+ or fluorescence in situ hybridization [FISH] ratio >= 2.0)\r\n* Phase I: unresectable locally advanced or metastatic breast cancer\r\n* Phase II: clinical stage 2-3 early stage breast cancer
Clinical evidence for a stage T3 or T4 breast cancer
Pathologic or clinical evidence for a stage T4 breast cancer
Newly diagnosed clinical stage II or III ER+/HER2+ breast cancer with complete surgical excision of the breast cancer after neoadjuvant therapy as the treatment goal
a diagnosis of stage I, II, or III breast cancer;
Diagnosed with stage III colon or stage II/III rectal cancer that will receive neoadjuvant or adjuvant chemotherapy but have not yet started
The patient must have clinical node negative, stage I breast cancer
COHORT II: The patient must have clinical node negative, stage I breast cancer
Newly diagnosed clinical stage II or III breast cancer with complete surgical excision of the breast cancer after neoadjuvant chemotherapy as the treatment goal
The patient must have stage 0, I, or II breast cancer; if stage II, the tumor size must be 3 cm or less
New diagnosis of histologically confirmed early-stage breast cancer (ESBC), defined as operable Stage I to Stage IIIA breast cancer.
Patients with prior history of stage I-III breast cancer currently without evidence of metastatic disease are eligible if can tolerate further chemotherapy, patients with newly diagnosed synchronous bilateral breast cancers are also eligible if at least one tumor is triple negative (response will be assessed in both breasts if invasive cancer is present in both)
definitively treated, stage I/II ER+ breast cancer
New diagnosis of histologically confirmed early-stage breast cancer (ESBC), defined as operable Stage I to Stage IIIA breast cancer.
Subjects with HER-2 expressing stage I – III breast cancer with residual disease in the breast or axillary nodes post-neoadjuvant chemotherapy
History of histologically-confirmed stage 0, I, II, or III breast carcinoma without evidence of disease at trial entry; participants with a resected local recurrence are eligible; site study physicians will review histology from documented pathology reports (which will be recorded in the Inclusion Criteria Case Report Form [CRF]); a separate consent will be obtained for release of medical records to document history of breast cancer diagnosis, staging, and treatment (which will be captured on the Medical History CRF); participants who have a documented history in their medical record of stage 0, I, II, or III breast carcinoma without evidence of disease at trial entry are eligible
Stage III or IV cancer, other than breast cancer, in =< 5 years prior to registration
Subjects with advanced stage breast cancer
Stage II through IIIC HER-2/erbB-2 positive breast cancer with node positive disease.
Histologically confirmed, AJCC stage II or III breast cancer
Histologically confirmed invasive breast carcinoma, with all of the following characteristics: (i) Primary tumor greater than or equal to (>/=) 2 centimeters (cm) in largest diameter (cT1-3) by MRI; (ii) Stage I to operable Stage III breast cancer; (iii) Documented absence of distant metastases (M0)
Relapsed or refractory disease (Stage III or IV): NSCLC or pancreatic cancer must have failed at least 1 prior treatment. Breast cancer must have failed at least 2 prior treatments.
Early stage breast cancer (stage I [tumor size >= 1 cm], II and IIIA)
Past history of treated (newly diagnosed or recurrent) breast, colorectal, prostate, gynecologic (only uterine and cervical) cancers (stage I, II, or III) or any stage lymphoma (Hodgkin’s or non-Hodgkin’s)
Diagnosed with clinical or pathologic stage I?III invasive breast cancer with TX?T3 tumor
Planning to undergo adjuvant or neoadjuvant chemotherapy for stage I-III breast cancer
PHASE I: Diagnosis of stage I to III breast cancer
PHASE II: Diagnosis of stage I to III breast cancer
Histologically confirmed stage I, II or III breast cancer (if the patient has had more than one breast cancer, then the most recent diagnosis)
Survivors with a primary diagnosis of stage I-III breast, ovarian, uterine, or endometrial cancer
Women diagnosed with early stage, resectable breast cancer (Stage 0, I, II, or III) prior to age 45, and are within 5 years of diagnosis
Newly diagnosed and surgically treated females with stage I-III breast cancer
Histologically confirmed diagnosis of early stage breast cancer (stage I-III)
1-3 years post-completion of chemotherapy or/and radiation therapy for stage I-III breast cancer
Women newly diagnosed (stage I-III) breast cancer
Newly diagnosed with stage I-III breast cancer
Diagnosed with stage I, II, or III (a/b) breast cancer
Diagnosed with stage I-III lung cancer
Stage II-III breast cancer
Be diagnosed with breast cancer at stage 0, I, II, III or IV
Women newly diagnosed with stage I to III breast cancer who will be receiving adjuvant or neoadjuvant doxorubicin-based chemotherapy
Diagnosis of stage I to III breast cancer
Diagnosed with any stage breast, GI, or lung cancer
Patients with stage I-III breast cancer
Diagnosed with stage 0, I, II, or IIIa breast cancer, confirmed by medical record
Participants must self-identify as having a medical history of histologically confirmed stage 0, I, II, III breast cancer, or I with no evidence of metastatic disease
Have a history of stage I, II, or III breast cancer
Patients must have evidence of histologically confirmed invasive breast cancer, stage I, II or III, and be at least 2 years post diagnosis
Diagnosed with stage 0-III hormone-receptor positive breast cancer (BCa)
Histologically or cytologically confirmed, stage I-III breast cancer
Diagnosed with early stage (I-III) breast cancer, without evidence of metastatic disease
Prior diagnosis of stage 0 to stage III breast cancer
Have a diagnosis of breast cancer (BC) (stage I-III)
Have breast cancer stage 0-IIIA
Women with stage II or III breast cancer that will be scheduled to undergo a 4 to 6-week course of radiotherapy
Has been diagnosed with early-stage breast cancer
Breast cancer stage I-III
Histologic or cytologic proven breast cancer or colon cancer (stage I, II or III)
Women previously diagnosed with stage 0-IIIA breast cancer
Histologically confirmed stage I, II or III breast cancer (if the patient has had more than one breast cancer, then the most recent diagnosis)
Patients with early-stage breast cancer (stage I-III)
Have been diagnosed with stage 0-III breast cancer; bilateral or multiple primary breast cancers are permitted
In early survivorship phase, defined as being 1-12 months post completion of treatment for stage 0-3 breast cancer
PHASE II: Has a first, primary diagnosis of unilateral stage 0, 1, 2, or 3a breast cancer
Diagnosed with stage 0-III breast cancer within the past 3 years
A diagnosis of breast cancer, stage I, II, or III
Women with stage 1-3 breast cancer who are within first two rounds of chemotherapy OR women who have stage 4 breast cancer at initial diagnosis and are initiating first line chemotherapy; note: women with stage 4 breast cancer must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Stage I-III gynecologic cancer (any site) or breast cancer
Women with stage 0-III breast cancer who will be undergoing daily adjuvant radiation for 4-6 weeks (patients only)
History of histologically or cytologically proven stage I-III breast cancer receiving intravenous chemotherapy on an every 14 days or every 21 days schedule
History of stage 0-III breast cancer
Diagnosed with stage I-II endometrial cancer
Has diagnosis of non-recurrent stage I-III breast cancer
Women with a history of cancer, any stage, with breast or gynecologic cancer
Are diagnosed with primary breast cancer (BC) (stages I-III)
SCREENING PHASE: Histologically proven stage I-III carcinoma of the breast
INTERVENTION PHASE: Histologically proven stage I-III carcinoma of the breast
Stage 0-IIIA breast cancer survivors and their partner
History of stage 0-III breast cancer or stage I-III ovarian cancer; all antitumor therapies, excluding hormonal therapy, have been completed at least 60 days prior to enrollment
Subjects with newly diagnosed stage I (T > 1 cm), II or III TNBC who have not undergone definitive breast surgery and have not received systemic chemotherapy will be eligible
Stage I and II breast cancer patients undergoing active radiation therapy
Diagnosis of stage 0 to III breast cancer
Newly diagnosed breast cancer (stage I, II, III)
Newly diagnosed with stage I-III breast cancer
Stage 0-III invasive carcinoma of the breast
Diagnosis of stage I, II, or III ovarian cancer
Patients with stage 0-III breast cancer, status-post surgery treated with standard chemotherapy/chemoprevention and/or radiation
History of stage I-III breast, gastrointestinal or gynecologic cancer
Diagnosed with stage I-III cancer other than cancers of the brain or spinal cord (confirmed by patient self-report on the Health History Questionnaire; if patient is unable to confirm either the site of her cancer or that her stage of cancer is < stage IV, we will send a letter to her physician to confirm this criterion)
2) Patients must have a diagnosis of breast cancer for which they must not have received or been scheduled for primary breast surgery at time of project intervention, and must be eligible for surgical resection (i.e. Stage I-III).
Stage I-III female breast cancer (including inflammatory and newly diagnosed, or locally recurrent but not metastatic breast cancer being treated with curative intent)
AJCC stage I - III non-inflammatory, HER2-positive (according to ASCO-CAP guidelines 5) breast cancer
Eligibility criteria will include: Postmenopausal women with of first incidence of early stage (stages 0 - III) hormone receptor positive breast cancer stabilized on anastrozole therapy for at least 3 months
Stage I-III breast cancer (including inflammatory and newly diagnosed recurrent breast cancer) or lymphoma stage I-IV; (patients should have a > 2 year life expectancy)
The patient can undergo biopsy or surgery of a primary tumor site for suspected or proven invasive breast cancer of clinical stage I to III
History of stage I-III breast cancer
Breast cancer (any stage)
Participants who are breast cancer free (mammogram “negative” within 1 month of testing) with the absence of clinical suspicion of breast cancer on physical exam or with stage II or stage III breast cancer will be invited to participate in the study
Patients without known bone metastases who are newly diagnosed with ? stage 3 breast cancer, ? stage 3 lung cancer, or ? stage 2 prostate cancer (and/or PSA >10 micrograms/L), including patient with recurrent breast, lung or prostate cancer
Women with stage I-III breast cancer who began their cancer treatment 1-2 years prior to this study and have received anthracycline based chemotherapy
A new diagnosis of invasive breast cancer > 1.0 cm in size, ER+ clinical stage I-III
The patient is diagnosed with non-invasive breast cancer, benign breast disease, or other than stage II or stage III invasive breast cancer
Stage 4 breast cancer
First diagnosis with stage 1-2 breast or stage 1-2 lung cancer; and voluntary participation
AND diagnosed with Stage I-III incident breast or colorectal cancers;
Stage II, III or IV disease as defined by the Ann Arbor Staging System
Clinical stage II (T3-4, N-) or stage III (any T, N+) based on magnetic resonance imaging (MRI)
RMS types included under embryonal rhabdomyosarcoma (ERMS) include those classified in the 1995 International Classification of Rhabdomyosarcoma (ICR) as ERMS (classic, spindle cell, and botryoid variants), which are reclassified in the 2013 World Health Organization (WHO) classification as ERMS (classic, dense and botryoid variants) and spindle cell/sclerosing RMS (encompassing the historical spindle cell ERMS variant and the newly recognized sclerosing RMS variant); classification of alveolar rhabdomyosarcoma (ARMS) in the 2013 WHO classification is the same as in the ICR and includes classic and solid variants\r\n* ERMS\r\n** Stage 1, group III (non-orbit)\r\n** Stage 3, group I/II\r\n** Stage 2/3, group III\r\n** Stage 4, group IV, < 10 years old\r\n* ARMS:\r\n** Stages 1-3, groups I-III
Patients must have stage II, III, or IV disease
Stage III-IV SCCHN and select stage II participants (T2N0 oral cavity cancer with > 5 mm depth invasion)
Ann Arbor stage II-IV disease (Stage I primary mediastinal B-cell lymphoma will also be eligible)
Histologically confirmed CD30-positive, CD20-positive untreated primary mediastinal B-cell lymphoma (any Ann Arbor stage), diffuse large B-cell lymphoma (Ann Arbor stage III or IV), or grey zone lymphoma (any Ann Arbor stage); patients with heterogeneous, weak or equivocal CD30 staining will also be included (no specific cut off percentage for CD30 stain is required)
Stages II, III, or IV (Ann Arbor Staging)
CLL (Part 1): Rai Stage III or IV disease, or stage 0-II disease that meets National Cancer Institute Working Group (NCIWG) criteria for active disease requiring therapy that may include either of the following disease-related symptoms:
Stage I, II, III, or IV disease; NOTE: stage I disease are eligible only if the disease is not amenable to external beam radiation therapy
Prior endoscopic mucosal resection (EMR) with a diagnosis of stage II or III esophageal cancer is eligible, irrespective of margin status
Ann Arbor stage II-IV
Eligible tumors must meet one of the following criteria: Stage II or III, or T4, any N, M0, including clinical or pathologic inflammatory cancer or Regional Stage IV, where supraclavicular lymph nodes are the only sites metastasis
Inoperable per local Investigator (Masaoka stage III or IV)
Female subjects with CA125-associated, advanced ovarian cancer (FIGO Stage III/IV) previously treated and now presenting with recurrent or persistent disease.
Cohort 1: Phase II: patient must have HER2+ (regardless of hormonal receptor status) stage III IBC
AJCC stage III/IV differentiated thyroid cancer
Patients with histologically-confirmed Low Tumor Burden Follicular Lymphoma, without B symptoms, Ann Arbor stage II to IVA NHL (CD20+ FL of Grades 1, 2, or 3a)
Radiographically confirmed endometrial adenocarcinoma of stages III-IV requiring adjuvant therapy; if stage III disease is suspected, there should be multiple pelvic and/and or lymph nodes involved
Have TNM clinical stage III, IVA, or IVB disease
All patients with Surgical Stage III or IVA endometrial carcinoma per FIGO 2009 staging criteria, including clear cell and serous papillary and undifferentiated carcinomas.
Ann Arbor stage I - stage IV DLBCL at the time of relapsed/refractory disease to be eligible
Disease must be stage III or IV
Prior endoscopic mucosal resection (EMR) with a diagnosis of stage II-III esophageal cancer is eligible
Ann Arbor stage I or II disease
Ann Arbor Stage II, III or IV
Stage I-III (according to ENSAT classification 2008; see Appendix 2)
Visceral aGVHD defined as: at least stage III/IV acute liver or stage II/III gastrointestinal (GI) GVHD by clinical criteria and/or GI and/or liver biopsy confirmation showing no alternative explanation for symptoms of GVHD
Patients must have Durie-Salmon stage II or III disease
Clinical stage III or IV
Patients with metastatic disease (only stage III or IVA-B patients permitted)
At least one adverse prognostic factor: \r\n* Initial relapse =< 12 months after primary chemotherapy\r\n* Staged as Ann Arbor classification initial stage III or IV disease\r\n* Chemotherapy resistant disease\r\n* Failure to achieve a complete response (CR) with cytoreductive chemotherapy or persistent positive fludeoxyglucose F 18 (18FDG)-positron emission tomography (PET) imaging
All Stage IV patients are eligible, irrespective of residual disease, after primary or interval debulking. Stage III patients are required to have visible residual disease after primary surgery. Patients with inoperable Stage III and IV disease are eligible
Patients must have non-bulky stage I or II disease by Ann Arbor classification\r\n* This staging excludes fludeoxyglucose F 18 (FDG)-PET evaluation\r\n* Patients who have stage I or II non-bulky disease based on diagnostic CT scan, but are upstaged to stage III or IV based on FDG-PET evaluation, are also eligible\r\n* Stage and bulk are assigned using measurements obtained prior to biopsy
ISS Stage III; or
ISS stage III; or
Stages II bulky disease (defined as mass size of more than 10 cm), stage III, or IV (Ann Arbor staging); patients with stage I and stage II non-bulky disease are excluded from this study
Clinical Masaoka stage II (> 5 cm), III, or IVA, including suspected invasion of mediastinum, pericardium, lung, great vessels or chest wall, and/or pleural metastases
Ann Arbor stage II to IV.
Patients with selected Stage III or IV disease (T2 N2-3 M0, T3-4 any N M0, T1 N2b, N2c or N3p16 negative oropharynx cancer or T1-2 any N hypopharynx cancer) including no distant metastases.
Stage II, III, or IV disease
Patients must have histologically confirmed advanced (FIGO Stage III or IV), persistent, or recurrent endometrial carcinoma, which is not likely to be curable by surgery or radiotherapy. Histologic documentation of the recurrence is not required.
Previously untreated stage III/IV advanced or metastatic MEL (Part 1C only)
Residual Cancer Burden (RBC) classification II or III6
Stage III A or B disease with minimum diagnostic evaluation within 6 weeks to include:
Ann Arbor stage 3 or 4 or stage 2 with bulky disease
Female patients must have high risk resected stage I or 2 disease (papillary serous, clear cell, carcinosarcoma histology or grade 3), advanced stage (III or IV, all histologies) or recurrent endometrial cancer (all histologies); patients do not need measurable disease and can enroll following surgery
Stage II, III, or IV disease
Stage III/IV disease by Ann Arbor Staging
Subjects must have histologically-confirmed diagnosis of IDH1 gene-mutated cholangiocarcinoma Stage II, III, or IV (intra-hepatic, extra-hepatic and perihilar) that is not eligible for curative resection, transplantation, or ablative therapies. Tumors of mixed histology are not allowed.
Residual Cancer Burden (RBC) classification II or III6
FIGO stage IA1, IB2, II, III or IV disease
Stage III/IV disease (stage II is also eligible if disease is not encompassible within a single radiation field)
Ann Arbor stage IIB, IIIB, IVA, or IVB
Stage II (not candidates for local x-ray therapy), III, or IV disease by the Ann Arbor Classification
Stage IB, II-A, II-B, III and IV
Histologically or cytologically proven B-cell malignancies; either Burkitt leukemia or B-AL (= Burkitt leukemia = L3-AL), or diffuse large B-cell NHL, or aggressive mature B-cell NHL non otherwise specified or specifiable (phase III)\r\n* Stage III with elevated LDH level (B-high) (LDH > twice the institutional upper limit of the adult normal values [> Nx2]), any stage IV, or B-AL (phase III)
Extent of disease: stage I - IV; patients with nodular histology mantle cell lymphoma must have Ann Arbor stage III or IV disease to be eligible\r\n* Patients with mantle zone type histology will not be eligible\r\n* Patients with other mantle cell histologies are eligible regardless of stage
Stages II-IV of the above cancer
Intra-abdominal desmoid disease, stage III or IV
Stage II, III, and IV disease by Ann Arbor classification
Stage III or IV disease, or Stage II bulky disease (defined as tumor diameter greater than or equal to [>/=] 7 centimeters [cm])
Ann Arbor Stage I disease
Histologically confirmed diagnosis of follicular lymphoma CD20+ (Grade 1, 2 or 3a) Ann Arbor Stage II, III or IV disease.
Patients with Rai stage III-IV - OR - Patients with Rai stage 0-II
FIGO stage II-IV;
Stage II, III or IV cardiac failure
Disease may be stage I, II, III or IVA (as long as it is deemed resectable by the surgical team)
Diagnosed with radiologically and biopsy or cytology confirmed inoperable perihilar cholangiocarcinoma Bismuth Tumor Stage III/IV
Patient must have measurable stage IV disease (includes M1a, M1b stages or recurrent disease) (according to the 7th edition of the TNM classification system); however, patients with T4NX disease (stage III B) with nodule(s) in ipsilateral lung lobe are not eligible, because such patients were not included in historical controls
Stage III or IV disease at any time in the past (Ann Arbor Staging System for Non-Hodgkin’s Lymphomas)
Ann Arbor Stage II, III, or IV
Stage II, III or IV disease
Stage II disease with bulky disease (? 7cm lesion), Stage III, or Stage IV disease
Histologically or cytologically confirmed squamous cell carcinoma, previously untreated stage II, III, or IVA HNC; patients with clinical stage III or IVA disease must undergo computed tomography (CT) or magnetic resonance imaging (MRI) to rule out the presence of distant metastases
Advanced (FIGO stage III or IV), recurrent or metastatic disease.
Part III:
Stage II, III or IV (Ann Arbor Staging)
Patients must have suspected International Federation of Gynecology and Obstetrics (FIGO) stage III or IV disease
Ann Arbor stage I disease.
Inoperable or metastatic extra cranial stage III or IV disease
Stage I-III
Ann Arbor stage III or IV disease at diagnosis or at relapse/refractory disease confirmation
Ann Arbor stage III or IV disease (Cohort A only)
Localized endometrial cancer (stage I and II); no evidence of stage III or IV disease
Mallampati I-III
Diagnosis of adenocarcinoma colorectal cancer (stage I, II, III, IV)
Stage I-III
Staging to rule out metastatic disease is recommended for subjects with clinical stage III disease
Histologic or cytologic confirmation of head & neck cancer (stage I-IV) or non-small cell lung cancer (stage II & III)
Stage I, II, and III prostate cancer
Stage II, III, or IV NSCLC for whom radiation therapy of 60 Gy and concurrent weekly paclitaxel/carboplatin is recommended
Participants undergoing definitive surgery at diagnosis must have pathologic stage II or III disease
Participants undergoing preoperative systemic therapy must have clinical stage II or III disease at presentation (clinical stage I disease is excluded)
Prior systemic therapy, radiotherapy, or investigational agent in participants undergoing surgery for stage I, II, or III colon cancer
Patients undergoing unilateral SLNDs either levels I-III, I-IV, II-III, or II-IV for oral cavity, oropharynx (if the resection does not connect to the neck), thyroid, salivary gland, parotid, and skin carcinoma
A treatment plan involving levels I-III, I-IV, II-III, or II-IV, as recommended by National Comprehensive Cancer Network (NCCN) guidelines
stage II-III, planned to be treated with radical surgery
Patients must have Barcelona Clinic Liver Cancer (BCLC) stage: intermediate (B) or advanced (C) within 28 days prior to study entry
Patients must have a diagnosis of neuroblastoma or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites; the following disease groups are eligible:\r\n* Patients with International Neuroblastoma Risk Group (INRG) stage M disease are eligible if found to have either of the following features: \r\n** MYCN amplification (> 4-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features; OR \r\n** Age > 547 days regardless of biologic features\r\n* Patients with INRG stage MS disease with MYCN amplification\r\n* Patients with INRG stage L2 disease with MYCN amplification \r\n* Patients > 547 days of age initially diagnosed with INRG stage L1, L2 or MS disease who progressed to Stage M without prior chemotherapy may enroll within 4 weeks of progression to Stage M\r\n* Patients >= 365 days of age initially diagnosed with MYCN amplified INRG stage L1 disease who progress to Stage M without systemic therapy may enroll within 4 weeks of progression to stage M
Histologic documentation of women or men with node positive, HER2 negative, anatomic stage II or III breast carcinoma and high risk node negative (defined as estrogen receptor [ER] and progesterone receptor [PR] negative and tumor size > 2 cm) within one year of diagnosis and free of recurrence; patients with pN1mic are eligible; if neoadjuvant therapy was received, either initial clinical stage (determined by physical and or radiologic examination) or post-operative pathologic stage can be used for eligibility purposes, with the higher stage determining eligibility; histologic documentation of node positivity is required; bilateral breast cancers are allowed, as long as both cancers are HER2 negative and at least one of the cancers meets eligibility
Patients must have histologically or cytologically confirmed extensive stage small cell lung cancer and must be a candidate for systemic therapy; NOTE: The extensive disease SCLC classification for this protocol includes all patients with disease sites not defined as limited stage; limited stage disease category includes patients with disease restricted to one hemithorax with regional lymph node metastases, including hilar, ipsilateral and contralateral mediastinal, and/or ipsilateral supraclavicular nodes; extensive disease patients are defined as those patients with extrathoracic metastatic disease, malignant pleural effusion, bilateral or contralateral supraclavicular adenopathy
Patients who have received prior chemoradiation for limited-stage SCLC must have been treated with curative intent at least 6 months since last treatment from diagnosis of extensive-stage SCLC
Low risk stratum (stage I ovarian immature teratoma and stage I malignant GCT [all sites]): Patients must be < 50 years of age at enrollment
Low risk stage I immature teratoma (IT); site: ovarian; stage: Children's Oncology Group (COG) stage I, Federation of Gynecology and Obstetrics (FIGO) stage IA and IB; grade: 2 or 3; histology: pure immature teratoma, mixed immature and mature teratoma, (no pathological evidence of mediastinal germ cell tumor [MGCT]); tumor markers: alpha-FP =< 1,000 ng/mL, beta-HCG institutional normal; age (years) < 50
Low risk stage I MCGT; site: ovarian, testicular, or extragonadal; stage: COG stage I, FIGO stage IA and IB, American Joint Committee on Cancer (AJCC) testicular stage IA and IB; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed); age (years) < 50
Standard risk 1 (SR1); site: ovarian, testicular, or extragonadal; stage: COG stage II-IV, FIGO stage IC, FIGO stage II-IV; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed); age (years) < 11
Standard risk 2 (SR2)\r\n* Site: ovarian; stage: COG stage II and III, FIGO stage IC, II and III; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed); age (years) >= 11 and < 25\r\n* Site: testicular; stage: COG stage II-IV, AJCC stage II, III, International Germ Cell Consensus Classification (IGCCC) good risk; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed); tumor markers: for IGCCC good risk: alpha-FP < 1,000 ng/mL, beta-HCG < 5,000 IU/mL and lactate dehydrogenase (LDH) < 1.5 x normal; age (years) >= 11 and < 25\r\n* Site: extragonadal; stage: COG stage II; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed) age (years) >= 11 and < 25
Patients with any diagnoses not listed including:\r\n* Stage I testicular cancer patients who have undergone primary RPLND (retroperitoneal lymph node dissection)\r\n* Pure dysgerminoma and pure seminoma\r\n* Pure mature teratoma\r\n* Pure immature teratoma COG stage I with alpha-fetoprotein (AFP) >= 1000 ng/mL\r\n* Pure immature teratoma COG stage II - IV or FIGO stage IC to IV\r\n* Poor risk disease (age >= 11 years old and COG stage IV ovarian, COG stage III or IV EG, or IGCCC intermediate or poor risk testicular), or\r\n* Primary central nervous system (CNS) germ cell tumor
Stage T2a/b (> 5 cm) and grade 2 or 3 AND
Patients must be:\r\n* < 12 months (< 365 days) of age at diagnosis with INRG stage L1; or\r\n* < 18 months (< 547 days) of age at diagnosis with INRG stage L2 or stage Ms neuroblastoma/ganglioneuroblastoma
Clinical stage >= T2NxM0 or TanyN+ disease for which radical or partial nephrectomy is planned
Patients with newly diagnosed, pathologically confirmed cHL meeting one of the following Ann Arbor stages are eligible:\r\n* Stage IIB with bulk\r\n* Stage IIIB\r\n* Stage IVA\r\n* Stage IVB\r\n** If study eligibility by staging is uncertain, consultation with Imaging and Radiation Oncology Core (IROC) Rhode Island (RI) may be obtained prior to study enrollment
Patients with stage I disease are not eligible
Patients with apparent stage I disease who have not undergone a staging procedure
Subjects who are 12-18 months of age with INSS Stage 4 and all stage 3 subjects with favorable biologic features (ie, nonamplified MYCN, favorable pathology, and DNA index > 1) are not eligible.
Clinical Diagnosis of CTCL stage IA, IB, or IIA with biopsy within last 3 months
CTCL that is stage IIB or great or stage IIA with stage N2 with >5% circulating Sezary cells or CD8+ or large cell transformation or Progressive CTCL
Stage B (not applicable for transarterial chemoembolization [TACE]), or stage C based on Barcelona Clinic Liver Cancer (BCLC) staging system
Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C
Has stage III or stage IV disease that is not surgically resectable. Stage IIB (T3N0M0B0-1) cutaneous T cell lymphoma (CTCL) participants are eligible.
Has stage III or stage IV disease that is not surgically resectable. Stage IIB (T3N0M0B0-1) CTCL participants are eligible.
Must meet criteria for high risk disease\r\n* Patients ? 365 days initially diagnosed with INSS stage 1 or 2 who progressed to a stage 4 without interval chemotherapy
Biopsy-proven, previously untreated stage III or IV squamous cell carcinoma of the larynx, Primary tumor stage (T2, T3) and nodal stage (N0, N1, N2, N3).
Any T stage with ? N2 disease;
T4 disease, any N stage;
T3 Oral Cavity, any N stage; or
Stage 1, 2, 3 or early and intermediate stage IVa (T1N0-2B, T2N0-2B) (level 2, non-matted) disease without evidence of distant metastases or extracapsular extension; primary site must be lateralized for a functional dissection
Clinical stage TIC or T2a
Histologically confirmed early stage urothelial carcinoma of the bladder defined as Ta, T1, or Tis stage; tumor staging must be confirmed by TURBT performed within 42 days prior to registration
Locoregional disease with clinical stage of T1N1 or T2-3N0-2
Histologically confirmed endometrial carcinoma: endometrioid type, serous, and clear cell to include tumors originating in the cervix, but are primarily located in the uterus, and for whom vaginal cuff brachytherapy is indicated, with principal investigator (PI) confirmation; carcinosarcoma and other sarcomas are permitted; Federation of Gynecology and Obstetrics (FIGO) 2009 stage I and stage II, with one of the following combinations of stage and grade:\r\n* Stage IA, grade 2, 3\r\n* Stage IB, grades 1-3\r\n* Stage II, grades 1-3
Clinical or pathologic stage T2 –T4 disease including T4a and 4b if feasible to treat with radiation therapy
Cervical carcinoma Stage 1B or less
Patients with advanced stage non-mycosis fungoides (MF) CTCL are eligible including, but not limited to, advanced stage lymphomatoid papulosis (LyP) or primary cutaneous anaplastic large cell lymphoma (pcALCL)
Subjects must have a clinical diagnosis of CTCL (mycosis fungoides), Stage IA, Stage IB, or Stage IIA.
Has FIGO Stage IVB
Stage I-IIIA (stage I tumors must be >= 4 cm)
Patients with stage I-IVA are eligible
Stage 4 cancer
Eligibility for stage 2 of the study, if the extension stage is opened, will be determined by ribonucleic acid sequencing (RNAseq) analysis and master regulator profile of a single fresh needle biopsy specimen obtained during study screening
High-risk NB as defined as any of the following: \r\n* Stage 4 with MYCN amplification (any age)\r\n* Stage 4 without MYCN amplification (> 1.5 years of age)\r\n* Stage 3 with MYCN amplification (unresectable; any age)\r\n* Stage 4S with MYCN amplification (any age)
Stage IA, IB, IIA, IIB, or IIIA (according to AJCC 7th edition). Patients with stage IIIA must not have more than one mediastinal lymph node station involved by tumor
Unresectable stage II, IIIA, or IIIB disease
There is no requirement nor restriction for prior therapy or stage
Stage I or selected stage IIa according to the 7th version of the International Association for the Study of Lung Cancer (IASLC) system: stage I (T1 or T2a [tumor size =< 5 cm] N0M0) stage IIa (T2 [tumor size > 5 cm but =< 7 cm] N0M0)
Histologically confirmed clinical or pathological stage 2 through stage 3c primary adenocarcinoma of the breast
Stage I and II glottic carcinoma
Patients must have high-risk NB (MYCN-amplified stage 2/3/4/4S of any age and MYCN-nonamplified stage 4 in patients greater than 18 months of age)
Histologically confirmed mycosis fungoides (MF) or Sezary syndrome (SS); Phase 1: >= stage IIB OR >= stage IB-IIA folliculotropic/transformed MF; Phase 2: >= stage IB\r\n* Stage of disease according to TNMB classification\r\n* Pathology report must be diagnostic or be consistent with MF/SS criteria\r\n* SS is defined as meeting T4 plus B2 criteria; where the biopsy of erythrodermic skin may only reveal suggestive but not diagnostic histopathological features, the diagnosis may be based on either node biopsy or fulfillment of B2 criteria\r\n* For MF where the histological diagnosis by light microscopic examination is not confirmed, diagnostic criteria that has been recommended by the International Society of Cutaneous Lymphomas (ISCL) should be used
Stage at least T2 or greater
Pathologically confirmed unicentric invasive breast cancer defined as radiologic clinical stage T1 or T2 (=< 5 cm), N0 or N1 (=< 4 abnormal axillary nodes on initial ultrasound), clinical stage M0
Have Barcelona Clinic Liver Cancer (BCLC) stage C disease or BCLC stage B disease not amenable to locoregional therapy or refractory to locoregional therapy, and not amenable to a curative treatment approach
Must have clinically node negative stage I (T1N0) or stage II (T2N0) breast cancer\r\n* Preoperative ultrasound of the axilla with biopsy of suspicious nodes is recommended as clinically indicated per the discretion of the treating physician
Clinical stage IB (>= 3 cm per computed tomography [CT]), stage IIA/IIB, or stage IIIA (N0-2) amenable to surgical resection
Patients with T stage T1-3
Patients with N stage N0-N2c
Measurable, unresectable stage III (in transit lesions) or stage IVA, IVB or IVC disease
Has clinical stage T2-T4a N0/X M0 urothelial carcinoma; clinical T stage is based on the pre-study standard of care transurethral resection of the bladder tumor (TURBT) sample and imaging studies
High-risk NB as defined by risk-related treatment guidelines' and the International NB Staging System, i.e., stage 4 with (any age) or without (> 365 days of age) MYCN amplification, MYCN-amplified stage 3 (unresectable; any age), or MYCN-amplified stage 4S
Patients with MF/SS must have stage IB, IIA, IIB, III or IV disease; patients with primary cutaneous CD30-positive lymphoproliferative disorder must have multifocal symptomatic or extensive lesions requiring systemic treatment
Patients with TNM Stage IVC disease
Biopsy-confirmed CD4+ mycosis fungoides or Sézary syndrome, stage IB to IIIB
Baseline clinical stage of T1N0 or inoperable T4 (unequivocal organ involvement) are to be excluded
Patients must be classified post-operatively as Stage IB, II or IIIA on the basis of pathologic criteria.
Surgical Stage IVA includes patients with bladder or bowel mucosal involvement, but no spread outside the pelvis.
Patients with FIGO 2009 Stage IVB endometrial cancer.
Insufficient breast imaging to judge clinical stage
Insufficient breast imaging to judge clinical stage
Clinical stage N0, M0
Histologic diagnosis of either limited stage SCLC (LS-SCLC), or extensive stage SCLC (ES-SCLC) or neuroendocrine tumor
Stage - NSCLC with primary resection option for potential cure, as assessed by a faculty surgeon at SKCCC or MSKCC; this may include clinical stage IB (>= 4 cm), II and IIIA; subjects with N3 nodal involvement are not included
Histological/cytologically documented primary International Federation of Gynecology and Obstetrics (FIGO) stage 3C1, 3C2, stage 4A, and 4B uterine serous carcinoma; in addition, certain stage 3A and B disease are also allowed\r\n* Residual disease after primary surgery:\r\n** Eligible:\r\n*** Stage 3A and B (pelvic, but confined to adnexa or vagina), residual disease present\r\n*** Stage 3CI (pelvic node positive)\r\n*** Stage 3CII (para-aortic node positive)\r\n*** Stage 4A (bladder or pelvic bowel)\r\n*** Stage 4B (distant metastases [mets] including abdominal mets), completely resected\r\n** Not eligible\r\n*** Stage 3A and B (pelvic, but confined to adnexa or vagina), completely resected\r\n*** Stage 4B (distant mets including abdominal mets), residual disease present
Pathologically confirmed stage pT1-T3, pN0, M0 disease
Patients must have histologically confirmed adenocarcinoma of the breast associated with the following clinical stage: IIA, IIB, IIIA, IIIB, or IIIC; patients with stage IV disease are also eligible if there is an intention to perform breast surgery after neoadjuvant therapy is completed, or in patients participating in clinical trials where surgery after neoadjuvant therapy may be an option (eg. E2108)
Newly diagnosed, advanced stage, high-risk neuroblastoma defined as one of the following:\r\n* Children < 1 year with International Neuroblastoma Staging System (INSS) stage 2a, 2b, 3, 4 or 4S disease and MYCN amplification (> 10 copies, or greater than four-fold increase in MYCN signal as compared to reference signal)\r\n* INSS 2a or 2b disease and MYCN amplification, regardless of age or additional biologic features\r\n* INSS stage 3 and:\r\n** MYCN amplification (> 10 copies, or greater than four-fold increase in MYCN signal as compared to reference signal, regardless of age or additional biologic features)\r\n** Age > 18 months (> 547 days) with unfavorable pathology, regardless of MYCN status\r\n* INSS stage 4 and:\r\n** MYCN amplification, regardless of age or additional biologic features\r\n** Age > 18 months (> 547 days) regardless of biologic features\r\n** Age 12 – 18 months (365 – 547 days) with any of the following three unfavorable biologic features (MYCN amplification, unfavorable pathology and/or deoxyribonucleic acid [DNA] index = 1) or any biologic feature that is indeterminate/unknown\r\n* Children >= 365 days initially diagnosed with: INSS stage 1, 2, 4S who have progressed to a stage 4 without interval chemotherapy
FIGO 2008 stage 1B2, 2B, 3B, 4A
FIGO stage 3A disease
Advanced stage HCC (Barcelona Clinic Liver Cancer [BCLC] Stage C or B per American Association for the Study of Liver Disease [AASLD] guidelines)
Cervical carcinoma stage 1B or less
Stage IIIA or Potentially resectable superior sulcus tumors
Histologically-documented high-risk endometrioid adenocarcinoma with no visible residual disease, defined by the following criteria:\r\n* Surgical stage I disease with < 50 myometrial invasion and grade 3 tumor (IAG3) with lymphovascular space involvement;\r\n* Surgical stage I disease with >= 50% myometrial invasion and grade 2 or 3 tumor (IBG2, IBG3);\r\n* Any surgical stage II disease (II);\r\n* Any surgical stage III disease (IIIA, IIIB, IIIC); and\r\n* Any surgical stage IV disease with no residual macroscopic tumor
High-risk NB as defined by risk-related treatment guidelines and the International NB Staging System, i.e., stage 4 with (any age) or without (> 18 months old) myelocytomatosis viral related oncogene (MYCN) amplification, MYCN-amplified stage 3 (unresectable; any age), MYCN-amplified stage 4S, or disease resistant to standard chemotherapy
Patients with any stage of disease will be eligible
Stage IIIb
Mayo stage II or IIIa
Inclusion Criteria:\n\n        Each participant must meet all the following inclusion criteria to be enrolled in the\n        study:\n\n          1. Histologically confirmed CD30+ classical HL.\n\n          2. Advanced stage, newly diagnosed HL (Stage III and Stage IV disease).\n\n          3. Treatment-naive HL.\n\n          4. Have performance scores of greater than or equal to (>=) 50 for Lansky\n             Play-performance or Karnofsky Performance Status.\n\n        Exclusion Criteria:\n\n          1. Nodular lymphocyte predominant HL.\n\n          2. Known active cerebral/meningeal disease, including signs or symptoms of progressive\n             multifocal leukoencephalopathy (PML) or any history of PML.\n\n          3. Any sensory or motor peripheral neuropathy.\n\n          4. Symptomatic neurologic disease compromising normal activities of daily living or\n             requiring medications.
Scheduled to undergo immediate, post-mastectomy, tissue assisted breast reconstruction, Reconstruction shall be either one-stage (direct-to-implant) or two-stage, unilateral or bilateral, prophylactic or therapeutic
Barcelona Clinic Liver Cancer (BCLC) stage B or C that cannot benefit from treatments of established efficacy such as resection, local ablation, chemoembolization.
Patient with disease (stage) eligible per cohort
Rai stage 0 - II without active disease according to IWCLL 2008 criteria
Histologically confirmed cutaneous T-cell non-Hodgkin lymphoma (CTCL) per World Health Organization (WHO) classification 2016 including, mycosis fungoides (MF) or Sezary syndrome (SS); phase 1 : >= stage IIB OR >= stage IB-IIA folliculotropic/transformed MF; expansion cohort: >= stage IB\r\n* MF/SS stage of disease according to TNMB classification\r\n* SS is defined as meeting T4 plus B2 criteria; where the biopsy of erythrodermic skin may only reveal suggestive but not diagnostic histopathologic features, the diagnosis may be based on either node biopsy or fulfillment of B2 criteria\r\n* For MF where the histological diagnosis by light microscopic examination is not confirmed, diagnostic criteria that been recommended by the International Society for Cutaneous Lymphomas (ISCL) should be used
Patients must be appropriate candidates for at least 2 cycles of ABVD or AVD (this could include patients ranging from favorable risk early stage disease to poor prognosis advanced stage disease)
Tis-T3 Urothelial cancer; patients will be stratified according to clinical stage
Pathological stage I-IVa HNSCC
Cervical carcinoma of Stage 1B or less.
FOR PATIENTS IN STAGE 1 (PATIENTS #1-#17)
STAGE I
Pathologic diagnosis of stage IB2-IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix or stage II-IVA squamous or adenocarcinoma of the vulva that is not amenable to curative surgical resection alone
All subjects must have one of the following stages: stage IA (T1NO); IB (T2NO), II & IIIA (N2 negative); IIIA (N2+), IIIB (N3+)
Patients with newly diagnosed, histologically confirmed Hodgkin lymphoma (HD) who meet the following criteria:\r\n* Stage IA and IB (excluding non-bulky nodular lymphocyte predominant)\r\n* Stage IIA and IIB\r\n* Stage IIIA\r\n* Stage IVA
United Network for Organ Sharing (UNOS) stage T1, T2, or T3 disease
Breast cancer patients with stage 0, stage I, stage IIA
Stage 2 endometrial and ovarian cancer patients must have at least one lesion amenable to biopsy; this determination will be made by a member of the interventional radiology team or surgical associate investigator and an associate investigator; this requirement is not necessary for patients in stage 1
Must have prior biopsy at any time point diagnostic for confirmed MF stage IIA-IVA, and must have failed at least one standard therapy (topical or systemic); this is mandatory
Stage III or stage IVA or IVB disease prior to induction chemotherapy with no proven hematogenous metastatic disease
Clinical stage Tx, T1-T4, N1-3, M0
PHASE II: Patients must have extensive stage, histologically or cytologically confirmed small cell lung cancer; NOTE: the extensive disease classification for this protocol includes all patients with disease sites not defined as limited stage; limited stage disease category includes patients with disease restricted to one hemithorax with regional lymph node metastases, including hilar, ipsilateral and contralateral mediastinal, and/or ipsilateral supraclavicular nodes; extensive disease patients are defined as those patients with extrathoracic metastatic disease, malignant pleural effusion, bilateral or contralateral supraclavicular adenopathy
Clinical stage Tis or T1mi N0 M0
Has Barcelona Clinic Liver Cancer (BCLC) Stage C disease, or BCLC Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy, and not amenable to a curative treatment approach.
Subjects with FIGO Stage Ic, Stage II, Stage III, Stage IV, recurrent, or persistent (unresectable) histologically confirmed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube carcinoma.
Barcelona Clinic Liver Cancer (BCLC) Stage C disease (Llovet et al 1999), or BCLC Stage B disease.
Eligible patients will have locally advanced cervical cancer suitable for primary treatment with chemoradiation with curative intent, in addition to:            \r\n* Federation of Gynecology and Obstetrics (FIGO) 2008 stage IB1 & node positive, IB2, IIA, IIB, IIIB, or IVA disease
FIGO 2008 stage IIIA disease
Single organ involvement (Stage 1-3 skin, Stage 1 upper GI, or Stage 1-2 lower GI)
Multiple organ involvement (Stage 1-3 skin plus stage 1 upper GI, Stage 1-3 skin plus stage 1 lower GI, Stage 1-3 skin plus stage 1 lower GI plus stage 1 upper GI, Stage 1-3 skin plus stage 1-4 liver, or Stage 1 lower GI plus stage 1 upper GI)
Participants receiving alectinib in either Stage 1 or Stage 2: must be ALK positive as assessed by Food and Drug Administration (FDA) approved test and must not have received prior treatment for their advanced NSCLC.
Histologically confirmed stage 1 through stage 3c primary adenocarcinoma of the breast
Stage M1
Stage 1: both NT-proBNP and troponin T under threshold
Stage 2: either NT-proBNP or troponin T (but not both) over threshold;
Stage T3-4 disease
No prior treatment with GDC-0810 (allowed only during dose expansion stage)
Prior chemotherapy for extensive-stage SCLC
Prior treatment with immunotherapy for any stage NSCLC, including early-stage (neoadjuvant or adjuvant) disease
Has Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy, and not amenable to a curative treatment approach
Tumour Clinical stage T3 or T4 on MRI
Cervical carcinoma of Stage 1B or less.
Patients must have adequate TIL (at least 40 x 10^6 cells at the pre-expansion stage)
Subjects categorized to stage B (not applicable for transarterial chemoembolization [TACE]) or stage C based on Barcelona Clinic Liver Cancer (BCLC) staging system
High-risk NB as defined by risk-related treatment guidelines and the International NB Staging System i.e., stage 4 with (any age) or without (> 365 days of age) v-MYC myelocytomatosis viral related oncogene, neuroblastoma derived (avian) (MYCN) amplification, MYCN-amplified stage 3 (unresectable; any age), or MYCN-amplified stage 4S
Measurable Stage IIIA or IIIB disease
Clinical stage T2-4a; N0/X; M0
The patient must have a pathologically confirmed (by histology or cytology) diagnosis of NSCLC, which is currently Stage 3B or Stage 4 disease.
Prior chemotherapy for extensive-stage SCLC
Subject has BCLC stage B or C.
Subjects with either limited or extensive disease stage at the initial diagnosis
Patients must have histologically confirmed MCC that is Stage III (IIIB) or Stage IV, as defined by the 2010 AJCC staging criteria for MCC. MCC of unknown primary is allowed.
Patients must have had the invasive primary completely excised, including any in situ component but excluding melanocytic atypia, with a narrow margin, either in one stage or more than one stage in the case where an incision or punch biopsy has previously been performed. This information, including measured margins of lateral and deep clearance must be documented on the pathology report.
Documented clinical stage IA, IB or IIA CTCL
All grossly visible disease in the bladder must be fully resected and pathologic stage will be confirmed at the study institution
Patients must be stage 0-II based on Rai staging system; must have no indication for treatment for SLL per NCI-WG criteria
Direct laryngoscopy showing no evidence of greater than stage II true glottic larynx cancer
Evidence of fixed vocal cord (stage cT3)
International Federation of Gynecology and Obstetrics (FIGO) stage IA2 or IB1 disease
Patients who are categorized under Barcelona-Cl?nic Liver Cancer (BCLC)-C stage
Patients with early stage disease (FIGO Stage I, IIA, IIB or IIC)
Patients with synchronous primary endometrial cancer unless both of the following criteria are met: 1) stage <2 2) less than 60 years old at the time of diagnosis of endometrial cancer with stage IA or IB grade 1 or 2, or stage IA grade 3 endometrioid adenocarcinoma OR ? 60 years old at the time of diagnosis of endometrial cancer with Stage IA grade 1 or 2 endometrioid adenocarcinoma. Patients with serous or clear cell adenocarcinoma or carcinosarcoma of the endometrium are not eligible.
Clinical stage IB (>= 4 cm per computed tomography [CT]), stage IIA/IIB, or stage III (N0-2) amenable to surgical resection
Barcelona Clinic Liver Cancer (BCLC) stage C, and those with BCLC-B stage who cannot tolerate or failed transarterial chemoembolization (TACE)
Stage IIIB (AJCC Stage IIIB - Any T,N3M0 or T4N2M0) or Metastatic (AJCC Stage IV- any T, any N, M1), progressive, recurrent or refractory NSCLC. Patients may not be eligible for other curative intent treatment (e.g., surgical resection). For the purpose of eligibility for this trial, the above-cited disease states are defined as follows:
Clinical stage T1-4/N0-3/M0 at presentation (patients with T1a/bN0 tumors will not be eligible)
Patient's disease must be pathological N-stage positive
Patient must not have pathologically N stage negative disease
Have stage IA, IB or IIA: T1 or T2 (patches or plaques) with measurable lesions
Stage IIB or greater CTCL
Advanced stage NSCLC (stage IVa [malignant pleural effusion (is now staged as stage IVa by the most recent staging system), or stage IV, or recurrent disease])
Clinical stage T2-T4a N0/X M0 disease
At least three years since colectomy with IRA/proctocolectomy with pouch, and demonstrating polyposis as defined by Stage 1, 2, 3, of the proposed InSiGHT 2011 Staging System (Appendix B) and summarized as follows: Stage 1: 10-25 polyps, all < 5 mm Stage 2: 10-25 polyps, at least one > 1 cm Stage 3: >25 polyps amenable to complete removal, or any incompletely removed sessile polyp, or any evidence of high grade dysplasia, even if completely removed. [Note: For staging purposes only.]
Women with stage IA or IB1 cancer
Clinical stage 2 or greater with localized disease
Patients may have active mediastinal disease in N2 nodal stations if he/she has not received prior mediastinal RT\r\n* No restriction on prior T or N stage for patients who develop M1 disease at some point after initial diagnosis of stage I-III lung cancer and treatment
Expansion Stage:
Patients with Histologically confirmed stage IA1 (with lymph vascular invasion), stage IA2, or stage IB1 disease
Subject has unresectable stage B (intermediate), or C (advanced) Hepatocellular carcinoma according to the Barcelona Clinic Liver Cancer staging.Stage B subjects must have progressed after, or are not eligible for curative resection, transplantation, embolic, or ablative therapies
Stage IB-IIIA
Limited stage SCLC appropriate for definitive treatment with chemoradiation
Stage T1-4, N0-3, M0
Patients with T1N0M0 stage I disease
Locally advanced (Stage 3B) or metastatic (Stage 4) disease
Clinical stage T2-T4a, N0/x, M0 disease
Stage IB-IIIA
Histologically documented, Stage Ia to operable Stage IIIa, triple-negative carcinoma of the breast with primary tumor greter than or equal to (>/=) 1.5 centimeters (cm) in largest diameter (cT1-3) by MRI
Participants with cT4 or cN3 stage breast tumors
Participants with cT4 or cN3 stage breast tumors
Subjects with FIGO Clinical Stage IA cervical cancer ? 2 cm in size undergoing minimally invasive hysterectomy, trachelectomy, or conization with lymph node mapping. Subjects with clinical Stage IA1 cervical cancer without lympho vascular space involvement (LVSI) and negative margins on cone biopsy are not to be included.
Cervical carcinoma of Stage 1B or less.
Women with unilateral stage I or II BCRL
Patients with stage IA to IIB disease; select patients with resectable stage IIIA disease (T3N1, T4N0, T4N1) will also be eligible if approved by the principal investigator (PI)
This trial will include subjects with stage IB-IVB MF/SS (maximal stage since diagnosis will determine eligibility), and who have relapsed, are refractory, or progressed after at least one standard systemic therapy; current disease stage at time of entry will also be documented but will not be used for eligibility
Stage 4c metastases.
Resectable disease-clinical stage I (T/0/N0miT1N0-N0mi), IIA-IIIA (T2 N0/T3N0 or T1-3 N1-N2a) or unresectable disease – clinical stage IIIB/IIIC (T4 or T1-3 N2b-3); no evidence of metastatic disease
Amyloid cardiac biomarker stage I or II disease Staging defined by NT-proBNP and troponin T cut-offs of < 332 pg/mL and <0.035 ng/mL, respectively, as thresholds: Stage I, both under threshold; and Stage II, either troponin or NT-proBNP (but not both) over threshold. If troponin T is not available at local institution, troponin I may be used, but threshold is <0.1 ng/mL.23
Second line or greater/Refractory/Relapsed, Stage I, Stage II, Stage III
Any stage disease is allowed
Stage must be classified as one of the following:\r\n* Ann Arbor stage IA or IIA with:\r\n** Non-bulky mediastinal disease (< 33% mediastinal to thoracic ratio on chest x-ray [CXR])\r\n** < 3 nodal regions involved on the same side of the diaphragm\r\n** No “E” lesion
Patients have a diagnosis of neuroblastoma (International Classification of Diseases for Oncology [ICD-O] morphology 9500/3) or ganglioneuroblastoma verified by histology or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites; patients with the following disease stages at diagnosis are eligible, if they meet the other specified criteria:\r\n* Patients with newly diagnosed neuroblastoma with International Neuroblastoma Staging System (INSS) stage 4 are eligible with the following: \r\n** v-MYC myelocytomatosis viral related oncogene, neuroblastoma derived (avian) (MYCN) amplification (> 4-fold increase in MYCN signals as compared to reference signals) and age >= 365 days regardless of additional biologic features\r\n** Age > 18 months (> 547 days) regardless of biologic features\r\n** Age 12-18 months (365-547 days) with any of the following 3 unfavorable biologic features (MYCN amplification, unfavorable pathology and/or deoxyribonucleic acid [DNA] index = 1) or any biologic feature that is indeterminant/unsatisfactory/unknown\r\n* Patients with newly diagnosed neuroblastoma with INSS stage 3 are eligible with the following:\r\n** MYCN amplification (> 4-fold increase in MYCN signals as compared to reference signals), and age >= 365 days, regardless of additional biologic features\r\n** Age > 18 months (> 547 days) with unfavorable pathology, regardless of MYCN status\r\n* Patients with newly diagnosed INSS stage 2a/2b with MYCN amplification (> 4-fold increase in MYCN signals as compared to reference signals) and age >= 365 days, regardless of additional biologic features\r\n* Patients >= 365 days initially diagnosed with: INSS stage 1, 2, 4S who progressed to a stage 4 without interval chemotherapy; these patients must have been enrolled on ANBL00B1; it is to be noted that study enrollment must occur within 4 weeks of progression to stage 4 for INSS stage 1, 2, 4S
Barcelona Clinic Liver Cancer (BCLC) stage B
Mycosis fungoides patients that have stage T2-4 N0-1 M0B0 disease
Final American Joint Committee on Cancer (AJCC) stage IIa – IIIa (pathologic stage T0N1a-2a, T1N1a-2a, T2N1a-2a, T3N0-2a, all M0 status); pathological stage for all patients not receiving neoadjuvant chemotherapy; higher of the clinical or pathological T and N stage, if receiving neoadjuvant chemotherapy; patients with pathological N0 at the time of mastectomy are only eligible if biopsy-proven clinically N1 or N2 disease is documented prior to induction chemotherapy
Patients with stage IA1 disease who are LVSI negative
Patients with >= stage IB2 disease
PATIENT INCLUSION: Clinical diagnosis stage 4 solid or hematologic malignancy or nonresectable stage 3 gastrointestinal (Gi) cancer
Experiencing their first, stage 0 – IIIA breast cancer diagnosis (either clinical or definitive early stage at enrollment)
Stage 3B BC
Inflammatory or stage 4 BC
Cancer stage: T1 - 4N x M0
Three populations of patients are eligible for enrollment:\r\n* Patients with early stage disease at diagnosis (stage I-II) who were treated with chemotherapy alone and relapsed with early stage disease (stage RI-II)\r\n* Patients with early stage disease at diagnosis (stage I-II) who were treated with chemotherapy alone and have early stage (stage RI-II) primary refractory disease (residual disease on a scan 1 month after the completion of initial therapy) without B-symptoms and with each area of disease less than 10 cm in size\r\n* Patients with early stage disease at diagnosis (stage I-II) who were treated with combined modality therapy (chemotherapy and radiation) who relapse with early stage disease (stage RIII) outside the prior radiation therapy field
Stage IB-IVB MF/SS, and who have relapsed, are refractory, or progressed after at least one standard systemic therapy; maximal stage since diagnosis will determine eligibility; current disease stage at time of entry will also be documented but will not be used for eligibility
Any disease stage
Clinical stage I EC
Phase 1: Early stage (stage 1 and 2) CRC survivors who are 6 month or greater post-treatment
Tumor stage II or greater
Eligible disease(s)/stage(s): nasopharyngeal carcinoma, paranasal sinus cancers/any stage
STAGE I
STAGE II
Stage I participants are ineligible
Newly diagnosed with high grade stage 2, any grade stage 3 or higher endometrial cancer in the past 6 months
Patients will be included if their initial stage was T1 N0 M0 or T2 N0 M0
Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy.
T stage greater than clinical T1
STAGE 1:
STAGE 2 PATIENT PARTICIPANTS:
T stage >= T3 (mass extending outside the bladder)
T stage: cTis – T2
Documentation of WHO clinical stage 3 or 4 condition within 6 months of entry
Patients must have completed curative-intent therapy (including surgery, radiation, and/or chemotherapy) for a first tobacco-related oral premalignant lesion (OPL) or HNSCC of any stage (eligible lesions include high grade dysplasia; carcinoma in situ; or stage I-IVa HNSCC); NOTE: the presence of a measurable OPL at baseline is not required
Pathologic stage T0-T3N0-N1M0
Early stage and/or treatment naïve, or
Primary tumor stage T1-3 at initial diagnosis
Patients with operable focal or multifocal (T1-T3, stage II and IIIA invasive ductal carcinoma [all receptor phenotypes]), and who have completed neoadjuvant chemotherapy with a clinical complete response (by clinical examination)
Pathologically confirmed diagnosis of breast cancer, clinical stage I-II (T1-3 N0 M0, T0-2 N1 M0); diagnosis must be by needle biopsy; patients diagnosed by surgical excision are excluded; for patients enrolled after receipt and completion of neoadjuvant chemotherapy, the clinical stage must be determined based on pre-chemotherapy assessment
FOR STAGE 2:
Participants must have biopsy confirmed and clinical stage I, stage II, or stage III noninflammatory breast carcinoma; if biopsy was done at an outside hospital, pathology will be reviewed at (BWH, Brigham and Women's Faulkner Hospital [BWFH])
Participants must have biopsy confirmed and clinical stage 1 or stage 2 breast carcinoma; if biopsy was done at an outside hospital, pathology will be reviewed at Brigham and Women's Hospital (BWH)/Dana-Farber Cancer Institute (DFCI)
Any tumor stage, any N, M0
Any stage is eligible
Clinical stage: =< T2a & N0 or NX & M0 or MX
Melanoma tumor that requires a wide local excision in the operating room; this may include any stage of melanoma from stage IA to stage IV that requires a wide excision in the operating room
Patient’s clinical stage must be documented as tumor size less than 5 cm, with no palpable nodes and no evidence of metastatic disease (T1 or T2 N0 M0); for patients who will receive neoadjuvant systemic therapy, pre-treatment clinical stage should be used
Patients must be deemed appropriate for doxorubicin-based chemotherapy regardless of individual diagnosis or stage of disease
Patients must meet one (or more) of the following criteria:\r\n* Preoperative diagnosis of ovarian, fallopian tube, or primary peritoneal carcinoma (all stage, grade and histology)\r\n* Preoperative diagnosis of grade III endometrial carcinoma (all stage, all histology)\r\n* Preoperative diagnosis of uterine serous carcinoma (all stage, all grade)\r\n* Preoperative diagnosis of clear cell endometrial carcinoma (all stage, all grade)\r\n* Preoperative diagnosis of endometrial carcinosarcoma (all stage, all grade)\r\n* Gastrointestinal carcinoma (all histology, stage and grade)\r\n* Pancreatic carcinoma (all histology, stage and grade)\r\n* Lung cancer (all histology, stage and grade)\r\n* Esophageal carcinoma (all histology, stage and grade)\r\n* Suspected or pathologically confirmed metastatic disease to the lung (all disease primaries)\r\n* Suspected or pathologically confirmed malignant pleural effusion (all disease primaries)
Subjects must be classified as TNM stage I, II, or III; alternatively, subjects may be classified as Barcelona Clinic Liver Cancer (BCLC) stage A or B
Pathological T3 stage of disease (i.e., EPE or SVI), or
Stage 4 patients are not eligible
Clinical stage < cT3
Clinical stage: T3/T4
Patients must not have been treated with any of the following prior to step 1 initial registration:\r\n* Cetuximab, panitumumab, or any other monoclonal antibody against EGFR or inhibitor of EGFR\r\n* HER-2 targeting for treatment of colorectal cancer; patients who have received prior trastuzumab or pertuzumab for other indications such as prior history of adjuvant or neoadjuvant breast cancer treatment prior to the development of advanced colorectal cancer are eligible
Diagnosis of metastatic adenocarcinoma of colon or rectum without previous chemotherapy or any other systemic therapy for metastatic colorectal cancer
No prior chemotherapy for metastatic colorectal cancer
Has pathologically documented unresectable, recurrent, or metastatic colorectal adenocarcinoma (until sponsor's notification to the study sites, subject must be a RAS/BRAF wild-type cancer)
Dose Escalation Cohort: must have breast cancer, colorectal cancer, adrenocortical carcinoma, chromophobe renal cell carcinoma.
Colorectal cancer other than adenocarcinoma, e.g., sarcoma, lymphoma, carcinoid.
Colorectal cancer (CRC) (not mismatch repair deficient by local assay including PCR and/or immunohistochemistry)
Must have previously treated metastatic colorectal cancer
BRAF V600 mutant colorectal cancer
Pathologically documented diagnosis of colorectal adenocarcinoma.
Malignant melanoma, papillary thyroid cancer, colorectal cancer, or hematologic malignancy including multiple myeloma
Pts with colorectal cancer must be KRAS wild-type
Malignancies other than colorectal cancer within 5 years prior to Cycle 1 Day 1
Colorectal carcinoma (CRC).
Currently receiving other systemic therapy for metastatic colorectal cancer
COHORT B, GROUP 3: COLORECTAL CANCER: Patients must have colorectal adenocarcinoma that harbored a KRAS mutation
COHORT B, GROUP 3: COLORECTAL CANCER: Patients must have failed a minimum of one previous line of chemotherapy
Recurrent and/or metastatic unresectable colorectal cancer with hepatic metastases
Metastatic colorectal cancer patients have progressed following at least one line of fluorouracil (5-FU)-based chemotherapy
The study is intended to enroll patients with pancreatic and colorectal cancer; patients with other types of solid tumors will require approval by the principal investigator
Patients previously treated with systemic chemotherapy and/or biologic agents for colorectal cancer are eligible
Have histologically confirmed microsatellite stable metastatic colorectal cancer and have received at least one line of treatment for metastatic colorectal cancer including fluoropyrimidines, oxaliplatin and/or irinotecan
Participants must have metastatic colorectal or pancreatic cancer
Prior history of colorectal cancer
PHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nHistologically or cytologically confirmed advanced colorectal cancer; patients must have progressed on, been intolerant of or refused prior oxaliplatin- and irinotecan-containing chemotherapeutic regimen, and have disease that is not amenable to potentially curative resection; patients who have a known KRAS (or NRAS or BRAF) wild type tumor must have progressed, been intolerant of or refused cetuximab or panitumumab-based chemotherapy
Prior chemotherapy or radiotherapy for colorectal cancer
Colorectal cancer
Any prior systemic treatment for metastatic colorectal cancer
Adjuvant systemic treatment for colorectal cancer within last 12 months
Patients with colorectal cancer should have failed at least one oxaliplatin-containing regimen
Subjects with advanced colorectal, gastric, hepatic or pancreatic cancer
Has received prior systemic therapy for Stage IV colorectal cancer. May have received prior adjuvant chemotherapy for colorectal cancer as long as it was completed at least 6 months prior to randomization on this study
Subjects with histologically confirmed melanoma, NSCLC, transitional cell carcinoma of the GU tract, TNBC, SCCHN, ovarian cancer, MSI high colorectal cancer (CRC), RCC, gastric cancer, HCC and DLBCL (Phase 2).
Subject is diagnosed with colorectal cancer
Clinical diagnosis of appendiceal or colorectal neoplasm with peritoneal mucinosis or metastasis
Part B: First-Line Colorectal Cancer
Part B: Second-Line Colorectal Cancer
Tumor blocks available from previous surgery/biopsy; at the tumor specific expansion, only patients with metastatic colorectal and renal cell cancers will be enrolled; patients with metastatic colorectal and renal cancer must have been treated and progressed or intolerant to standard care therapy; patients with colorectal cancer must have been treated in the past with irinotecan and/or oxaliplatin and/or avastin/EGFR therapy or intolerant to these agents; no more than 4 lines of therapy permitted in the metastatic setting; patients with colorectal cancer may enroll irrespective of K-Ras mutational status, although this will be documented; patients with renal cell cancer must have been treated with a VEGF targeted therapy and/or mTOR inhibitor; prior treatment with vorinostat and HCQ are not permitted in each tumor type
Patients with wild-type or mutant Kirsten rat sarcoma 2 viral oncogene homolog (KRAS) metastatic colorectal cancer (mCRC)
Previous malignancy other than Colorectal cancer (CRC) in the last 5 years except for basal cell cancer of the skin or pre-invasive cancer of the cervix
histopathologically confirmed advanced or metastatic colorectal cancer, excluding primary tumors of appendiceal origin
Must have started adjuvant FOLFOX chemotherapy within 8 weeks of resection for colorectal carcinoma
28 patients with refractory colorectal cancer.
Prior systemic chemotherapy, immunotherapy (including interferon), or biological therapy, radiation therapy and/or surgery for resection of solid tumor (limited to: melanoma, kidney cancer, lung cancer, colorectal carcinoma, prostate cancer, and neuroendocrine tumor) are allowed.
Kirsten rat sarcoma viral oncogene homolog (KRAS) mutated colorectal cancer
Metatastic colorectal cancer
Colorectal cancer other than adenocarcinoma, e.g., sarcoma, lymphoma, carcinoid.
Group 2: Patients with BRAF mutated colorectal cancer
Metastatic colorectal cancer
Family history of familial cancer syndromes (leukemia, breast, ovarian, colorectal, etc.)
Patients with a history of colorectal cancer treated by surgical resection who develop radiological or clinical evidence of metastatic cancer do not require separate histological or cytological confirmation of metastatic disease unless:\r\n* Either an interval of > 5 years has elapsed between the primary surgery and the development of metastatic disease, OR\r\n* The primary cancer was stage I\r\nClinicians should consider biopsy of lesions to establish the diagnosis of metastatic colorectal cancer in each case if there is substantial clinical ambiguity regarding the nature or source of apparent metastases
Prior chemotherapy, other systemic therapy, or any investigational agent for treatment of advanced or metastatic colorectal cancer; patients who completed adjuvant or neoadjuvant chemotherapy > 12 months prior to colorectal cancer recurrence are eligible
Part F: Colorectal Cancer
Patients must have a primary L sided colorectal cancer (at or distal to the splenic flexure)
Have a colorectal or coloanal reconstruction with or without reservoir/pouch.
Advanced colorectal carcinoma.
Patients must show signs of progression (by imaging, or tumor marker elevation) after being treated with a first line or greater treatment for their un-resectable or metastatic colorectal cancer
CRC (Colorectal cancer): Patients with metastatic CRC and known KRAS (Kirsten rat sarcoma viral oncogene homolog) status who are eligible for treatment with regorafenib in accordance with the approved labeling.
Have a history of Stage IV Colorectal Cancer (CRC) with metastases to the liver only
Any prior treatment for metastatic colorectal cancer, except for use of palliative radiosensitizers
Adjuvant chemotherapy for colorectal cancer completed < 12 months prior to study consent
Evaluable or measurable radiographic evidence of colorectal cancer
Patients with an obstructive synchronous colorectal tumor requiring up-front surgery or chemoradiation
Has received at least 2 prior chemotherapeutic regimens for colorectal cancer;
Diagnosed colorectal cancer with oligometastatic colorectal cancer in the lung
Prior anti-cancer treatment for metastatic colorectal cancer
Received any chemotherapeutic or targeted agent for metastatic colorectal cancer within two weeks of initiation of study drug
Subjects with metastatic colorectal cancer may continue “maintenance” therapy with capecitabine and/or bevacizumab
Colorectal cancer (for patients enrolled to expansion part)
Prior treatment with taxane therapy for either colorectal cancer or small bowel adenocarcinoma
Primary colorectal cancer diagnosis
Prior chemotherapy for metastatic colorectal cancer is not allowed.
Patients must have KRAS/NRAS/BRAF wild-type colorectal cancer
Diagnosed with breast, colorectal, or prostate cancer (stages I-III)
metastatic colorectal cancer (mCRC) that is microsatellite stable (MSS)
Diagnosed with stage III or IV colorectal cancer
Have been diagnosed with localized breast or prostate (stages 1-2) or colorectal cancer (stage 1-3)
PHASE 0: Previously underwent curative surgical treatment of metastatic colorectal or peritoneal cancer at University of Pittsburgh Medical Center (UPMC) Shadyside
PHASE 1 & 2: Scheduled for curative surgical treatment of metastatic colorectal or peritoneal cancer at UPMC Shadyside
Diagnosed with stage 3 or 4 breast, cervical, colorectal, endometrial, hepatobiliary, lung, melanoma, gynecological, prostate cancer in the past six months
Diagnosed with incurable (defined as metastatic or receiving chemotherapy with palliative intent) esophageal, gastric, pancreas, hepatobiliary, colorectal, or lung cancer within the prior 8 weeks (including patients with prior diagnosis of cancer who developed incurable disease)
Scheduled to receive first-line intravenous chemotherapy treatment for colorectal cancer (stages II-IV)
Patients with a primary diagnosis of either breast, lung, prostate, or colorectal cancer within the last two years
Diagnosed with stage I-III colorectal cancer
Within 12 months of completing active treatment for colorectal cancer
Stage I-III colorectal cancer (CRC).
Patient diagnosed with colorectal cancer
Primary family caregivers of cancer patients with gastrointestinal (colorectal, pancreatic, gastric), gynecologic, urinary, or lung cancers who are entering the City of Hope for treatment or follow-up
Patients with a history of other malignancies will not be excluded, as long as they are currently receiving treatment for lung, breast, colorectal, prostate, GYN, or other solid tumor cancer
Histologically confirmed stage I-III colorectal or breast cancer who have undergone curative-intent complete surgical resection and completed all adjuvant cytotoxic chemotherapy and radiation (if indicated) at least 2 months prior to enrollment; breast cancer patients on hormonal therapy or trastuzumab only therapy and colorectal cancer patients on adjunctive therapies not considered cytotoxic chemotherapy (including those participating in Cancer and Leukemia Group B [CALGB] 80702 receiving only celecoxib/placebo) are eligible
Scheduled to receive any form of further adjuvant cancer therapy (except hormonal or biologic therapy for breast cancer or adjunctive noncytotoxic chemotherapy for colorectal cancer including participation in CALGB 80702 while on celecoxib/placebo)
Prisoners and individuals who are under the age of 18 will be specifically excluded from participation in the study; individuals must have a primary colorectal or endometrial cancer, not a recurrence of a previous colorectal or endometrial cancer
Individuals with personal history of colorectal cancer (CRC) or colorectal polyps
Have a first degree relative with a history of breast or colorectal cancer
Outpatients scheduled for screening or surveillance colonoscopy for polyps or colorectal cancer )
Patients at high risk of colorectal cancer e.g. ulcerative colitis
Patients must not have a known history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, or inflammatory bowel disease
Diagnosis of colorectal adenoma of any grade
Patients receiving prior chemotherapy or chemoradiation for colorectal cancer (ie, neoadjuvant chemoradiation for stage II or III rectal cancer)
History of colorectal cancer; exception: individuals with stage I or II colorectal cancer who have not received any chemotherapy
Chinese and Korean American patients who are not up to date for colorectal cancer screening
Colorectal cancer
At high risk of developing colorectal cancer, based upon a history of having a colonoscopy and having any colorectal adenoma diagnosed and/or removed within the past 3 years
No history of colorectal cancer, including germ-line heritable colorectal cancers such as familial adenomatous polyposis (FAP) and hereditary nonpolyposis colorectal cancer (HNPCC)
History of at least one of the following conditions in the previous 12 months:\r\n* Colorectal adenoma(s) >= 1 cm in maximal diameter\r\n* Colorectal adenoma(s) with villous or tubulovillous histology\r\n* Colorectal adenoma(s) with high grade (severe) dysplasia
History of any colorectal cancer
History of heritable cancer syndrome (familial adenomatous polyposis [FAP], hereditary nonpolyposis colorectal cancer [HNPCC])
Currently non-adherent to colorectal cancer screening
Previously resected colorectal cancer
Family history of polyposis syndrome (e.g., familial adenomatous polyposis [FAP], hereditary non-polyposis colorectal cancer [HNPCC]) or colorectal cancer (first degree relatives younger than 60 years old)
History of difficulty with sigmoidoscopy or abnormal colorectal anatomy
Diagnosed with primary or metastatic cancer in one or more of the following locations: breast, colorectal, lung, pancreas
Received prior chemotherapy for colorectal cancer
Participants with non-colorectal, non-gastric, or non-pancreatic cancer should have confirmed CEA expression in tumor tissue. CEA expression should be centrally confirmed. For colorectal cancer (CRC) participants, CEA assessment should be performed but the result is not required for participant selection.
A pathologically documented colorectal cancer that:
Have a primary diagnosis of non-metastatic colorectal cancer and have had surgery and are now receiving adjuvant chemotherapy
Average-risk patients due for colorectal cancer (CRC) screening at the time of a primary care appointment who initiate a portal session within the two-week period following their visit
Diagnosis of any stage I - IV colorectal cancer or recurrent colorectal cancer (Arm 1)
Treat patients diagnosed with breast, prostate or colorectal cancer