The primary tumor in the lung must be biopsy confirmed non-small cell lung cancer within 180 days of randomization
Participants receiving a histologic diagnosis of epithelial ovarian cancer (EOC), peritoneal primary carcinoma, or fallopian tube cancer
Have recurrent invasive epithelial ovarian, fallopian tube, or primary peritoneal cancer that was treated only with surgery (example [e.g.], participants with Stage IA or Stage IB epithelial ovarian or fallopian tube cancers)
Have synchronous primary endometrial cancer
Have a prior history of primary endometrial cancer, except: Stage IA cancer; superficial myometrial invasion, without lymphovascular invasion; grade less than (<) 3 or poorly differentiated subtypes, and this includes papillary serous, clear cell or other International Federation of Gynecological Oncologists (FIGO) Grade 3 lesions
Part 2B: Patient with Non-Small Cell Lung Cancer (NSCLC), Endometrial cancers, and MSI-H solid tumors.
Recurrent rectal cancer
Invasive lobular cancer
New diagnosis of DCIS without invasive cancer; date of diagnosis defined as the date of the first pathology report that diagnosed the patient with DCIS
Advanced Non Small Cell Lung Cancer (NSCLC)
Documented incurable cancer with one of the following histologies: non-small cell lung cancer, malignant melanoma, renal cell cancer, triple negative breast cancer, colorectal cancer with microsatellite instability (MSI), bladder cancer, and metastatic castration resistant prostate cancer.
Patients that are determined to have a rare cancer with unknown primary site are eligible under cohort #32 (tumor of unknown primary [cancer of unknown primary; CuP]), provided that there is histologic documentation of metastatic malignancy with no discernible primary site identified from histopathologic review, physical exam and associated cross-sectional imaging of the chest, abdomen, and pelvis
Patients must have pathologically proven squamous cell carcinoma (SCCA) cancer of the lung confirmed by tumor biopsy and/or fine-needle aspiration; disease must be stage IV SCCA, or recurrent; the primary diagnosis of SCCA should be established using the current World Health Organization (WHO)/International Association for the Study of Lung Cancer (IASLC)-classification of Thoracic Malignancies; the diagnosis is based on hematoxylin and eosin (H&E) stained slides with or without specific defined immunohistochemistry (IHC) characteristic (p40/p63 positive, transcription termination factor [TTF1] negative) if required for diagnosis; mixed histologies are not allowed
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
High grade ovarian cancer, including high grade serous; clear cell; endometrioid, grade 3; and others (adenocarcinoma, nitric oxide synthase [NOS]; mixed epithelial carcinoma; undifferentiated carcinoma); NOTE: low grade serous, mucinous and carcinosarcoma histologies are excluded; ovarian cancer = ovarian, fallopian tube or primary peritoneal cancer; required data element: submission of pathology report
Life-threatening illness unrelated to cancer
Participants must have a pathologically-confirmed diagnosis of non-small cell lung cancer (NSCLC)
Patient has one of the following histologically or cytologically confirmed advanced malignancies: acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), glioblastoma multiforme (GBM), melanoma, non-small cell lung cancer (NSCLC), ovarian cancer, pancreatic cancer, sarcoma, renal cell carcinoma (RCC)
Small cell lung cancer (SCLC).
Group 4: Anaplastic thyroid cancer
Subject has received anti-cancer Chinese medicine or anti-cancer herbal remedies within 14 days prior to Cycle 1 Day-2.
Any prior therapy for lung cancer
For Phase 2a, subjects with one of the following tumor types will be enrolled: i. Urothelial cancer with HER2 or HER3 mutation ii. Biliary tract cancer with HER2 or HER3 mutation iii. Breast cancer with HER2 or HER3 mutation iv. Breast cancer with HER2 amplification or overexpression v. NSCLC with HER2 or HER3 mutation vi. CRC with HER2 mutation or amplification vii. Other tumors with HER2 mutation/amplification/overexpression or HER3 mutation (gastric/GEJ, endometrial).
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)
Extensive disease per criteria of the International Association for the Study of Lung Cancer (IASLC)-American Joint Committee on Cancer (AJCC) TNM staging system
Cervical cancer in situ
Histological confirmation of clear cell renal cancer
Cohort A Dose Expansion (Ribociclib + PDR001): Metastatic epithelial ovarian cancer, fallopian tube or peritoneal cancer; all histologies (including serous, mucinous, endometrioid, clear cell, MMMTs and mixed histologies) and tumor grades are eligible
Has histologically-confirmed cSCC as the primary site of malignancy (metastatic skin involvement from another primary cancer or from an unknown primary cancer is not permitted).
Inability to return to Memorial Sloan-Kettering Cancer Center (MSKCC) for frequent scheduled hydration sessions post-chemotherapy
Patients with colorectal cancer should have progressed on at least one fluorouracil plus irinotecan or oxaliplatin containing regimen
Phase 2 Cohort C (thyroid cancer): Subjects must have a histologically or cytologically confirmed diagnosis of metastatic thyroid cancer (stage IV) that carries either a RET rearrangement or activating RET mutation, as determined by FISH, RT-PCR, or NGS via a CLIA-certified LDT
Ovarian cancer
Non-small cell lung cancer (NSCLC)
Small cell lung cancer (SCLC)
Participants must have histologically or cytologically confirmed disease from melanoma, triple negative breast cancer, head and neck cancer, lung cancer, bladder cancer, renal cell cancer
Patients must have a histological or cytological evidence/confirmation of epithelial ovarian cancer, primary peritoneal carcinomatosis, or fallopian tube cancer
Non-small cell lung cancer (NSCLC) (adenocarcinoma)
Leptomeningeal involvement of cancer
Have a histologically confirmed diagnosis of high-grade serous or Grade 2 or Grade 3 endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer
Histologic or cytologic diagnosis of cancer
Prior exposure to cancer immunotherapy including any immune checkpoint inhibitor and/or cancer vaccines
Have had cancer other than MB, NB, ES or RMS for Part A of the study or cancer other than MB in the previous 5 years for Parts A and B
Evidence of history of bleeding disorder, dialysis, or coexisting cancer that is distinct in primary site or histology from the cancer evaluated in this study
In Part A, the patients must have an advanced malignancy including but not limited to high-grade serous cancer of the ovary, fallopian tube, or peritoneum (EOC), triple negative breast cancer (TNBC), SCLC, primary peritoneal cancer, and any tumor likely to harbor DNA damage repair deficiencies susceptible to treatment with a PARP inhibitor or likely to be responsive to a PD-1 blocker.
Histologically documented metastatic cancer (solid tumors, not including hematologic malignancies)
Progressive cancer at the time of study entry
Prior cancer therapy or anti-cancer vaccine within 4 weeks of initial study treatment.
Participants must have any of the following tumor types, confirmed by available pathology records or current biopsy, that is advanced, nonresectable, or recurrent and progressing since last antitumor therapy, and for which no alternative standard therapy exists: pancreatic adenocarcinoma, renal clear cell carcinoma, SCCHN (squamous cell carcinoma of head and neck), NSCLC (non-small cell lung cancer), colorectal cancer (CRC), hepatocellular carcinoma (HCC), ovarian serous epithelial cancer, bladder transitional cancer, cervical cancer, and triple-negative breast cancer
Histologically diagnosed metastatic cancer (diagnosis made or confirmed at Memorial Sloan-Kettering Cancer Center [MSKCC] for MSKCC participants; institutional pathologic determination accepted from participating multicenter sites)
Histologic confirmation of ovarian, primary peritoneal or fallopian tube cancer of any subtype
Patient with primary or recurrent International Federation of Gynecology and Obstetrics (FIGO) stage III or IV ovarian, fallopian tube, peritoneal carcinoma, or uterine cancer, confined to abdominal cavity, including those who have completed neoadjuvant chemotherapy and primary surgery
Preoperative or intraoperative (frozen section) diagnosis of ovarian, peritoneal, fallopian tubal or uterine cancer
Patients with esophageal cancer with unresected or recurrent primary tumors in the esophagus are only permitted after discussion of patient with study chair
Patients are stage IV (M1) with any combination of T and N with oligometastatic disease as defined by 5 or fewer total sites of metastatic disease involving 3 or fewer organ systems\r\n* Examples of patients eligible for trial\r\n** T3N2M1 non-small cell lung cancer (NSCLC) with 1 central nervous system (CNS) metastatic lesion, 2 liver lesions, and 1 adrenal lesion.\r\n** T4N1M1 colorectal cancer with 1 liver lesion, 4 bone lesions \r\n** T3N0M1 gastric cancer with 1 supraclavicular lymph node, 2 liver lesions, and 2 CNS lesions
Another active malignancy requiring therapy such as radiation, chemotherapy, or immunotherapy; exceptions to this are as follows: localized non-melanotic skin cancer and any cancer that in the judgment of the investigator has been treated with curative intent and will not interfere with the study treatment plan and response assessment; patients with >= 25% of the bone marrow radiated for other diseases are not eligible
Have a diagnosis of advanced platinum resistant epithelial ovarian cancer (EOC)/fallopian tube cancer/primary peritoneal cancer (PPC) • Up to 2-3 prior lines of therapy
No active, second potentially life-threatening cancer
Women who have high-grade serous ovarian, primary peritoneal or fallopian tube cancer.
Epithelial Endometrial Cancer: histologically confirmed diagnosis (by either primary surgical specimen or biopsy for recurrence) of recurrent previously treated EEC.
Participants must have a biopsy-proven tumor consistent with small cell lung cancer and intracranial lesions radiographically consistent with or pathologically proven to be brain metastases; patients who have undergone prior systemic therapy are eligible
Must have previously treated metastatic colorectal cancer
BRAF V600 mutant colorectal cancer
Patients must have a known diagnosis of either metastatic castration-resistant prostate cancer (mCRPC) or non-small cell lung cancer (NSCLC) with evidence of measurable disease.
Histologically or cytologically confirmed advanced ovarian cancer: epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer (excluding borderline ovarian cancer) that is resistant or refractory to platinum therapy and no other standard therapy with proven clinical benefit is available.
Histological diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer, excluding the mucinous subtype.
A histologic diagnosis of salivary duct carcinoma (other subtypes of salivary gland cancer are excluded).
Small cell lung cancer
Participants must have a biopsy-proven diagnosis of primary or recurrent gynecologic cancer for which intracavitary or interstitial brachytherapy is planned as standard treatment; eligible disease sites include primary or recurrent cancer of endometrial, ovarian, cervical, vaginal, or vulvar origin
Histopathologic evidence of cancer based upon pathologist's report.
Tumor tissue local laboratory HER2 testing results (clinical pathology report) based on FDA or other regulatory agency approved, validated or commercially available IHC or ISH HER2 assay. Pre-screening for HER2 is allowed only for subjects with breast and gastric cancer, GE junction or esophageal cancer, where applicable. Subjects with other types of cancer must have previously tested for HER2 status by HER2 IHC or ISH assay.
Histological diagnosis of melanoma confirmed at Memorial Sloan-Kettering Cancer Center (MSKCC)
Must have esophageal cancer that cannot be operated on, or treated with definitive chemoradiation with curative intent, that is advanced, reoccurring or has spread out
Squamous cell or undifferentiated gastric cancer
Part 2, Cohorts 1-3, all patients must have a histologically-confirmed diagnosis of high grade serous ovarian cancer (including fallopian tube cancer and/or primary peritoneal cancer)
History of another cancer is exclusionary unless it is believed to be likely cured or is unlikely to be fatal in the next 3 years (e.g. squamous cell carcinoma, superficial bladder cancer, chronic lymphocytic leukemia, etc)
Patient with Colorectal cancer, epithelial ovarian cell or fallopian tube carcinoma, urothelial carcinoma, Triple Negative Breast cancer, pancreatic cancer, AML/MDS or Multiple Myeloma
Histologically documented metastatic cancer (solid tumors, not including hematologic malignancies)
Molecular testing results from clinical laboratory improvement amendments (CLIA)-certified laboratories (using tissue and/or blood) demonstrating HER2 overexpression or amplification. Participants must have one of the following tumor types: biliary cancer, salivary cancer, or bladder cancer. a) For participants screened using a blood assay: obtain tissue-based testing result confirming study eligibility (within first 4 weeks after enrollment)
Non-small cell lung cancer (NSCLC) or pancreatic cancer identified by exon 19 deletions or exon 21 L858R substitution mutations
Eligible patients must have histopathologically confirmed Hürthle cell thyroid cancer by central review
Patients with prior history of either small cell lung cancer or NSCLC regardless of the treatment received, other than patients who have recurrent disease following resection
Any prior therapy for lung cancer
Patients must have clinically and radiographically suspected and previously untreated International Federation of Gynecologic and Obstetrics (FIGO) stage III or IV epithelial ovarian, primary peritoneal or fallopian tube cancer, high grade, for whom the plan of management will include neoadjuvant chemotherapy (NACT) with interval tumor reductive surgery (TRS) who have undergone biopsies for histologic confirmation
Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, unless all of the following conditions are met: stage not greater than I-A, grade 1 or 2, no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including serous, clear cell or other FIGO grade 3 lesions
Other active cancer
Subjects with peritoneal disease who have failed prior standard chemotherapy and have histologic confirmation of platinum-resistant or refractory epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, endometrial cancer, cervical cancer, vaginal and vulvar cancer, uterine sarcomas including leiomyosarcoma, carcinosarcoma or high grade endometrial stromal sarcoma, gastroesophageal cancer, pancreatic cancer, cholangiocarcinoma, colorectal cancer, gastrointestinal neuroendocrine tumors, or mesothelioma will be enrolled.
Previously treated for advanced cancer with no additional therapy options available known to prolong survival.
Histologically or cytologically-confirmed recurrent or resistant (progression within 6 months following the last administered platinum based therapy or progression after subsequent therapy in previously relapsed subjects), stage III-IV epithelial ovarian, fallopian tube or peritoneal cancer subjects (according to American Joint Committee on Cancer/Union for International Cancer Control TNM and International Federation of Gynecology and Obstetrics Staging System, 7th edition) whose disease has progressed following adjuvant therapy or therapy for metastatic disease.
FAZ053 single agent: NSCLC/ TNBC/ Endometrial cancer / Anaplastic thyroid cancer/Selected indication(s) in dose expansion group every 6 Weeks (Q6W) dosing regimen
Participant has a history of bladder cancer (including in situ bladder cancer)
Diagnostic of small cell lung cancer
Pts with colorectal cancer must be KRAS wild-type
Other cancer therapy including chemotherapy, small molecules, and antibodies within 5 half-lives of the cancer therapy before first ZW25 dosing
Malignancies other than colorectal cancer within 5 years prior to Cycle 1 Day 1
Histologic diagnosis of a non-small cell lung cancer or lung metastasis from a solid tumor; one biopsy site is adequate for multiple sites of thoracic disease
Histologic proof of melanoma reviewed and confirmed by Memorial Sloan-Kettering Cancer Center (MSKCC)
Must have histological or cytological evidence of a diagnosis of cancer that is not amenable to curative therapy.
Have a pathologically confirmed diagnosis of colorectal cancer, which is metastatic or otherwise unresectable
Histological or cytological diagnosis of solid cancer or lymphoma that is considered incurable and without therapies with established benefit. Biopsy is not necessary for subjects with known prior diagnosis and clinical or radiographic evidence of recurrence.
Small cell lung cancer (SCLC).
Patients with incurable malignancies with >= 50% 2-year cancer-associated mortality (as estimated by two physician and where appropriate according to 2014 NCDB data); diseases include, but are not limited to:\r\n* Ampullary carcinoma\r\n* Appendiceal cancer\r\n* Colorectal cancer (CRC)\r\n* Extrahepatic cholangiocarcinoma (EHCC)\r\n* Esophageal adenocarcinoma\r\n* Gallbladder cancer (GBCA)\r\n* Gastric adenocarcinoma\r\n* Head and neck cancer\r\n* Hepatocellular carcinoma (HCC)\r\n* Intrahepatic cholangiocarcinoma (IHCC)\r\n* Melanoma\r\n* Non-KIT GIST (gastrointestinal stromal tumor)\r\n* Non-small cell lung cancer (NSCLC)\r\n* Ovarian cancer\r\n* Pancreatic ductal adenocarcinoma (PDAC)\r\n* Sarcoma (high-grade)\r\n* Small bowel adenocarcinoma (including duodenal)\r\n* Triple-negative breast cancer (TNBC)\r\n* Urothelial cancer\r\n** Note: we will limit gastrointestinal malignancies to no more than 65% of the case mix
Currently receiving other systemic therapy for metastatic colorectal cancer
Component of small-cell cancer or sarcomatoid cancer
Cancer that is recurrent, metastatic, or unresectable and for which no effective or curative measures exist.
Part 1: Ovarian, fallopian tube, primary peritoneal, endometrial, or cervical cancer
High grade, rapidly proliferative solid tumors (eg, small cell lung cancer, germ cell tumors, neuroblastoma) with extensive tumor burden.
Patients must have histopathological confirmation of pancreatic adenocarcinoma prior to entering this study by the Laboratory of Pathology of the National Cancer Institute (NCI) prior to entering this study
For the Phase I part of the study, eligible patients must have incurable poorly differentiated thyroid cancer; OR anaplastic thyroid cancer; OR radioiodine refractory differentiated thyroid cancer that is refractory to a tyrosine kinase inhibitor (TKI); OR patients who cannot tolerate a TKI are also eligible; histological confirmation of poorly differentiated, undifferentiated or anaplastic histology is required for untreated cases, but is not required for the refractory cases
Patients enrolling in the sporadic high grade serous epithelial or high grade endometrioid ovarian cancer group, cohort 2, must have a negative family history of hereditary breast ovarian cancer (HBOC) syndrome, or negative gBRCA1/2m test
For cohorts 1-3, 5 and 6: patients must have breast and/or epithelial or endometrioid ovarian cancer, primary peritoneal cancer, and/or fallopian tube cancer histologically or cytologically confirmed at the National Cancer Institute (NCI) that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective; ER/PR/HER2 status needs to be documented either by an outside source or at NCI; patients with gBRCA1/2m with history of or active breast and ovarian cancers are considered for cohort 1; those without gBRCA1/2m will follow exclusion criteria
Any other cancer, unless the patient has been disease-free for ?5 years
Chronic use of immune-suppressive drugs (ie, systemic corticosteroids used in the management of cancer or non-cancer related illnesses, eg, COPD).
Confirmation of diagnosis of metastatic melanoma by the Laboratory of Pathology of National Cancer Institute (NCI)
For expansion cohorts: Subjects will be eligible for Part 2 only if they have histological or cytological confirmed squamous non-small cell lung cancer (sqNSCLC), lung adenocarcinoma, head and neck cancer or bladder cancer (BC). All subjects in Part 2 will be stratified according to high FGFR expression levels FGFR mutation using archival or fresh tumor biopsy specimen. BC subjects with low overall FGFR expression levels can be included if activating FGFR3(FGFR tyrosine kinases3) mutations are confirmed
Pathologically confirmed invasive non-small cell lung cancer within 12 weeks prior to study registration. OR Pathologically confirmed invasive non-small cell lung cancer within 6 months prior to study registration if the patient received induction chemotherapy.
PART I: Adults with malignant soft tissue and bone tumors and recurrent or progressive, metastatic solid tumors who have progressed on standard therapies with known benefit but for whom anti-HER2 therapy is not clinically indicated:\r\n* Patients with ovarian, cervical, colon, gastric/gastroesophageal junction, non-small cell lung, renal cell, bladder, malignant soft tissue and bone tumor, prostate cancer or other solid tumors that is known to be HER2 1+, 2+ or 3+ by immunohistochemistry (IHC) OR have a Vysis fluorescent in situ hybridization (FISH) result >= 1.8\r\n* Patients with breast cancer that is known to be HER2 1+ or 2+ by IHC or with a Vysis FISH result of 1.8 - < 2.2
Expansion cohort B, groups 1, 2, 3, 4, 5, 6 and 7: Patients must have advanced pathologically proven mutant KRAS non-small cell lung cancer (group 1), pancreatic cancer (group 2; documentation of KRAS mutation not required), mutant KRAS colorectal cancer (group 3), head and neck squamous cell carcinoma (group 4), mesothelioma (group 5), hepatocellular cancer (group 6), and biliary carcinoma (group 7)
COHORT B GROUP 1: NON-SMALL CELL LUNG CANCER: Patients must have advanced non-small cell lung cancer with mutant KRAS
COHORT B GROUP 1: NON-SMALL CELL LUNG CANCER: Patients must have failed a minimum of one previous line of chemotherapy for advanced disease
COHORT B, GROUP 2: PANCREATIC CANCER: Patients must have failed a minimum of one previous line of therapy for advanced disease
COHORT B, GROUP 3: COLORECTAL CANCER: Patients must have colorectal adenocarcinoma that harbored a KRAS mutation
COHORT B, GROUP 1: NON-SMALL CELL LUNG CANCER: Patients must not have clinical significant hemoptysis
Diagnosis of superficial bladder cancer
Diagnosis of muscle-invasive bladder cancer
Limited primary non-small cell lung cancers (NSCLCs) (T1aN0M0, T1bN0M0, T2aN0M0, T2bN0M0, or T3N0M0) or metastatic lung tumors with no evidence of uncontrolled extrathoracic metastases
Cervical cancer\r\n* Patients who are unable to undergo surgery and must have treatment for an inoperable primary cervical cancer\r\n* Patients with locally advanced cervical cancer in whom brachytherapy will be integrated as a boost to external beam radiation either a palliative or curative setting (definitive or postoperative setting)
Lung cancer\r\n* Patients with an endobronchial component causing symptoms\r\n* Patients who cannot undergo resection because of poor lung function or distant lung metastasis
Histological or cytological proof of chemotherapy-naive, extensive, small cell lung cancer or neuroendocrine cancers that are either high grade or poorly differentiated
Confirmed histopathologic diagnosis by National Cancer Institute (NCI) Laboratory of Pathology
Biopsy proven KSHV-associated MCD, confirmed in the Laboratory of Pathology, Center for Cancer Research (CCR)
Patients must have histologically or cytologically confirmed high grade serous or high grade endometrioid ovarian, fallopian tube, primary peritoneal cancer
Patients must have histologically or cytologically confirmed:\r\n* Recurrent endometrial cancer (all histologies, including carcinosarcoma)\r\n* Recurrent ovarian, primary peritoneal (female only), or fallopian tube cancer\r\n** all histologies except low grade serous or clear cell carcinoma unless the patient has a known\r\nsomatic or germline breast cancer (BRCA) mutation disease that is metastatic and for which standard curative\r\nmeasures do not exist or are no longer effective
For the dose expansion cohort, patients with recurrent endometrial cancer, recurrent BRCA mutated ovarian cancer (except first-recurrence platinum sensitive ovarian cancer), and platinum resistant ovarian cancer are eligible
Patients with clear cell or low grade ovarian cancer unless the patient has a known germline or somatic breast cancer (BRCA) mutation or a mutation in another homologous recombination gene
Confirmation of diagnosis of metastatic gastrointestinal epithelial cancer by the National Cancer Institute (NCI) Laboratory of Pathology.
Have a diagnosis of multiple myeloma (MM); the MM diagnosis must be confirmed by internal pathology review of a fresh biopsy specimen at the Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance (FHCRC/SCCA)
All subjects must have history of histologically confirmed small cell lung cancer. Brain biopsy is not required unless diagnosis is judged to be in doubt by the treating physician
Confirmation of the diagnosis of metastatic cancer by the Laboratory of Pathology of NCI
Inability to perform phone call and clinical follow-up at MD Anderson Cancer Center (MDACC)
Ovarian cancer of serous histology
Incurable cancer
Ovarian cancer cohort only: Subjects must have high-grade non-mucinous histology (carcinosarcomas are allowed).
Histological or cytological evidence/confirmation of urothelial cancer.
Subjects with any previously untreated and concurrent cancer that is distinct in primary site or histology from HCC except cervical cancer in-situ, treated nonmelanoma skin cancers, localized prostate cancer not requiring systemic therapy undergoing surveillance, or superficial bladder tumor; subjects surviving a cancer that was curatively treated and without evidence of disease for more than 2 years before enrollment are allowed provided that cancer therapy was completed at least 2 years prior to study entry (date of the informed consent form)
Histologically confirmed epithelial or biphasic pleural or peritoneal mesothelioma not amenable to potentially curative surgical resection; however, patients with biphasic tumors that have a more than or equal to 50% sarcomatoid component will be excluded; the diagnosis will be confirmed by the Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI)
Greater than 2 lines of prior systemic therapy for metastatic non-small cell lung cancer
Presence of another major cancer.
For part B and part C, Presence of other active invasive cancers other than NSCLC or history of treatment for invasive cancer other than NSCLC in the past 3 years. Exceptions are:
Subjects with histologically confirmed advanced, progressive, well-differentiated nonfunctional NET of the pancreas, lung or gastrointestinal (GI) tract per the 7th International Association for the Study of Lung Cancer classification (IASLC) or the American Joint Committee on Cancer (AJCC) staging handbook, 7th edition
Recurrent and/or metastatic unresectable colorectal cancer with hepatic metastases
GENERAL: Prior systemic chemotherapy for epithelial ovarian, fallopian tube, or primary peritoneal cancer.
COHORT 3: ENDOMETRIAL CANCER: AST and ALT levels =< 3 X ULN
Histologically or cytologically confirmed non-small cell lung cancer; if a diagnostic biopsy is available, a pre-treatment biopsy is not required. Patients with a suspected lung cancer may be consented, but pathology must be confirmed prior to initiating treatment on study. Neuroendocrine carcinomas (e.g. small cell lung cancer [SCLC], carcinoid tumors) are not eligible. Carcinomas with neuroendocrine differentiation are eligible.
Life-threatening illness unrelated to cancer
Ovarian Expansion Cohort: Subjects with recurrent disease or histologically or cytologically confirmed Stage III/IV diagnosis of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal carcinoma who have previously progressed while receiving or within 6 months of completing a platinum-containing regimen.
History of anal cancer
Patients currently receiving cancer therapy.
For patients with pancreatic cancer:\r\n* Stage I-III cytologically or histologically-proven pancreatic adenocarcinoma\r\n* Cancer confirmed to be surgically resectable, with surgery evaluation with planned resection\r\n* Patients may have prior neoadjuvant chemotherapy, but no neoadjuvant chemoradiation\r\n* No cancer chemotherapy treatment 2 weeks prior to day 2 of treatment
For patients with metastatic colorectal cancer:\r\n* Stage IV histologically-proven colorectal adenocarcinoma\r\n* Liver metastasis confirmed to be surgically resectable, with surgery evaluation and planned resection; may have minimal extrahepatic disease that is determined to be resectable\r\n* Tumor must be confirmed to be microsatellite stable (MSS); if not already reported at a Clinical Laboratory Improvement Act (CLIA)-certified laboratory, we will be able to perform this at Emory University\r\n* No prior immunotherapy\r\n* No cancer chemotherapy treatment 2 weeks prior to day 1 of treatment
Have discontinued previous treatments for cancer.
No prior treatment for this diagnosis of cancer
Have a diagnosis of BCMA+ multiple myeloma (MM) (>= 5% BCMA+ by flow cytometry on CD138 co-expressing plasma cells obtained within 45 days of study enrollment); the MM diagnosis must be confirmed by internal pathology review of a fresh biopsy specimen at the Fred Hutchinson Cancer Research Center (FHCRC)/Seattle Cancer Care Alliance (SCCA)
Completed cancer treatment with no evidence of active cancer; all post-surgical swelling must be resolved.
Life-threatening illness unrelated to cancer
Diagnosis of primary ovarian cancer of any histology (patients with diagnoses of fallopian tube and primary peritoneal cancer are also eligible), or primary uterine cancer of papillary serous histology
Patients with a separate non-cutaneous cancer diagnosis for which the patient has not been without evidence of disease for at least 5 years
Patients with a current diagnosis of borderline epithelial ovarian tumor (formerly “tumors of low malignant potential”) or recurrent invasive epithelial ovarian cancer treated with surgery only (such as those with stage Ia or Ib low grade lesions) are not eligible; patients with a prior diagnosis of a borderline tumor that was surgically resected and who subsequently develop an unrelated, new invasive epithelial ovarian or peritoneal primary cancer are eligible, provided that they have not received prior chemotherapy for any ovarian tumor
Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, are excluded, unless all of the following conditions are met: stage not greater than I-B; no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell or other Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions
Histologic diagnosis of recurrent epithelial ovarian, fallopian, peritoneal cancer
Diagnosis of primary lung cancer stage I, II, or IIIa OR secondary lung cancer
Confirmation of the diagnosis of metastatic cancer by the Laboratory of Pathology of National Cancer Institute (NCI)
Primary resectable rectal cancer
Participants must have a pathologically-confirmed diagnosis of non-small cell lung cancer (NSCLC)
Confirmation of diagnosis by internal pathology review of initial or subsequent biopsy or other pathologic material at Fred Hutchinson Cancer Research Center (FHCRC)/Seattle Cancer Care Alliance (SCCA)/University of Washington (UW)/Harborview Medical Center (HMC)
Mixed small-cell lung cancer and sarcomatoid variant NSCLC histology
Documentation that the patient is a candidate for chemoradiation of their nasopharyngeal cancer by one of the study investigators
The subject has a diagnosis of another malignancy within 2 years before the first dose of study treatment, except for superficial skin cancer, localized prostate cancer on active surveillance, or localized solid tumors deemed cured by surgery and not treated with systemic anticancer therapy and not expected to require anticancer therapy in the next 2 years i.e., while the subject may be taking study treatment
Any prior treatment for pancreatic cancer
Another cancer with expected survival of < 2 years
Fractures due to prostatic cancer or other osteoblastic metastases to the spine
Metastatic, radioactive iodine (RAI) refractory, differentiated thyroid cancer (including papillary and follicular thyroid cancer and their sub-types such as Hurthle cell thyroid cancer as well as poorly differentiated thyroid cancer); RAI refractoriness is defined as absence of uptake of RAI on either a low dose diagnostic test or a post-treatment RAI scan in measurable lesions or radiographic progression of disease within 12 months of the last course of RAI treatment despite the recorded uptake of RAI with that previous therapy or having a cumulative lifetime administered dose of greater than 600 mCi.
Patients who have received any prior treatment for management of their epithelial ovarian, fallopian tube or peritoneal primary cancer
Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, unless all of the following conditions are met: stage not greater than I-A, grade 1 or 2, no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including serous, clear cell or other FIGO grade 3 lesions
Undergoing or have plans to undergo changes to current cancer treatment.
Histologically proven non-small cell lung cancer (NSCLC)
Patient with a history of previous bladder cancer:
Diagnosis of recurrent and/or metastatic thyroid cancer
Cancer survivors of the state of Maryland cancers of interest
Estimated time to first treatment of 3 years or less according to MD Anderson Cancer Center (MDACC) nomogram.
Patients must have histopathological confirmation of colorectal carcinoma (CRC) by the laboratory of pathology of the National Cancer Institute (NCI) prior to entering this study
Histologically or cytologically confirmed diagnosis of metastatic non-small cell lung cancer (NSCLC) (stage IV, American Joint Committee on Cancer [AJCC] v7.0) that carries an ALK rearrangement, as determined by the Food and Drug Administration (FDA)-approved fluorescence in situ hybridization (FISH) test, using Vysis ALK Break apart FISH Probe, or the Ventana immunohistochemistry (IHC) test; diagnosis using next generation sequencing (NGS) via a local diagnostic test will be accepted for enrollment but will need to be confirmed with either FISH or IHC
Patients with any active invasive cancer are not eligible
Any other cancer (excluding radically operated localized squamous skin cancer) with clinical activity within the last 2 years
Confirmation of the diagnosis of cancer by the Laboratory of Pathology of the NCI
Patients must have previously received standard systemic therapy for their advanced cancer and have been either non-responders (progressive disease) or have recurred; specifically;\r\n* For patients with metastatic colorectal cancer, they must have had at least two systemic chemotherapy regimens that include fluorouracil (5FU), leucovorin, bevacizumab, oxaliplatin and irinotecan or have contraindications to receiving those medications\r\n* For pancreatic cancer, they must have received gemcitabine, 5FU and oxaliplatin or have contraindications to receiving those medications\r\n* Patients with non-small cell lung cancer (NSCLC) must have had appropriate targeted therapy as indicated by abnormalities in ALK, EGFR or expression of PDL-1; other patients must have had platinum-based chemotherapy\r\n* Patients with ovarian cancer or prostate cancer must have had approved first line chemotherapy
Inclusion Criteria:\n\n        -Part A - single-agent dose-escalation part: Patients with histologically confirmed solid\n        tumors or non-Hodgkin's lymphoma (NHL).\n\n        Part B - single-agent expansion part:\n\n          -  Patients with DNA Damage Response (DDR) defects or Mismatched Repair (MMR) deficiency\n             putative biomarker-positive advanced solid tumors of the following histologies: i)\n             castration-resistant prostate cancer (CRPC); ii) lung cancer, including\n             adenocarcinoma, squamous carcinoma, or small cell lung cancer (SCLC); iii) colorectal\n             cancer (CRC) and iv) gynecological tumors (ovarian cancer, endometrial cancer, or\n             cervical cancer).\n\n          -  Patients with advanced mantle cell lymphoma (MCL). Patients with diffuse large B cell\n             lymphoma (DLBCL) known to be positive for DDR defects.\n\n          -  Part C (dose escalation in combination with radium-223 dichloride)\n             Castration-resistant prostate cancer with symptomatic bone metastases (positive bone\n             scan the last 3 months) and no known visceral metastatic disease.\n\n        The following inclusion criteria apply to ALL (dose-escalation and expansion) patients:\n\n          -  Patients with tumors resistant or refractory to standard treatment and for which, in\n             the opinion of the investigator, experimental treatment with BAY1895344 may be of\n             benefit, or patients who refused standard treatment\n\n          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n\n          -  Adequate bone marrow function as assessed by the following laboratory tests\n\n               1. Part A + B: Hemoglobin (HB) >=8.5 g/dL; patients with chronic erythropoietin\n                  treatment consistent with institutional guidelines can be included Part\n                  C:Hemoglobin ?9.0 g/dL\n\n               2. Platelet count >=100,000/mm*3\n\n               3. Absolute neutrophil count (ANC) >=1500/mm*3\n\n        Exclusion Criteria:\n\n          -  Known hypersensitivity to the study drugs or excipients of the preparations or any\n             agent given in association with this study\n\n          -  History of cardiac disease: congestive heart failure New York Heart Association (NYHA)\n             class >II, unstable angina (angina symptoms at rest), new-onset angina (within the\n             past 6 months before study entry), myocardial infarction within the past 6 months\n             before study entry, or cardiac arrhythmias requiring anti-arrhythmic therapy (beta\n             blockers, calcium channel blockers, and digoxin are permitted)\n\n          -  Moderate or severe hepatic impairment, i.e. Child-Pugh class B or C\n\n          -  Patients with known human immunodeficiency virus (HIV) infection\n\n          -  Patients who have an active hepatitis B virus (HBV) or hepatitis C virus (HCV)\n             infection requiring treatment. Patients with chronic HBV or HCV infection are eligible\n             at the investigator's discretion provided that the disease is stable and sufficiently\n             controlled under treatment.\n\n          -  Infections of CTCAE(Common Terminology Criteria for Adverse Events Version) Grade 2\n             not responding to therapy or active clinically serious infections of CTCAE Grade >2
Has metastatic non-small cell lung cancer
Additional criteria for expansion cohorts: A) patients must have histologically-confirmed advanced or recurrent ovarian cancer with RPA or that had progression during prior PARP inhibitor treatment, endometrial cancer with RPA, or other solid tumor types with RPA; B) measurable and biopsy-accessible disease; C) patient must be willing to undergo biopsy procedure; D) prior treatment with PARP inhibitors is allowed
Histologically or cytologically confirmed previously untreated non-small cell lung cancer. If a diagnostic biopsy is available, a pre-treatment biopsy is not required. Patients with a suspected lung cancer are eligible, but pathology must be confirmed prior to initiating treatment on study. Neuroendocrine carcinomas are not eligible. Carcinomas with neuroendocrine differentiation are eligible
Patients with metastatic or node positive non-small cell lung cancer (NSCLC)
Original diagnosis and/or histological confirmation of high-grade serous, high-grade endometrioid, undifferentiated/unclassifiable epithelial ovarian, fallopian tube or primary peritoneal cancer.
History of blocked intestines because of ovarian cancer, unless fully resolved.
Confirmed tissue diagnosis of esophageal squamous cell cancer, adenocarcinoma or poorly differentiated carcinoma, with pathology reviewed at Memorial Sloan-Kettering Cancer Center (MSKCC)
Histological confirmation of non-small cell lung cancer
Histologic/cytologic documentation of non-small cell lung cancer (NSCLC)
Histologically confirmed stage IV or recurrent non-small cell lung cancer (NSCLC) per the 7th International Association for the Study of Lung Cancer classification with squamous or non-squamous histology
Other known active cancer(s) likely to require treatment in the next two (2) years
Prior cancer diagnosis, except appropriately treated localized epithelial skin cancer or cervical cancer.
Patients must have histopathological confirmation of biliary tract carcinoma (BTC) by the Laboratory of Pathology of the National Cancer Institute (NCI) prior to entering this study OR histopathological confirmation of carcinoma in the setting of clinical and radiological characteristics which, together with the pathology, are highly suggestive of a diagnosis of biliary tract carcinoma; the term BTC includes intra- or extrahepatic cholangiocarcinoma, gallbladder cancer or ampullary cancer
Patient must have pathologically-confirmed and previously untreated:\r\n* Non-small cell lung cancer, stage IIIA (T1-3 N2 M0) OR\r\n* Localized esophageal cancer, >= T2, or N+, and M0 according to the American Joint Committee on Cancer (AJCC) 7th edition staging
Cystic pancreatic cancer; microcystic disease may be eligible
Have endocrine pancreatic tumors or ampullary cancer.
Pathologically (histologically or cytologically) proven diagnosis of anaplastic thyroid cancer (a diagnosis that is noted to be consistent with anaplastic thyroid cancer is acceptable)
Patients must have histologically confirmed thymoma or thymic carcinoma by the pathology department/Center for Cancer Research (CCR)/National Cancer Institute (NCI)
Patients must have histologically confirmed medullary thyroid cancer by the laboratory of pathology or a pathology report and history consistent with medullary thyroid cancer; it is not uncommon for a secondary, minor pathologic focus of another form of thyroid cancer to be coincidentally found in 15-20% of patients with medullary thyroid cancer; in such cases, eligibility is based on the discretion of the investigator
Patients must have histologically confirmed MM by Memorial Sloan-Kettering Cancer Center (MSKCC) pathologist, with MM cells expressing BCMA, previously treated with 2+ prior lines of therapy including an immunomodulatory imide drug (IMiD) and a PI, either with refractory, persistent, or progressive disease
Prior history of invasive HPV-related anogenital cancer (cervical, vaginal, vulvar, penile, or anal cancer), or oropharyngeal cancer (base of tongue, tonsil); prior cancer at other sites (including most of oral cavity) or larynx are not exclusions
Patient who are capable to return to MD Anderson Cancer Center (MDACC) for follow-up
Previously treated with a maximum of 4 cancer-directed treatment regimens.
Diagnosis of NB as defined by a) histopathology (confirmed by the Memorial Sloan Kettering Cancer Center [MSK] Department of Pathology), or b) BM metastases or metaiodobenzylguanidine (MIBG)-avid lesion(s) plus high urine catecholamine levels
No evidence of recurrent local or distant breast cancer by physical examination, blood tests (complete blood count [CBC], liver function tests [LFTs], alkaline phosphatase [alk phos]), or symptom-directed imaging, per National Comprehensive Cancer Network (NCCN) guidelines
Patients with newly diagnosed advanced stage (III/IV) ovarian cancer (ovarian/fallopian tube/peritoneal cancer) who have been recommended to receive neoadjuvant carboplatin/paclitaxel chemotherapy with subsequent cytoreductive surgery
Histology (reviewed at MD Anderson Cancer Center [MDACC]) showing recurrent high grade epithelial ovarian, peritoneal, or fallopian tube cancer.
Patients must have advance, recurrent or metastatic endometrial cancer
Evidence that the endometrial cancer is advanced, recurrent, or persistent and has relapsed or is refractory to curative therapy or established treatments.
Arm A dose level 4 (75 mg/m^2 cisplatin): patients with histologically proven chemotherapy-naive advanced unresectable solid tumors for which pemetrexed combined with cisplatin is an indicated regimen (malignant mesothelioma, non-small cell lung cancer, ovarian cancer and thymoma)
As per self report, identifying as an informal caregiver to Memorial Sloan Kettering Cancer Center (MSKCC) patients of any site or stage of cancer
Life-threatening illness unrelated to cancer
Consented for tissue collection on Mays Cancer Center repository 07-32
Has a histological confirmation of pancreatic cancer, mismatch deficient colorectal cancer, or non-small cell lung cancer (NSCLC) that is refractory to standard therapy or for which no standard of care regimen currently exists
Did not achieve pathological complete response (pCR) to any chemotherapy that was given with the intention to induce best response prior surgery. pCR is defined as the current American Joint Committee on Cancer (AJCC) breast cancer staging.
Has a pathologically proven recurrent or metastatic non-squamous non-small cell lung cancer
Patients with pathologically proven non-small cell lung cancer
Differentiated thyroid cancer
Undifferentiated, anaplastic or medullary thyroid cancer
Any known active cancer other than pancreatic primary
Histologically or cytologically proven HPVOC or cervical cancer or anal cancer, based on the presence of HPV type16, detected by immunohistochemistry with P16 staining followed by polymerase chain reaction (PCR) of tumor tissue from the primary or metastatic lesions
Participant may have serous, endometrioid, clear cell, mucinous or undifferentiated type of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer\r\n* Histologic confirmation of the original primary tumor is required via the pathology report
A diagnosis of dedifferentiated liposarcoma confirmed at Memorial Sloan Kettering Cancer Center (MSKCC)
History of any other active cancer diagnosis
Measurable unresectable cancer expressing CD70 as assessed by immunohistochemistry of resected tissue (>= 2+ CD70 positive on >= 50% of cancer cells, or >= 1+ CD70 positive on >= 75% of cancer cells)
Patients must have histologic proof of urothelial cancer; this includes bladder cancer, in addition to other tumors of the urothelial lining including renal pelvis, ureteral, and urethral cancer; upper tract urothelial carcinoma will also be included; this group may include any patient requiring cystectomy, including muscle invasive disease (cT2-3aN0M0), whose tumor could not be completely removed at transurethral resection
Histologically confirmed epithelial or biphasic mesothelioma not amenable to potentially curative surgical resection; however, patients with biphasic tumors that have a >= 50% sarcomatoid component will be excluded; the diagnosis will be confirmed by the Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI)
For LY3300054 + merestinib in pancreatic cancer:
Patients must have histologically confirmed endometrial cancer, epithelial ovarian, fallopian tube, or primary peritoneal cancer (all histologic subtypes)
No previous therapy for pancreatic cancer
Confirmation of diagnosis of metastatic cancer by the Laboratory of Pathology at the Montefiore Medical Center
Received any prior treatment with any taxane (docetaxel or paclitaxel) for small cell lung cancer
Pathologically (histologically) proven diagnosis of non-muscle invasive (Ta, Tis or T1) bladder cancer
Not have a prior history of non-bladder cancer unless the cancer is clinically stable
Have muscle-invasive (>= T2) bladder cancer
Platinum sensitive relapsed small cell lung cancer (module 1)
gBRCAm ovarian cancer (modules 3 and 5)
Metastatic or relapsed Gastric cancer (adenocarcinoma) (module 4)
gBRCAm negative ovarian cancer (modules 6 and 7)
History of bladder cancer
Have histologically or cytologically confirmed gynecologic tumor of mullerian origin, specifically epithelial ovarian, fallopian tube, primary peritoneal, or uterine endometrial cancer
Histology showing high-grade epithelial non-mucinous ovarian, primary peritoneal, or fallopian tube cancer
Prior treatment for ovarian, fallopian tube, or primary peritoneal cancer
Pathologically confirmed diagnosis of cancer
Confirmation of diagnosis by internal pathology review of initial or subsequent biopsy or other pathologic material at the Fred Hutchinson Cancer Research Center (FHCRC)/Seattle Cancer Care Alliance (SCCA)
Pathologically confirmed non-small lung cancer
Histologically or cytologically confirmed diagnosis of anaplastic thyroid cancer or undifferentiated thyroid cancer; a diagnosis of possible anaplastic thyroid cancer (ATC)/undifferentiated thyroid cancer (UTC) will be allowed if the clinical presentation is consistent with anaplastic or undifferentiated thyroid cancer
Patients with lung cancer with squamous histology
Other known active cancer(s) likely to require treatment in the next two (2) years
Recurrent or progressive advanced stage non-small cell lung cancer (no small cell component); NOTE: pathology reports documenting the diagnosis of NSCLC are required to be reviewed to confirm outside diagnosis
superficial bladder cancer;
Recurrent high-risk non-muscle-invasive bladder cancer after prior intravesical BCG therapy meeting all of the following criteria: \r\n* Histologically documented diagnosis of urothelial carcinoma confirmed by the Department of Pathology at Memorial Sloan Kettering Cancer Center (MSKCC)\r\n* Documentation of activating FGFR3 mutation or gene fusion on an assay performed in a Clinical Laboratory Improvement Act (CLIA)-certified laboratory\r\n* History of high-grade non-muscle-invasive bladder cancer (NMIBC)\r\n* Clinical evidence of high-grade, stage pTa NMIBC\r\n* Prior intravesical therapy with at least one induction course of BCG\r\n* Multiple papillary lesions with at least one amenable to marker tumor study (=< 1 cm, non-invasive; or could be partially resected to leave a non-invasive lesion =< 1 cm) OR solitary papillary lesion amenable to marker tumor study (=< 1 cm, non-invasive)
Diagnosis of NB as defined by international criteria, i.e., histopathology (confirmed by the Memorial Sloan Kettering Cancer Center [MSKCC] Department of Pathology) or bone marrow metastases plus high urine catecholamine levels
Biopsy-proven non-hematopoietic malignancy, except for small cell lung cancer, germ cell cancer, or unknown primary tumor
Diagnosis of International Federation of Gynecology and Obstetrics (FIGO) grade 3 endometrioid cancer, serous, clear cell, or mixed high grade endometrial cancer with confirmation on research-related endometrial biopsy
FIGO grade 1 or 2 endometrioid cancer
Prior treatment for endometrial cancer
Confirmation of diagnosis of metastatic melanoma by the Laboratory of Pathology of National Cancer Institute (NCI)
Patient has histologically confirmed (1) colorectal cancer, triple negative breast cancer, pancreatic cancer, non-small cell lung cancer, head and neck cancer, ovarian cancer, lymphoma, sarcoma, bladder cancer, or melanoma with defects in one or more of the following genes: ABL2, ACVR1B, APC, ASXL1, ATM, ATR, BLM, BRCA1, BRCA2, CDK12, CDKN1A, CDKN1B, CDKN2A, CHD4, CYLD, DICER1, DNMT3A, ERBB3, EZH2, FGFR2, FLT3, GATA3, HGF, KDM6A, KDR, KEAP1, KIT, KMT2D, KRAS, MAGI2, MAP3K1, MED12, MET, MSH-2, MSH-6, MYC, NA, NF1, NF2, NOTCH1, NOTCH2, NRAS, NSD1, PIK3C2B, PIK3CA, PIK3CB, PIK3R1, PTCH1, PTPN11, RB1, RUNX1, SETD2, SMARCA4, SOX9, STAG2, TAF1, TBX3, TET2, TP53, XPO1; (2) documented IDH1 mutated solid tumor (other than glioma); or (3) documented IDH1 mutated or MGMT promoter methylation positive glioblastoma multiforme (GBM) or anaplastic astrocytoma. Note: Genetic abnormalities must be documented by Foundation Medicine (or equivalent) genomic profile report.
Cervical esophageal cancer will not be entered in this study
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
Pre-operative or post-operative or planned radiation therapy for the current lung cancer
Patients who had excisional biopsy for diagnosis of their cancer (i.e., instead of a core biopsy)
History of another invasive cancer within 5 years with the exceptions of nonmelanoma skin cancers and American Joint Committee on Cancer (AJCC) stage 0 or 1 cancers that have a remote probability of recurrence in the opinion of the investigator
A histologically confirmed diagnosis of high-grade serous epithelial ovarian cancer including primary peritoneal and fallopian tube malignancies; all other histologies, including mixed histology, are excluded
Patients with a history of primary endometrial cancer are excluded unless the following conditions are met:\r\n* Stage not greater than IA\r\n* Not a poorly differentiated subtype (including papillary serous, clear cell or other International Federation of Gynecology and Obstetrics [FIGO] grade 3 lesions)
Participants must have metastatic colorectal or pancreatic cancer
Prior history of colorectal cancer
Patients with recurrent endometrial cancer.
Subjects with histologically confirmed SCLC, non-small cell lung cancer (NSCLC), ovarian cancer, cervical cancer, and neuroendocrine cancers will be eligible; pathological confirmation of diagnosis will be done at National Cancer Institute (NCI) Laboratory of Pathology; patients with other histologies will be allowed if no standard treatment options exist
Histological confirmation of SCLC or extrapulmonary small cell cancer, to be performed by the NCI Laboratory of Pathology
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
Subjects with ovarian and endometrial cancer (endometrial cancer only in the expansion cohort) with:
Subject has primary ovarian (including low malignant potential), fallopian tube, or primary peritoneal cancer Federation of Gynecology and Obstetrics (FIGO) stage III or IV defined surgically at the completion of initial abdominal surgery
Have received any type of cancer immunotherapy including the same pancreatic cancer vaccine
ADDITIONAL CRITERIA FOR STUDY CONTINUATION: Radiographic evidence of pancreatic cancer recurrence
Pathologically confirmed non-small lung cancer
Non-small cell lung cancer of squamous histology
Have suspected or known invasive (>= T1) bladder cancer
Have non-invasive (< T1) bladder cancer
Prior radiotherapy for pancreatic cancer
Patients with pathologically confirmed pancreatic cancer referred for image-guided radiation therapy (IGRT)
Previous treatment for pancreatic cancer
Patient is NOT receiving any other anti-cancer agents or radiotherapy at the time of study entry
Histologic or cytologic diagnosis of adenocarcinoma non-small cell lung cancer
Previously treated for advanced cancer and there are no curative therapy options available
Previously treated for advanced cancer with no additional therapy options available known to prolong survival
Patients must have histologic or cytologic proof of a non-hematologic malignancy confirmed by Memorial Sloan-Kettering Cancer Center (MSKCC) pathologic review
Patients must have a diagnosis of neuroblastoma (International Classification of Disease for Oncology [ICD-O] morphology 9500/3) confirmed by Memorial Sloan-Kettering Cancer Center (MSKCC) pathologic review
Any suspicion for invasive cancer
Patients must have histologically or cytologically confirmed, known or highly suspected advanced (International Federation of Gynecology and Obstetrics [FIGO] stage II-IV) ovarian, primary peritoneal, or fallopian tube cancer, scheduled for primary or interval cytoreductive surgery
Patients must NOT receive other anti-cancer agents while on study
Lymphovascular invasion (LVI) on TORS resection of the primary cancer
Metastatic or locally advanced refractory/recurrent cancer that expresses MAGE-A3 as assessed by one of the following methods: reverse transcriptase (RT)-polymerase chain reaction (PCR) on tumor tissue defined as 30,000 copies of MAGE-A3 per 10^6 glyceraldehyde-3-phosphate dehydrogenase (GAPDH) copies, or by immunohistochemistry of resected tissue defined as 10% or greater of tumor cells being 2-3+ for MAGE-A3, or serum antibody reactive with MAGE-A3; metastatic cancer diagnosis will be confirmed by the Laboratory of Pathology at the National Cancer Institute (NCI)
Pre-operative diagnosis or suspicion of papillary thyroid cancer, usually by fine needle aspiration (FNA)
Previously untreated stage IV lung adenocarcinoma confirmed at the Memorial Sloan-Kettering Cancer Center (MSKCC)
Metastatic or locally advanced refractory/recurrent cancer that expresses MAGE-A3 as assessed by one of the following methods: reverse transcriptase (RT)-polymerase chain reaction (PCR) on tumor tissue defined as 30,000 copies of MAGE-A3 per 10^6 glyceraldehyde 3-phosphate dehydrogenase (GAPDH) copies, or by immunohistochemistry of resected tissue defined as 10% or greater of tumor cells being 2-3+ for MAGE-A3, or serum antibody reactive with MAGE-A3; metastatic cancer diagnosis will be confirmed by the Laboratory of Pathology at the National Cancer Institute (NCI)
Diagnosis of NB as defined by international criteria, i.e., histopathology (confirmed by the Memorial Sloan Kettering Cancer Center [MSKCC] Department of Pathology) or BM metastases plus high urine catecholamine levels
Must have:\r\n* Recurrent or progressive ovarian cancer, primary peritoneal cancer or fallopian tube cancer after prior treatment with platinum and taxanes\r\n* Histologic confirmation of the original primary tumor\r\n* Prior bilateral oophorectomy
Cancer antigen (CA) 19-9 level (to establish baseline)
Active life-threatening cancer requiring treatment other than ALL
Confirmation of diagnosis of metastatic cancer including melanoma by the Laboratory of Pathology of the National Cancer Institute (NCI)
Patients with primary ampullary, biliary or duodenal cancer would be excluded
Have a prior histologic diagnosis of cancer other than small cell lung cancer, lymphoma, and germ cell histologies
History of, or active bladder cancer
Diagnosis of NB defined by a) histopathology (confirmed by the Memorial Sloan Kettering Cancer Center [MSKCC] Department of Pathology), or b) bone marrow (BM) metastases or meta-iodobenzylguanidine (MIBG)-avid lesion(s) plus high urine catecholamine levels
Histologic or cytologic confirmation of lung cancer (squamous, ras-mutated adenocarcinoma or small cell lung cancer)
Pathologically proven diagnosis of unresected stage II-IIIB, or recurrent after surgical resection or stereotactic body radiation therapy (SBRT) non-small cell lung cancer
Histologic confirmation of disease in the Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI), National Institutes of Health (NIH)
Uterine cancer participants will be International Federation of Gynecology and Obstetrics (FIGO) stage IIIC and may have endometrioid cancer, clear cell cancer, uterine papillary serous cancer, carcinosarcoma, or endometrial stromal sarcoma
Evidence of extra-abdominal cancer dissemination or hematogenous cancer dissemination
Potentially resectable or unresectable esophageal cancer patients
Any patient deemed eligible for chemoradiation for esophageal cancer treatment
Patients with active second malignancy are allowed as long as it is determined by the treating physician that the treatment of esophageal cancer is of higher priority through proper evaluation; however patients with active stage 4, metastatic cancers, receiving other systemic therapies at the time of the esophageal cancer diagnosis, will not be eligible
Patients must have adequate transoral exposure of the oral cavity and laryngopharynx for TORS instrumentation; for the non-surgical arm: Patients planned to receive non-surgical treatment (e.g., chemo and/or radiation); the 7 surgical (TORS) arms include: tonsil cancer: T1, tonsil cancer: T2, base of tongue cancer: T1, base of tongue cancer: T2, supraglottic cancer, unknown primary cancer, and other tumors; the 3 non-surgical arms are: tonsil cancer, base of tongue cancer, and supraglottic/hypopharyngeal/other cancers
Early stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue
Diagnosis of non-small cell lung cancer.
Diagnosis of recurrent and/or metastatic thyroid cancer
A reasonable suspicion of ovarian cancer by the treating oncologist is required, evidenced by abdominal carcinomatosis, omental caking, pleural effusions or ascites AND an elevated CA125 > 250 OR CA125:carcinoembryonic antigen (CEA) ratio > 25 OR CA125 =< 250 with no evidence of gastrointestinal (GI) cancer
Subjects with comorbidities that would limit their two year survival for reasons other than ovarian cancer
Pathologic diagnosis to be confirmed at Massachusetts General Hospital (MGH) or other Dana-Farber/Harvard Cancer Center (DF/HCC) institution; in cases of progressive or recurrent disease, pathologic diagnosis may be from time of original biopsy and/or surgery
Radiographic evidence of pancreatic cancer recurrence
Diagnosis of neuroblastoma (NB) as defined by international criteria, i.e., histopathology (confirmed by the Memorial Sloan-Kettering Cancer Center [MSKCC] Department of Pathology) or bone marrow metastases plus high urine catecholamine levels
Pathologically proven diagnosis of small cell lung cancer (SCLC)
The cancer must be unresectable
The cancer must be unresectable
Patients must have the diagnosis of NB in accordance with the international criteria, i.e., either histopathology (confirmed by the Memorial Sloan Kettering Cancer Center [MSKCC] Department of Pathology) or bone marrow (BM) involvement plus elevated urinary catecholamines
Patients must have a tissue diagnosis of grade 1, 2 and/or 3 A/B LYG (or a diagnosis consistent with LYG) confirmed by the Laboratory of Pathology, National Cancer Institute (NCI); final histopathologic classification and pathologic grade will be determined by Stefania Pittaluga, M.D. or her designee
Diagnosis confirmed by staff of the Hematopathology Section, Laboratory of Pathology, National Cancer Institute (NCI)
Patients with histologically or cytologically confirmed diagnosis of advanced, epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian tube cancer who have all of the following:
Histologically confirmed diagnosis of one of the following cancers: melanoma (including mucosal and/or ocular), bladder/urothelial, non-small cell lung cancer, pancreatic adenocarcinoma, breast, colorectal, gastric, esophageal, renal cell, hepatic, ovarian, head and neck, and cholangiocarcinoma
Participants must have histologically or cytologically confirmed endometrial, ovarian (including ovarian, fallopian tube, primary peritoneal), cervical, vaginal, or vulvar cancer that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
Synchronous cancer.
Life-threatening illness unrelated to cancer
Part 1: advanced stage solid tumors; Part 2: non-small cell lung cancer (NSCLC), pancreatic cancer and cutaneous melanoma
Inclusion Criteria:\n\n        Caregivers\n\n          -  Mothers and fathers (biologic/adoptive/step parents/legal guardians) of pediatric\n             cancer survivors\n\n          -  18 years or older\n\n          -  Fluent in English\n\n        Pediatric Cancer Survivors\n\n          -  Diagnosis of cancer\n\n          -  between 5-17 years of age at study entry\n\n          -  off active cancer treatment for 6 months to 4 years, or in the maintenance phase of\n             treatment\n\n          -  reside with a participating caregiver\n\n          -  able to engage in PA tailored to current medical status\n\n          -  NOT taking medications that affect body weight, e.g., steroids within 6 months of\n             enrollment\n\n          -  at or above the 85th BMI %ile.\n\n        Exclusion Criteria:\n\n        Caregivers\n\n          -  are non-ambulatory\n\n          -  do not reside with the PCS at least 50% of the time.\n\n        Pediatric cancer survivor\n\n          -  relapse during the intervention\n\n          -  taken a medication known to affect body weight such as oral steroids or antipsychotic\n             medications within 6 months of enrollment
Subjects with locally invasive or metastatic, epithelial ovarian, fallopian tube, or primary peritoneal cancer
Subjects with low-grade ovarian, fallopian tube, or Primary peritoneal cancer
In Stage 1, recurrent or metastatic PR-expressing cancer that has the potential to benefit from an anti-progestin treatment including but not limited to endometrial cancer, ovarian, or breast cancer or uterine sarcoma. In Stage 2, recurrent or metastatic PR-expression uterine endometrioid adenocarcinoma that is determined to be APRpos.
In situ cervical cancer
Patients with medullary thyroid cancer
Previously treated with at least one prior irinotecan-containing regimen for colorectal cancer.
Patient must have diagnosis of lung cancer, breast cancer, colorectal cancer, cholangiocarcinoma, gastric cancer, pancreatic cancer, prostate cancer, uterine cancer, ovarian cancer, esophageal cancer, or head and neck cancer
Operable cancer
Cancer of pancreas, colon or rectum
Lung cancer
Renal cell cancer
Colorectal cancer
Histologically proven rectal cancer
Surgically unresectable rectal cancer
Dukes C colon cancer, high risk Dukes B colon cancer, Dukes B rectal cancer or Dukes C rectal cancer (see Appendix 1 for definition of High Risk Dukes B)
Currently benefiting from the treatment with ruxolitinib alone, ruxolitinib plus background cancer therapy, or background cancer therapy alone, as determined by the investigator.
Patients with PRIMARY HEPATIC CANCER must have an undetectable viral load for Hepatitis B and C.
Patients with Primary Hepatic Cancer have not recently been treated with antivirals.
History of other cancer within 3 years
Previously treated with at least one prior irinotecan-containing regimen for colorectal cancer
Histologically confirmed recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer for which there is no known or established treatment available with curative intent.
Histological diagnosis must be based on surgical or core biopsy not just fine needle aspiration. Biopsies performed at other institutions must undergo pathology review and confirmation at MD Anderson Cancer Center.
Patients with biopsy-confirmed ovarian or other gynecologic cancers (fallopian tube, peritoneal, endometrial, or cervical cancer) who have recurred after or progressed on frontline and one or more second-line standard treatments are eligible for the dose-finding phase; enrollment for the expansion cohort will be limited to subjects with high grade epithelial ovarian, fallopian tube, or peritoneal carcinomas
Confirmed diagnosis of differentiated thyroid cancer (follicular or papillary thyroid cancer and their variants)
BLADDER: Patients must be considered to be an operative candidate by the urology service at MD Anderson Cancer Center
Histological diagnosis of recurrent or metastatic cervical, vaginal, or vulvar cancer
Non-muscle invasive, localized bladder cancer (Tis, Ta, T1)
Resectable pancreatic cancer
Histopathologic documentation (must be performed or reviewed at MD Anderson) of recurrent high grade epithelial ovarian cancer.
Histology showing recurrent high grade epithelial ovarian, peritoneal, or fallopian tube cancer
Chemotherapy, hormonal, or biologic treatment for ovarian, fallopian tube, or primary peritoneal cancer in the last 21 days
Recurrent non-small cell lung cancer
After the T cell infusion, patients may not be on any other treatments for their cancer aside from those included in the treatment section of the protocol
The participant must have a histologic diagnosis of recurrent high grade serous ovarian cancer (ovarian, tubal, peritoneal), to be treated with chemotherapy
Indication for radical cystectomy for urothelial cancer
Histologically proven diagnosis of salivary cancer by central pathology review
No definitive resection of pancreatic cancer
Non-invasive, superficial bladder cancer.
Secondary Treatment (eg, adjuvant systemic chemotherapy for bladder cancer) following surgical removal of bladder cancer
Patients must have histologically or cytologically confirmed metastatic endometrial cancer; eligible histologies for the experimental cohort are: endometrioid or serous; eligible histologies for the exploratory cohort are: carcinosarcoma, clear cell, mixed, adenosquamous and any other rare sub-type of endometrial cancer
Any antineoplastic therapy for this cancer before randomization
Synchronous colon cancer
Patients with deleterious BRCA 1/2 mutated ovarian cancer are not eligible
Patients with small cell lung cancer (SCLC) documented by histology or cytology from brushing, washing, or needle aspiration of a defined lesion, but not from sputum cytology alone
For patients with oropharyngeal cancer only: p16 negative, confirmed by central pathology review
The target tumor is limited to neuroblastoma and other GD2-positive solid tumors; diagnosis should be histologically verified at Children’s Hospital of Michigan (CHM) or Memorial Sloan Kettering Cancer Center (MSKCC)
TREATMENT: Patients with ovarian cancer and breast cancer gene (BRCA) mutations must have received specific poly(adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor therapy; if these patients have other mutations of interest, they will be eligible to receive agents based on that mutation
Patients must have histologically or cytologically confirmed small cell lung cancer whose disease has relapsed or progressed after >= 1 prior therapy, one of which must have been a platinum doublet; pathology confirmation must be done at Sidney Kimmel Comprehensive Cancer Center (SKCCC) or at the local participating site
Histologic confirmation of disease in the Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI), National Institutes of Health (NIH)
Patients with a history of other invasive malignancies, with the exception of nonmelanoma skin cancer and other specific malignancies as noted below, are excluded if there is any evidence of other malignancy being present within the last three years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy\r\n* Carcinoma in situ of the breast or cervix\r\n* Primary endometrial cancer meeting the following conditions: stage not greater than IA, grade 1 or 2, no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell, or other federation of gynecology and obstetrics (FIGO) grade 3 lesions
Patients must have histologically or cytologically confirmed ovarian cancer, peritoneal cancer or fallopian tube cancer and must have a histological diagnosis of either serous or endometrioid cancer based on local histopathological findings; both endometrioid and serous histology should be high-grade for eligibility of non-mutation carriers; patients with clear cell, mixed epithelial, undifferentiated carcinoma, or transitional cell carcinoma histologies are also eligible, provided that the patient has a known deleterious germline BRCA1 or BRCA2 mutation identified through testing at a clinical laboratory\r\n* Note: Due to the long acceptance of BRCA testing through Myriad, Myriad testing will be accepted; if testing for BRCA is done by other organizations, documentation from a qualified medical professional (e.g., ovarian cancer specialty physician involved in the field, high risk genetics physician, genetics counselor) listing the mutation and confirming that the laboratory results showed a recognized germ line deleterious BRCA 1 or BRCA 2 mutation or BRCA rearrangement is required; a copy of Myriad or other BRCA mutational analysis (positive or variants of unknown significance [VUS] or negative) reports will be requested but not required for study enrollment
Patients must not have extrahepatic cancer
Patients with colorectal cancer should have failed at least one oxaliplatin-containing regimen
Diagnosis of recurrent epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer that has failed or progressed after at least 1 prior salvage chemotherapy regimen directed at recurrent/metastatic disease
For ovarian, fallopian tube, and peritoneal cancers only: platinum-resistant, defined as =< 183 days from the date of the most recent dose of chemotherapy containing either carboplatin or cisplatin until the first evidence of cancer recurrence or progression either symptoms directly attributable to cancer, radiographic recurrence of cancer, or cancer antigen 125 (CA-125) > 70, confirmed >= 7 days later (confirmation of elevated CA-125 may be beyond 183 days and still count as platinum-resistant)
Concomitant treatment with corticosteroids greater than physiologic doses (used in the management of cancer or non-cancer-related illnesses); topical (if not including the proposed vaccination sites) or inhalational steroids are allowed
Prior resection of lung cancer is allowed, if at least five years have elapsed between previous resection and registration
Histologic confirmation of non small cell lung cancer or other solid primary tumor metastatic to lungs
Medically inoperable stage I or II non small cell lung cancer with negative lymph nodes or metastatic cancer to lung with less than or equal to 3 lesions
Subject must be also enrolled on an National Cancer Institute (NCI) allogeneic transplant protocol
Subjects with advanced colorectal, gastric, hepatic or pancreatic cancer
Diagnosis must be confirmed by the National Cancer Institute (NCI) Laboratory of Pathology
Renal cell cancer
Histological confirmation of, or cytology reported and confirmed, anaplastic thyroid cancer in thyroid mass and/or regional lymph nodes\r\n* NOTE: A diagnosis reported as “poorly differentiated carcinoma consistent with anaplastic thyroid cancer” will be accepted
Diagnosis of presumed non-muscle invasive bladder cancer based on office based cystoscopy (primary or recurrent), and planned transurethral resection of bladder tumor (TURBT)
Pathologically (histologically) proven diagnosis of primary carcinoma of the bladder (transitional cell cancer) within 8 weeks of registration; operable patients whose tumors are primary carcinomas of the bladder and exhibit histologic evidence of muscularis propria invasion and are American Joint Committee on Cancer (AJCC) clinical stages T2-T4a, Nx or N0, M0
Patients with human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer or ovarian cancer should have received at least two lines of systemic therapy in the advanced setting
Prior systemic anti-cancer therapy for pancreatic cancer; note that prior chemotherapy for a different cancer is allowable
Diagnosis: Patients must have histologically confirmed medullary thyroid cancer by the Laboratory of Pathology or a pathology report and history consistent with medullary thyroid cancer; it is not uncommon for a secondary, minor pathologic focus of another form of thyroid cancer to be coincidentally found in 15-20% of patients with medullary thyroid cancer; in such cases, eligibility is based on the discretion of the investigator
Confirmation of diagnosis of metastatic ocular melanoma by the Laboratory of Pathology of the National Cancer Institute (NCI)
Patients with a history of cancer other than skin cancer within 5 years of the initiation of protocol treatment
Prior history of lung cancer
Pathologically proven diagnosis of endometrial or cervical cancer
Patients must have FDG-avid (maximum SUV >= 4.0) (from PET scan of any date, any scanner) and histologically or cytologically proven non-small cell lung cancer
Morphologic confirmation of a diagnosis of AML or ALL at Memorial Sloan-Kettering Cancer Center (MSKCC)
Pathologically (histologically or cytologically) proven diagnosis of anaplastic thyroid cancer (a diagnosis that is noted to be “consistent with anaplastic thyroid cancer” with the presence of a thyroid mass is acceptable)\r\n* Note: tissue collection for central review is mandatory, but central review is not required for eligibility; treatment will be started prior to central review
All patients must have a procedure for determining diagnosis of epithelial ovarian, fallopian tube, primary peritoneal, or carcinosarcoma with appropriate tissue for histologic evaluation
Patients with a current diagnosis of borderline epithelial ovarian tumor (formerly “tumors of low malignant potential”) or recurrent invasive epithelial ovarian, primary peritoneal or fallopian tube cancer treated with surgery only (such as patients with stage IA or IB low-grade epithelial ovarian or fallopian tube cancers) are not eligible\r\n* NOTE: Patients with a prior diagnosis of a borderline tumor that was surgically resected and who subsequently develop an unrelated, new invasive epithelial ovarian, peritoneal primary or fallopian tube cancer are eligible, provided that they have not received prior chemotherapy for any ovarian tumor
Patients with synchronous primary endometrial cancer or a past history of endometrial cancer, unless all of the following conditions are met:\r\n* Stage not greater than IB\r\n* No more than superficial myometrial invasion\r\n* No vascular or lymphatic invasion\r\n* No poorly differentiated subtypes, including papillary serous, clear cell, or other International Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions
Pathologically proven diagnosis of stage IIIA (T1-T3) (American Joint Committee on Cancer [AJCC] Staging, 7th edition) with a single primary lung parenchymal lesion and ipsilateral positive mediastinal nodes within 12 weeks of registration; note: the primary tumor does not require tissue diagnosis; documentation of non-small cell carcinoma may originate from the mediastinal node biopsy or aspiration
Patients who are to be given HDR brachytherapy for treatment of solid tumor of the following:\r\n* Gynecologic (primary cervix and recurrent cervix/uterine cancer)\r\n* Prostate (locally advanced/recurrent cancer)
Patients with hematologic malignancies, myelodysplasia, or myeloproliferative disorders; the diagnosis must be histologically confirmed by the Laboratory of Pathology of the National Cancer Institute (NCI) or Hackensack (there will be no central pathology review)
Participants with synchronous primary endometrial cancer, or a past history of endometrial cancer unless all of the following conditions are met: endometrial cancer stage not greater than IA, no vascular or lymphatic invasion, no poorly differentiated subtypes including serous, clear cell, or other FIGO grade 3 lesions.
Diagnosed with advanced epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer
Diagnosis of clear cell or low grade ovarian cancer
Current systemic therapy for bladder cancer
Patients with a prior histologic diagnosis of borderline, low malignant potential (grade 0) epithelial carcinoma that was surgically resected and who subsequently developed an unrelated, new invasive epithelial ovarian or peritoneal primary cancer are eligible provided that they meet the criteria listed above
Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, are excluded, unless all of the following conditions are met: stage not greater than I-B; no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell or other International Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions
Nonmelanomatous skin cancer.
Patient must have histologically confirmed, advanced (FIGO Stage III or IV) high-grade predominantly serous or endometrioid ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have completed first line platinum based chemotherapy (neoadjuvant or adjuvant)
Patient has mucinous or clear cell subtypes of epithelial ovarian cancer, carcinosarcoma or undifferentiated ovarian cancer
Diagnosis of non-small cell lung cancer
Diagnosed with recurrent stage IIIB non-small cell lung cancer and failed previous concurrent chemoradiation with no further curative options.
Squamous cell or undifferentiated gastric cancer
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).
Tumor biopsies are required. If a subject has inaccessible lesions, such as in ovarian cancer, HCC, or gastric cancer, or highly vascular lesions, such as RCC, enrollment may be considered with medical monitor approval, and archived tissue may be acceptable.
Prior BRCA-associated cancer as long as there is no current evidence of the cancer
Patients must have pathologically or cytologically Memorial Sloan-Kettering Cancer Center (MSKCC) confirmed diagnosis of gastric or GEJ adenocarcinoma
Histologically confirmed Stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer, including malignant mixed Müllerian tumors with high grade serous component
History of other cancer within 3 years.
Gastric Cancer
Pancreatic Cancer
Small Cell Lung Cancer
Bladder Cancer
Ovarian Cancer
Serious illness other than cancer that would preclude safe participation in the study.
Histologically confirmed epithelial ovarian, fallopian tube, or peritoneal cancer, including malignant mixed Müllerian tumors with high grade serous component.
Pancreatic Cancer
Non-small Cell Lung Cancer (NSCLC):
Patients with a histologically confirmed diagnosis of non-small cell lung cancer (NSCLC), including neuroendocrine tumors or small cell lung cancer (SCLC) who are being evaluated for palliative WBRT (with or without neurosurgical resection or stereotactic radiosurgery [SRS]) for radiologically or histologically diagnosed brain metastases presumed to be from the lung cancer are eligible for this Phase I study; group 2 will only include NSCLC patients
History of another invasive cancer within 3 years before screening, with the exception of fully treated cancers with a remote probability of recurrence
Confirmed High Grade Serous Ovarian Cancer, and positive nuclear immunohistochemical (IHC) staining for p53
Subjects with a history of endometrial cancer are eligible only if they presented with a stage lower than 1A and if the histology was a subtype other than poorly differentiated
Patients must have appropriate staging studies identifying them as American Joint Committee on Cancer (AJCC) stage II or III non small cell lung cancer, (according to AJCC staging, 6th edition), or recurrent non small cell lung cancer; histologic confirmation of cancer will be required by biopsy or cytology within 9 months of study entry
Adequate recovery from most recent systemic or local treatment for cancer
Phase 2: Subjects with advanced or metastatic endometrial cancer, gastric cancer (including stomach, esophageal, and GEJ), and SCCHN.
Histologically or cytologically confirmed carcinoma (prostate cancer, renal cell carcinoma, head and neck cancer, triple-negative breast cancer, bladder cancer, non-small cell lung cancer) or melanoma that overexpresses B7-H3.
An incidental focus of medullary thyroid cancer (MTC), DTC, and/or poorly differentiated thyroid cancer in a participant with ATC is allowed.
Have discontinued previous treatments for cancer;
Patients must have histologically or cytologically confirmed epithelial ovarian, primary peritoneal and fallopian tube carcinoma; all histologic subtypes of epithelial ovarian cancer are eligible, but only patients with high grade serous ovarian cancer will be considered for the statistical analysis; non-high grade serous cancers will be allowed in an exploratory cohort
Advanced non-small cell lung cancer
Histologically proven advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer
Patients with recurrent epithelial ovarian cancer, fallopian tube cancers or primary peritoneal carcinoma defined as:
Without a history of a cancer diagnosis
Without history of cancer diagnosis using chemotherapy
Diagnosis of squamous or undifferentiated gastric cancer
Patients with histologically diagnosed relapsed high grade serous ovarian cancer (including primary peritoneal and/or fallopian tube cancer) or high grade endometrioid cancer. Patients are eligible to undergo BRCA testing even if they have not yet had recurrence or progression of disease >6 months (>/=183 days) after completion of their last platinum therapy.
History of another invasive cancer within 3 years of randomization;
No other active malignancy requiring therapy such as radiation, chemotherapy, or immunotherapy; exceptions to this are as follows: localized non-melanotic skin cancer and any cancer that in the judgment of the investigator has been treated with curative intent and will not interfere with the study treatment plan and response assessment
Part B: First-Line Colorectal Cancer
Part B: Second-Line Colorectal Cancer
Inclusion Criteria:\n\n          -  Male or female patients, >18 years of age, able to understand and give written\n             informed consent.\n\n          -  Histologically or cytologically confirmed epithelial cancer of one of the following\n             types:\n\n          -  Colorectal\n\n          -  Gastric adenocarcinoma\n\n          -  Esophageal cancer\n\n          -  Hepatocellular carcinoma\n\n          -  Non-small cell lung cancer\n\n          -  Small cell lung cancer\n\n          -  Ovarian epithelial cancer\n\n          -  Cervical Cancer\n\n          -  Endometrial Cancer\n\n          -  Breast cancer\n\n          -  Hormone-refractory prostate cancer\n\n          -  Pancreatic ductal adenocarcinoma\n\n          -  Head and neck cancers- squamous cell\n\n          -  Renal cell cancer (clear cell)\n\n          -  Urothelial cancers\n\n          -  Glioblastoma multiforme\n\n          -  Follicular thyroid cancer\n\n        (Note: Confirmation of Trop-2 expression by immunohistology or other means is not required,\n        but the Sponsor will request tissue specimens from archived materials for determination of\n        Trop-2 expression.)\n\n          -  Stage IV (metastatic) disease.\n\n          -  Refractory to or relapsed after at least one prior standard therapeutic regimen\n             (Appendix 1 lists approved or standard chemotherapeutic agents for each cancer type.\n             Patients who have not received all approved or standard treatments for their cancer\n             must be informed that these alternatives to receiving IMMU-132 are available prior to\n             consenting to participate in this trial.)\n\n          -  Adequate performance status (ECOG 0 or 1)\n\n          -  Expected survival > 6 months.\n\n          -  Measurable disease by CT or MRI.\n\n          -  At least 2 weeks beyond treatment (chemotherapy, investigational drugs including small\n             molecular inhibitors, immunotherapy and/or radiation therapy) or major surgery and\n             recovered from all acute toxicities to Grade 1 or less (except alopecia).\n\n          -  At least 2 weeks beyond high dose systemic corticosteroids (however, low dose\n             corticosteroids < 20 mg prednisone or equivalent daily are permitted).\n\n          -  Adequate hematology without ongoing transfusional support (hemoglobin > 9 g/dL, ANC >\n             1,500 per mm3, platelets > 100,000 per mm3).\n\n          -  Adequate renal and hepatic function (creatinine ? 2.0 x IULN, bilirubin ? 1.5 IULN,\n             AST and ALT ? 3.0 x IULN or 5 x IULN if know liver metastases).\n\n          -  Otherwise, all toxicity at study entry < Grade 1.\n\n        Exclusion Criteria:\n\n        -•Women who are pregnant or lactating.\n\n          -  Women of childbearing potential and fertile men unwilling to use effective\n             contraception during study until conclusion of 12-week post-treatment evaluation\n             period.\n\n          -  Patients with Gilbert's disease.\n\n          -  Patients with brain metastases can be enrolled only if treated, non-progressive brain\n             metastases and off high-dose steroids (>20 mg prednisone or equivalent) for at least 4\n             weeks.\n\n          -  Presence of bulky disease (defined as any single mass > 7 cm in its greatest\n             dimension). Patients with a mass over 7 cm, but otherwise eligible, may be considered\n             for enrollment after discussion and approval with the medical monitor.\n\n          -  Patients with active ? grade 2 anorexia, nausea or vomiting, and/or signs of\n             intestinal obstruction.\n\n          -  Patients with non-melanoma skin cancer or carcinoma in situ of the cervix are\n             eligible, while patients with other prior malignancies must have had at least a 3-year\n             disease-free interval.\n\n          -  Patients known to be HIV positive, hepatitis B positive, or hepatitis C positive.\n\n          -  Known history of unstable angina, MI, or CHF present within 6 months or clinically\n             significant cardiac arrhythmia (other than stable atrial fibrillation) requiring\n             anti-arrhythmia therapy.\n\n          -  Known history of clinically significant active COPD, or other moderate-to-severe\n             chronic respiratory illness present within 6 months.\n\n          -  Prior history of clinically significant bleeding, intestinal obstruction, or GI\n             perforation within 6 months of initiation of study treatment.\n\n          -  Infection requiring intravenous antibiotic use within 1 week.\n\n          -  history of an anaphylactic reaction to irinotecan or ? Grade 3 GI toxicity to prior\n             irinotecan,\n\n          -  Other concurrent medical or psychiatric conditions that, in the Investigator's\n             opinion, may be likely to confound study interpretation or prevent completion of study\n             procedures and follow-up examinations.
Newly diagnosed or recurrent thymoma - World Health Organization (WHO) A, AB, B1, B2, or B3 or thymic carcinoma, pathologically confirmed at Memorial Sloan Kettering Cancer Center (MSKCC), MD Anderson Cancer Center (MDACC) or City of Hope
Subjects with one or more prior treatments for their pancreatic cancer.
SUB-PROTOCOL AIM A: Histological confirmation of renal cell carcinoma, head and neck cancer, endometrial cancer, breast cancer, ovarian cancer, prostate cancer, squamous cell cervical or uterine cancer, or bladder cancer
Prior nasopharyngeal cancer, salivary gland or sinus tumors.
No previous anti-cancer treatment
Must have pancreatic, ovarian, gastric, non-small cell cancer or mesothelioma. For dose expansion, must have tumor that is positive for mesothelin
Cancer must be considered incurable by the treating clinician
No history of another active cancer
Prior surgery for cancer of the anus that removed all macroscopic anal cancer
Prior systemic chemotherapy (for lung cancer) and/or thoracic/neck radiotherapy for any reason and/or surgical resection of present cancer
Prior therapy with any molecular targeted drugs (for lung 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
Previous treatment with > 2 anticancer regimens for ovarian cancer
Confirmed histologic diagnosis of invasive adenocarcinoma of the breast, including Memorial Sloan-Kettering Cancer Center (MSKCC) pathology confirmation
epithelial ovarian cancer (fallopian tube and primary peritoneal cancers are eligible)
gastric cancer (including gastro-esophageal junction)
colon cancer
Have mixed hepatocellular biliary tract cancer histology.
Has histologically confirmed epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer
Has epithelial ovarian cancer (EOC) with mucinous histology subtype
Cohort B: Histologically confirmed metastatic solid tumor of epithelial origin, excluding non-small cell lung carcinoma (NSCLC), including but not limited to ovarian cancer, colorectal cancer, pancreatic cancer, gastric cancer, renal cancer, bladder cancer, or breast cancer with radiographic evidence by MRI of at least one measurable brain lesion as defined by RANO criteria that does not require corticosteroids for symptomatic control
Metastatic or unresectable cancer that expresses KIT as documented in the patient's pathology report.
Life threatening illness unrelated to cancer.
Main inclusion criteria:\n\n          1. Female patient, with histologically or cytologically confirmed advanced / metastatic\n             epithelial ovarian cancer either :\n\n               -  refractory to first line platinum treatment (defined as progressive disease while\n                  receiving or persistent disease after platinum-based therapy, according to GOG),\n                  or\n\n               -  candidate to third line treatment.\n\n          2. Patient has recovered of all acute toxic side effects of prior therapy or surgical\n             procedures to grade ?1 National Cancer Institute-Common Toxicity Criteria (NCI-CTCAE\n             v4.02), except for the laboratory values\n\n          3. Patient has at least one target lesion that can be measured in one dimension,\n             according to the Response Evaluation Criteria in Solid Tumors (RECIST)\n\n          4. ECOG Performance status ? 2\n\n          5. Patient with adequate organ function per laboratory tests evaluations\n\n          6. Patient with life expectancy > 3 months\n\n          7. Patient weight > 40 kg and BMI > 18\n\n          8. Female patient ? 18 years\n\n          9. Patient with nutritional risk index (NRI) ? 83.5, i.e. with no or moderate\n             malnutrition;\n\n         10. Female patient of childbearing potential (entering the study after a menstrual period\n             and who have a negative pregnancy test), who agrees to use two methods (one for the\n             patient and one for the partner) of medically acceptable forms of contraception during\n             the study and for 3 months after the last treatment intake.\n\n        Main exclusion criteria:\n\n          1. Patient intolerant to gemcitabine\n\n          2. Patient who has not recovered from any significant treatment toxicities prior to\n             baseline (?Grade 2)\n\n          3. Patient presenting with serious cardiac disorders defined in the protocol\n\n          4. Pregnant or nursing female patient\n\n          5. Patient with active central nervous system (CNS) metastasis or with history of CNS\n             metastasis\n\n          6. Patient treated for a cancer other than epithelial ovarian cancer within 5 years\n             before enrolment, with the exception of basal cell carcinoma or cervical cancer in\n             situ\n\n        WASH-OUT:\n\n          1. Patient is at least 4 weeks from any major surgery (at baseline/W0)\n\n          2. Patient treated with any investigational agent within 4 weeks prior baseline\n\n          3. Patient who had systemic chemotherapy within 4 weeks before baseline\n\n          4. Patient who had radiotherapy within 4 weeks before baseline
Ovarian cancer confirmed BRCA wild-type from a prior test.
Small-cell lung cancer (SCLC) defined as a histologically confirmed diagnosis of SCLC and must have received at least 1 chemotherapy-containing regimen for advanced disease (recurrent or metastatic).
For the expansion stage, histologically confirmed renal cell cancer (RCC), urothelial bladder cancer (UBC), triple-negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), melanoma, head and neck squamous cell carcinoma (HNSCC), gastric cancer, ovarian cancer, cervical cancer, endometrial cancer, or Merkel cell cancer
An active, second potentially life-threatening cancer
For Phase 1B: histology specified below i. NSCLC (subjects with documented EGFR mutation or ALK rearrangement should be excluded) ii. ovarian cancer iii. gastric cancer iv. HCC (Barcelona-Clinic Liver Cancer stage C, stage B not amenable to locoregional therapy or refractory to locoregional therapy, and not amenable to a curative treatment approach, and Child-Pugh A) v. HNSCC vi. esophageal carcinoma vii. TNBC viii. cholangiocarcinoma ix. RCC, bladder cancer, melanoma, Merkel-cell carcinoma, sarcoma, GIST, or cuSCC. Or any other solid tumors with known MSI-H or dMMR status, such as CRC or pancreatic cancer
Patients must have pathologically confirmed non-muscle invasive bladder cancer (NMIBC) high grade disease (HG), as defined by the 2004 WHO classification system
Subjects who have had radiotherapy for pancreatic cancer
Histological or cytological confirmed small cell lung cancer (SCLC)
Small cell cancer not lung in origin
Persistent or recurrent serous epithelial ovarian cancer or primary peritoneal carcinoma
Any ongoing toxicity ? Grade 2 attributable to prior Non-Small-Cell Lung Cancer (NSCLC) treatment
28 patients with refractory colorectal cancer.
Non-invasive, superficial bladder cancer.
Confirmed diagnosis of high-grade serous or endometrioid epithelial ovarian, primary peritoneal, or fallopian tube cancer.
History of prior cancer except for non-melanoma skin cancer, breast cancer curatively > 3 years ago, curatively treated solid tumor (>5 years ago without evidence of recurrence), and synchronous endometrial cancer (Stage 1A) with ovarian cancer.
Any previous systemic chemotherapy for cancer or radiotherapy for cancer
Bladder cancer
Histologic confirmation of prostate cancer at Memorial Sloan-Kettering Cancer Center (MSKCC)
Residual Cancer Burden (RBC) classification II or III6
Diagnosis of NB as defined by international criteria i.e., histopathology (confirmed by the Memorial Sloan Kettering Cancer Center [MSKCC] Department of Pathology) or bone marrow metastases plus high urine catecholamine levels
Histopathologically confirmed diagnosis of one of the following cancer types:\r\n* Salivary gland cancer without the presence of extracapsular extension and/or positive surgical margin\r\n* Skin cancer\r\n* Melanoma
Females aged ?18 years with previous histologically proven diagnosis of high grade serous, high grade endometroid or clear cell ovarian cancer, fallopian tube or primary peritoneal carcinoma
At least three prior lines of therapy for advanced ovarian cancer as defined in the protocol
Must have gastric cancer or gastroesophageal junction cancer that cannot be operated on and that is advanced or has spread out
Part 1: Any advanced solid tumor malignancy; Part 2: Subjects with squamous non-small cell lung cancer, cholangiocarcinoma/gastric cancer, urothelial cancer, breast/endometrial cancer, multiple myeloma, or MPNs that have a tumor or malignancy that has been evaluated and confirmed to harbor genetic alterations in FGF or FGFR genes. A subject's fibroblast growth factor (FGF) or fibroblast growth factor receptor (FGFR) alteration may be based on local or central laboratory results. Part 3: Dose finding: subjects with solid tumor malignancies who qualify for combo therapy; dose-expansion: FGF/FGFR+ subjects qualified to receive combo therapy
Histologically or cytologically confirmed, Stage IV non-small cell lung cancer (per the Union Internationale contre le Cancer/American Join Committee on Cancer staging system, 7th edition) or recurrent incurable non-small cell lung cancer that has progressed after first-line chemotherapy.
Prior Therapy: Platinum doublet chemotherapy for current diagnosis of advanced lung cancer. Only one prior line of chemotherapy for advanced lung cancer allowed. Adjuvant chemotherapy, neoadjuvant chemotherapy, or chemoradiotherapy given for early stage lung cancer at least 6 months prior to diagnosis of recurrent/metastatic disease is not counted as a line of therapy for advanced lung cancer. Patients who received platinum doublet therapy with or without radiotherapy as part of treatment for early stage non-small cell lung cancer less than 6 months after developing stage 4 or recurrent incurable disease will be considered study eligible by the criterion of having received one line of chemotherapy for non-small cell lung cancer.
Histologic confirmation of metastatic non-small cell lung cancer (NSCLC) and confirmed ALK rearrangement.
Other pancreatic cancer histology (islet cell, acinar, neuroendocrine tumors)
Resectable pancreatic cancer
Participants must have histologic or cytologic confirmation of epithelial ovarian cancer, fallopian tube or peritoneal cancer; all histologies (including serous, mucinous, endometrioid, clear cell, malignant mixed mesodermal tumor [MMMTs], and mixed histologies) are eligible; all tumor grades are eligible
Have a histologically confirmed diagnosis of epithelial ovarian cancer, fallopian tube or peritoneal cancer; all histologies of epithelial ovarian cancer are eligible except for carcinosarcomas
Is participating in another medical device trial involving colectomy with anastomosis First 20 subjects ONLY: • Is diagnosed with high risk cancer as determined by preoperative clinical evidence or diagnostic imaging (if patient's cancer stage has been downstaged through treatment prior to baseline screening, subject is allowed to be included):
Patients may have synchronous endometrial and ovarian cancer primaries
Pathologic diagnosis of ovarian, fallopian tube or primary peritoneal cancer confirmed by pathology review at Memorial Sloan Kettering (MSK)
Histopathological documentation of prostate cancer confirmed in either the Laboratory of Pathology at the National Institutes of Health (NIH) Clinical Center, Walter Reed National Military Medical Center, Memorial Sloan Kettering Cancer Center (MSKCC), or Dana-Farber Cancer Institute (DFCI) or Beth Israel Deaconess Medical Center (BIDMC) prior to enrollment; if no pathologic specimen is available, patients may enroll with a pathologist’s report showing a histologic diagnosis of prostate cancer and a clinical course consistent with the disease
Patients may have had a prior diagnosis of cancer if it has been > 5 years since their last treatment and are considered free of disease
Subjects who have a previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study, or any previous cancer curatively treated >3 years before the start of study Treatment.
Active malignancy requiring therapy such as radiation, chemotherapy, or immunotherapy; exceptions to this are as follows: localized nonmelanotic skin cancer and any cancer that in the judgment of the investigator has been treated with curative intent and will not interfere with the study treatment plan and response assessment
Patients with histologically documented diagnosis of epithelial ovarian cancer including serous papillary, endometrioid, mucinous, clear cell, poorly differentiated or mixed adenocarcinomas
Patient must have recurrent epithelial ovarian cancer and may have received unlimited prior chemotherapeutic regimens for management of recurrent cancer
No prior treatment for pancreatic cancer
Prior cancer diagnosis, except appropriately treated localized epithelial skin cancer or cervical cancer
Diagnosis of advanced solid tumors limited to: melanoma, kidney cancer, lung cancer, colorectal carcinoma, prostate cancer, and neuroendocrine tumor progressing on standard therapy.
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.
Must have confirmation of the histologic diagnosis of high-grade (grade 2 or 3) epithelial, non-mucinous, non-borderline, ovarian, fallopian tube, or primary peritoneal carcinoma; may be based on original pathology report or review of original slides
Eligibility for pediatric patients will be determined in conjunction with an MD Anderson Cancer Center (MDACC) pediatrician
Confirmed diagnosis of unresectable epithelial ovarian, fallopian tube or primary peritoneal cancer.
Treated medullary or papillary thyroid cancer
Squamous cell or undifferentiated gastric cancer
Have results from testing of HPV status for oropharyngeal cancer
Participants must have histologically or cytologically confirmed ovarian cancer, peritoneal cancer or fallopian tube cancer and must have a histological diagnosis of either high grade serous or high grade endometrioid cancer based on local histopathological findings; participants with a deleterious BRCA-mutation on a commercial Clinical Laboratory Improvement Amendments (CLIA) assay with other high-grade histologies are also eligible\r\n* Myriad testing will be accepted as documentation of a deleterious mutation; if testing for BRCA is done by other organizations, documentation from a qualified medical professional (e.g., ovarian cancer specialty physician involved in the field, high risk genetics physician, genetics counselor) listing the mutation and confirming that the laboratory results show a recognized germline deleterious BRCA1 or BRCA2 mutation or BRCA rearrangements is required to document the presence of a deleterious mutation
Patients must have histologically or cytologically confirmed stage IV non-small cell lung cancer, or recurrent non-small cell lung cancer which is not amenable to curative intent therapy
Unresectable recurrent or metastatic head and neck cancer (HNC) (non-squamous cell cancer allowed), renal cell cancer (RCC) (non-clear cell types allowed), melanoma and lung cancer and candidates for RT
Recurrent and/or metastatic HPV-related carcinoma of the cervix, anus, vagina, vulva, penis, or oropharynx; the cancer diagnosis must be confirmed by slide review in the Memorial Sloan-Kettering Cancer Center (MSKCC) Department of Pathology; HPV positive status must be demonstrated by HPV in situ-hybridization (ISH) and/or by p16 immunohistochemistry (IHC)\r\n* Note: for cervix squamous cancer, HPV ISH test or p16 IHC test is not required
Alternative anti-cancer treatment
Patients must have Memorial Sloan-Kettering Cancer Center (MSKCC) pathologically confirmed diagnosis of one of the following tumor types: \r\n* Ovarian, fallopian tube or primary peritoneal cancer\r\n* Ovarian carcinosarcoma\r\n* Endometrial cancer\r\n* Endometrial carcinosarcoma
Histological/cytological confirmation of biliary cancer
Urothelial cancer that is suitable for local therapy administered with curative intent
Pathologically or cytologically Memorial Sloan-Kettering Cancer Center (MSKCC) confirmed esophagogastric adenocarcinoma
Curatively resected nonmelanomatous skin cancer
Patient has biopsy-proven diagnosis of cancer and radiographic evidence of bone metastasis to serve as target lesion(s)
Patient has 1-3 major painful osseous metastases (target lesions); these do not require biopsy if they are radiographically consistent with osseous metastases; the target lesions may be from any primary cancer or unknown primary cancer, including multiple myeloma
Patients with synchronous primary endometrial cancer or a past history of endometrial cancer, unless all of the following conditions are met: \r\n* Stage not greater than IB \r\n* No more than superficial myometrial invasion \r\n* No vascular or lymphatic invasion \r\n* No poorly differentiated subtypes, including serous, clear cell or other International Federation of Gynecologists and Obstetricians (FIGO) grade 3 lesions
Epithelial ovarian cancer of low malignant potential (borderline tumor)
Neuroendocrine cancer of the thyroid or thymus.
Patients are eligible if they have the following: metastatic or unresectable breast cancer, recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal cancer
The cancer that has no proven effective therapy
Have a cancer of the blood
Metatastic colorectal cancer
Non-small cell lung cancer
History of breast cancer, endometrial cancer or ovarian cancer or taking aromatase inhibitors or selective estrogen receptor modulators
Histologically- or cytologically-confirmed ovarian cancer, colorectal cancer, non-triple negative breast cancer, renal cell carcinoma and cervical cancer, with at least one lesion measurable by irRC not previously irradiated.
Patient's index tumor(s) is primary lung cancer.
Residual Cancer Burden (RBC) classification II or III6
Histological documented diagnosis of small cell lung cancer (SCLC) confirmed by a Memorial Sloan Kettering Cancer Center (MSKCC) pathologist.
Histological or cytologic diagnosis of squamous cell cancer
Life-threatening illness unrelated to cancer
PART A: Existing formalin fixed paraffin embedded biopsy of the lung cancer with potentially sufficient material for analysis
Pathologically confirmed diagnosis of non-anaplastic non-medullary thyroid cancer that is either grossly recurrent after surgery or unresectable with or without metastatic disease
Female patients with histologically diagnosed relapsed high grade serous ovarian cancer (including primary peritoneal and / or fallopian tube cancer) or high grade endometrioid cancer.
Prior oophorectomy for cancer prevention is allowed
Barcelona Clinical Liver Cancer Classification (BCLC) B or C
Female patients with newly diagnosed, histologically confirmed, high risk advanced (FIGO stage III - IV) BRCA mutated high grade serous or high grade endometrioid ovarian cancer, primary peritoneal cancer and / or fallopian - tube cancer who have completed first line platinum based chemotherapy (intravenous or intraperitoneal).
Patients who have previously been diagnosed and treated for earlier stage ovarian, fallopian tube or primary peritoneal cancer.
Must have received or been previously offered standard first-line chemotherapy for advanced non-small cell lung cancer
Any other cancer from which the patient has been disease-free for 5 years
Cytologic or histologic proof pancreatic ductal carcinoma is required prior to study entry; diagnosis must be confirmed by a Dana-Farber Harvard Cancer Center (DFHCC) institution pathology department prior to registration
NO prior chemotherapy for current diagnosis of lung cancer
Subjects must have a histological diagnosis of cancer
Uncontrolled cancer requiring the institution of new anti-cancer therapy during the study period
Histological or cytological confirmation diagnosis of Non Small Cell Lung Cancer (NSCLC).
A minimum of 10 patients in the trial (~50%) will need to have a PIK3CA mutation in their cancer
Group 1: Patients with BRAF mutated cancer, except those with colorectal or non-small cell lung cancers
Group 2: Patients with BRAF mutated colorectal cancer
Group 5: Patients with MEK mutated cancer
Group 6: Patients with BRAF mutated non-small cell lung cancer
Group 7: Patients with ERK mutated cancer
History of another “active” invasive primary cancer requiring ongoing treatment
History of breast cancer or endometrial cancer confirmed at Memorial Sloan-Kettering Cancer Center (MSKCC) or outside pathology report
Patients may have had a prior diagnosis of cancer if it has been > 5 years since their last treatment
Patients must have histologically or cytologically confirmed papillary thyroid cancer, follicular thyroid cancer (tall cell variant, insular thyroid cancer, follicular variant of papillary thyroid cancers, poorly differentiated thyroid cancer or any of the above mixed histology will be allowed); patients with anaplastic thyroid cancer are excluded
Histologically confirmed epithelial ovarian, peritoneal, or fallopian tube cancer, and uterine papillary serous carcinomas (UPSC), and gynecologic malignant mixed müllerian tumors (MMMTs).
Histopathological confirmation of prostate cancer by the Laboratory of Pathology of the National Cancer Institute (NCI), Pathology Department of the Walter Reed National Military Medical Center or Yale is required prior to entering this study; patients whose pathology specimens are no longer available may be enrolled if the patient has a clinical course that is consistent with prostate cancer and available documentation from an outside pathology laboratory of the diagnosis; all efforts should be made to have the material forwarded to the research team for use in correlative studies in cases where original tissue blocks or archival biopsy material is available
Histologic proof of melanoma reviewed and confirmed by Memorial Sloan Kettering Cancer Center (MSKCC)
Patient must have a histologically or cytologically confirmed diagnosis of pancreatic cancer or poorly differentiated neuroendocrine tumor and must have been treated with a regimen with known benefit for pancreatic cancer/poorly differentiated neuroendocrine tumor (MTD expansion cohort only)
Have been diagnosed with ovarian, fallopian tube, or primary peritoneal cancer
Have been previously treated with Gemcitabine for ovarian, fallopian tube or primary peritoneal cancer
No previous therapy for pancreatic cancer
Histological confirmation of malignancy (non-small cell lung cancer, breast cancer [hormone refractory], prostate cancer [hormone refractory], lymphoma, renal cell carcinoma, myeloma) by either biopsy or cytology of the primary or metastatic lesion
Participants must have histologically or cytologically confirmed invasive epithelial ovarian, tubal or primary peritoneal cancer; all histologies (including serous, mucinous, endometrioid, clear cell, malignant mixed mesodermal tumors [MMMTs] and mixed histologies) are eligible
Histological confirmation of thymoma (Group 1 only) or thymic carcinoma by the pathology department/Center for Cancer Research (CCR)/National Cancer Institute (NCI) or the pathology department of participating institutions
Any other concomitant anti-cancer treatment.
Patients with diagnosis of advanced cancer with lung metastases; patients with no prior therapy are eligible if there is no known superior alternative medical therapy; for phase Ib expansion cohort diagnosis of osteosarcoma, lung metastases will be required
Patients with advanced cancer with resectable lung metastases
Patients must have metastatic histologically or cytologically confirmed uveal melanoma; (if histologic or cytologic confirmation of the primary is not available, confirmation of the primary diagnosis of uveal melanoma by the treating investigator can be clinically obtained, as per standard practice for uveal melanoma); pathologic confirmation of diagnosis will be performed at Columbia University, Memorial Sloan-Kettering Cancer Center (MSKCC) or Vanderbilt University Medical Center
Patients with hydronephrosis secondary to bladder cancer
Prior chemotherapy or treatment for metastatic non-small cell lung cancer
Patients with a known synchronous primary endometrial cancer, or a past history of primary endometrial cancer, are excluded, unless all of the following conditions are met: stage not greater than IA, no more than superficial myometrial invasion, without vascular or lymphatic invasion, no poorly differentiated subtypes (including papillary serous, clear cell or other FIGO grade 3 lesions)
Past or current anti-cancer treatment except corticosteroids during less than one week.
Patients assumed to have a stageII?IV epithelial ovarian, fallopian tube, or primary peritoneal cancer as a pre-surgery diagnosis
Patients assumed to have a borderline malignancy of the ovary, fallopian tube, or primary peritoneal cancer
Stages II-IV of the above cancer
Intention for chemotherapy administration at MD Anderson Cancer Center
Patients who receive neoadjuvant chemotherapy for their ovarian, primary peritoneal, or fallopian tube cancer
Patients with non-epithelial ovarian tumors that do not require adjuvant chemotherapy, borderline epithelial ovarian tumor, or recurrent invasive epithelial ovarian, low grade ovarian cancer, primary peritoneal, or fallopian tube cancer treated with surgery only (such as patients with stage IA or IB); patients with a prior diagnosis of a borderline tumor that was surgically resected and who subsequently develop an unrelated new invasive epithelial ovarian, primary peritoneal, or fallopian tube cancer are eligible, provided that they have not received chemotherapy for any tumor; no stromal cancers or germ cell cancers or low malignant potential; patients found post operatively to have ineligible histology will be removed from the study
Patients with a synchronous primary endometrial cancer, or a past history of primary endometrial cancer are excluded unless all of the following conditions are met: stage not greater than stage IA; no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell, or other International Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions
Duodenal cancer on biopsy.
Have a histologically confirmed diagnosis of high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer
Must have metastatic colorectal cancer or pancreatic cancer with stable disease after first line chemotherapy or patients with colorectal or pancreatic cancer who have progressed with standard chemotherapy options\r\n* Standard chemotherapy examples for metastatic colorectal cancer include 5-FU (fluorouracil)/capecitabine with either oxaliplatin or irinotecan based regimen with or without bevacizumab or cetuximab\r\n* Standard chemotherapy examples for metastatic pancreatic cancer include gemzar based regimen or FOLFIRINOX (5-FU, oxaliplatin, and irinotecan)
Part B: Non-small cell lung cancer of any subtype that is advanced and/or metastatic
Part F: Colorectal Cancer
Valproic acid for the treatment of cancer
Memorial Sloan Kettering Cancer Center (MSKCC) histologically confirmed ovarian, fallopian tube or primary peritoneal carcinoma
Histologically or cytologically confirmed diagnosis of cancer (including epithelial carcinoma, sarcoma, and melanoma); the diagnosis can be done at Memorial Sloan-Kettering Cancer Center (MSKCC) or at participating institutions
Pathologic diagnosis of non-small cell lung cancer prior to enrollment
EXPANSION COHORT ONLY: Metastatic or locally advanced unresectable urothelial carcinoma with histologic or cytologic confirmation at Dana-Farber Cancer Institute (DFCI) or Memorial Sloan-Kettering Cancer Center (MSKCC)
Underlying cancer in remission
Subject has recurrent ovarian (including low malignant potential), fallopian tube or primary peritoneal cancer
Histopathologic confirmation of anaplastic thyroid cancer (or histopathologic report consistent with anaplastic thyroid cancer) at Memorial Sloan Kettering Cancer Center with clinical evidence of metastatic disease not curable by either surgery or radiation therapy
Efficacy Expansion Cohort (Second-Line Cervical Cancer)
Pathologic evidence of advanced stage IV or recurrent lung adenocarcinoma reviewed at Memorial Sloan Kettering Cancer Center (MSKCC)
Patients must have a primary L sided colorectal cancer (at or distal to the splenic flexure)
Patient must have pathologically or cytologically Memorial Sloan-Kettering Cancer Center (MSKCC) confirmed esophageal, gastric or gastroesophageal junction (GEJ) adenocarcinoma by the enrolling institution
Advanced biopsy-proven metastatic non-small cell lung cancer
PHASE I: Participants must have histologically or cytologically confirmed epithelial ovarian cancer, primary peritoneal serous cancer, fallopian tube cancer, or triple-negative breast cancer
PHASE II: Participants must have histologically or cytologically grade 2 or 3 (high-grade) papillary-serous or endometrioid epithelial ovarian cancer, primary peritoneal serous cancer, or fallopian tube cancer; participants with epithelial ovarian, primary peritoneal, or fallopian tube cancers of other high-grade histologies who carry a known deleterious breast cancer gene (BRCA) germline mutation by standard clinical testing (Myriad BRAC Analysis) will also be considered eligible
PHASE I-T: Participants must have histologically or cytologically confirmed epithelial ovarian cancer, primary peritoneal serous cancer, or fallopian tube cancer
Ovarian cancer, primary peritoneal, and fallopian tube participants in the Phase 1 and Phase 1-T portions of this trial must have either measurable cancer by RECIST 1.1 criteria or an elevated cancer antigen (CA)125 level at least twice the upper limit of normal on two separate occasions at least 1 day but not more than 3 months apart; at least one of the samples should be within 1 week of starting treatment; patients with both an elevated CA125 and measurable cancer will be followed by RECIST 1.1 criteria; patients with only an elevated CA125 level will be followed by modified Gynecologic Cancer Intergroup (GCIG) criteria
PRIOR THERAPY PHASE I and PHASE I-T:\r\n* Prior chemotherapy for ovarian cancer patients must have included a first-line platinum-based regimen with or without intravenous consolidation chemotherapy\r\n* Breast cancer patients must have recurred post both an Adriamycin- and taxane-containing regimen\r\n* Prior hormonal-based therapy for ovarian, primary peritoneal serous, fallopian tube cancer, or breast cancer is acceptable\r\n* Patients may not have had a prior PAR polymerase (PARP)-inhibitor in the recurrent or metastatic setting; prior treatment with BSI-201 (iniparib) is allowed\r\n* Patients may not have had a prior anti-angiogenic agent in the recurrent or metastatic setting
Memorial Sloan-Kettering Cancer Center (MSKCC)-reviewed pathologically proven diagnosis of primary bladder urothelial carcinoma without evidence of regional (nodal) or distant spread (cT1-T4a, Nx or N0)
Patients with borderline epithelial ovarian tumor (formerly \tumors of low malignant potential\) or recurrent invasive epithelial ovarian, primary peritoneal or fallopian tube cancer treated with surgery only are not eligible. Patients with a prior diagnosis of a borderline tumor that was surgically resected and who subsequently develop an unrelated, new invasive epithelial ovarian, peritoneal primary or fallopian tube cancer are eligible, provided that they have not received prior chemotherapy for any ovarian tumor.
Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, are excluded, unless all of the following conditions are met: Stage not greater than IB; no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell or other FIGO Grade 3 lesions.
Patients with well differentiated thyroid cancer are eligible for protocol as follows:
Confirmed pathological diagnosis by the Laboratory of Pathology, National Cancer Institute (NCI)
Patients must have histologically documented metastatic or unresectable non-small cell lung cancer, head and neck cancer, urothelial transitional cell carcinoma, or breast cancer whose disease has progressed after at least one line of standard therapy
Patients with suspected colorectal cancer with nodules in the lung or liver (1-2 cm in diameter) will be eligible for this study.
Patients with suspected lung cancer with nodules in the lung or liver (1-2 cm in diameter) will be eligible for this study.
Any other cancer from which the subject has been disease-free for ?2 years
Phase l: Melanoma, RCC, triple negative breast cancer, bladder cancer, head and neck cancer or non-small cell lung cancer.
Has recurrent rectal or rectosigmoid cancer.
Participants in the Dose Escalation portion must have one of the following advanced or recurrent malignancies: gastrointestinal (colorectal or gastric); ovarian; melanoma; non-small cell lung adenocarcinoma; or bladder.
Histopathologic diagnosis of ovarian cancer (including primary peritoneal and fallopian tube cancers) must be confirmed in the Laboratory of Pathology, National Cancer Institute (NCI)
Diagnosis of metastatic lung cancer, with histologic confirmation of the primary NSCLC histology and with at least one lesion amenable for intra-tumoral injection of MV-NIS.
Prior systemic anti-cancer therapy for small cell lung cancer
The participant has a solid tumor. Parts 2 and 3 are limited to participants with non-small cell lung cancer. Part 4 is limited to participants with small cell lung, head and neck, pancreatic, colorectal, and cervical cancers
Patients with histologically proven, unresectable, evaluable metastatic colorectal cancer, by RECIST criteria
Pathologically confirmed diagnosis of malignant pleural mesothelioma at Memorial Sloan Kettering Cancer Center (MSKCC)
Any other cancer from which the subject has been disease-free for ?3 years
Confirmed solid or hematological TP53 null type cancer.
Patients must have either heregulin-positive cancer, cancer with RAS mutation, IGF-1 positive cancer, or RAS wild type cancer.
For patients with oropharyngeal cancer, p16 status is known or can be determined
Women with suspected epithelial ovarian, fallopian tube or primary peritoneal carcinoma scheduled to undergo surgical exploration with no prior treatment for the cancer; signs of ovarian cancer include, but are not limited to: an elevated CA125, a complex pelvic mass, ascites, and carcinomatosis; these signs are not necessary for suspicion or enrollment in this protocol
Anti-cancer chemotherapy, experimental cancer therapy including clinical trial, or cancer immunotherapy within 4 weeks prior to the first dose of the investigational drug.
Toxic effects of previous anti-cancer chemotherapy, experimental cancer therapy, or cancer immunotherapy have not normalized.
Diagnosis of recurrent epithelial ovarian, primary peritoneal or fallopian tube cancer; histologic or cytologic confirmation of the original primary tumor is required
Individuals with KRAS-mutated metastatic or recurrent non-small cell lung cancer
Less than or equal to 3 weeks since receiving treatment with biologic, small molecule, chemotherapy or other agent for non-small cell lung cancer and 28 days since any prior immunotherapy (such as nivolumab)
The cancer has no proven effective therapy
Molecular characterization of non-squamous non-small cell lung cancer will be recommended prior to enrollment per standard of care/institutional guidelines; consistent with current National Comprehensive Cancer Network (NCCN) guidelines and the recent Food and Drug Administration (FDA)-approval indication of erlotinib for first-line treatment of advanced non-small cell lung cancer in persons with tumor EGFR mutations, participants who have known EGFR sensitizing mutations in tumors will be permitted to enter the study and receive erlotinib as initial monotherapy; for participants who have received one or more prior lines of chemotherapy, molecular characterization of tumors is required whenever possible with an understanding that inability to obtain sufficient tissue specimen for characterization will not preclude enrollment into the study
Confirmation of diagnosis of metastatic melanoma by the Laboratory of Pathology of the National Cancer Institute (NCI)
Histologic or cytologic confirmed locally advanced or metastatic small cell lung cancer, ovarian cancer, or cervical cancer (Part 1); small cell lung cancer and ovarian cancer (Part 2)
Patients with ovarian and small cell lung cancer must have failed initial therapy
Presence of other active cancers, or history of treatment for invasive cancer ?3 years
Confirmation of diagnosis of metastatic melanoma by the Laboratory of Pathology of the National Cancer Institute (NCI)
Registered with Clinical Trials Office at Karmanos Cancer Institute/Wayne State University
Have had prior or concurrent cancer distinct in primary site or histology from CRC within 5 years prior to randomization EXCEPT for curatively treated cervical cancer in situ, nonmelanoma skin cancer, Stage 0 intramucosal gastric cancer after endoscopic complete removal, or superficial bladder tumors classified as noninvasive tumor (Ta), carcinoma in situ (Tis), or tumor invades lamina propria (T1).
The patient has a history of another primary cancer, with the exception of:
Diagnosis of localized or metastatic unresectable MTC; the histological diagnosis of MTC must be confirmed on review of submitted tumor tissue by the Laboratory of Pathology in the National Cancer Institute
Histologically confirmed biliary tract or gallbladder cancer that have relapsed or are refractory after one prior gemcitabine-based chemotherapy regimen for advanced biliary cancer
Any prior treatment for metastatic colorectal cancer, except for use of palliative radiosensitizers
Initial core biopsy showing invasive lobular cancer
No other active cancer
Survivor of childhood cancer for ?5 years (N = 24) and no history of childhood cancer (N = 24)
localized thyroid cancer
MESOTHELIOMA COHORTS (COHORTS 1 AND 2 ONLY): Subjects must have histologically confirmed epithelial or biphasic mesothelioma not amenable to potentially curative surgical resection; however, patients with biphasic tumors that have a >= 50% sarcomatoid component will be excluded; the diagnosis will be confirmed by the Laboratory of Pathology/Center for Cancer Research (CCR)/National Cancer Institute (NCI)
DOSE ESCALATION COHORT ONLY: Adult patients with histologic documentation of an advanced solid tumor for whom gemcitabine and carboplatin would be appropriate first line therapy, including but not limited to urothelial cancer, non-small cell lung cancer, pancreatic and ovarian carcinoma
EGFR GERMLINE MUTATION TESTING: One of the following criteria:\r\n* Personal history of invasive lung cancer or one of the pre-invasive histologies associated with the development of lung cancer (adenocarcinoma in situ [AIS], minimally invasive adenocarcinomas [MIA] or atypical adenomatous hyperplasia [AAH]) and more than two affected family members with invasive lung cancer or one of the pre-invasive histologies associated with the development of lung cancer; OR\r\n* First-degree relatives of an individual enrolled in the study with a known EGFR germline mutation
Prior cancer treatment for this cancer, including gross total tumor excision
Patients with breast cancer that is pathologically confirmed at Memorial Sloan Kettering Cancer Center (MSKCC) (pathology from outside institutions is acceptable for the screening phase of the protocol) and defined by the following:\r\n* HER2 negative (in cases of mixed HER2 results, the most recent pathology results considered reflective of the active cancer will be considered) \r\n* Previously treated with at least 1 chemotherapy regimen for metastatic disease and documented progression
Prior systemic anticancer therapy for metastatic squamous cell lung cancer
Non-small cell lung cancer metastatic to the pleura that extends outside of the pleura requiring immediate therapy
Histologically documented ovarian, primary peritoneal or fallopian tube cancer
Patients must have a prior diagnosis of cancer inside the thoracic cavity; both primary thoracic malignancies (such as lung cancer) as well as metastatic lesions (such as metastatic breast cancer or colorectal cancer to the lungs) are allowed; patient must have pathologic confirmation of the recurrent thoracic tumor, or have an enlarging thoracic mass (as seen on two computed tomography [CT] scans at least 6 weeks apart, with either a > 25% or > 5 mm increase in longest dimension)
All stages of cancer are eligible
Histological documentation of epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
For Part B4 (non-small cell lung cancer) only:
Histologically confirmed diagnosis of locally advanced, recurrent, and/or metastatic triple-negative breast cancer, ovarian cancer, gastric cancer, colorectal cancer, pancreatic cancer, melanoma, or mesothelioma
Part B: Have a diagnosis of bladder cancer.
Key inclusion criteria:\n\n          1. Histological or cytological confirmation of epithelial ovarian, primary peritoneal, or\n             fallopian cancer from any previous time point.\n\n          2. Recurrent or relapsed after completion of initial therapy of epithelial ovarian,\n             primary peritoneal, or fallopian cancer from any previous time point (includes\n             completion of surgery with or without postoperative chemotherapy, including\n             maintenance chemotherapy)\n\n          3. Elevation of CA-125 according to the following definitions:\n\n               -  Patients with an elevated CA-125 before chemotherapy and normalization of CA-125\n                  with/after chemotherapy must show evidence of CA-125 greater than or equal to 2\n                  times the upper limit of normal (ULN) on 2 occasions at least 1 week apart\n\n               -  Patients with an elevated CA-125 before cancer chemotherapy, which never\n                  normalizes, must show evidence of CA-125 greater than or equal to 2 times the\n                  nadir value on 2 occasions at least 1 week apart\n\n               -  Patients with CA-125 in the normal range before cancer chemotherapy must show\n                  evidence of CA-125 greater than or equal to 2 times the ULN on 2 occasions at\n                  least 1 week apart\n\n                    -  For patients who have received subsequent treatment for recurrent cancer,\n                       \chemotherapy\ in the above criteria refers to the most recent round of\n                       chemotherapy.\n\n          4. Patients with a history of ovarian cancer who are asymptomatic and who do not have\n             documented previous CA-125 levels may enroll if the CA-125 is greater than three times\n             the ULN on two occasions, at least one week apart\n\n          5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0\n\n        Key exclusion criteria:\n\n          1. Symptoms (other than ? grade 1 fatigue, anxiety, depression, or other psychological\n             symptoms) that, in the opinion of the treating oncologist, are a direct result of\n             cancer recurrence. (Examples of symptoms that would preclude enrollment include\n             unintentional weight loss, ? grade 2 fatigue, and new abdominal pain unrelated to\n             operative procedures for the ovarian malignancy.)\n\n          2. Receiving any other investigational agent that would be considered a treatment for the\n             primary neoplasm. Anti-cancer chemotherapy, radiotherapy, immunotherapy, or\n             investigational agents ?14 days of first dose of study drug\n\n          3. Major surgery ?28 days before start of treatment\n\n          4. History of another primary malignancy with an associated disease-free interval of less\n             than 5 years, except for curatively treated basal cell or squamous cell carcinoma of\n             the skin or in situ cancer of the cervix.
Advanced solid tumors with histologic diagnosis confirming cancer
Advanced cervical or endometrial cancer, T3/T4 lesions
Histologically diagnosed ovarian cancer, fallopian tube cancer or primary peritoneal cancer
Epithelial ovarian cancer or gynecological cancer
Non-small cell lung cancer
Small cell lung cancer
Part 3 (enrollment closed): advanced, metastatic or non-resectable epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer with
Other major cancer in the past 3 years.
Histologically confirmed serous epithelial ovarian cancer with peritoneal metastases
Less than 4 weeks since last treatment for ovarian cancer
Thyroid cancer histology or cytology that is aggressive (anaplastic/undifferentiated thyroid cancer, poorly differentiated thyroid cancer, Hurthle cell carcinoma, tall-cell variant of papillary thyroid cancer, sclerosing variant of papillary thyroid cancer)
For subjects with gastric cancer:
Non-invasive, superficial bladder cancer.
Diagnosed colorectal cancer with oligometastatic colorectal cancer in the lung
Lung adenocarcinoma histology confirmed at Memorial Sloan-Kettering Cancer Center (MSKCC)
Pathologically confirmed: Non-small cell lung cancer (NSCLC, adenocarcinoma or squamous-cell carcinoma), Breast Cancer (HER2 positive or triple negative), Pancreatic Cancer (adenocarcinoma)
Have a history of muscle invasive bladder cancer
Prior anti-cancer treatment for metastatic colorectal cancer
Non- metastasis, unresectable, adenocarcinoma pancreatic cancer patients
Patients must have histopathological confirmation of colorectal carcinoma (CRC) by the Laboratory of Pathology of the National Cancer Institute (NCI) prior to entering this study
Histological or cytological confirmed metastatic colorectal cancer
Life-threatening illness unrelated to cancer.
Subjects with metastatic colorectal cancer may continue “maintenance” therapy with capecitabine and/or bevacizumab
Pathologic evidence of advanced (non-operable or metastatic) biopsy-proven stage IV or recurrent lung cancer reviewed at Memorial Sloan-Kettering Cancer Center (MSKCC)
6 weeks from surgery for stage 1 or 2 Non Small Cell Lung Cancer
Use of anti-cancer treatments within 28 days
Presence of another active cancer
Patients must have histological proof of a cancer - melanoma, breast, or lung cancer - which has spread to the CNS or glioblastoma (GBM) or other primary malignant neoplasm of the CNS which has been treated with standard treatments, which may include radiation, and must be measurable (RECIST).
Patients must understand the nature of the study and be willing to sign an informed consent that complies with the investigator/DEKK-TEC policies and approved by the Human Investigation Review Committee. Patients must have CNS involvement - from a malignancy. Lung cancer may be either small cell or non-small cell.
History of another primary cancer, with the exception of:
Histologically documented epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer that is platinum sensitive.
PSOC (i.e., epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer) with documented radiographic progression or relapse within 6 to 18 months of most recent platinum-based chemotherapy.
Previous systemic therapy to treat small-cell lung cancer (SCLC). Subjects with recurrent or progressive limited-stage SCLC after previous systemic treatment are not eligible for study participation.
Additionally, for patients who are considered for enrollment into the indication specific expansion cohorts in Stage 2, the current cancer must be either KRAS-mutant colorectal cancer (CRC) or KRAS-mutant non-small cell lung cancer (NSCLC)
Histologically or cytologically confirmed diagnosis of one of the following solid tumor malignancies for which no standard therapeutic alternatives exist: bladder cancer, breast cancer, castrate-resistant prostate cancer, cervical cancer, colorectal cancer (CRC), gastric cancer, hepatocellular carcinoma (HCC), melanoma, non-small cell lung cancer (NSCLC), ovarian cancer, pancreatic cancer, squamous cancers of the head and neck region (including parotid and nasopharynx).
Histologic or cytologic confirmation of non-small cell lung cancer (NSCLC)
Colorectal cancer (for patients enrolled to expansion part)
Nasopharyngeal cancer
Histologic or cytologic confirmed diagnosis of small cell lung cancer, either limited or extensive disease at initial presentation is allowed
Pathologic evidence of Small Cell Lung Cancer, or Non-Small Cell Lung Cancer.
Life-threatening illness unrelated to cancer
Part 1 and 2: Histologically or cytologically confirmed malignancy that is metastatic or unresectable and for which standard curative measures or other therapy that may provide clinical benefit do not exist or are no longer effective. Subjects must also 1) have a documented BRCA1 or BRCA2 mutation that is considered to be deleterious by the investigator, OR 2) have high grade serous ovarian, fallopian tube, or peritoneal cancer. Subjects with molecular features indicative of DNA repair defects (such as mutation in the Fanconi anemia pathway genes or methylation of the BRCA1 promoter) may be considered eligible for following discussion with the medical monitor. Part 3: Histologically or cytologically confirmed breast, ovarian, fallopian tube or primary peritoneal cancer that is metastatic or unresectable and for which standard curative measures or other therapy that may provide clinical benefit do not exist or are no longer effective. Platinum-resistant ovarian cancer is not permitted. Subjects must also 1) have a documented BRCA1 or BRCA2 mutation that is considered to be deleterious by the investigator and 2) have received 3 or fewer regimens of cytotoxic chemotherapy in the metastatic setting and 3) have evaluable disease as defined by RECIST 1.1 or GCIC-CA-125 criteria.
Diagnosis of a chronic pulmonary disorder (a diagnosis of lung cancer is not required as the symptom of dyspnea, not cancer itself, is targeted)
CANCER-RELATED CRITERIA
Life-threatening illness unrelated to cancer
Prior treatment with taxane therapy for either colorectal cancer or small bowel adenocarcinoma
Must have Non-small Cell Lung Cancer with ALK+ mutation or other mutations or rearrangements potentially sensitive to crizotinib
Histologically confirmed non-small cell lung cancer with < 50% squamous-cell non-small cell lung cancer or colorectal cancer for which no potentially curative treatment options are available
Patients must be suspected of having a diagnosis of ovarian, fallopian tube or primary peritoneal cancer with a planned cytoreductive surgery
Borderline ovarian cancer with ascites
Histologic diagnosis of epithelial ovarian, fallopian tube or primary peritoneal cancer on frozen section diagnosis
Non-epithelial ovarian cancer or metastatic cancer to the ovaries
Borderline ovarian cancer without ascites
Therapy with rosiglitazone (Avandia) or pioglitazone (Actos) at any time since the diagnosis of thyroid cancer
Subjects with non-small cell lung cancer and triple-negative breast cancer are preferred
Prior surgery or chemotherapy for this presentation of lung cancer (history of prior lung cancer that has been treated and deemed inactive by the clinician is acceptable; recurrent tumors may be treated on protocol as long as SBRT will be the definitive treatment)
History of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinical or radiographic evidence of extrahepatic disease; confirmation of diagnosis must be performed at Memorial Sloan Kettering Cancer Center (MSKCC)
Patients must have high-grade serous or endometrioid or high-grade predominantly serous or endometrioid histology, regardless of HRD or germline breast cancer susceptibility gene (gBRCA) mutation status. Patients with non mucinous epithelial ovarian cancer and gBRCA mutation are eligible.
Prior cancer vaccines are not allowed, with the exception as specified in protocol
Participants must have relapsed or refractory cancer.
A minimum of 4 Squamous Non-Small Cell Lung Cancer (Sq-NSCLC)
Scheduled for partial nephrectomy at Memorial Sloan Kettering Cancer Center (MSKCC) (open or minimally invasive technique) during which renal ischemia is anticipated
Nasopharyngeal cancer
treated medullary or papillary thyroid cancer
Histopathological confirmation of prostate cancer by the Laboratory of Pathology of the National Cancer Institute (NCI) or Walter Reed National Military Medical Center prior to entering this study; patients enrolled at participating sites may have histopathological confirmation at the enrolling center prior to entering the study; patients whose pathology specimens are no longer available may be enrolled if the patient has a clinical course that is consistent with prostate cancer and available documentation from an outside pathology laboratory of the diagnosis; all efforts should be made to have the material forwarded to the research team for use in correlative studies in cases where original tissue blocks or archival biopsy material is available
Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC)
Cancer should be staged via American Joint Committee on Cancer (AJCC) as IIIA or IIIB
Prior therapy, with the intent to treat, the current diagnosis of lung cancer
Cancer should be staged via American Joint Committee on Cancer (AJCC) as IIA, IIB, or III (T3 or T4, any N, M0)
Primary colorectal cancer diagnosis
Pathologically confirmed recurrent or metastatic advanced solid tumor, for which there is no curative-intent treatment option; pathology confirmation must be performed at Memorial Sloan-Kettering Cancer Center (MSKCC)
Subjects with squamous non-small cell lung cancer and triple-negative breast cancer or other solid tumor types for which Notch activation has been demonstrated (such as pancreatic, ovarian and melanoma) during dose expansion
Patients must have known HIV infection and histologically confirmed solid malignancy that is metastatic or unresectable and is therefore incurable; although the focus of this trial will be on upper aerodigestive cancers (non-small cell lung cancer, head and neck squamous cell carcinoma, and non-gastroesophageal junction esophageal cancer), patients with other incurable solid tumor with disease potentially sensitive to carboplatin and/or taxanes (including but not limited to salivary gland cancer, gastric cancer, breast cancer, ovarian cancer, or anal cancer, BUT excluding Kaposi sarcoma), will be eligible
Pathologic confirmation of cancer by the Laboratory of Pathology, National Cancer Institute (NCI)
Tumor wholly or partially contains small cell lung cancer
Cytologic or histologic diagnosis of a carcinoma felt by the investigator to be compatible with epithelial cancer of the ovary, fallopian tube, or primary peritoneum
Baseline cancer antigen (CA)-125 must be >= 70 units/mL
Patients with borderline ovarian tumors, recurrent epithelial ovarian or primary peritoneal cancer or non-epithelial ovarian cancer are not eligible
Histologically or cytologically confirmed non-small cell lung cancer or other “platinum responsive malignancies”, including but not limited to: esophageal cancer, ovarian cancer, germ cell malignancies, transitional cell cancer, that are not curable with chemotherapy, surgery or radiotherapy; a tissue block, 10 unstained slides or fresh tissue biopsy is required; patients with central nervous system (CNS) metastases which are symptomatic must have received therapy (surgery, XRT, gamma knife) and be neurologically stable and off steroids; patients with asymptomatic lesions without significant edema and no evidence of shift are allowed to participate without prior CNS therapy; such patients are anticipated to receive specific CNS therapy after 2-4 courses of study therapy
Diagnosis of metastatic malignant melanoma or metastatic renal cell cancer confirmed by the Laboratory of Pathology, National Cancer Institute (NCI)
Patients that have a probable diagnosis of non-small cell lung cancer, of any stage, with obstructive or hemorrhagic endobronchial disease will be considered for enrollment
Patients must have KRAS/NRAS/BRAF wild-type colorectal cancer
Subjects on anti-cancer medication whether biologic or pharmaceutical
Patients must have histologically or cytologically confirmed stage IV non-small cell lung cancer, or recurrent non-small cell lung cancer which is not amenable to curative intent therapy
Unwilling to participate in follow-up clinical appointments at MD Anderson Cancer Center (MDACC)
Presence of previous or concomitant neoplasm with exclusion of in situ cervical cancer
Any advanced solid malignancy will be eligible, with a strong preference for tumors that are known to commonly harbor defects in homologous recombination repair including triple-negative breast cancer, high-grade serous ovarian cancer, non-small cell lung cancer, small cell lung cancer, mesothelioma castration-resistant prostate cancer, pancreatic adenocarcinoma, gastric cancer and head & neck squamous cell cancer
Confirmation of diagnosis of metastatic melanoma by the Laboratory of Pathology of National Cancer Institute (NCI)
Confirmation of diagnosis of thyroid cancer by the Laboratory of Pathology of the National Cancer Institute (NCI)
Subjects on anti-cancer medication whether biologic or pharmaceutical
Other active malignancy requiring therapy; exceptions: non-melanotic skin cancer or any cancer that in the judgment of the investigator will not interfere with treatment plan and response assessment; patients with >= 25% of the bone marrow radiated for other diseases are not eligible
Biopsy proven non-small cell lung cancer
Has ?20% of cancer in any biopsy core,
Has ? 7 mm of cancer in any biopsy core,
For dose expansion cohort, patients must have histologic or cytologic confirmed non-small cell lung cancer that are not curable
Women who report that their motivation/desire for sexual intimacy has decreased since her cancer diagnosis
Eligible patients will have either confirmed or suspected new diagnosis of lung cancer and have sought a surgical consult relating to this diagnosis
Have a confirmed diagnosis of cancer
Female patients presenting with initial diagnosis of any type of cancer
Patient wishes to become pregnant\r\n* Note: patients who have undergone oocyte/embryo/ovarian tissue cryopreservation at breast cancer diagnosis and/or have a previous history of assisted reproductive technology (ART) are eligible
Any current smoker who meets the Centers for Medicare and Medicaid Services (CMS) eligibility criteria for lung cancer screening will be eligible for our intervention; thus, patients with a history of lung and/or other cancer(s) (who do not have current signs or symptoms of lung cancer) will be eligible
PATIENT: Receiving primary cancer care at one of the participating sites
History of cervical cancer
T4 cancer
Past history of any lung cancer
A diagnosis of cancer with no restrictions placed on type of cancer, other than that patients with metastatic disease will be excluded; eligibility criteria are not restricted to Memorial Sloan Kettering (MSK) confirmed biopsy/diagnosis; participating institution's testing is sufficient for other study sites
Anyone with a previous cancer diagnosis (excluding skin cancer)
Patient has uncontrolled cancer pain despite analgesic therapy
Radiation treatment for this cancer was completed (or will be completed) at MD Anderson Cancer Center (post-RT study only)
Receiving radiation treatment for this cancer at any site within the MDACC Cancer Network (Cancer Network study only)
Diagnosis of stages II-IV non-small cell lung cancer (NSCLC)
Patients scheduled for radical prostatectomy for the treatment of prostate cancer with one of the consenting surgeons at Memorial Sloan Kettering Cancer Center (MSKCC)
Histological diagnosis of cancer
Patients who will receive induction chemotherapy followed by combined chemoradiotherapy at Memorial Sloan-Kettering Cancer Center (MSKCC) for localized stage I-III esophageal or gastroesophageal junction cancer
Breast cancer diagnosis, stage 1, 2, or 3 (solely for patients enrolled at Montefiore Medical Center, St. Barnabas, Jacobi Medical Center, and North Central Bronx)
Be a cancer care provider (CCP) working at one of the above cancer centers
Have direct contact with cancer patients
FOCUS GROUP: IC to a Memorial Sloan Kettering Cancer Center (MSKCC) patient with GBM who died a year or more ago
A diagnosis of either non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), or mesothelioma, not being treated with a curative intent
Primary cancer care at the Massachusetts General Hospital (MGH) Cancer Center or Dana-Farber Cancer Institute (DFCI)
AIM 2: Have an actual or potential diagnosis of thoracic cancer
Patient has stage 3B or 4 non-small cell lung cancer (NSLC) or extensive stage small cell lung cancer (SCLC) and is within one month of treatment initiation
Patients with advanced cancer who are receiving treatment at Dana-Farber Cancer Institute (DFCI) in the thoracic oncology group and the DFCI-affiliated St. Elizabeth’s Hospital
Diagnosis of cancer.
Secondary cancer diagnosis (prior or current) within the past 5 years
Have a diagnosis of cancer or a caregiver to a cancer survivor
Previous diagnosis of cancer
Women with of primary or recurrent diagnosis of ovarian, uterine, peritoneal, cervical or vulvar cancer with any of the following:\r\n* < 30 % projected 5 year survival based on histopathological stage\r\n* Non-pelvic recurrent malignancy\r\n* Persistent or progressive disease despite primary treatment with surgery, chemotherapy or\r\n* Palliative performance scale < 60
metastatic colorectal cancer (mCRC) that is microsatellite stable (MSS)
Individuals with a history of another malignancy are not eligible if the cancer is under active treatment or the cancer can be seen on radiology scans or if they are off cancer treatment but in the opinion of their oncologist have a high risk of relapse within 5 years
Other active cancer
Diagnosed with advanced non-small cell lung cancer (NSCLC), small cell lung cancer, or mesothelioma, being treated with non-curative intent, and informed of advanced disease within the prior eight weeks
Primary cancer care at one of the three participating sites
Documented pancreas cancer by cytology, or histology
(Patient participation) Diagnosis of advanced cancer
Have completed cancer-related treatment within the past 3 years
History of a cancer diagnosis
Diagnosis of cancer or caregiver of someone with cancer
Subject has had previous Spray Cryotherapy for esophageal cancer.
Have completed active treatment for their cancer diagnosis (excluding hormonal therapy)
Patients undergoing open liver resection without bowel resection/anastomosis for malignancy at MD Anderson Cancer Center
Cancer treatment or follow-up for lymphoma at the Massachusetts General Hospital (MGH) Cancer Center
PHASE 0: Previously underwent curative surgical treatment of metastatic colorectal or peritoneal cancer at University of Pittsburgh Medical Center (UPMC) Shadyside
All patients undergoing RC for bladder cancer with urinary diversion at MD Anderson Cancer Center (MDACC).
Secondary cancer diagnosis within the last 5 years
Documented attention deficit hyperactivity disorder (ADHD) predating cancer diagnosis
Pancreatic cancer of any type, biopsy-proven
Neuroendocrine cancer
PATIENT: Cancer diagnosis should have been made within five years from the next scheduled appointment to the DCC
Patients with uncontrolled pain related to cancer or cancer treatment; uncontrolled pain will be defined as\r\n* Pain which persists for more than 7 days and is rated >= 6 on NPRS\r\n* Use of breakthrough medication more than 4 times in 24 hours or being treated with oral morphine equivalent of 100 mg/d or more
Diagnosed with stage 3 or 4 breast, cervical, colorectal, endometrial, hepatobiliary, lung, melanoma, gynecological, prostate cancer in the past six months
Workshop A (2017 - 10 weeks- City of Hope)\r\n* Either one of the following:\r\n* City of Hope (COH) cancer patient (all types and at any time point of their disease) OR\r\n* Caretaker/friend family member of the cancer patient
Workshops B and C (2018 - 5 weeks - City of Hope)\r\n* Cancer patients (all types and at any time point in their disease)\r\n* Note: documentation to confirm this eligibility criteria will not be requested; self-reporting as a cancer patient will be considered adequate
Diagnosis of cancer with evidence of active disease
Outpatient at MD Anderson Cancer Center
Patients who plan to receive chemotherapy at Dana-Farber Cancer Institute (DFCI) to treat recurrent, incurable gynecologic cancers (i.e., ovarian, uterine, and cervical that has recurred despite >= 1 prior treatments)
Desires to undergo ovarian stimulation and oocyte retrieval prior to cancer treatment
Diagnosis of cancer
Adults undergoing hematopoietic stem cell transplantation (HSCT) at the University of Wisconsin Carbone Cancer Center (UWCCC)
Diagnosis of RCC that is defined as metastatic by standard criteria (American Joint Committee on Cancer [AJCC] 7th edition, 2010)
CAREGIVER: Spouse or cohabitating intimate partner of an advanced cancer patient being evaluated at the University of Pittsburgh Medical Center (UPMC)’s Liver Cancer Center (LCC)
Diagnosis of cancer
Lymphedema Group: No active cancer
Active cancer
No Lymphedema Group: No active cancer
Patients who are receiving neoadjuvant chemotherapy treatment at University of Texas (UT) MD Anderson Cancer Center
Patients who are not receiving their primary cancer care and chemotherapy at MD Anderson Cancer Center
Diagnosis of metastatic cancer no greater than 6 weeks prior to expected study enrollment
Patients currently enrolled onto therapeutic cancer clinical trial(s) involving non-standard cancer drugs
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)
Undergoing primary resection of esophageal cancer and resultant esophagectomy
Diagnosed with pancreatic, esophageal, rectal, colon, hepatobiliary, or gastric cancer (including patients with prior diagnosis of another cancer)
Prior diagnoses of any other type of cancer (excluding some skin cancers)
A diagnosis of pancreatic or other periampullary cancer is suspected preoperatively
History of a cancer diagnosis
No active cancer therapy (excluding chemoprevention) in the past year, and no cancer therapy planned in the next 6 months
As per medical record, radical prostatectomy (RP) conducted either at Memorial Sloan-Kettering Cancer Center (MSKCC) or at another institution
Currently a patient of Dr. Christian Nelson at Memorial Sloan Kettering Cancer Center Counseling Center
A personal history of colorectal cancer
Poor diagnosis or other cancer
PHASE 2: PATIENT EXCLUSION CRITERIA: Patients with cancer diagnoses that are not typically considered pediatric cancer, including basal and squamous cell skin cancer, breast, colorectal, lung, melanoma, merkel cell skin cancer, ovarian, testicular, kidney cancer diagnosed at age > 17, and nasopharyngeal diagnosed at age > 17
PHASE 3A/3B: PATIENT EXCLUSION CRITERIA: Patients with cancer diagnoses that are not typically considered pediatric cancer, including basal and squamous cell skin cancer, breast, colorectal, lung, melanoma, merkel cell skin cancer, ovarian, testicular, kidney cancer diagnosed at age > 17, and nasopharyngeal diagnosed at age > 17
A new diagnosis (within 3 months) of advanced cancer and/or patients receiving ongoing care from a medical oncologist (solid tumors) or a new recurrence of the primary cancer in an advanced stage
Receives ongoing care from a medical oncologist at the Seidman Cancer Center (SCC)
History of curative-intent radiotherapy at MD Anderson Cancer Center (MDACC) for a new primary H&N cancer in past 15 years
Parents will be eligible if they have a diagnosis of incurable cancer of any type
Have a child 5-17 years old living at home who has been told their parent’s cancer diagnosis
Any condition which might be worsened by estrogen, such as breast cancer, uterine cancer, ovarian cancer, endometriosis or uterine fibroids
Patient must have either a history of cancer or active cancer
PATIENTS ONLY: Currently receiving treatment (e.g. radiotherapy, chemotherapy) at MD Anderson Cancer Center
Diagnosis of any invasive gynecologic cancer without evidence of disease
Experiencing 2 or more of the following symptoms felt to be associated (per the patient) with gynecologic cancer or previous gynecologic cancer treatment: anxiety (worry or feeling stressed), cognitive impairment (difficulty concentrating, focusing, memory loss), depression, existential/spiritual distress (hopelessness, lack of meaning in life, lack of peace), fatigue, pain, and sexual dysfunction; these symptoms may be new or worsened since cancer diagnosis; both symptoms from this list must have been present one week prior to eligibility assessment
Expected to continue cancer care at University of Wisconsin Carbone Cancer Center (UWCCC) for the duration of the study
10.0 years post first cancer diagnosis
A diagnosis of advanced cancer (defined as metastatic or recurrent) with fatigue >= 4/10 (0-10 scale) on the Edmonton Symptom Assessment Scale (ESAS)
No prior type I endometrial cancer diagnosis
Prior diagnosis of other cancer
Are undergoing treatment for pancreatic cancer at Fox Chase Cancer Center (FCCC)
Recurrent cancer
Have any other active cancer
Diagnosis of cancer, with evidence of primary or secondary lung involvement
Diagnosis of cancer
Evaluation by a pain management physician and confirmation that cancer is the primary etiology of patient’s pain
Recurrence of cancer or other active cancer
Pathologically confirmed gastric, gastroesophageal junction (GEJ) or esophageal, adenocarcinoma at either Memorial Sloan-Kettering Cancer Center (MSKCC) or a participating site (biopsy may be performed at other institutions but slides must be confirmed at MSKCC or a participating site, as is routine care at our institution)
Women with a history of leukemia, ovarian cancer or a cancer that likely involve the ovaries at the time of ovarian tissue collection
Subject must be clinically referred for a thyroidectomy for known or potential cancer
Completed cancer treatment with curative intent
Resident of rural and/or Appalachian Kentucky (KY) county at cancer diagnosis
Diagnosis of cancer with evidence of active disease
Outpatient at MD Anderson Cancer Center seen by the supportive care service, thoracic medical oncology, cancer pain clinic, or cardiopulmonary clinic
Currently between 1.0-4.99 years from the completion of active cancer therapy
Within 12 months of completing active treatment for colorectal cancer
Have had a diagnosis of cancer treated with chemotherapy.
Have not had a cancer recurrence
Cancer patient
History of oropharyngeal swallowing disorder prior to cancer diagnosis
CAREGIVERS: Has a current cancer diagnosis
CARE-RECIPIENTS: Has an additional cancer diagnosis
No evidence of cancer (NED)
Patients at MD Anderson with a cancer history who are either undergoing active treatment or who have completed treatment for their cancer
A current/prior cancer diagnosis
Medical history of cancer other than colorectal cancer or non-melanoma skin cancer, untreated or unstable mental or psychiatric disorder, learning disability, traumatic brain injury, drug or alcohol abuse, debilitating medical disorder such as advanced cardiac, respiratory or renal disease
Adolescents and young adults who have completed cancer treatment within the past three months of all cancer types and stages will be recruited for this study
BCS will not be excluded based on cancer treatments received or a history of diagnosis of mild depression, anxiety, and hypertension and diabetes
Woman diagnosed with ovarian, primary peritoneal or fallopian tube cancer
Recent (< 4 week) first diagnosis of a borderline-resectable pancreatic adenocarcinoma, assigned to receive neoadjuvant therapy and surgery at University of Colorado Cancer Center, physician clearance to participate in exercise program
Participants with a second cancer diagnosis at the time of enrollment will be excluded
Patients are actively being treated for another cancer at the time of enrollment
BC patients at Moffitt Cancer Center (MCC)
Have had ovarian cancer or fallopian tube cancer at any age
Diagnosis of cancer within last two years
Newly diagnosed with any stage of primary ovarian cancer, primary peritoneal cancer or primary fallopian tube cancer in the past 6 months
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
Primary family caregivers of cancer patients with > 6 months prognosis
Histologic proof or unequivocal cytologic proof (fine needle aspiration, biopsy, or two positive sputa) of small cell lung cancer (SCLC)
Be scheduled to start outpatient intravenous (IV) chemotherapy for reasons other than symptom palliation at Moffitt Cancer Center (MCC) or Sylvester Comprehensive Cancer Center (SCCC)
Patients with metastatic cancer or a second primary cancer
Active cancer/metastatic cancer
Time from completion of cancer treatment to study entry: >= 2 years
Individuals who have a personal history of hereditary breast or ovarian cancer\r\n* A subset of 60 women without a personal history of hereditary or ovarian cancer will be included in an exploratory subset analysis
Meet National Comprehensive Cancer Network (NCCN) criteria for consideration of genetic testing for hereditary breast cancer
Inclusion Criteria: Subjects will be drawn from the pool of all parents who are primary\n        caregivers of children diagnosed with any form of cancer 4-16 weeks prior to contact about\n        the Problem Solving Skills Training intervention and cared for at one of the 4 data\n        collection sites. No attempt will be made to stratify the sample by any particular\n        demographic variables (e.g., age, ethnic background, or type of cancer diagnosed in their\n        child), except that monolingual Spanish-speaking parents will be specifically recruited to\n        provide adequate representation for statistical analysis at Childrens Hospital Los Angeles\n        and UT/MD Anderson Cancer Center. Goal: 20% total enrollment.\n\n        Exclusion Criteria: Parents of children with cancer will be excluded if (1) they do not\n        read or speak English or Spanish; (2) their child is in severe a medical crisis, as\n        determined by the oncologist, or (3) they live a prohibitive distance to complete the\n        intervention (typically, >50 miles from the Center) and do not have access to a telephone\n        for phone intervention sessions. Internet access will be facilitated as part of the e-PSST\n        intervention arm. These exclusionary criteria are identical to our previous work; <10% of\n        eligible mothers have been excluded.
PHASE II: Completed initial surgical consult with breast cancer surgeon at Cancer Institute of New Jersey (CINJ)/Massachusetts General Hospital (MGH)/Memorial Sloan Kettering Cancer Center (MSKCC) and is considering CPM, regardless of the surgical treatment of their primary breast cancer (lumpectomy/mastectomy)
Willing to undergo a form of cancer therapy and subsequent follow-up care
Subjects with malignant dysphagia due to esophageal cancer or esophagogastric junction cancer who are undergoing upper endoscopic ultrasound or upper endoscopy for pre-treatment staging or symptom evaluation
Participants will be patients of Vanderbilt-Ingram Cancer Center (VICC) with a diagnosis of cancer
Planned treatment for stages I – III cancer at VICC or at MMC (patient)
Prior cancer diagnosis
Refusal of any cancer treatment(s)
Subjective concern about declines in cognitive functioning related to a diagnosis of cancer and/or cancer related treatment
Cancer onset before the age of 21
To preserve a homogenous cohort and comply with the departmentally-organized research infrastructure, we will include preoperative abdominal cancer patients undergoing surgery, or healthcare provider from all specialties at MD Anderson Cancer Center (MDACC) or volunteer from MDACC Volunteer Service.
Diagnosed with advanced non-small cell lung cancer (NSCLC), small cell lung cancer, or mesothelioma, being treated with non-curative intent, and informed of advanced disease within the prior eight weeks
Primary cancer care at the Massachusetts General Hospital (MGH) Cancer Center
Retrospective chart review: Individuals will have pathologically confirmed breast cancer or gynecological (GYN) malignancies including uterine, ovarian, or cervical cancers, stages I-III; treated in the previous two years (2013-2014)
Biopsy-proven endometrial cancer
Advanced cancer patient scheduled to receive regorafenib
Use of dexamethasone for cancer related fatigue
International Classification of Disease, 9th revision (ICD 9) cancer diagnosis seen at each site in the past two years
Documentation of current smoking in the cancer registry
Have not experienced a cancer recurrence, and
Active cancer defined as metastatic disease and/or any evidence of cancer on cross-sectional or positron emission tomography (PET) imaging, cancer related surgery, chemotherapy or radiation therapy within the past 6 months; note: non-melanoma skin cancer does not meet the cancer requirement
Receiving or planning to receive outpatient therapy for any cancer
Additionally, at time of enrollment, participants must be post-treatment (with the exception of adjuvant therapy) for their primary cancer and not actively undergoing treatment for a secondary, metastatic, or recurrence of cancer (local or distant)
Background cancer pain that is =< 3/10 in the last 24 hours
Breakthrough cancer pain that is >= 4/10 in the last 24 hours
Patients who have lymphedema due to cancer recurrence
Diagnosis of bladder cancer
Confirmed diagnosis of primary breast, cervical, endometrial, or ovarian cancer
PATIENT: Confirmed incurable lung cancer (non-small cell lung cancer [NSCLC], small cell lung cancer, or mesothelioma) or non-colorectal gastrointestinal (GI) cancer (esophageal, gastric, hepatic, biliary, or pancreatic or GI unknown primary) not being treated with curative intent
PATIENT: Planning to receive all medical care for cancer at the enrolling institution
All the female breast cancer survivors will be at least two months from receiving cancer treatment (surgery, adjuvant therapy or radiation) and within three years from completing cancer treatment, except for tamoxifen/aromatase inhibitors
History of lung cancer
At least four weeks after cancer diagnosis
Pilot: Ovarian cancer patients who have completed cancer treatment
RCT: Participants will include ovarian cancer patients who are considered by their primary oncologist to be candidates for IP/IV chemotherapy
NON-CANCER PATIENT GROUP: Caucasian or African-American/Black
NON-CANCER PATIENT GROUP: Cancer-free
Patients with lung or esophageal cancer stages I through IIIB who are going to receive at least 5 weeks of daily thoracic radiation therapy with or without chemotherapy in the department of radiation oncology at M. D. Anderson Cancer Center (MDACC) and have an eligible and consenting family caregiver living with the patient while he/she receives treatment (i.e., adult child, sibling, parent)
Scheduled to receive anthracycline chemotherapy followed by anti-HER2 therapy at Memorial Sloan-Kettering Cancer Center (MSKCC)
Histologic diagnosis confirmed by Memorial Sloan-Kettering Cancer Center (MSKCC) pathologist as mantle cell lymphoma
mesothelioma, pancreatic cancer: 1-3 prior treatments
ovarian cancer: 2-4 prior treatments
colon cancer: 2-4 prior treatments
Diagnosed with advanced epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
Diagnosis of clear cell or low grade ovarian cancer
Histology showing high-grade epithelial non-mucinous ovarian, primary peritoneal, or fallopian tube cancer
Patients with ovarian cancer not medically fit for diagnostic laparoscopy prior to initiation of therapy
No prior history of anal cancer, including SISCCA
Participants must have histologically confirmed diagnosis of locally advanced and/or metastatic triple negative breast cancer, ovarian cancer, bladder cancer, gastric cancer, or soft tissue sarcoma, with exceptions defined in the exclusion criteria
Recurrent cancer
PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Primary caretaker of a cancer patient
Receiving cancer care at either Massachusetts General Hospital Cancer Center or community affiliates (North Shore, Emerson, and Massachusetts General Hospital [MGH] West)
History of gynecologic cancer
Cancer (solid tumor) diagnosis or mass suspicious of cancer within past six months as per clinical judgment
Cancer treatment expected plan to include hospitalization for surgical treatment for at least 2 days at Memorial Sloan-Kettering Cancer Center (MSKCC) as per the patients’ clinical team
Histologically-confirmed invasive breast cancer by Memorial Sloan-Kettering Cancer Center (MSKCC)
Patients with gynecologic cancer who are undergoing vaginal brachytherapy as part of their treatment
Patient is at least 3 weeks post-diagnosis of stage III or IV non-small cell or extensive small cell lung cancer and has received care at the Indiana University Simon Cancer Center or another Indiana University Health hospital or clinic
Participants with concurrent active cancer or active cancer within the last 5 years are ineligible unless, at the discretion of the investigator, the patient is deemed to have cancer or cancer treatment that the investigators do not think will interfere with any of the biological measures of the study
Diagnosis of advanced (metastatic or recurrent) lung, breast, colorectal, prostate, or gynecological (GYN), or other solid tumor cancer; the symptom cluster of pain, fatigue, and sleep disturbance is common in these patients
No active cancer
Patients must have histologically or cytologically confirmed solid tumor or heme malignancy; exceptions include patients with pancreatic cancer or colon cancer who are receiving oxaliplatin and are thus eligible for Comprehensive Cancer Center of Wake Forest University (CCCWFU) 98112; patients undergoing inpatient induction therapy for acute leukemia; and those hospitalized for marrow or peripheral blood stem cell transplantation
Diagnosis of gynecological cancer of any type or strong suspicion for cancer
Diagnosis of cancer with evidence of active disease
Outpatient at MD Anderson Cancer Center seen by the Supportive Care Service, Thoracic Medical Oncology or Cardiopulmonary Center
Diagnosis of cancer
Outpatient at MD Anderson Cancer Center seen by the Supportive Care Service or Thoracic Medical Oncology
Patients with an initial diagnosis of ovarian, fallopian tube or primary peritoneal cancer who completed primary ovarian cancer surgery or 3 cycles of neoadjuvant chemotherapy with interval cytoreductive surgery (ICS)
Final pathologic diagnosis of stage I-IV ovarian, primary peritoneal or fallopian tube cancer with plan to receive primary adjuvant chemotherapy or completion of chemotherapy after ICS
Patients with recurrent ovarian cancer receiving chemotherapy
History of non-metastatic breast cancer (ductal carcinoma in situ [DCIS] or stage I, II, or III) as recorded in the medical record at Memorial Sloan-Kettering Cancer Center (MSKCC), by self-report, or by outside correspondence, including a study checklist signed by a physician for patients outside of MSKCC
Active cancer, defined as a pathologic diagnosis of or treatment for any cancer, other than basal-cell or squamous-cell carcinoma of the skin, within the past six months; or patients with known recurrent or metastatic disease within the past six months; a pathology report issued at the enrolling site confirming the diagnosis of cancer is required for study enrollment
Minocycline Trial only: patients with a pathological or clinical diagnosis of pancreatic cancer and beginning or continuing FOLFIRINOX or gemcitabine-based chemotherapy
Observational Arm only: patients with a pathological or clinical diagnosis of pancreatic cancer and beginning or continuing FOLFIRINOX chemotherapy
Diagnosis of cancer
Cancer patients currently on cancer therapy with a positive screening for SD (screening PSQI score >= 5)
Confirmed metastatic lung cancer (non-small cell lung cancer [NSCLC], small cell lung cancer [SCLC], and mesothelioma [meso]) or non-colorectal gastrointestinal (GI) cancer (esophageal, gastric and hepatobiliary) not being treated with curative intent
All patients with a histological diagnosis of cancer
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)
Peer mentors will be past gynecologic cancer patients not currently undergoing treatment for their cancer, and considered without evidence of disease
Currently undergoing treatment for active gynecologic cancer
Inability to perform phone call and clinical follow-up at MD Anderson Cancer Center (MDACC)
Diagnosis of a non-malignant disease and receiving radiation for a pathological diagnosis that is non-cancer
Report sleep problems that began or got worse with the diagnosis of cancer or with chemotherapy; (did your sleep problems begin or get worse with the diagnosis of cancer or with chemotherapy?)
Stage I-IV gynecologic cancer (including ovarian, uterine, cervical, vulvar, or vaginal cancer)
Any cancer diagnosis
Actively undergoing any chemotherapy treatment at Maroone Cancer Center
Patients who have never utilized art therapy at Maroone Cancer Center
Able and willing to participate in an art therapy session at Maroone Cancer Center
Patients without cancer diagnosis
Patients not actively undergoing chemotherapy at Maroone Cancer Center
Patients who have previously utilized art therapy at Maroone Cancer Center
Chronic pain is not cancer-related
Distressing cancer-related recollections that cause physiological reactivity
History of depression before the cancer diagnosis
Patients are undergoing other cancer treatments
Family caregivers will need to be the primary family caregiver as identified by the lung cancer patient (ten caregivers from each of the following cancer care continuum points will be recruited)
Cancer care continuum points are defined as follows:\r\n* Diagnosis: A lung cancer patient who has received diagnosis within the last 45 days but has not yet started treatment\r\n* Treatment: A lung cancer patients who has started initial treatment (chemotherapy, radiation, surgery) for diagnosis within the last 30 days, is actively receiving treatment, and has a prognosis of more than one year\r\n* Survivorship: A lung cancer patient who has completed treatment and who is clinically disease free at the time of caregiver enrollment to study\r\n* End of Life: A lung cancer patient who is estimated to have 6 months or less to live
Undergoing surgical management for a suspected diagnosis of gynecologic malignancy (endometrial, ovarian, vulvar, vaginal, primary peritoneal, fallopian tube)
Receiving care at University of Michigan Comprehensive Cancer Center Gynecologic Oncology Clinic or at St. Joseph Mercy Hospital, Alexander Cancer Care Center
Participants must be a spouse or domestic partner of a cancer survivor and will be recruited via the Hematopoietic Stem Cell Transplant Database at Fred Hutchinson Cancer Research Center (FHCRC)
No prior history of cancer;
Prior history of cancer (other than skin cancer);
No evidence of cancer (NED)
Previous diagnosis of endometrial cancer, successfully treated through surgery
No previous diagnosis of endometrial cancer
Previous treatment of any cancer excluding skin cancer
Patients with histologically confirmed diagnosis of cancer; NOTE: patients with active cancer or post treatment are allowed on the study
Pathologically confirmed, unresectable primary or recurrent non-small cell lung cancer
Pathologically confirmed, unresectable primary or recurrent non-small cell lung cancer
Participants must not have been asked previously to participate in another therapeutic cancer clinical trial
Newly prescribed one of the designated oral cancer medications for treatment of cancer
Patient of one of the participating National Cancer Institute comprehensive cancer centers
Patients receiving chemotherapy for a recurrent gynecologic cancer at the University of Wisconsin-Madison Carbone Cancer Center (UWCCC)
Stage 1-4 invasive breast cancer that is histologically confirmed at Memorial Sloan-Kettering Cancer Center (MSKCC)
Classified as International Society of Lymphology (ISL) stage II or higher as determined by a Memorial Sloan-Kettering Cancer Center (MSKCC) certified lymphedema therapist (CLT)
Patients who intend to remain under the MD Anderson Cancer Center (MDACC) surgeon's care until completion of the reconstruction
All patients with mesothelioma or other pathologies undergoing a pleurectomy decortication at MD Anderson Cancer Center
Grade G1 - G3 bladder cancer
History of diagnosis of cancer
Cancer patients without BRONJ who have been treated with intravenous zoledronate for >= 1 year duration
No patients with recurrence of lung cancer after prior resection
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
Participants with active cancer diagnosis (exception: skin cancer, biopsy-proven atypical lobular, ductal hyperplasia and/or lobular carcinoma in situ)
Have one relative with ovarian cancer
Personal history of ovarian cancer
Previous genetic testing or counseling regarding cancer risk
Patient with prior history of colon cancer
Scheduled for surgery at Brigham and Women’s Hospital for known or highly suspected stage III or IV ovarian cancer (i.e. elevated cancer antigen [CA]-125 with a pelvic mass, ascites, and carcinomatosis)
Patients with any stage epithelial ovarian cancer, including cancers arising from the fallopian tube and primary peritoneal cancer, or patients with other gynecologic malignancy (any stage), who are chemotherapy-naive, and scheduled to undergo at least 6 cycles of intravenous platinum/taxane-based chemotherapy
Individuals with personal history of colorectal cancer (CRC) or colorectal polyps
Have a personal or family history of any hereditary/genetic cancer syndrome such as BRCA1 and BRCA2 polymorphisms, hereditary nonpolyposis colon cancer, or familial adenomatous polyposis
Patients who are or become ineligible as defined by USPSTF guidelines for lung cancer screening.
Women who are regularly screened for cervical cancer are not eligible
Women must have a cervix to receive cervical cancer screening
History of esophageal dysplasia or cancer
Patients will have one of the following diseases: primary hepatocellular cancer, hepatobiliary cancer, or metastatic disease to the liver
No history of invasive cervical cancer
Have a history of cervical cancer
Are enrolled in any other cancer prevention/outreach related study
Patients with known cancer
Outpatients scheduled for screening or surveillance colonoscopy for polyps or colorectal cancer )
Patients with a histological diagnosis of clinical stage I epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma
CONTROL (HEALTHY) GROUP: No history of cancer
History of anal cancer, penile, vulvar, vaginal, or cervical cancer, or signs of any of these malignancies at baseline; participants with prior carcinoma in situ will not be considered to have prior cancer for eligibility purposes
Women who have a core biopsy or excisional biopsy containing invasive cancer
Active cancer defined as metastatic disease and/or any evidence of cancer on cross-sectional or positron emission tomography (PET) imaging, cancer related surgery, chemotherapy or radiation therapy within the past 6 months; Note: non-melanoma skin cancer does not meet the cancer requirement
Women with a personal history of ovarian, fallopian tube, or primary peritoneal cancer
Cancer survivor
Current participation in another cancer chemoprevention study
Reports at least one year of lung cancer screening experience
Employed as a full-time Site Coordinator at participating lung cancer screening site
Seeking baseline or annual follow-up low dose computed tomography (LDCT) lung cancer screening
Any prior investigational immune therapy, such as for lung cancer prevention or treatment or for CIS of the cervix
Prior germ cell cancer
Currently being actively treated for cancer other than nonmelanoma skin cancer.
History of cancer diagnosis at least one year prior
No future cancer therapy planned
History of skin cancer diagnosis
No evidence of disease (in situ or invasive cancer that would normally be treated by resection) at trial entry as determined by the investigator; diagnosis of invasive cancer must be at least 5 years prior to initiation on trial
Prior history of cervical, vulvar, or vaginal cancer
Cervical, vulvar, or vaginal lesions suspicious for cancer based on clinical appearance (e.g. necrotic, ulcerated, and/or fungating masses), unless biopsies show no invasive cancer
Meets guidelines for lung cancer screening, as determined by radiology team.
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
Diagnosis of cancer requiring systemic therapy in the past 5 years
Consent to the tissue Cancer Therapy and Research Center (CTRC) biorepository
Patients should receive their definitive treatment at Wake Forest University (WFU) Cancer Center or at Medical University of South Carolina (MUSC) Cancer Center
Clinical breast exam interpreted as benign (not suspicious for cancer) at Memorial Sloan Kettering (MSK)
Any current invasive cancer diagnosis
Has a current or previous diagnosis of any type of cancer
Individuals who have registered to undergo lung cancer screening and who agree to be called for possible participation
At time of approach, >= 5 years from initial cancer diagnosis or >= 5 years from first HCT, whichever is later.
History of ovarian cancer
Chinese and Korean American patients who are not up to date for colorectal cancer screening
Male and female patients who present to the urology clinic for recurrent non-muscle invasive bladder cancer (NMIBC) or muscle invasive bladder cancer (MIBC) and are candidates for radical cystectomy will be screened for participation
Taking active cancer treatment
Prior history of esophageal cancer
Prior colon cancer (>= 3 years out from invasive cancer)
Any history of current or prior rectal cancer
Ovarian cancer:
Colorectal cancer
Gastric and esophageal cancer
Up to date with all age appropriate cancer screening tests, as per American Cancer Society guidelines
Has evidence of cancer at the time of enrolment, or has surveillance tests planned within 21 weeks after enrollment
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 invasive cancer diagnosis =< 12 months prior to randomization, excepting nonmelanoma skin cancer; patients with T1a adenocarcinoma of the esophagus arising in the setting of Barrett’s esophagus are eligible for enrollment in the trial
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
Bladder cancer
Subject has invasive lobular cancer
Patients must have histologically or cytologically confirmed (at original diagnosis or subsequent recurrence or progression) lymphoma, chronic lymphocytic lymphoma (CLL) or solid tumor; patients with lymphoma or CLL must have radiologically or clinically evaluable disease, and be refractory to standard therapy as defined by relapse within 6 months of last treatment (see note below); patients with solid tumors must have radiologically or clinically evaluable disease that is metastatic, unresectable, progressive, or recurrent, and for which standard curative measures do not exist or are no longer effective\r\n* Patients with a liver mass, raised alpha-fetoprotein level (>= 500 ng/mL) and positive serology for hepatitis, consistent with a diagnosis of hepatocellular carcinoma will be eligible without the need for pathologic confirmation of the diagnosis\r\n* Patients with prostate cancer, renal cell cancer, neuroendocrine tumors, lung cancer, colorectal cancers, soft tissue sarcomas, glioma and thyroid cancer are excluded in the normal and mild cohorts due to a lack of efficacy in these tumor types in phase 2 studies; patients with breast, pancreatic, bladder, head and neck cancers, as well as melanoma and other malignancies are eligible\r\n* Note: patients with prostate cancer, renal cell cancer, lung cancer, colorectal cancers, soft tissue sarcomas, glioma and thyroid cancer are allowed to enroll in the moderate and severe cohorts provided the patients:\r\n** Sign a separate consent form which outlines the lack of efficacy observed in prior studies\r\n** Are consented to the study by a protocol-specified designee who is not their longitudinal oncologist; patients with neuroendocrine tumors are still excluded from the moderate and severe cohorts\r\n* Note: as romidepsin is approved for patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) or cutaneous T cell lymphoma (CTCL), these patients would be eligible WITHOUT the requirement of having ‘relapsed within 6 months of last treatment’
Patients with prostate cancer, renal cell cancer, neuroendocrine tumors, lung cancer, colorectal cancers, soft tissue sarcomas, glioma, and thyroid cancer are excluded in the normal and mild cohorts due to a lack of efficacy in these tumor types in phase 2 studies; patients with prostate cancer, renal cell cancer, lung cancer, colorectal cancers, soft tissue sarcomas, glioma and thyroid cancer are allowed to enroll in the moderate and severe cohorts only; patients with neuroendocrine tumors are still excluded from the moderate and severe cohorts
Inclusion Criteria:\n\n        Diagnosis of locally advanced or metastatic cancer that has progressed despite standard\n        therapy or for which no effective standard therapy exists and histological confirmation of\n        one of the following diseases indicated below:\n\n        Single Agent Dose escalation part:documented B-RAF mutant colorectal cancer or pancreatic\n        adenocarcinoma. In addition, tumors of any histological origin with documented genetic\n        alterations upstream in the Wnt signaling pathway are eligible with prior agreement with\n        Novartis.\n\n        Single Agent Dose expansion part: documented B-RAF mutant colorectal cancer with documented\n        RNF43 mutation and/or RSPO fusion or pancreatic adenocarcinoma with documented RNF43\n        mutation. In addition, patients with tumors of any histological origin with documented\n        genetic alterations upstream in the Wnt signaling pathway (e.g. RNF43 or RSPO fusion) are\n        eligible with prior agreement with Novartis\n\n        LGK974 with PDR001: Dose escalation: patients with the following cancers that were\n        previously treated with anti-PD-1 therapy and whose best response on that therapy was\n        progressive disease (i.e. primary refractory): melanoma, lung SCC, HNSCC. Patients with\n        esophageal SCC, cervical SCC or TNBC who are either naïve or primary refractory to prior\n        anti-PD-1 therapy.\n\n        LGK974 with PDR001: Dose expansion: patients with pancreatic cancer, or TNBC, or melanoma,\n        or head and neck cancer.\n\n        Exclusion Criteria:\n\n          -  Impaired cardiac function\n\n          -  Impairment of gastrointestinal function or gastrointestinal disease that may\n             significantly alter the absorption of oral LGK974 (e.g., ulcerative diseases,\n             uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel\n             resection)\n\n          -  Brain metastases that have not been adequately treated\n\n          -  Malignant disease other than that being treated in this study\n\n          -  Laboratory abnormalities as specified in the protocol\n\n          -  Osteoporosis, severe or untreated osteopenia\n\n          -  Bone fractures within the past year\n\n          -  Pathologic bone fracture\n\n          -  Active, known or suspected autoimmune disease or severe hypersensitivity reactions to\n             other monoclonal antibodies\n\n        Other protocol-defined inclusion/exclusion criteria may apply
Unresectable advanced or metastatic ACC, non-urothelial bladder/upper tract cancer, non-adenocarcinoma prostate cancer, penile cancer or treatment refractory germ-cell tumor
Women with a history of ovarian, fallopian tube, or primary peritoneal cancer
Women currently undergoing cancer treatment or with a known active cancer; history of malignancy is allowed as long as the patient has completed treatment > 3 months prior to enrollment
Women who have received cancer surgery, chemotherapy, biological therapy (e.g., trastuzumab), or radiotherapy for the treatment of any cancer within 6 months of study participation
Previously resected colorectal cancer
Clinical diagnosis of bladder cancer
Current participation in a cancer intervention prevention study, except for smoking cessation
Patients must have completed primary breast or ovarian cancer therapy (i.e., surgery, chemotherapy, immunotherapy and/or radiation therapy as appropriate per standard of care for patient's specific cancer)
No findings in the rectum of advanced adenoma, chronic inflammation, or 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)
Be an intestinal cancer survivor that is a minimum of 4 months post chemotherapy/radiation treatment; OR be a healthy adult with no prior history of treatment for cancer
Active cancer or metastatic disease, except in the case of stage 0 chronic lymphocytic leukemia or nonmelanoma skin cancer
Active cancer diagnosis or metastatic disease, except in the case of stage 0 chronic lymphocytic leukemia or nonmelanoma skin cancer
Diagnosis of pathologically confirmed lung cancer by tumor biopsy and/or fine-needle aspiration
History of childhood cancer
>= 2 years since completion of cancer-directed therapy for first cancer
Participants should preferably have histologically confirmed non-small cell lung cancer, but patients with a clinical and radiographic diagnosis of non-small cell lung cancer who are candidates for stereotactic body radiation therapy may also be eligible
History of thyroid cancer
Patient with lung cancer (presumed or biopsy proven) undergoing evaluation for resection
Diagnosis of histologically proven node-positive lung cancer (n=20) OR base of skull or brain tumor (n=20)
Subject has histologic or cytologic confirmation of lung cancer (non-small cell lung cancer [NSCLC] or small cell) and has been recommended thoracic radiotherapy as part of standard of care management
HEALTHY CONTROLS: Women with no suspected gynecological cancer
GYNECOLOGIC CANCER: Women with suspected gynecological cancer
GYNECOLOGIC CANCER: No contraindications for MR or PET imaging
GYNECOLOGIC CANCER: Scheduled to undergo a hysterectomy and/or salpingo-oophorectomy
Subjects with suspected sarcoidosis, lymphoma, or metastatic cancer from other sites (i.e. those without a known or suspected lung primary)
Patients who are not expected to receive cancer therapy before imaging sessions are completed.
Patients with small cell lung cancer receiving twice daily (b.i.d.) radiation
Patients with esophageal cancer receiving trastuzamab
Must have diagnosis of urothelial cancer
Patients with PSMA-positive tumors including prostate cancer, breast cancer, lung cancer, and other tumor types know to express PSMA
Subjects with completely obstructing esophageal cancer
History of anal or cervical cancer
Registered with the clinical trials office of the Karmanos Cancer Center/Wayne State University
Patient must have proven or suspected non small cell lung cancer (NSCLC) and be clinical stage I or IIa, according to the 7th edition staging system of the American Joint Commission on Cancer for lung cancer (T1 or T2a, N0 or N1, M0)
Patients undergoing SABR for the treatment of a lung tumor, inclusive of non-small cell lung cancer or lung metastases
Planned radical prostatectomy at Memorial Sloan-Kettering Cancer Center (MSKCC)
Dosimetry Studies Arm (Completed July 2015): \r\n* Healthy volunteer OR participant with biopsy-proven diagnosis of head and neck squamous cell carcinoma (HNSCC), any histopathologic type of lung cancer, or any other type of cancer that can be treated with platinum-based chemotherapy (which includes but is not limited to ovarian, lung, gastric, hepatic, and pancreatic cancers)
Known pathological diagnosis of any solid cancer
Newly diagnosed biopsy proven locoregional invasive breast cancer at MD Anderson Cancer Center, or referred to MD Anderson for treatment after initial radiologic (mammographic, sonographic, etc.) exams at an outside institution in whom NAC is planned
Greater than 2 cores positive for Gleason 3+4 cancer
Gleason 4+3 or higher cancer in any single biopsy core
Women must be enrolled in the Ovarian Cancer Screening Program (OCSP); eligibility criteria for the OCSP are: 50 years of age or older, or be postmenopausal and have not had a prior salpingo-oophorectomy or have a family history of ovarian cancer in a primary relative or have a self-history of breast cancer
History of ovarian cancer
Histologically confirmed lung cancer, or clinically diagnosed lung cancer
Histologically confirmed diagnosis of melanoma, breast cancer, or gynecologic cancer at Memorial Sloan-Kettering Cancer Center (MSKCC)
Have been diagnosed with a malignancy/tumor/cancer, including but not limited to: brain tumor, breast cancer, lung cancer, esophageal cancer, lymphoma, or sarcoma
HEALTHY VOLUNTEERS (Group 4): Group 4 participants must have no history of cancer, pancreatic disease, or family history of pancreatic cancer\r\n* Family history will be defined as pancreatic cancer occurring in one first-degree relative and two other relatives, or two first-degree relatives
Registered patient at Memorial Sloan-Kettering Cancer Center (MSKCC)
Pathologic confirmation of non-small cell lung cancer (NSCLC) at Memorial Sloan-Kettering Cancer Center (MSKCC)
Patients with (current or past) history of solid malignancy, myeloproliferative neoplasm, myeloma, and/or lymphoma histology confirmed by Memorial Sloan-Kettering Cancer Center (MSKCC) Department of Pathology
Histologically confirmed diagnosis of melanoma or malignant brain tumor at Memorial Sloan-Kettering Cancer Center (MSKCC)
Patient with known bladder cancer
Prior histologic diagnosis of cancer or awaiting biopsy or surgery for cancer evaluation of a mass detected on exam or standard imaging; this includes solid tumors as well as hematologic malignancies
Confirmed diagnosis of non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC)
Inclusion Criteria:\n\n        The target population includes adults with small lung nodules that may represent a new\n        diagnosis of lung cancer, who typically would be managed by CT surveillance in usual\n        clinical practice. Thus, we will enroll all patients:\n\n          -  aged ?35 years\n\n          -  at least one nodule measuring ?15 mm in average diameter on chest CT.\n\n        Exclusion Criteria:\n\n          -  Pregnant Women\n\n          -  Age <35 years\n\n          -  Known diagnosis of cancer (except non-melanoma skin cancer) within 5 years
Biopsy proven non-small cell lung cancer
No prior treatment for ovarian cancer
Patients who have non-invasive or non-epithelial ovarian cancer on pathological confirmation; patients with synchronous stage I endometrial cancer will not be excluded
=< 50% of any given core involved with cancer
Primary or locally recurrent stage I-IIA non-small cell lung cancer (NSCLC): T1-T2 N0 M0; tumor must be large enough to be above the detection threshold of PET imaging as determined by study investigators
Participant in whom it may be considered a viable clinical option to perform neck dissection when primary cancers are at high risk for neck metastasis (see definition above);\r\n* These will include: 1) oral cavity cancer; 2) oropharynx cancer, including base of tongue and tonsil cancers; 3) larynx cancer; or 4) supraglottic cancer
Subjects with suspected sarcoidosis, lymphoma, or metastatic cancer from other sites (i.e. those without a known or suspected lung primary)
Bladder cancer (current or prior)
OVARIAN CANCER PARTICIPANTS: Participant has suspected or biopsy proven ovarian cancer and is scheduled to undergo surgical excision of the cancerous lesion(s) OR\r\n* Participant has biopsy proven ovarian cancer but is not a surgical candidate
OVARIAN CANCER PARTICIPANTS: Patient is able to remain still for duration of each imaging procedure
OVARIAN CANCER PARTICIPANTS: Patients participating in other research imaging protocols will be excluded from this study
Women matched to age with our 16 post-cancer treatment participants
Patients with histologically-confirmed (confirmation done at Memorial Sloan-Kettering Cancer Center [MSKCC]) malignancies
Patients who have consented to a therapeutic protocol for the treatment of their cancer
Histology confirmed by Memorial Sloan-Kettering Cancer Center (MSKCC) Department of Pathology
Patients must have pathologically confirmed diagnosis of unilateral ductal carcinoma in situ with no evidence of microinvasive or invasive disease obtained by core needle biopsy within 4 months of registration; if the core biopsy describes “suspicion of microinvasion”, patients remain eligible; patients diagnosed by surgical excision are not eligible; patients with synchronous bilateral disease (i.e.,\r\nsynchronous DCIS or invasive cancer) are not eligible\r\n* Patients will be staged prior to registration according to the clinical staging criteria adapted from the American Joint Committee on Cancer (AJCC) Cancer Staging Data Forms of the AJCC Cancer Staging Manual, 7th Edition, 2009; Note: for consistency purposes, AJCC 7th Edition will continue to be used throughout the entire study enrollment period
Patient must have no other active cancer at the time of diagnosis of cervical cancer
FINAL ENROLLMENT BIOPSY PARAMETERS: no demonstrated cancer diameter > 1.2 cm
Staging imaging workup including a baseline MRI of the prostate and pelvis performed at Memorial Sloan-Kettering Cancer Center (MSKCC)
Patients with head and neck cancer who are scheduled for node dissection surgeries at New York University (NYU) Langone Medical Center or Bellevue hospital, or for a PET/CT at the Cancer Center (160 E 34th St) for treatment planning are eligible
Biopsy proven papillary thyroid cancer (regardless of genotype and including all subtypes such as follicular or mixed papillary follicular) or suspicious for thyroid cancer
Patients with synchronous primary endometrial cancer or a past history of endometrial cancer, unless all of the following conditions are met:\r\n* Stage not greater than IB\r\n* No more than superficial myometrial invasion\r\n* No vascular or lymphatic invasion\r\n* No poorly differentiated subtypes, including serous, clear cell, or other International Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions
Patient must not be receiving any other anti-cancer agent
Epithelial ovarian cancer outside of the peritoneal cavity, with the exception of pleural effusions
Patients must not currently be using other anti-cancer agent
Histologically or cytologically confirmed diagnosis of metastatic non-small cell lung cancer (NSCLC) (stage IV, American Joint Committee on Cancer [AJCC] v7.0) that carries (a) an ALK rearrangement, as determined by fluorescence in-situ hybridization (FISH), immunohistochemistry, or next generation sequencing (NGS) of either tissue or plasma, or (b) a ROS1 rearrangement as determined by FISH or reverse transcriptase-polymerase chain reaction (RT-PCR) or NGS via a local diagnostic test (LDT) or plasma analysis
Women presenting for evaluation at Memorial Sloan-Kettering Cancer Center (MSKCC) with biopsy proven invasive ductal cancer (IDC) or invasive lobular cancer (ILC)
Patients must either have histologic or pathologically confirmed non-small cell lung cancer (NSCLC) or suspicious nodules/lesions which are going to be surgically resected before they are pathologically confirmed
Patients who have had a prior lung cancer within the last five years from the current diagnosis
Patients with any prior systemic therapy for the current diagnosis of lung cancer
The patient has endometrial cancer and is scheduled for robotic hysterectomy and lymphadenectomy
Enrolled at MD Anderson Cancer Center (MDACC), written consent
Patients with histologically confirmed prostate cancer at Memorial Sloan-Kettering Cancer Center (MSKCC)
Patients with histologic or cytologic proof of pancreatic cancer, for whom the treatment plan, at the time of enrollment, is chemoradiation
All nasopharyngeal, paranasal sinus, salivary cancer, and thyroid malignancies
Patients who have had cystectomies for bladder cancer; or
GROUP 2: Oncologic patients at MD Anderson Cancer Center (MDACC):
A primary histopathological and/or cytopathological diagnosis of small cell lung cancer (SCLC)
Cancer patients receiving radiation treatment to the thorax to at least 45 Gy; patient must have pathologic confirmation of diagnosis, or have an enlarging lung mass on at least two scans spaced 3 months apart, and FDG avidity on PET scan
Men with prostate cancer who elect surgery as the primary treatment of their cancer and to be performed at the Moffitt Cancer Center
Location of cancer specified in the pathology report
Location of cancer not specified
Cancer survivors with no evidence of disease for at least 6 months as determined by the oncologist and no longer receiving cancer treatment
Participants will be excluded if they have a recurrence that requires anti-cancer treatment
Be receiving any active pharmaceutical treatments for cancer
NORMAL VOLUNTEERS: Be receiving any active pharmaceutical treatments for cancer
A subset of cancer patients being imaged with PET/CT for diagnosis and/or staging of disease at Case Comprehensive Cancer Center
Diagnosis of rectal cancer
Patients with lung cancer visible on CT who are scheduled to receive external beam radiation treatment will be eligible for this study
Patients with primary locally advanced rectal adenocarcinoma (0-18 cm from the anal verge) confirmed by Memorial Sloan-Kettering Cancer Center (MSKCC) pathologist and eligible to undergo chemoradiation and surgical resection at MSKCC
Undergoing pancreatic cancer resection
Patient must have proven or suspected non-small cell lung cancer (NSCLC) (squamous cell, adenocarcinoma, or large cell) and be clinical stage I or II, according to the 1998 staging system of the American Joint Commission on Cancer for lung cancer (T1-3 N0, T1-2 N1)
Patient must not have a previous history of laryngeal cancer
Patients with presumed advanced-stage high grade serous ovarian, fallopian tube, or primary peritoneal carcinoma, based on the presence of carcinomatosis, and/or elevated cancer antigen (CA)125, and/or ovarian mass(es), or at the discretion of the treating physician
Prior treatment for ovarian, fallopian tube, or primary peritoneal cancer
Patients with histology other than adenocarcinoma, e.g., neuroendocrine cancer or acinar cancers, are ineligible*
Taking active cancer treatment
History of respiratory tract cancer
Have a confirmed diagnosis of type I endometrial cancer (endometrioid) based on pre-operative endometrial biopsy or dilation and curettage (D&C)
BIODISTRIBUTION COHORT: History of known or suspected epithelial ovarian, fallopian tube, or primary peritoneal cancer (may have primary or metastatic cancer at the time of study enrollment)
DYNAMIC COHORT: History of known or suspected epithelial ovarian, fallopian tube, or primary peritoneal cancer (may have primary or recurrent cancer at the time of study enrollment)
Consented for tissue collection on Mays Cancer Center repository 07-32 (for Mays Cancer Center patients only)
Histologically-confirmed diagnosis of pancreatic adenocarcinoma, mesothelioma,\r\nmesothelin-positive ovarian cancer, or NSCLC; a new biopsy is not required; the diagnostic biopsy sample will be sufficient; IHC confirmation of mesothelin positivity is not necessary for pancreatic adenocarcinoma and mesothelioma; mesothelin expression in ovarian cancer and NSCLC will be tested by IHC, and any degree of positivity (1+, 2+, or 3+) will be accepted
Inclusion Criteria:\n\n        Cisplatin Combination Expansion:\n\n        Arm 1:Patients with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic\n        setting; Arm 2: Patients with TNBC and one or two prior cytotoxic therapies in the\n        metastatic setting.\n\n          -  Arm A: castrate resistant prostate cancer, advanced breast cancer, or non-small cell\n             lunch cancer that are candidates for treatment with a docetaxel-based combination.\n\n          -  Arm B: Urothelial transitional cell cancer, triple negative breast cancer, ovarian\n             cancer or non small cell lunch cancer that are candidates for a cisplatin-based\n             combination.\n\n          -  Arm C: Her2+ breast cancer refractory to prior herceptin or lapatinib, her2+\n             esophagal-gastric cancer, head and neck squamous cell cancer, or non small cell lunch\n             cancer that are candidates for treatment with a dacomitinib-based combination.\n\n          -  Availability of archival tumor biopsy sample or willing to provide fresh biopsy if not\n             available.\n\n          -  Eastern Cooperative Oncology Group [ECOG] performance must be 0 or 1.\n\n          -  Adequate bone marrow, renal and liver function.\n\n        Exclusion Criteria:\n\n          -  Prior therapy for Cisplatin Combination Expansion:\n\n               -  Prior platinum (carboplatin or cisplatin) in either the adjuvant or metastatic\n                  setting;\n\n               -  Prior radiation to >25% bone marrow as estimated by the Investigator.\n\n          -  Patients with known symptomatic brain metastases.\n\n          -  Chemotherapy, radiotherapy, biologics or investigational agent within 4 weeks of the\n             lead-in dose.\n\n          -  Major surgery within 4 weeks of the baseline disease assessments.\n\n          -  >2 prior regimens containing cytotoxic chemotherapy in the metastatic setting.\n\n          -  Active bacterial, fungal or viral infection.\n\n          -  Uncontrolled or significant cardiovascular disease.
Patients must be suspected of having a diagnosis of ovarian, fallopian tube or primary peritoneal cancer with a planned cytoreductive surgery
Borderline ovarian cancer with ascites is allowable
Histologic diagnosis of epithelial ovarian, fallopian tube or primary peritoneal cancer confirmed on frozen section diagnosis during debulking surgery
Non-epithelial ovarian cancer or metastatic cancer from another site to the ovaries
Borderline ovarian cancer without ascites
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.
Requires a clinically necessary esophagectomy for esophageal cancer or other indications.
Patients with presumed advanced-stage high grade serous ovarian, fallopian tube, or primary peritoneal carcinoma, based on the presence of carcinomatosis, and/or elevated cancer antigen 125 (CA125), and/or ovarian mass(es), or at the discretion of the treating physician
Prior treatment for ovarian, fallopian tube, or primary peritoneal cancer
A pathologically documented colorectal cancer that:
Patients must have a current diagnosis of breast cancer, non-small cell lung cancer, or colorectal cancer; the current diagnosis may be an initial diagnosis or recurrence and/or progression of previously diagnosed disease; cancer may be metastatic or non-metastatic
Previous history of lung cancer
Patient is being treated at a Duke Cancer Network (DCN) affiliate site
Physicians (medical oncologists, urologists, and radiation oncologists) who regularly treat patients with prostate cancer at one of the two research sites (Wayne State University/Karmanos Cancer Institute [WSU/KCI] or Hopkins) and who can recruit patients to available trials
PATIENT: Undergoing treatment for cancer by one of the consented HCPs as per the HCP and/or EMR
Receiving care at the Massachusetts General Hospital (MGH) Cancer Center
AIM 2: Less than three relevant comorbidities (diabetes, heart disease, stroke and cancer, where cancer counts as 2 comorbidities for women but 1 for men)
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
Any patient with recurrent or progressive cancer
PATIENTS: Adult patients (>= 18 years) with a diagnosis of metastatic solid cancer
PATIENTS: Diagnosis of metastatic cancer < 3 months from the date of hospital admission
Oncologists who do not have enough patients with advanced cancer
Have a history of invasive (>= T1) bladder cancer
Diagnosis of any stage I - IV colorectal cancer or recurrent colorectal cancer (Arm 1)
Admitted to being a current smoker or recent quitter upon admission to MD Anderson Cancer Center (MDACC) (Arm 4)
Enrolled at 3 trial sites in: (1) Washington, District of Columbia (DC) (Lombardi Comprehensive Cancer Center; LCCC), (2) Boston, Massachusetts (MA) (Dana-Farber Cancer Institute; DFCI), and (3) New York, New York (NY) (Mount Sinai Medical Center; MSMC)
Focus on one of the following disease categories: non-small cell lung cancer, colon cancer, breast cancer, prostate cancer, kidney cancer, lymphoma
Be seen regularly (at least monthly) at a Memorial Sloan-Kettering Cancer Center (MSKCC) gastrointestinal (GI) medical oncology clinic
Has an exocrine GI cancer with MSKCC pathology confirmation at the primary or metastatic anatomic site
Patients must know their cancer diagnosis
Any health care provider (physician, advanced practice clinician) at a study site (Fox Chase Cancer Center [FCCC] and Fox Chase Cancer Center Partners [FCCCP]) who provides care for NSCLC and/or CRC survivors
Patients must have been seen for a visit for cancer surveillance between 2009 and 2013
Cancer Registry cases for diseases other than colon or rectal adenocarcinoma and non-small cell lung cancer (squamous or adenocarcinoma histology)
Patients currently receiving active therapy for any cancer, including CRC or NSCLC
Patients who have not undergone a visit for cancer surveillance since 2009
Had their cancer care primarily managed by a participating clinician
Diagnostic of small cell lung cancer or carcinoid tumors
Bladder cancer (current or prior)
Individual pediatric patient with current or previous known or suspected thyroid cancer or nodule(s)
Individual adult patient with current or previous known or suspected thyroid cancer or nodule(s) if they come from a family with a high suspicion of hereditary cancer
Individuals from families with a high suspicion of hereditary thyroid cancer:\r\n* Families with a current or previous diagnosis of a thyroid cancer/nodule occurring in childhood (< 18 years old)\r\n* Families with a high suspicion of hereditary thyroid cancer/nodules other than above to include:\r\n** Families with thyroid cancer in multiple individuals\r\n** Families with thyroid cancer and a known genetic syndrome\r\n** Families with thyroid cancer and a suspected genetic syndrome (e.g. multiple childhood cancers in the family, multiple primary cancers, multiple endocrinopathies, etc.)
Off of all cancer therapy for >= 2 years
Criteria1, Participant provided informed consent prior to any study-specific activities/procedures -Criteria 2, Confirmation of triple negative breast cancer or colorectal cancer with liver metastases by laboratory testing
Female patients 18 years of age and older 2. Have a primary diagnosis, or at high clinical suspicion, of primary ovarian cancer (of epithelial type), planned for primary surgical cytoreduction, interval debulking, or have recurrent ovarian cancer surgery, and:
Epithelial ovarian cancer (including primary peritoneal disease and/or fallopian tube carcinomas and/or endometrial adenocarcinomas).
Non-small cell lung cancer (NSCLC).
Urothelial cancer.
Evaluable disease by serum markers in the case of ovarian cancer [Gynecologic Cancer Intergroup (GCIG) specific criteria]; and
Anti-cancer agents: must not be receiving other anti-cancer agents at time of enrollment and must not be planning to take other anti-cancer agents during DLT period
Inclusion:\n\n          -  21 years of age or older\n\n          -  Have a cancer diagnosis\n\n          -  Self identify as African American\n\n          -  Therapeutic Phase I, II or III clinical trial at Massey Cancer Center (regardless of\n             whether or not they join the therapeutic trial)\n\n          -  Be able to provide informed consent\n\n          -  We will also recruit one family member/caregiver (N = 357) of each participating\n             patient\n\n          -  Consented patients will not be excluded from this study if their family member\n             declines to participate by completing the Cancer Communication Assessment Tool for\n             Families (CCAT-F).
FNA results positive for cancer cells
Current or pending participation in a clinical trial examining therapy for the\n             treatment of any cancer (including unresectable or metastatic melanoma)
Current use of therapy to treat a primary cancer other than melanoma
Patients must have biopsy-proven bladder cancer
All Memorial Sloan-Kettering Cancer Center (MSKCC) prognostic scores allowed
Any other cancer from which the subject has been disease free for 3 years
Patients with cancer that spread to the brain
Have a primary diagnosis, or at high clinical suspicion, of primary ovarian cancer (of epithelial type), planned for primary debulking or interval debulking surgery, and:
Known FR alpha-negative ovarian cancer
Patients planning to undergo radiation therapy for primary or recurrent carcinomas of the lung or cancer that is metastatic to the lung.
Patients who are at least 18 years old, who have been identified by the BMT social worker as having a cancer or pre-cancer diagnosis and are Minnesota residents with potential legal needs (see the list below), expected to proceed to transplant, considered the primary client for legal services or are at least 18 years old and have a legal-designate.
Patients with non-cancer diagnoses, as CALL only provides services for cancer or pre-cancer diagnoses.
Histologically confirmed Epitheilial Ovarian Cancer (EOC), Fallopian Tube Cancer (FTC) or Primary Peritoneal Cancer (PPC).
Has life-threatening illness unrelated to cancer.
Second primary cancer which is active and requiring treatment
Previous or coexisting cancer(s) distinct in primary site or histology from the cancer evaluated in this study EXCEPT:
Papillary thyroid cancer (PTC)
Follicular thyroid cancer (FTC)
Patients with a separate non-cutaneous cancer diagnosis for which the patient has not been without evidence of disease for at least 5 years
Cancer treatment within the past 3 weeks
Histologically or cytologically confirmed stage III-IV (non-metastatic) SCCHN as defined by American Joint Committee on Cancer (AJCC); nasopharyngeal cancer patients will be excluded; note that in rare instances, a cancer may be clearly invasive on imaging, but pathology may not be definitive (e.g. in-situ carcinoma); in such cases, the patient will be eligible if the unanimous opinion of the institutional tumor board is that the situation is definitive for invasive SCCHN