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Nivolumab and Ipilimumab in Treating Patients With Rare Tumors

ABSTRACT: This phase II trial studies nivolumab and ipilimumab in treating patients with rare tumors. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial enrolls participants for the following cohorts based on condition: 1. Epithelial tumors of nasal cavity, sinuses, nasopharynx: A) Squamous cell carcinoma with variants of nasal cavity, sinuses, and nasopharynx and trachea (excluding laryngeal, nasopharyngeal cancer [NPC], and squamous cell carcinoma of the head and neck [SCCHN]) B) Adenocarcinoma and variants of nasal cavity, sinuses, and nasopharynx (closed to accrual 07/27/2018) 2. Epithelial tumors of major salivary glands (closed to accrual 03/20/2018) 3. Salivary gland type tumors of head and neck, lip, esophagus, stomach, trachea and lung, breast and other location (closed to accrual) 4. Undifferentiated carcinoma of gastrointestinal (GI) tract 5. Adenocarcinoma with variants of small intestine (closed to accrual 05/10/2018) 6. Squamous cell carcinoma with variants of GI tract (stomach small intestine, colon, rectum, pancreas) (closed to accrual 10/17/2018) 7. Fibromixoma and low grade mucinous adenocarcinoma (pseudomixoma peritonei) of the appendix and ovary (closed to accrual 03/20/2018) 8. Rare pancreatic tumors including acinar cell carcinoma, mucinous cystadenocarcinoma or serous cystadenocarcinoma. Pancreatic adenocarcinoma is not eligible (closed to accrual) 9. Intrahepatic cholangiocarcinoma (closed to accrual 03/20/2018) 10. Extrahepatic cholangiocarcinoma and bile duct tumors (closed to accrual 03/20/2018) 11. Sarcomatoid carcinoma of lung 12. Bronchoalveolar carcinoma lung. This condition is now also referred to as adenocarcinoma in situ, minimally invasive adenocarcinoma, lepidic predominant adenocarcinoma, or invasive mucinous adenocarcinoma 13. Non-epithelial tumors of the ovary: A) Germ cell tumor of ovary B) Mullerian mixed tumor and adenosarcoma (closed to accrual 03/30/2018) 14. Trophoblastic tumor: A) Choriocarcinoma (closed to accrual) 15. Transitional cell carcinoma other than that of the renal, pelvis, ureter, or bladder (closed to accrual) 16. Cell tumor of the testes and extragonadal germ tumors: A) Seminoma and testicular sex cord cancer B) Non seminomatous tumor C) Teratoma with malignant transformation (closed to accrual) 17. Epithelial tumors of penis - squamous adenocarcinoma cell carcinoma with variants of penis (closed to accrual) 18. Squamous cell carcinoma variants of the genitourinary (GU) system 19. Spindle cell carcinoma of kidney, pelvis, ureter 20. Adenocarcinoma with variants of GU system (excluding prostate cancer) (closed to accrual 07/27/2018) 21. Odontogenic malignant tumors 22. Pancreatic neuroendocrine tumor (PNET) (formerly named: Endocrine carcinoma of pancreas and digestive tract.) (closed to accrual) 23. Neuroendocrine carcinoma including carcinoid of the lung (closed to accrual 12/19/2017) 24. Pheochromocytoma, malignant (closed to accrual) 25. Paraganglioma (closed to accrual 11/29/2018) 26. Carcinomas of pituitary gland, thyroid gland parathyroid gland and adrenal cortex (closed to accrual) 27. Desmoid tumors 28. Peripheral nerve sheath tumors and NF1-related tumors (closed to accrual 09/19/2018) 29. Malignant giant cell tumors 30. Chordoma (closed to accrual 11/29/2018) 31. Adrenal cortical tumors (closed to accrual 06/27/2018) 32. Tumor of unknown primary (Cancer of Unknown Primary; CuP) (closed to accrual 12/22/2017) 33. Not Otherwise Categorized (NOC) Rare Tumors [To obtain permission to enroll in the NOC cohort, contact: S1609SC@swog.org] (closed to accrual 03/15/2019) 34. Adenoid cystic carcinoma (closed to accrual 02/06/2018) 35. Vulvar cancer (closed to accrual) 36. MetaPLASTIC carcinoma (of the breast) (closed to accrual) 37. Gastrointestinal stromal tumor (GIST) (closed to accrual 09/26/2018) 38. Perivascular epithelioid cell tumor (PEComa) 39. Apocrine tumors/extramammary Paget’s disease (closed to accrual) 40. Peritoneal mesothelioma 41. Basal cell carcinoma (temporarily closed to accrual 04/29/2020) 42. Clear cell cervical cancer 43. Esthenioneuroblastoma (closed to accrual) 44. Endometrial carcinosarcoma (malignant mixed Mullerian tumors) (closed to accrual) 45. Clear cell endometrial cancer 46. Clear cell ovarian cancer (closed to accrual) 47. Gestational trophoblastic disease (GTD) 48. Gallbladder cancer 49. Small cell carcinoma of the ovary, hypercalcemic type 50. PD-L1 amplified tumors 51. Angiosarcoma 52. High-grade neuroendocrine carcinoma (pancreatic neuroendocrine tumor [PNET] should be enrolled in Cohort 22; prostatic neuroendocrine carcinomas should be enrolled into Cohort 53). Small cell lung cancer is not eligible (closed to accrual) 53. Treatment-emergent small-cell neuroendocrine prostate cancer (t-SCNC)

DISEASE(S): Adenocarcinoma,Teratoma,Thyroid Neoplasms,Endometrial Transitional Cell Carcinoma,Ovarian Mucinous Adenocarcinoma,Primary Peritoneal High Grade Serous Adenocarcinoma,Adenocarcinoma, Clear Cell,Neoplasms,Nerve Sheath Neoplasms,Testicular Non-seminomatous Germ Cell Tumor,Cystadenocarcinoma,Malignant Odontogenic Neoplasm,Small Intestinal Adenocarcinoma,Acinar Cell Carcinoma,Basal Cell Carcinoma,Extrahepatic Bile Duct Carcinoma,Nasopharyngeal Papillary Adenocarcinoma,Pancreatic Neuroendocrine Carcinoma,Gallbladder Carcinoma,Ovarian Germ Cell Tumor,Tracheal Carcinoma,Nasopharyngeal Undifferentiated Carcinoma,Adrenocortical Carcinoma,Urethral Adenocarcinoma,Ureter Squamous Cell Carcinoma,Mixed Tumor, Mullerian,Peritoneal Mesothelial Neoplasm,Neoplasms, Mesothelial,Malignant Peripheral Nerve Sheath Tumor,Small Intestinal Squamous Cell Carcinoma,Gastric Neuroendocrine Carcinoma,Neuroendocrine Tumors,Adenocarcinoma, Bronchiolo-alveolar,Fibroma,Extramammary Paget Disease,Rare Disorder,Vaginal Adenocarcinoma,Pseudomyxoma Peritonei,Adrenal Gland Pheochromocytoma,Adenocarcinoma, Papillary,Ovarian Adenocarcinoma,Neoplasms, Germ Cell And Embryonal,Intrahepatic Cholangiocarcinoma,Malignant Testicular Sex Cord-stromal Tumor,Neoplasms, Unknown Primary,Vulvar Carcinoma,Hemangiosarcoma,Sex Cord-gonadal Stromal Tumors,Gastrointestinal Stromal Tumor,Carcinoma, Adenoid Cystic,Seminoma,Paranasal Sinus Carcinoma,Ovarian Squamous Cell Carcinoma,Carcinoma, Neuroendocrine,Carcinoma, Islet Cell,Adenocarcinoma Of Lung,Giant Cell Carcinoma,Gastrointestinal Stromal Tumors,Major Salivary Gland Carcinoma,Spindle Cell Neoplasm,Scrotal Squamous Cell Carcinoma,Carcinoma,Pheochromocytoma,Oropharyngeal Undifferentiated Carcinoma,Carcinoma, Transitional Cell,Pancreatic Acinar Cell Carcinoma,Anal Canal Neuroendocrine Carcinoma,Angiosarcoma,Choriocarcinoma,Vulvar Neoplasms,Ureter Adenocarcinoma,Lung Carcinoid Tumor,Mucinous Adenocarcinoma,Carcinoma, Giant Cell,Carcinoma, Acinar Cell,Bladder Adenocarcinoma,Human Papillomavirus-independent Cervical Adenocarcinoma, Clear Cell-type,Gastric Undifferentiated Carcinoma,Oral Cavity Carcinoma,Cervical Adenocarcinoma,Nasal Cavity Carcinoma,Nasopharyngeal Carcinoma,Apocrine Neoplasm,Carcinoid Tumor,Intestinal Neuroendocrine Carcinoma,Serous Cystadenocarcinoma,Penile Squamous Cell Carcinoma,Gastric Squamous Cell Carcinoma,Seminal Vesicle Adenocarcinoma,Colorectal Squamous Cell Carcinoma,Placental Choriocarcinoma,Carcinoma, Squamous Cell,Adrenal Cortical Carcinoma,Paget Disease, Extramammary,Adenocarcinoma, Mucinous,Esophageal Neuroendocrine Carcinoma,Carcinoma, Endometrioid,Ovarian Transitional Cell Carcinoma,Transitional Cell Carcinoma,Thyroid Gland Carcinoma,Carcinoma, Basal Cell,Fallopian Tube Transitional Cell Carcinoma,Mixed Mesodermal (mullerian) Tumor,Urethral Squamous Cell Carcinoma,Esophageal Undifferentiated Carcinoma,Vaginal Squamous Cell Carcinoma, Not Otherwise Specified,Bartholin Gland Transitional Cell Carcinoma,Gestational Trophoblastic Tumor,Lung Sarcomatoid Carcinoma,Appendix Mucinous Adenocarcinoma,Chordoma,Fibromatosis, Aggressive,Pecoma,Cystadenocarcinoma, Mucinous,Nasal Cavity Adenocarcinoma,Malignant Solid Neoplasm,Cystadenocarcinoma, Serous,Cholangiocarcinoma,Breast Metaplastic Carcinoma,Paranasal Sinus Adenocarcinoma,Fibromyxoid Tumor,Teratoma With Somatic-type Malignancy,Fallopian Tube Adenocarcinoma,Trophoblastic Neoplasms,Metastatic Malignant Neoplasm Of Unknown Primary,Paraganglioma,Endometrioid Adenocarcinoma,Parathyroid Gland Carcinoma,Metastatic Pituitary Neuroendocrine Tumor,Adenoid Cystic Carcinoma,Anal Canal Undifferentiated Carcinoma,Minimally Invasive Lung Adenocarcinoma,Desmoid Fibromatosis,Mucinous Cystadenocarcinoma,Neurofibrosarcoma

PROVIDER: 2219879 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Two prognostically significant subtypes of high-grade lung neuroendocrine tumors independent of small-cell and large-cell neuroendocrine carcinomas identified by gene expression profiles. BACKGROUND: Classification of high-grade neuroendocrine tumors (HGNT) of the lung currently recognises large-cell neuroendocrine carcinoma (LCNEC) and small-cell lung carcinoma (SCLC) as distinct groups. However, a similarity in histology for these two carcinomas and uncertain clinical course have led to suggestions that a single HGNT classification would be more appropriate. Gene expression profiling, which can reproduce histopathological classification, and often defines new subclasses with prognostic significance, can be used to resolve HGNT classification. METHODS: We used cDNA microarrays with 40386 elements to analyze the gene expression profiles of 38 surgically resected samples of lung neuroendocrine tumors and 11 SCLC cell lines. Samples of large-cell carcinoma, adenocarcinoma, and normal lung were also included to give a total of 105 samples analyzed. The data were subjected to filtering to yield informative genes before unsupervised hierarchical clustering that identified relatedness of tumor samples. FINDINGS: Distinct groups for carcinoids, large-cell carcinoma, adenocarcinoma, and normal lung were readily identified. However, we were unable to distinguish LCNEC from SCLC by gene expression profiling. Three independent rounds of unsupervised hierarchical clustering consistently divided SCLC samples into two main groups with LCNEC samples largely integrated with these groups. Furthermore, patients in one of the groups identified by clustering had a significantly better clinical outcome than the other (83% vs 12% survived for 5 years; p=0.0094. None of the highly proliferative SCLC cell lines subsequently analyzed clustered with this good-prognosis group. INTERPRETATION: Our findings show that HGNT of the lung can be classified into two groups independent of SCLC and LCNEC. To this end, we have identified many genes, some of which encode well-characterized markers of cancer that distinguish the HGNT groups. These results have implications for the diagnosis, classification, and treatment of lung neuroendocrine tumors, and provide important insights into their underlying biology. Keywords: other

Project description:Purpose: Small-cell prostate carcinoma (SCPC) morphology predicts for a distinct clinical behavior, resistance to androgen ablation, and frequent but short responses to chemotherapy. The model systems we report reflect the biology of the human disease and can be used to improve our understanding of SCPC and to develop new therapeutic strategies for it. Experimental Design: We developed a set of CRPC xenografts and examined their fidelity to their human tumors of origin. We compared the expression and genomic profiles of SCPC and large cell neuroendocrine carcinoma (LCNEC) xenografts to those of typical prostate adenocarcinoma xenografts and used a panel of 60 human tumors to validate our findings using immunohistochemistry. Results: We show that SCPC and LCNEC xenograft models retain high fidelity to their human tumors of origin and are characterized by a marked upregulation of UBE2C and other M-phase cell cycle genes in the absence of AR, retinoblastoma (RB1) and cyclin D1 (CCND1) expression and confirm these findings in a panel of CRPC patients’ samples. In addition, array comparative genomic hybridization of the xenografts showed that the SCPC/LCNEC tumors display more copy number variations than the adenocarcinoma counterparts and that there is amplification of the UBE2C locus and microdeletions of RB1 in a subset of these, but no AR nor CCND1 deletions. Moreover, the AR, RB1, and CCND1 promoters showed no CpG methylation in the SCPC xenografts. Conclusion: Modeling human prostate cancer with xenografts allows in-depth and detailed studies of its underlying biology. The detailed clinical annotation of the donor tumors enables associations of anticipated relevance to be made. Futures studies in the xenografts will address the functional significance of the findings. 22 samples were analysed, that included MDA PCa 79 (n = 3), 117-9 (n = 3), 130 (n = 2), 144-4 (n = 4), 144-13 (n = 5), 146-10 (n = 3), 155-2 (n = 1), and 155-12 (n = 1). MDA PCA 79, 117-9 and 130 samples had the pathologic characteristics of prostate adenocarcinoma and were compared against MDA PCA 144-4, 144-13, 146-10 and 155-12 that have the pathologic features of prostate small cell/ large cell neuroendocrine carcinoma

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Nivolumab and Ipilimumab in Treating Patients With Rare Tumors

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