No prior invasive malignancy, unless disease-free for >= 3 years prior to registration (exceptions: non-melanoma skin cancer, in-situ cancers)Xx_NEWLINE_xXWith the exception of non-melanoma skin cancer and other specific malignancies as noted above, other invasive malignancies with any evidence of other cancers present within the last 5 years or previous cancer treatment that contraindicates this protocol therapyXx_NEWLINE_xXHistory of another malignancy\r\n* Exception: patients who have been disease-free for 3 years or patients with a history of completely resected non-melanoma skin cancer and/or patients with indolent secondary malignancies, are eligible; consult the Cancer Therapy Evaluation Program (CTEP) medical monitor if unsure whether second malignancies meet the requirements specified aboveXx_NEWLINE_xXPrior invasive malignancy (except non-melanomatous skin cancer and T1 renal cell carcinoma) unless disease free for a minimum of 2 years (note that carcinoma in situ of the breast, oral cavity, or cervix are all permissible)Xx_NEWLINE_xXThe patient has a concurrent active malignancy other than treated non-melanoma skin cancers or in situ neoplasm; a patient with a prior history of malignancy is eligible, provided that they have been free of disease for >= 5 yearsXx_NEWLINE_xXPatients must not have any history of locally advanced or metastatic cancer requiring systemic therapy within 5 years from randomization, with the exception of in-situ carcinomas and non-melanoma skin cancer; patients must have no previous primary lung cancer diagnosed concurrently or within the past 2 yearsXx_NEWLINE_xXNo history of other malignancy within the past 4 years, except for malignancies with a > 95% likelihood of cure (e.g. non-melanoma skin cancer, papillary thyroid cancer, in situ cervical cancer); patients cannot have metastatic breast or other cancerXx_NEWLINE_xXOther invasive malignancy =< 5 years prior to registration; exceptions are colonic polyps, non-melanoma skin cancer, ductal carcinoma in situ, bladder carcinoma in situ, or carcinoma-in-situ of the cervixXx_NEWLINE_xXNo prior or current invasive malignancy (except non-melanomatous skin cancer, localized bladder and prostate cancer) unless disease free for a minimum of 2 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible);Xx_NEWLINE_xXPatients must NOT have previous or concurrent malignancy; exceptions are made for patients who meet any of the following conditions:\r\n* Non-melanoma skin cancer, in situ cervical cancer, superficial bladder cancer, or breast cancer in situ OR\r\n* Prior malignancy completely excised or removed and patient has been continuously disease free for > 5 years OR\r\n* Prior malignancy cured by non-surgical modalities and patient has been continuously disease free for > 5 yearsXx_NEWLINE_xXPatients with a history of a curatively treated malignancy must be disease-free for at least two years except for carcinoma in situ of cervix and/or non-melanomatous skin cancer; patients must not have received chemotherapy or investigational therapy within two years of surgical resection of the primary tumorXx_NEWLINE_xXHistory of active malignancy; patients with a history of cancer that has been adequately treated and are free of disease recurrence for 3 years or more are allowed to participate; patients with non-melanoma skin cancers or carcinoma in situ of the bladder that have been adequately excised are eligible to participateXx_NEWLINE_xXPrior invasive (except non-melanoma skin cancer) malignancy unless disease-free for a minimum of 3 years (1095 days) not in the pelvis (for example, carcinoma in situ of the oral cavity is permissible; however, patients with prior history of bladder cancer are not allowed); prior hematological (e.g., leukemia, lymphoma, myeloma) malignancy not allowedXx_NEWLINE_xXPrior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years, with the exception of those with a negligible risk of metastases or death, such as carcinoma in situ of the breast or cervixXx_NEWLINE_xXPatients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapyXx_NEWLINE_xXOther types of invasive malignancy that are not disease free within 3 years except for non-melanoma skin cancer, lentigo maligna, any carcinoma-in-situ or prostate cancer with low risk factorsXx_NEWLINE_xXPatients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapyXx_NEWLINE_xXPrior invasive malignancy (except non-melanomatous skin cancer or other in-situ malignancies, or stage Ta bladder cancer) unless disease free for a minimum of 2 yearsXx_NEWLINE_xXOther active malignancy within 5 years of registration; exceptions: non-melanotic skin cancer or carcinoma-in-situ of the cervix; note: if there is a history of prior malignancy, the patient is not eligible if they are receiving other specific treatment (with the exclusion of hormonal therapy or Her-2 inhibitors) for their cancer or if they have received prior total body irradiation which included the brainXx_NEWLINE_xXPrior invasive malignancy (except non-melanomatous skin cancer, low or intermediate risk prostate cancer, or in situ carcinoma of breast, oral cavity, skin, or cervix) unless disease free for a minimum of one year.Xx_NEWLINE_xXPrior invasive malignancy (except non-melanomatous skin cancer) unless disease-free for a minimum of 3 years; (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)Xx_NEWLINE_xXPatients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapyXx_NEWLINE_xXPrior invasive malignancy (except node negative, non-melanomatous skin cancer) unless disease free for a minimum of 1095 days (3 years) (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)Xx_NEWLINE_xXPrior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)Xx_NEWLINE_xXPrior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)Xx_NEWLINE_xXCo-existing or prior invasive malignancy (except non-melanomatous skin cancer), unless disease free for a minimum of 3 years; previous RT dose, date, fraction size, must be reportedXx_NEWLINE_xXPrior invasive malignancy (except non-melanomatous skin cancer, carcinoma in situ of the male breast, penis, oral cavity, or stage Ta of the bladder, or stage I completely resected melanoma) unless disease free for a minimum of 2 yearsXx_NEWLINE_xXPatients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five yearsXx_NEWLINE_xXPrior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (carcinoma in situ of the breast, oral cavity, cervix, melanoma in situ, or other non-invasive malignancies are permissible)Xx_NEWLINE_xXActive concurrent malignancy (except non melanoma skin cancer or carcinoma in situ of the cervix) or life threatening disease. If there is a history of prior malignancies or life threatening diseases, the patient must be disease free for at least 5 years.Xx_NEWLINE_xXPrior malignancy within the past 3 years except non-melanoma skin cancer or other localized cancer treated with curative intentXx_NEWLINE_xXHistory of malignancy other than disease under study within 3 years of study enrollment with exceptions below:\r\n* Exception: subjects with a history of completely resected non-melanoma skin cancer, or subjects with indolent second malignancies are eligibleXx_NEWLINE_xXHistory of other malignancy unless the subject has been disease-free for at least 3 years; non-invasive cancer history (such as carcinoma in situ [CIS] that has been resected) is allowedXx_NEWLINE_xXPrior malignancy:\r\nSubjects with a history of a prior malignancy other than angiosarcoma who have been disease-free for at least 2 years prior to the first dose of study drug and/or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligibleXx_NEWLINE_xXPatients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years are ineligibleXx_NEWLINE_xXPatients with active non-hematologic malignancies (except non-melanoma skin cancers) or those with non-hematologic malignancies (except non-melanoma skin cancers) who have been rendered with no evidence of disease, but have a greater than 20% chance of having disease recurrence within 5 years; this exclusion does not apply to patients with non-hematologic malignancies that do not require therapyXx_NEWLINE_xXELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C): No evidence of prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical carcinoma, or any surgically- or radiation-cured malignancy continuously disease free for >= 5 years so as not to interfere with interpretation of radiographic responseXx_NEWLINE_xXELIGIBILITY CRITERIA - PHASE II (ARM D): No evidence of prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical carcinoma, or any surgically- or radiation-cured malignancy continuously disease free for >= 5 years so as not to interfere with interpretation of radiographic responseXx_NEWLINE_xXSubjects with another primary malignancy that has not been in remission for at least 3 years, with the exception of non-melanoma skin cancer, curatively treated localized prostate cancer with non-detectable prostate-specific antigen, cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Papanicolaou (Pap) smear, and thyroid cancer (except anaplastic).Xx_NEWLINE_xXOther active malignancy, except non-melanomic skin cancerXx_NEWLINE_xXHistory of another primary malignancy that has not been in remission for at least 2 years. The following are exempt from the 2-year limit: non-melanoma skin cancer, completely resected Stage 1 solid tumor with low risk for recurrence, curatively treated localized prostate cancer, cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear, and in situ breast cancer that has been completely resected.Xx_NEWLINE_xXCuratively treated non-melanoma skin malignancyXx_NEWLINE_xXOther active malignancy =< 5 years prior to randomization; EXCEPTIONS: Nonmelanoma skin cancer or carcinoma-in-situ of the cervix, or cancers with low metastatic potential (e.g. Gleason score 6 prostate cancer) treated with curative therapy; NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancerXx_NEWLINE_xXHistory of a second primary cancer with the exception of 1) curatively treated non-melanomatous skin cancer, 2) curatively treated cervical or breast carcinoma in situ, or 3) other malignancy with no known active disease present and no treatment administered during the last 2 years.Xx_NEWLINE_xXHistory of another primary invasive malignancy that has not been definitively treated or in remission for at least 2 years; patients with non-melanoma skin cancers or with carcinomas in situ are eligible regardless of the time from diagnosis (including concomitant diagnoses)Xx_NEWLINE_xXHistory of prior or current synchronous malignancy, except:\r\n* Malignancy that was treated with curative intent and for which there has been no known active disease for > 3 years prior to enrollment\r\n* Curatively treated non-melanoma skin cancer, cervical cancer in situ, or prostatic intraepithelial neoplasia, without evidence of prostate cancerXx_NEWLINE_xXIndividuals with a history of a second malignancy are ineligible except for the following circumstances: \r\n* Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at a low risk for recurrence of that malignancy\r\n* Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ and non-melanoma cancer of the skin\r\n* Individuals with other cancers diagnosed within the past 5 years and felt to be at a low risk of recurrence should be discussed with the study sponsor to determine eligibilityXx_NEWLINE_xXPrevious malignant disease other than the target malignancy to be investigated in this trial within the last 5 years (with the exception of adequately treated non-melanoma skin cancers, carcinoma in situ of skin, bladder, cervix, colon/rectum, breast, or prostate) unless a complete remission without further recurrence was achieved at least 2 years prior to study entry and the subject was deemed to have been cured with no additional therapy required or anticipated to be required.Xx_NEWLINE_xXPatients with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, cervical/dysplasia, melanoma, or breast) are excluded unless definitive therapy has been completed at least 1 year prior to study entry and the patient is now without evidence of disease from that malignancy and no additional therapy is required or anticipated to be required during the study periodXx_NEWLINE_xXOther active malignancy =< 5 years prior to pre-registration\r\n* EXCEPTIONS: Non-melanoma skin cancer or carcinoma-in-situ of the cervix which has been adequately treated\r\n* NOTE: If there is a history of prior malignancy, patients must not be receiving other treatment for their cancer and the disease must be inactive/stableXx_NEWLINE_xXPatients with a history of any other invasive cancer (except non-melanoma skin cancer and excluding carcinoma in-situ), unless in complete remission and off of all therapy for that disease for >= 3 years, are ineligibleXx_NEWLINE_xXMalignancies other than TNBC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer)Xx_NEWLINE_xXDiagnosed with or treated for cancer within the previous 2 years, other than breast cancer or non-melanoma carcinoma of the skin.Xx_NEWLINE_xXIndividuals with a history of a second malignancy are ineligible except for the following circumstances; individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and non-melanoma cancer of the skin; patients with other cancers diagnosed within the past 5 years and felt to be at low risk of recurrence should be discussed with the study sponsor to determine eligibilityXx_NEWLINE_xXEXCLUSION CRITERIA FOR SECOND-LINE THERAPY: The subject has had another active malignancy within the past three years except for cervical cancer in situ, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin; questions regarding the inclusion of individual subjects should be directed to the study chairXx_NEWLINE_xXEXCLUSION CRITERIA FOR THIRD -LINE THERAPY: The subject has had another active malignancy within the past three years except for cervical cancer in situ, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin; questions regarding the inclusion of individual subjects should be directed to the study chairXx_NEWLINE_xXHistory of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or other malignancy with a similar expected curative outcomeXx_NEWLINE_xXNo other active malignancy within the past 2 years, except for non-melanoma skin cancers or carcinoma in situ of the cervixXx_NEWLINE_xXCuratively resected non-melanoma skin cancer;Xx_NEWLINE_xXActive malignancy within the previous 2 years (other than completely resected non-melanoma skin cancer or carcinoma in situ)Xx_NEWLINE_xXDisease free of prior malignancies for > 5 years with exception of patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resectionXx_NEWLINE_xXOther invasive malignancies within the last 2 years, except non-melanoma skin cancer and localized cured prostate, cervical cancer, and ductal breast carcinoma in situ (DCIS)Xx_NEWLINE_xXPatients with a history of other invasive malignancies, with the exception of non-melanoma skin cancers are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapyXx_NEWLINE_xXActive second primary malignancy other than non-melanoma skin cancers, nonmetastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancyXx_NEWLINE_xXOther active malignancy =< 3 years prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; Note: if there is a history of prior malignancy, they must not be receiving treatment for their cancerXx_NEWLINE_xXHistory of another malignancy\r\n* Exception: subjects who have been disease-free for 3 years, or subjects with a history of completely resected, non-melanoma skin cancer, or subjects with indolent second malignancies are eligible; T1a melanoma and melanoma in situ are permitted; consult GlaxoSmithKline (GSK) Medical Monitor if unsure whether second malignancies meet requirements specified aboveXx_NEWLINE_xXActive other malignancy, except non-melanoma skin cancer or carcinoma-in-situ (e.g., of cervix, breast, prostate). If there is a history of prior malignancy, patient must not be receiving other specific treatment (other than hormonal therapy) for the cancer.Xx_NEWLINE_xXPatients who have a history of another primary malignancy, with the exceptions of: non-melanoma skin cancer, and carcinoma in situ of the cervix, uteri, or breast from which the patient has been disease free for >= 3 yearsXx_NEWLINE_xXOther malignancy, unless the patient has been disease-free for at least 3 years following the completion of curative intent therapy, with the following exceptions:\r\n* Treated non-melanoma skin cancer, any in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed\r\n* Organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (PSA) values are also eligible for this study if hormonal therapy has been initiated, or radical prostatectomy or definitive prostate irradiation has been performedXx_NEWLINE_xXHistory of another malignancy; exception: patients who have been disease-free for 3 years (depending upon tumor type studied or clinical setting, 3 or 5 years can be used; e.g., for advanced melanoma and pancreatic studies 3 years is more appropriate due to aggressiveness of the disease, while 5 years can be more appropriate for prostate or ovarian cancer or adjuvant setting when life expectancy is longer), or patients with a history of completely resected non-melanoma skin cancer and/or patients with indolent secondary malignancies, are eligible; consult the CTEP medical monitor if unsure whether second malignancies meet the requirements specified above; exception: patients with history of RAS mutation-positive tumors are not eligible regardless of interval from the current study; prospective RAS testing is not required; however, if the results of previous RAS testing are known, they must be used in assessing eligibilityXx_NEWLINE_xXOther active invasive malignancies, with the exception of non-melanoma skin cancer and breast cancer (if without evidence of disease 2 years after completion of treatment)Xx_NEWLINE_xXDiagnosed with or received anti-cancer therapy for another primary malignancy within 3 years prior to entry (except for non-melanoma skin cancer or in situ cancers)Xx_NEWLINE_xXNo history of prior or synchronous malignancy, except\r\n* Prior malignancy was treated with curative intent and there is no known active disease present for greater than or equal to 3 years prior to study entry\r\n* Participants with adequately treated non-melanoma skin cancers, cervical carcinoma in situ, or prostatic intraepithelial neoplasia without evidence of prostate cancer are eligibleXx_NEWLINE_xXPatients with an active second malignancy (other than non-melanoma skin cancer or cervical cancer in situ) are NOT eligible for participationXx_NEWLINE_xXPatients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, 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 therapyXx_NEWLINE_xXIndividuals with a history of an active malignancy (other than the current lung cancer diagnosis) within the last 3 years (except non-melanoma skin cancer or a non-invasive/in situ cancer)Xx_NEWLINE_xXNo history of other cancer (except non-melanoma skin cancer or in situ breast cancer or cervix cancer) unless the tumor was successfully treated with curative intent at least 2 years before trial entryXx_NEWLINE_xXCurrently active other malignancy other than non-melanoma skin cancer.Xx_NEWLINE_xXParticipants with previous malignancies are excluded unless a complete remission was achieved at least 2 years prior to first treatment and no additional therapy is required or anticipated to be required during the study period as judged by the treating investigator; exceptions include non-melanoma skin cancers, and in situ cancers of any type (e.g. bladder, gastric, colon, cervical/dysplasia, melanoma, or breast carcinoma in situ)Xx_NEWLINE_xXConcomitant malignancies or previous malignancies with less than 2 years of disease-free interval at the time of enrollment (except non-melanoma skin cancer, cervical cancer in situ, prostate cancer with undetectable prostate specific antigen [PSA]); other concurrent malignancies must be discussed with the medical monitor prior to enrollmentXx_NEWLINE_xXHistory of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or other malignancy with a similar expected curative outcome.Xx_NEWLINE_xXMelanomaXx_NEWLINE_xXOther invasive cancer diagnosis within the past 5 years other than non-melanoma skin cancerXx_NEWLINE_xXHistory of other malignancy within 2 years prior to screening, except for ductal carcinoma in situ not requiring chemotherapy, appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, low-grade, localized prostate cancer (Gleason score ? 7) not requiring treatment or appropriately treated Stage I uterine cancer.Xx_NEWLINE_xXHistory of malignancy other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least 3 yearsXx_NEWLINE_xXDiagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease; patients with early stage prostate cancer, non melanoma skin cancer or carcinoma in situ of any type are not excluded; patients with malignancies that have undergone complete resection are not excludedXx_NEWLINE_xXWomen with previous history of cancer (including invasive or intra-ductal breast cancer) except for non-melanoma skin cancer.Xx_NEWLINE_xXSubjects with history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present that in the opinion of the investigator will not affect patient outcome in the setting of current HCC diagnosisXx_NEWLINE_xXHistory of another primary invasive cancer, hematologic malignancy, or myelodysplastic syndrome that has not been in remission for at least 3 years;\r\n* Exceptions: non-melanoma skin cancer and in situ cervical cancerXx_NEWLINE_xXMust not have an active second malignancy other than non-melanoma skin cancer or cervical carcinoma in situ; patients with history of malignancy are eligible provided primary treatment of that cancer was completed > 1 year prior to registration and the patient is free of clinical or radiologic evidence of recurrent or progressive malignancyXx_NEWLINE_xXEXCLUSION - PROCUREMENT: History of other cancer (except non-melanoma skin cancer or in situ breast cancer or cervix cancer) unless the tumor was successfully treated with curative intent at least 2 years before trial entryXx_NEWLINE_xXPrevious or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured AND no additional therapy is ongoing and required during the study period with the exception of bisphosphonates and anti-androgens and/or gonadorelin analogues for the treatment of prostate cancer are permitted; subjects with other active malignancy requiring concurrent intervention are excludedXx_NEWLINE_xXActive malignancy (other than NSCLC, non melanoma skin cancer, in situ cervical cancer, papillary thyroid cancer, LCIS/DCIS of the breast, or localized prostate cancer) within the last 3 years prior to randomization.Xx_NEWLINE_xXSubjects with previous malignancies (except non-melanoma skin cancers, in situ bladder, gastric, breast, colon or cervical cancers/dysplasia) are excluded unless a complete remission was achieved at least 1 years prior to study entry and no additional therapy (other than adjuvant hormonal therapy for breast cancer) is required or anticipated to be required during the study periodXx_NEWLINE_xXHistory of other malignancy within 5 years prior to screening, with the exception of those with a negligible risk of metastasis or death, such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancerXx_NEWLINE_xXPatients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 yearsXx_NEWLINE_xXPrior history of another malignancy (except for non-melanoma skin cancer or in situ cervical or breast cancer) unless disease free for at least three years; patients with prostate cancer are allowed if prostate specific antigen (PSA) is less than 1Xx_NEWLINE_xXPrior invasive malignancy unless disease free for a minimum of 3 years; however, skin cancer and in situ carcinomas of the breast, oral cavity, cervix, and other organs and are permissibleXx_NEWLINE_xXPatients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies are excluded if there is any evidence of other malignancy being present within the last three years (2 years for breast cancer); patients are also excluded if their previous cancer treatment contraindicates this protocol therapyXx_NEWLINE_xXIndividuals with a history of a second malignancy are ineligible except for the following circumstances; individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and non-melanoma cancer of the skin; participants with other cancers diagnosed within the past 5 years and felt to be at low risk of recurrence should be discussed with the study sponsor to determine eligibilityXx_NEWLINE_xXDiagnosed or treated for another malignancy within 2 years before administration of the first dose of the study drugs or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.Xx_NEWLINE_xXAny other malignancy requiring anti-tumor treatment in the past three years, excluding treated stage I prostate cancer, in situ cervical cancer, in situ breast cancer and non-melanomatous skin cancerXx_NEWLINE_xXParticipant has a history of invasive cancer (other than non-melanoma skin cancer or cervical cancer in situ) active within 18 months prior to the baseline study visit; (participants who have a history of cancer that was curatively treated without evidence of recurrence in the 18 months prior to the baseline study visit are considered eligible)Xx_NEWLINE_xXAdequately treated non-melanoma skin cancer or lentigo malignaXx_NEWLINE_xXOther active malignancy =< 5 years prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: if there is a history or prior malignancy, they must not be receiving other specific treatment for their cancerXx_NEWLINE_xXHas any other malignancy other than the one for which they are receiving tazemetostat Exception: Subject who has been disease-free of a prior malignancy for 5 years, or subject with a history of a completely resected non-melanoma skin cancer or successfully treated in situ carcinoma is eligible.Xx_NEWLINE_xXPrevious or concurrent malignancy other than non-melanoma skin cancer within 5 years of diagnosis of prostate cancerXx_NEWLINE_xXPrior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ? 3 years.Xx_NEWLINE_xXConcurrent second malignancy other than non-melanoma skin cancer, cervical carcinoma in situ, or controlled bladder cancerXx_NEWLINE_xXWill need or has needed active treatment of a second malignancy within the prior 3 years before enrollment, other than FL, non-melanoma skin cancers, localized prostate cancer treated with curative intent, or cervical carcinoma in situXx_NEWLINE_xXPrior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; non-invasive conditions such as carcinoma in situ of the breast, oral cavity, or cervix are all permissibleXx_NEWLINE_xXDiagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease; patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resectionXx_NEWLINE_xXHistory of another malignancy except for those who have been disease-free for 3 years, or patients with a history of completely resected non-melanoma skin cancer and/or patients with indolent secondary malignancies not requiring active therapy, are eligible; consult the study MSKCC principal investigator if unsure whether second malignancies meet the requirements specified aboveXx_NEWLINE_xXOther malignancies treated within the last 5 years, except in situ cervix carcinoma or non-melanoma skin cancer.Xx_NEWLINE_xXThe patient has an additional active malignancy that may confound the assessment of the study endpoints. Patients with a past cancer history (active malignancy within 2 years prior to study entry) with substantial potential for recurrence must be discussed with the Sponsor before study entry. Patients with the following concomitant neoplastic diagnoses are eligible: non-melanoma skin cancer, carcinoma in situ (including transitional cell carcinoma, cervical intraepithelial neoplasia), organ-confined prostate cancer with no evidence of progressive disease.Xx_NEWLINE_xXConcomitant invasive malignancy or invasive malignancy within the past five years other than non-melanomatous skin cancer; history of in situ carcinoma (e.g. ductal carcinoma in situ of breast, in situ carcinoma of the cervix, vulva or larynx) is permittedXx_NEWLINE_xXDiagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease; patients with non-melanoma skin cancer, carcinoma in situ of any type, or low risk cervical cancer are not excluded if they have undergone complete resection and are deemed free of disease by their treating physician; patients with low risk prostate cancer who are under observation are eligible if their urologist or oncologist does not expect them to require therapy within 1 yearXx_NEWLINE_xXDONOR: Related donors: no history of opportunistic infections, autoimmunity, hemoglobinopathy, red cell enzymopathy, or malignancy, apart from non-melanomatous skin cancer or healed cervical cancer in situXx_NEWLINE_xXOther malignancy requiring active therapy\r\n* EXCEPTIONS: Non-melanoma skin cancer, ductal breast carcinoma in situ (DCIS) or carcinoma-in-situ of the cervix\r\n* NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancerXx_NEWLINE_xXHistory of another malignancy within the past 2 years (some skin cancer and prostate cancers permitted)Xx_NEWLINE_xXKnown active invasive malignancy except for renal cell carcinoma and/or non-melanoma skin cancerXx_NEWLINE_xXPrevious or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be curedXx_NEWLINE_xXHistory of another invasive malignancy unless treated with curative intent 5 years or more prior to study entry; patients with localized carcinoma of the cervix, non-melanoma skin cancer, or early stage prostate cancer requiring observation only are eligible regardless of timing of diagnosisXx_NEWLINE_xXSecond malignancy requiring concurrent treatment or those with non-hematological malignancies (except non-melanoma skin cancers); cancer treated with curative intent < 5 years previously will not be allowed unless approved by the Protocol Chair; cancer treated with curative intent > 5 years previously is allowedXx_NEWLINE_xXPrior history of other cancers (except non-melanoma skin cancers or low-grade low-stage urothelial cancers)Xx_NEWLINE_xXHistory of other invasive malignancies, with the exception of non-melanoma skin cancer or successfully treated in situ carcinoma, if there is evidence of the malignancy being present within the last 3 years.Xx_NEWLINE_xXMelanomaXx_NEWLINE_xXNon-Melanoma skin cancersXx_NEWLINE_xXHistory of other malignancy =< 5 years prior to registration except for non-melanoma skin cancer, carcinoma in situ of the cervix, and ductal carcinoma in situ (DCIS)Xx_NEWLINE_xXOther malignancy within 3 years prior to entry into the study, except for treated early-stage melanoma or non-melanoma skin cancer, cervical carcinoma in situ, incidental or localized prostate cancer treated with prostatectomy or radiation therapy, or stage I colon cancer. Patients with other completely resected malignancies in the prior three years and no evidence of disease will be evaluated on a case-by-case basis with eligibility determined based on discussion with the principal investigatorXx_NEWLINE_xXDiagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease; patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resectionXx_NEWLINE_xXConcurrent active malignancy or prior malignancy that was active within the previous 3 years (other than completely resected carcinoma in situ, prostate cancer, or localized non-melanoma skin cancer)Xx_NEWLINE_xXPatients with a history of any other invasive cancer (except non-melanoma skin cancer and excluding carcinomas in-situ), unless in complete remission and off of all therapy for that disease for >= 3 years, are ineligibleXx_NEWLINE_xXNo prior systemic treatment (chemotherapy or biologic/molecular targeted therapy) or radiation treatment for head and neck cancer\r\n* Patients may have received chemotherapy or radiation for a previous, curatively treated non-HNSCC malignancy, provided at least 2 years have elapsed\r\n* Patients must be untreated with radiation above the clavicles\r\n* Patients with a history of curatively-treated non-HNSCC malignancy must be disease-free for at least 2 years except for carcinoma-in-situ of cervix, non-melanomatous skin cancer, or T1-2, N0, M0 resected differentiated thyroid carcinomaXx_NEWLINE_xXA second active malignancy except adequately treated non-melanoma skin cancer or other non-invasive or in situ neoplasmXx_NEWLINE_xXPrior history of another malignancy (except for non-melanoma skin cancer or in situ cervical or breast cancer) unless disease free for at least three years; patients with prostate cancer are allowed if prostate-specific antigen (PSA) is less than 1; patients with indolent malignancies under control and which, in the opinion of the treating investigator, are unlikely to be clinically relevant or affect survival during the course of the study treatment and follow-upXx_NEWLINE_xXActive concurrent malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix); if there is a history of prior malignancy, the patient must be disease-free for >= 3-years; patients whose lymphoma has transformed from a less aggressive histology remain eligibleXx_NEWLINE_xXHistory or concurrent malignancy of solid tumours, except for below. Exception: Subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible. Subjects with second malignancies that are indolent or definitively treated may be enrolled even if less than 5 years have elapsed since treatment. Consult the GSK Medical Monitor if unsure whether second malignancies meet requirements specified above.Xx_NEWLINE_xXTreatment for other carcinomas within the last three years, except cured non-melanoma skin and treated in-situ cervical cancerXx_NEWLINE_xXAny concurrent malignancy, except non-melanoma skin cancerXx_NEWLINE_xXConcomitant second malignancy except for non-melanoma skin cancer, and non-invasive cancer such as cervical carcinoma in situ (CIS), superficial bladder cancer without local recurrence or breast CISXx_NEWLINE_xXPatients who have controlled or responding leptomeningeal disease and develop brain metastases can remain on trial if their disease can be controlled with radiosurgery and does not require whole body radiation therapy (WBRT); NO history of any other concomitant cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix) unless in complete remission and off all therapy for the disease for a minimum of 3 yearsXx_NEWLINE_xXPatients with prior cancers, except: those diagnosed ? 5 years ago with no evidence of disease relapse and clinical expectation of relapse of less than 5%; prior successfully treated Level 1 cutaneous melanomas ? 2 years ago; or non-melanoma skin cancer; or carcinoma in situ of the cervixXx_NEWLINE_xXPatients with previous nonmelanoma malignancies are excluded unless a complete resection or remission was achieved at least 2 years prior to study entry and no additional therapy is required or anticipated to be required during the study period (exceptions include, but are not limited to, nonmelanoma skin cancers, in situ bladder cancer, in situ gastric cancer or gastrointestinal stromal tumor, in situ colon cancers, in situ cervical cancers/dysplasia, or breast carcinoma in situ)Xx_NEWLINE_xXPatients with a history within the last 3 years of another invasive malignancy (localized non-melanoma skin and bladder cancers are allowed).Xx_NEWLINE_xXPrior malignancy requiring therapy within the last 12 months (excluding non-melanoma skin cancer); hormone therapy for prostate cancer or adjuvant endocrine therapy for breast cancer would not be excludedXx_NEWLINE_xXDiagnosis or treatment for another systemic malignancy within 2 years before the first dose of study drugs, or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resectionXx_NEWLINE_xXPatients with other malignancies are ineligible for this study, other than non-melanoma skin cancersXx_NEWLINE_xXOther active malignancy within the last 3 years (except for non-melanoma skin cancer, a non-invasive/in situ cancer, or indolent non metastatic Gleason 6 prostate cancer)Xx_NEWLINE_xXPatients with second malignancy within 3 years of enrollment; patients curatively treated non-melanoma skin cancers or carcinoma in situ of the bladder, are not excludedXx_NEWLINE_xXPrevious or concurrent malignancy (with the exception of non-melanomatous skin cancer) within 5 years of the date of the consentXx_NEWLINE_xXHistory of any malignancy within the last 6 months except for those specified in this protocol and low-grade malignancies not requiring active treatment such as non-melanoma skin cancer, cervical intraepithelial neoplasia, or prostate cancer in situ.Xx_NEWLINE_xXAdequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.Xx_NEWLINE_xXCurrently active second malignancy or past history of malignancies diagnosed within the last 5 years that require active therapy and/or in remission with life expectancy of < 5 years, with the exception of resected non-melanoma skin cancers, non-muscle invasive bladder cancer, stage I head and neck cancer, or stage I colorectal cancerXx_NEWLINE_xXHistory of active malignancy other than non-melanoma skin cancer, carcinoma in situ (e.g. cervix, bladder, breast).Xx_NEWLINE_xXOther active malignancy =< 2 years prior to study enrollment. EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix. NOTE: If there is a history of prior malignancy, patients must not be receiving other specific treatment (i.e. hormonal therapy) for their cancerXx_NEWLINE_xXDiagnosed or treated for another malignancy within 2 years before administration of the first dose of study drug, or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.Xx_NEWLINE_xXHistory of another primary malignancy that has not been in remission for at least 3 years (the following are exempt from the 3-year limit: non-melanoma skin cancer, fully excised melanoma in situ [stage 0], curatively treated localized prostate cancer, and cervical or breast carcinoma in situ on biopsy or a squamous intraepithelial lesion on papanicolaou [PAP] smear);Xx_NEWLINE_xXPrevious malignancy (except for non-melanomatous skin cancer) < 5 yearsXx_NEWLINE_xXPresence of another invasive malignancy, which required systemic therapy within 12 months of protocol enrollment, except for resected skin cancers or prostate cancer that is in remissionXx_NEWLINE_xXOther malignancy, except non-melanoma skin cancer, that is active or has a >= 30% probability of recurrence within 12 monthsXx_NEWLINE_xXPatients with a history of prior malignancy with the exception of non-melanoma skin cancer, carcinoma in situ of the cervix, in situ carcinoma of the bladder, or other malignancy that has undergone potentially curative therapy with no evidence of disease for the last > 2 years and that is deemed by the investigator to be a low risk for recurrenceXx_NEWLINE_xXHistory of another invasive malignancy that has not been in remission for at least 3 years. Exceptions to the 3year limit include non-melanoma skin cancer, curatively treated localized prostate cancer, ductal carcinoma in situ, and cervical cancer in situ on biopsy or squamous intraepithelial lesion on PAP smear.Xx_NEWLINE_xXHistory of malignancy other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least 3 yearsXx_NEWLINE_xXOther active non-melanoma metastatic cancersXx_NEWLINE_xXPrior malignancy within the past 3 years (except non-melanomatous skin cancer and early stage treated prostate cancer)Xx_NEWLINE_xXEvidence within 2 years of the start of study treatment of another malignancy which required systemic treatment except for breast ductal carcinoma-in situ, cured non-melanoma skin cancer, or cured in situ cervical carcinoma.Xx_NEWLINE_xXHistory of another malignancy within the previous 2 years with > 30 % probability of relapse other than curatively treated non-melanomatous skin cancerXx_NEWLINE_xXHistory of other carcinomas within the last five years, except cured non-melanoma skin cancer, curatively treated in-situ cervical cancer, or localized prostate cancer with a current PSA of < 1.0 mg/dL on 2 successive evaluations, at least 3 months apart, with the most recent evaluation no more than 4 weeks prior to the start of study drugXx_NEWLINE_xXActive malignancy (with the exception of non-melanoma skin cancer), including relapse or progression of the underlying disease for which qualifying transplant was performedXx_NEWLINE_xXHistory of another primary malignancy that requires intervention beyond surveillance or that has not been in remission for at least 1 year (the following are exempt from the 1 year limit: non-melanoma skin cancer, curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on papanicolaou [PAP] smear)Xx_NEWLINE_xXConcomitant active malignancy that would be expected to require chemotherapy within 3 years of transplant (other than non-melanoma skin cancer)Xx_NEWLINE_xXHistory of other primary malignancy requiring systemic treatment =< 3 years prior to registration; patients must not be receiving chemotherapy or immunotherapy for another cancer; patients must not have another active malignancy requiring active treatment; EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervixXx_NEWLINE_xXPatients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapyXx_NEWLINE_xXAny known prior malignancy (not including non-melanoma skin cancers), unless treated with curative intentXx_NEWLINE_xXConcurrent active malignancy; exceptions include patients who have been disease free for 5 years, patients with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma, or patients with another malignancy that is indolent or definitively treatedXx_NEWLINE_xXConcurrent active malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervixXx_NEWLINE_xXKnown second primary or prior malignancy diagnosed within 5 years of study start date (other than previously treated non-melanoma skin cancer)Xx_NEWLINE_xXcuratively treated non-melanomatous skin cancerXx_NEWLINE_xXOther malignancy, except non-melanoma skin cancer, that is active or has a >/= 30% probability of recurrence within 12 months.Xx_NEWLINE_xXOther active malignancy requiring treatment in =< 6 months prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: if there is a history of prior malignancy, they must not be receiving other specific treatment for their cancerXx_NEWLINE_xXPrior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 yearsXx_NEWLINE_xXHas nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone resection.Xx_NEWLINE_xXCurrent or previous malignant disease (other than colorectal cancer) within the last 5 years; with the exception of the following if considered curatively treated: non-melanoma skin cancer(s), carcinoma in situ of the cervix, and ductal carcinoma in situ; subjects with another active malignancy requiring concurrent anti-cancer intervention are excluded; (Note the following does not exclude: effectively treated malignancy that has been in remission for more than 5 years and is considered to be cured AND no additional anti-cancer therapy is ongoing and required during the study period)Xx_NEWLINE_xXPior history of treated malignancy in the past 2 years. Subjects with non-melanoma skin cancer, localized prostate cancer, and carcinoma in situ of the breast of cervix are allowed.Xx_NEWLINE_xXSubjects with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period.Xx_NEWLINE_xXAny evidence of metastatic disease or another active malignancy within the past two years except for cervical cancer in situ, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin.Xx_NEWLINE_xXAdequately treated non-melanoma skin cancer ORXx_NEWLINE_xXPatients with active non-hematological malignancies (except non-melanoma skin cancers) or those with non-hematological malignancies (except non-melanoma skin cancers) who have been rendered with no evidence of disease, but have a greater than 20% chance of having disease recurrence within 5 years; this exclusion does not apply to patients with non-hematologic malignancies that do not require therapyXx_NEWLINE_xXSubjects with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last 3 years; subjects are also excluded if their previous cancer treatment contraindicates this protocol's therapyXx_NEWLINE_xXAny malignancy that required treatment (except non-melanoma skin cancer, or histologically confirmed complete excision of carcinoma in situ), within 2 years prior to study drug administration.Xx_NEWLINE_xXHistory of malignancy other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least 3 yearsXx_NEWLINE_xXHistory of another malignancy; \r\n* Exception: Subjects who have been disease-free for 3 years, or subjects with a history of completely resected non-melanoma skin cancer and/or subjects with indolent second malignancies are eligibleXx_NEWLINE_xXAny other malignancy from which the patient has been disease-free for less than 2 years, except for non-melanoma skin cancer, or in situ carcinoma of any siteXx_NEWLINE_xXPrior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1095 days (3 years) (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)Xx_NEWLINE_xXOther known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and proven no evidence of recurrence for 5 yearsXx_NEWLINE_xXEvidence of active malignancy (other than current NSCLC, non-melanoma skin cancer, in situ cervical cancer, papillary thyroid cancer, localized/stable renal masses, ductal carcinoma in situ (DCIS)/lobular carcinoma in situ (LCIS) of the breast, or localized and presumed cured prostate cancer) within the last 3 yearsXx_NEWLINE_xXDiagnosed or treated for another malignancy =< 2 years prior to registration or previously diagnosed with another malignancy and have any evidence of residual disease\r\n* NOTE: If there is a history or prior malignancy, patient must not be receiving other specific treatment for their cancer; patients with non-melanoma skin cancer or carcinoma in situ of any type, or low-risk prostate cancer after curative therapy, are not excluded if they have undergone complete resection\r\n* NOTE: Platelet transfusions to help patients meet eligibility criteria are not allowed =< 3 days prior to study registrationXx_NEWLINE_xXOther active malignancy =< 5 years prior to registration\r\n* EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix\r\n* NOTE: If there is a history or prior malignancy, the patient must not be receiving other specific treatment for their cancerXx_NEWLINE_xXPrevious malignancy within 3 years other than non-melanomatous skin cancers or cancers of low malignant potential such as non-invasive urothelial carcinomaXx_NEWLINE_xXActive concurrent malignancy (except non-invasive non-melanoma skin cancer, carcinoma in situ of the cervix, or prostate intraepithelial neoplasia); if there is a history of prior malignancy, the patient must be disease-free for >= 3-years at the time of study entryXx_NEWLINE_xXOther prior or concomitant malignancies with the exception of:\r\n* Non-melanoma skin cancer\r\n* In-situ malignancy\r\n* Low-risk prostate cancer after curative therapy\r\n* Other cancer for which the patient has been disease free for >= 5 years before the first dose of study drug and of low potential risk for recurrenceXx_NEWLINE_xXPrior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 yearsXx_NEWLINE_xXHistory of an invasive second primary malignancy diagnosed within the previous 3 years, except for appropriately treated stage I endometrial or cervical carcinoma or prostate carcinoma treated surgically, and non-melanoma skin cancerXx_NEWLINE_xXActive concurrent malignancy (except non-melanoma skin cancer, prostatic intraepithelial neoplasia, or carcinoma in situ of the cervix); if there is a history of prior malignancy, the patient must be disease-free for ? 3 years; patients whose lymphoma has transformed from a less aggressive histology remain eligibleXx_NEWLINE_xXHistory of another primary malignancy except for: (i) OPSCC with loco-regional recurrence after 6 months of curative-intent treatment and amenable to salvage surgery; (ii) malignancy treated with curative intent and with no evidence of active disease >= 2 years before the first dose of study drug and of low potential risk for recurrence; (iii) non-melanoma, skin cancer or lentigo maligna; in situ cervical, breast, prostate or bladder carcinomaXx_NEWLINE_xXNo history of an invasive malignancy (other than this breast cancer, or non-metastatic basal or squamous skin cancers) in the last 5 yearsXx_NEWLINE_xXSubjects must not have history of an invasive malignancy (other than this breast cancer, or non-metastatic basal or squamous skin cancers) in the last 5 yearsXx_NEWLINE_xXOther active malignancy =< 3 years prior to registration; EXCEPTIONS: treated non-melanoma skin cancer, carcinoma-in-situ of the cervix, treated stage 1-2, Gleason 7 or less, prostate cancer with a stable or undetectable prostate specific antigen (PSA) level, treated stage 1 breast cancer which is controlled and for which the patient received no thoracic radiation therapy (RT)Xx_NEWLINE_xXIndividuals with a history of a second malignancy are ineligible except for the following circumstances: individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if they are diagnosed and have completed treatment within the past 5 years: cervical cancer in situ, and non-melanoma cancer of the skin; patients with other cancers diagnosed within the past 5 years and felt to be at low risk of recurrence should be discussed with the principal investigator to determine eligibilityXx_NEWLINE_xXFOR ALL PHASES (Ib AND II): History of any other malignancy within the past 5 years, with the exception of non-melanoma skin cancer or carcinoma-in-situ of the cervixXx_NEWLINE_xXHistory of another primary malignancy that has not been in remission for at least 3 years (the following are exempt from the 3-year limit: non-melanoma skin cancer, fully excised melanoma in situ [stage 0], curatively treated localized prostate cancer, and cervical or breast carcinoma in situ on biopsy or a squamous intraepithelial lesion on papanicolaou [PAP] smear)Xx_NEWLINE_xXPatients must not have other invasive malignancies within the past 5 years (with the exception of non-melanoma skin cancers, non-invasive bladder cancer or localized prostate cancer for whom systemic therapy is not required)Xx_NEWLINE_xXPatients with direct evidence of regional or distant metastases after appropriate staging studies, or with synchronous non-lung primary or prior non-lung malignancy (other than nonmelanomatous skin cancer or in situ cancer) diagnosed within the past 3 years are not eligible. Patients with a history of curable non-lung cancer up to 3 years before registration and have been cancer-free for 2 years are eligibleXx_NEWLINE_xXPatients who have a history of another primary malignancy, with the exceptions of: non-melanoma skin cancer, and carcinoma in situ of the cervix, uteri, or breast from which the patient has been disease free for >= 3 yearsXx_NEWLINE_xXCRITERIA FOR LEUKAPHERESIS AND PRE-THERAPY EVALUATION: History of another primary malignancy that has not been in remission for at least 2 years with the following exceptions: nonmelanoma skin cancer, curatively treated localized prostate cancer, cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on pap smear, or other malignancy considered by the investigator to have a low risk of relapse or progressionXx_NEWLINE_xXPatients with a second malignancy, other than adequately treated non-melanoma skin cancers, in situ melanoma or in situ cervical cancer; patients with other non-mammary malignancies must have been disease-free for at least 5 yearsXx_NEWLINE_xXHistory of another malignancy; exception: subjects who have been disease-free for 3 years, or subjects with a history of completely resected non-melanoma skin cancer and/or subjects with indolent (early stage breast cancer or prostate cancer) second malignancies are eligible after discussion with the study principal investigator (PI)Xx_NEWLINE_xXNo active second cancers with the exception of localized non-melanoma skin cancer, in-situ cervical or in-situ bladder cancerXx_NEWLINE_xXHas an active concurrent malignancy/life-threatening disease. If there is a history of prior malignancies/life-threatening diseases, the subject is to be disease free for at least 5 years. Subjects with other prior malignancies less than 5 years before study entry may still be enrolled if they have received treatment resulting in complete resolution of the cancer and currently have no clinical, radiologic, or laboratory evidence of active or recurrent disease. Subjects will not be excluded for recurrent NMIBC, basal or squamous cell skin cancers, or noninvasive cancer of the cervix.Xx_NEWLINE_xXPrevious or concurrent history of non-pancreatic malignancy except for non-melanoma skin cancer.Xx_NEWLINE_xXOther active malignancy =< 3 years prior to registration\r\n* EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix\r\n* NOTE: if there is a history of prior malignancy, they must not be receiving other specific treatment for their cancerXx_NEWLINE_xXPatients with second malignancy within 3 years of enrollment; patients curatively treated non-melanoma skin cancers or carcinoma in situ of the bladder, are not excluded; patients with multiple endocrine neoplasia 2 (MEN2) and a history of pheochromocytoma will also not be excluded; in addition patients with prostate cancer who do not require systemic therapy will not be excluded; (a secondary, minor pathologic focus of another form of thyroid cancer may be coincidentally found in 15-20% of patients with medullary thyroid cancer; in such cases, eligibility is based on the discretion of the investigator)Xx_NEWLINE_xXPrior invasive malignancy (except non-melanomatous skin cancer) unless disease-free for a minimum of 1 yearXx_NEWLINE_xXUnstable medical condition (e.g., another malignancy requiring treatment, malignant hypertension, poorly controlled diabetes, another cancer except for fully excised non-melanoma skin cancer)Xx_NEWLINE_xXPatients with other active malignancy =< 3 years prior to registration for which active treatment is required must be excluded; patients with composite lymphomas that have a non-B-cell component must be excluded.\r\nEXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervixXx_NEWLINE_xXDiagnosis of other invasive malignancies within the preceding 3 years prior to screening with > 30% likelihood of relapse within the next 3 years, except non-melanoma skin cancer and non-muscle invasive urothelial cancerXx_NEWLINE_xXPatients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years are ineligible.Xx_NEWLINE_xXAny other malignancy which has been active or treated within the past three years, with the exception of cervical intra-epithelial neoplasia and non-melanoma skin cancerXx_NEWLINE_xXOther active malignancy =< 3 years prior to pre-registration; note: if there is a history of prior malignancy, the patient must not be receiving other specific treatment for cancer\r\n* EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervixXx_NEWLINE_xXPrior malignancy except for non-melanoma skin cancer and carcinoma in situ (of the cervix or bladder), unless diagnosed and definitively treated more than 3 years prior to 1st dose of investigational drugXx_NEWLINE_xXPatients must not have a history of any other cancer unless they are in complete remission and off of all therapy for that disease for a minimum of 3 years\r\n* Note: Non-melanoma skin cancer or carcinoma in-situ of the cervix are exceptions and may be permitted after discussion with study quality assurance manager (QAM)Xx_NEWLINE_xXPatient has a history of other malignancies within the last 5 years, except for non-melanoma skin cancer or carcinoma in situ of the cervixXx_NEWLINE_xXPresence of second active tumor, other than non-melanoma skin cancer, carcinoma in situ of the cervix, or Kaposi’s sarcoma (KS) that requires systemic therapyXx_NEWLINE_xXPatients with active malignancy (not including basal cell carcinoma, non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer treated with hormone therapy). Patients with history of other cancers should be free of disease for at least 2 years.Xx_NEWLINE_xXPatients with a history of malignancy are ineligible except for the following circumstances:\r\n* Patients with a history of invasive breast cancer are eligible if they have been disease-free for a minimum of five years\r\n* Patients with a malignancy history other than invasive breast cancer are eligible if they have no active malignancy and are deemed by the investigator to be at low risk for recurrence of that malignancy\r\n* Patients with the following cancers are eligible: ductal carcinoma in situ of the breast, cervical cancer in situ, and non-metastatic non-melanomatous skin cancersXx_NEWLINE_xXPatients with non-melanoma skin cancer or carcinoma in situ of the cervix are eligible, while patients with other prior malignancies must have had at least a 3-year disease-free interval.Xx_NEWLINE_xXDiagnosed or treated for another malignancy within 2 years before administration of the first dose of study drug or previously diagnosed with another malignancy and have any evidence of residual disease. Participants with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.Xx_NEWLINE_xXPrior malignancy (except non melanoma skin cancer) within 3 yearsXx_NEWLINE_xXOther active malignancy =< 2 years prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: if there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer; NOTE: adjuvant anti-estrogen/hormonal therapy for breast cancer is allowedXx_NEWLINE_xXConfirmed diagnosis of another malignancy within the past 6 months\r\n* Non-melanomatous skin lesions are acceptableXx_NEWLINE_xXSubjects must not have a history of a known secondary primary malignancy that is not in remission and/or that requires active therapy; exceptions include non-melanoma skin cancers and in situ cervical cancer that has undergone curative-intent local therapyXx_NEWLINE_xXPrevious or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be curedXx_NEWLINE_xXPrior history of invasive malignancy, except non-melanoma skin cancer, unless disease free for >= 3 years (yrs)Xx_NEWLINE_xXOther malignancy, except non-melanoma skin cancer, with a >= 30% probability of death within 24 monthsXx_NEWLINE_xXAdequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.Xx_NEWLINE_xXHistory of another primary malignancy that has not been in remission for at least 3 years; (the following are exempt from the 3-year limit: nonmelanoma skin cancer, fully excised melanoma in situ [stage 0], curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on PAP smear)Xx_NEWLINE_xXPatients diagnosed with an invasive cancer within 2 years prior to starting protocol therapy with the following exceptions: non-melanoma skin cancers, in-situ cancers, and prostate cancer Gleason =< to 6 (under surveillance or treated)Xx_NEWLINE_xXPatients diagnosed with an invasive cancer within 2 years prior to starting protocol therapy with the following exceptions: non-melanoma skin cancers, in-situ cancers, and prostate cancer gleason =< 6 (under surveillance or treated)Xx_NEWLINE_xXPatients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix or bladder), unless in complete remission and off all therapy for that disease for a minimum of 3 years, are ineligibleXx_NEWLINE_xXOther primary malignancy within past 5 years except carcinoma in situ of the cervix or urinary bladder or non-melanoma skin cancerXx_NEWLINE_xXNo active malignancy except for nonmelanoma skin cancer or in situ cervical cancer or treated non-pelvic cancer from which the patient has been continuously disease free more than three yearsXx_NEWLINE_xXPatients must not have other active invasive malignancies within the past 2 years (with the exception of non-melanoma skin cancers) (for CRPC cohort only)Xx_NEWLINE_xXHistory of or concurrent malignancy of solid tumours, except for below: Exception: Subjects who have been disease-free for 2 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.Xx_NEWLINE_xXSubjects with a history of prior malignancy with the exception of non-melanoma skin cancer, carcinoma in situ of the cervix, in situ carcinoma of the bladder, or other malignancy that has undergone potentially curative therapy with no evidence of disease for the last > 2 years and that is deemed by the investigator to be a low risk for recurrenceXx_NEWLINE_xXPrior invasive non-breast malignancy (except non-melanomatous skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 3 yrs prior to study entryXx_NEWLINE_xXAnother primary malignancy other than CML within the past 2 years except non-melanoma skin cancer, or carcinoma in situ of the cervix.Xx_NEWLINE_xXOther active malignancy =< 3 years prior to registration\r\n* EXCEPTIONS: Non-melanotic skin cancer, ductal carcinoma in-situ, or carcinoma-in-situ of the cervix\r\n* NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancerXx_NEWLINE_xXDiagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease; patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resectionXx_NEWLINE_xXPrior diagnosis of non-hematologic malignancy within 5 years of planned protocol therapy EXCEPT:\r\n* Diagnosis of breast ductal carcinoma in situ treated with curative intent\r\n* Diagnosis of prostate adenocarcinoma with Gleasons score =< 6 treated with curative intent\r\n* Non-melanomatous skin cancerXx_NEWLINE_xXHistory of recent malignancies < 5 years (except for cured non-melanomatous skin cancer or cured cervical carcinoma in situ)Xx_NEWLINE_xXActive concurrent malignancy (except non-melanoma skin cancer, carcinoma in situ of the cervix, low risk prostate cancer); if there is a history of prior malignancy, the patient must be disease-free for >= 2 yearsXx_NEWLINE_xXPrior malignancy in the past 5 years, except for carcinoma in situ of the cervix or bladder, or non-melanomatous skin cancerXx_NEWLINE_xXPrior malignancy within 5 years of enrollment excluding non?melanoma skin cancer or cervical carcinoma after curative resection, not requiring chemotherapyXx_NEWLINE_xXAny known additional malignancy (with exception of non-melanoma skin cancer, in-situ breast cancer or a malignancy diagnosed >= 3 years ago and with no evidence of requiring active treatment)Xx_NEWLINE_xXPatients with a history of another neoplasm, with the exception of non-metastatic, non-melanoma skin cancers, carcinoma in situ of the cervix, or cancer cured by surgery or small field radiotherapy, within 5 years of registration will be excludedXx_NEWLINE_xXPatients with another active malignancy that requires treatment excluding non-melanoma skin cancersXx_NEWLINE_xXConcurrent malignancy other than non-melanoma skin cancerXx_NEWLINE_xXPrior history of invasive non-breast malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1 year prior to registrationXx_NEWLINE_xXPatients must not have other invasive malignancies within the past 5 years (with the exception of non-melanoma skin cancers, non-invasive bladder cancer or localized prostate cancer for whom systemic therapy is not required)Xx_NEWLINE_xXNo active invasive malignancy in the past 2 years other than non-melanoma skin cancer; cancers that are in-situ are not considered invasiveXx_NEWLINE_xXPresence of a second malignancy, excluding non-melanomatous skin cancer unless in remission for 3 yearsXx_NEWLINE_xXPrior history of another malignancy (except for non-melanoma skin cancer, in situ cervical or breast cancer, or localized prostate cancer) unless disease free for at least one year and felt at low risk of relapse by treating physicianXx_NEWLINE_xXPrior invasive malignancy (except non-melanoma skin cancer or non-life limiting invasive malignancy that may not require treatment, such as low-risk prostate cancer) unless disease-free for a minimum of 3 years (for example, carcinoma in situ of breast, oral cavity or cervix are all permissible)Xx_NEWLINE_xXPatients with a history of active malignancy within 3 years prior to registration; note: exceptions to this requirement include adequately treated non-melanoma skin cancer or lentigo maligna or carcinoma in situ without evidence of disease or prostate cancers with a Gleason score < 8 and with prostatectomy and no lymph node involvementXx_NEWLINE_xXPatients with other malignancies within 5 years from enrollment, with the exception of non-melanoma skin cancer, cervix in situXx_NEWLINE_xXHistory of invasive cancer in the last 3 years (except for appropriately treated low-risk prostate cancer, treated non-melanoma/melanoma skin cancer, appropriately treated ductal carcinoma in situ or early stage invasive carcinoma of breast and appropriately treated in-situ/early stage cervical/endometrial cancer)Xx_NEWLINE_xXActive non-hematologic or lymphoid malignancy other than AML treated with immuno- or chemotherapy within the previous 12 months except active non-melanoma, non-invasive skin cancer will be allowed.Xx_NEWLINE_xXAny concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder cancer, early stage prostate cancer, or carcinoma in situ of the cervix; patients with a previous non-pancreatic, non-periampullary malignancy without evidence of disease for > 5 years will be allowed to enter the trialXx_NEWLINE_xXPatients with a second active malignancy, exceptions are localized non-melanoma skin cancers or prior in situ carcinomaXx_NEWLINE_xXInvasive solid tumor within 5 years; non-melanoma skin cancer or in situ malignancies are allowedXx_NEWLINE_xXPrior malignancy =< 5 years prior to registration (except non-melanotic skin cancer or carcinoma-in-situ of the cervix) (must be disease free for a minimum of 5 years); if there is a history of prior malignancy, patient must not be receiving other specific treatment (other than hormonal therapy) for cancerXx_NEWLINE_xXHistory of another primary malignancy that has not been in remission for at least 3 years (the following malignancies are exempt from the 3 year limit: non-melanoma skin cancer, fully-excised melanoma in situ [stage 0], curatively treated, localized prostate cancer, and cervical carcinoma in situ in biopsy or a squamous intraepithelial lesion on Papanicolau [PAP] smear)Xx_NEWLINE_xXHistory of another primary malignancy except adequately treated in situ carcinoma of the cervix or non-melanoma carcinoma of the skin or any other curatively treated malignancy that has not been treated in the prior 3 months or expected to require treatment for recurrence during the course of the studyXx_NEWLINE_xXA malignancy [other than the one treated in this study] which required radiotherapy or systemic treatment within the past 5 years, or has a >= 30% probability of recurrence within 24 months (except for non-melanoma skin cancer or Ta urothelial carcinomas)Xx_NEWLINE_xXOther malignancy requiring active therapy; exceptions: non-melanotic skin cancer or carcinoma-in-situ of the cervix; Note: if there is a history of prior malignancy, they must not be receiving other specific treatment for their cancerXx_NEWLINE_xXAny other malignancy from which the patient has been disease-free for less than 3 years, except for non-melanoma skin cancer, controlled localized prostate cancer, in situ carcinoma of any siteXx_NEWLINE_xXPatients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer within the last five yearsXx_NEWLINE_xXHistory of another primary malignancy within the last 3 years except: \r\n* Adequately treated in situ carcinoma of the cervix\r\n* Non-melanoma carcinoma of the skin\r\n* Any other curatively treated malignancy that has not been treated in the prior 3 months and is not expected to require treatment for recurrence during the course of the studyXx_NEWLINE_xXOther malignancy: patients will not be eligible if they have evidence of active malignancy (other than non-melanoma skin cancer or localized cervical cancer, or localized and presumed cured prostate cancer).Xx_NEWLINE_xXHistory of another malignancy; exception: patients who have been disease-free for 3 years, or patients with a history of completely resected non-melanoma skin cancer and/or patients with indolent secondary malignancies, are eligibleXx_NEWLINE_xXAny concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder cancer, early stage prostate cancer, or carcinoma in situ of the cervix; patients with a previous non-pancreatic, non-periampullary malignancy without evidence of disease for > 5 years will be allowed to enter the trialXx_NEWLINE_xXPatients with an active second malignancy or prior invasive malignancy unless disease free for a minimum of 3 years; non-melanoma skin cancer and previous early prostate cancer that had a non-rising PSA can be enrolledXx_NEWLINE_xXHave had a diagnosis of another malignancy, unless the patient has been disease-free for at least 3 years following the completion of curative intent therapy, with the following exceptions:\r\n* Patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed\r\n* Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (PSA) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performedXx_NEWLINE_xXPatients with a history of prior malignancy within 5 years of study entry with the exception of curatively treated non-melanomatous skin cancer or carcinoma in situ of the cervix or breastXx_NEWLINE_xXNo history of an invasive malignancy (other than this prostate cancer, or non-metastatic basal or squamous skin cancers) in the last 5 yearsXx_NEWLINE_xXDiagnosis of an invasive malignancy within 5 years (other than current prostate cancer or non-metastatic basal or squamous skin cancers)Xx_NEWLINE_xXHistory of prior malignancy with the exception of cervical intraepithelial neoplasia, non-melanoma skin cancer, and adequately treated localized prostate carcinoma (PSA <1.0). Patients with a history of other malignancies must have undergone potentially curative therapy and have no evidence of that disease for five yearsXx_NEWLINE_xXHistory of another primary invasive malignancy that has not been definitively treated or in remission for at least 2 years; patients with non-melanoma skin cancers or with carcinomas in situ are eligible regardless of the time from diagnosis (including concomitant diagnoses)Xx_NEWLINE_xXHistory of another primary invasive malignancy unless definitively treated or in remission for at least 2 years; patients with non-melanoma skin cancers or with carcinomas in situ are eligible regardless of the time from diagnosis (including concomitant diagnoses)Xx_NEWLINE_xXPresence of other significant cancer(s) or history of other significant cancer(s) within the last 3 years (patients who have been cancer-free for 3 years, or have a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma of the cervix are eligible)Xx_NEWLINE_xXHistory of another malignancy within the last five years except non-melanoma skin cancer, carcinoma in–situ of uterine cervix, uteri, and breast from which the patient has been disease free for at least 3 years; second primary breast cancers are allowed regardless of the number of years since they were first diagnosedXx_NEWLINE_xXHistory of another malignancy within 5 years prior to randomization except for non-melanomatous carcinoma of the skin or adequately treated, non-muscle-invasive, urothelial carcinoma of the bladder (i.e., TIS, Ta and low-grade T1 tumors)Xx_NEWLINE_xXOther active malignancy =< 3 years prior to registration; EXCEPTIONS: non-melanotic skin cancer, carcinoma-in-situ of the cervix, or 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; NOTE: if there is a history of prior malignancy, they must not be receiving other specific treatment such as radiation, chemotherapy, or immunotherapy for their cancerXx_NEWLINE_xXHas had a prior malignancy other than the malignancies under study - EXCEPTION: A subject who has been disease-free for 5 years, or a subject with a history of a completely resected non-melanoma skin cancer or successfully treated in situ carcinoma is eligibleXx_NEWLINE_xXHistory of another malignancy\r\n* Exception: patients who have been disease-free for 3 years, or patients with a history of completely resected non-melanoma skin cancer and/or patients with indolent secondary malignancies, are eligible; consult the Cancer Therapy Evaluation Program (CTEP) Medical Monitor if unsure whether second malignancies meet the requirements specified aboveXx_NEWLINE_xXWith the exception of non-melanoma skin cancer and other specific malignancies as noted above, subjects with other invasive malignancies, who had any evidence of the other cancer present within the last 1 year or whose previous cancer treatment contraindicates this protocol therapy, are excludedXx_NEWLINE_xXAny concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder cancer, or carcinoma in situ of the cervix; patients with a previous malignancy without evidence of disease for >= 3 years will be allowed to enter the trialXx_NEWLINE_xXPatients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of active malignancy within the last five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.Xx_NEWLINE_xXPatients must not have other active malignancies other than non-melanoma skin cancers or superficial bladder cancer; subjects with a history of other cancers who have been adequately treated and have been recurrence-free for >= 3 years are eligibleXx_NEWLINE_xXPHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nPatients with history of a previous malignancy within the last 2 years are ineligible, except non-melanoma skin cancer, papillary carcinoma of the thyroid or non-invasive cancer of the uterine cervix; eligibility of SCLC patients with inactive prior malignancy is a PI decision on an individual patient basisXx_NEWLINE_xXPrior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years; (for example, carcinoma in situ of the bladder or oral cavity is permissible)Xx_NEWLINE_xXPatients who have a history of another primary malignancy, with the exceptions of: non-melanoma skin cancer, and carcinoma in situ of the cervix, uterus, or breast from which the patient has been disease free for =< 3 yearsXx_NEWLINE_xXPatients with other active malignancies are ineligible for this study, other than non-melanoma skin cancersXx_NEWLINE_xXHistory of another malignancy within 5 years prior to randomisation except for non-melanomatous carcinoma of the skin; or, adequately treated, non-muscle-invasive urothelial carcinoma of the bladder (i.e. Tis, Ta and low grade T1 tumours).Xx_NEWLINE_xXPatients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapyXx_NEWLINE_xXDiagnosis or treatment for another systemic malignancy within 2 years before the first dose of study drugs, or previously diagnosed with another malignancy & have any evidence of residual disease; patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resectionXx_NEWLINE_xXOther malignancy that is either active or for which patient has received treatment in the last five years excluding non-melanoma skin cancer and carcinoma in situ of the cervixXx_NEWLINE_xXDiagnosed or treated for another malignancy within 2 years before study enrollment, or previously diagnosed with another malignancy and have any evidence of residual disease; patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resectionXx_NEWLINE_xXOther active malignancy at time of registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervixXx_NEWLINE_xXThe subject has no other diagnosis of cancer (unless non-melanoma skin cancer, an early form of cervical cancer, or another cancer diagnosed >= 2 years previously) and currently has no evidence of active other malignancy (unless non-melanoma skin cancer or an early form of cervical cancer)Xx_NEWLINE_xXPatients diagnosed with invasive malignancy are not eligible (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (e.g., oral cavity)Xx_NEWLINE_xXPatients with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, cervical/dysplasia, melanoma, or breast) are excluded unless definitive therapy has been completed at least 1 year prior to study entry and the patient is now without evidence of disease from that malignancy and no additional therapy is required or anticipated to be required during the study periodXx_NEWLINE_xXPrior invasive malignancy (except non-melanoma skin cancer), unless disease-free for at least 3 years; no patient with a history of pelvic or hematologic malignancy is eligible, regardless of disease-free intervalXx_NEWLINE_xXPrior invasive malignancies (except non-melanomatous skin cancers and carcinoma in situ of the cervix or bladder) unless disease free for >= 5 yearsXx_NEWLINE_xXDiagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed (> 2 years before study enrollment) with another malignancy and have any evidence of residual disease that is symptomatic or requiring treatment; patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resectionXx_NEWLINE_xXHistory of second malignancy, other than non-melanoma skin cancer or in situ carcinoma of the cervix or the breast, unless the tumor was successfully treated at least 2 years before trial entry and with no evidence of relapse or active cancerXx_NEWLINE_xXHistory of another primary invasive malignancy that has not been definitively treated or in remission for at least 2 years; patients with non-melanoma skin cancers or with carcinomas in situ are eligible regardless of the time from diagnosis (including concomitant diagnoses)Xx_NEWLINE_xXEvidence within 2 years of the start of study treatment of another malignancy which required systemic treatment except for cured nonmelanoma skin cancer or cured in situ cervical carcinomaXx_NEWLINE_xXHistory of another active malignancy in last 3 years; exception: subjects who have been disease-free for 3 years, or subjects with a history of completely resected nonmelanoma skin cancer and/or subjects with indolent second malignancies are eligibleXx_NEWLINE_xXadequately treated non-melanoma skin cancer,Xx_NEWLINE_xXAny concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder cancer, or carcinoma in situ of the cervix; patients with a previous malignancy without evidence of disease for >= 3 years will be allowed to enter the trialXx_NEWLINE_xXSubjects with active concurrent malignancies are excluded i.e. cancers other than NSCLC (except non-melanoma skin cancers, in situ bladder, gastric, breast, colon or cervical cancers/dysplasia)Xx_NEWLINE_xXAny other malignancy from which the patient has been disease-free for less than 2 years, except for non-melanoma skin cancer, in situ carcinoma of any siteXx_NEWLINE_xXPrior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 yearsXx_NEWLINE_xXPrior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for >= 3 years; (for example, carcinoma in situ of the breast, oral cavity, and cervix are all permissible)Xx_NEWLINE_xXHistory of another malignancy within 5 years prior to study entry, except curatively treated non-melanotic skin cancer, cervical cancer in situ, localized biopsy-proven prostate cancer, or stage I colon cancerXx_NEWLINE_xXTreatment for other carcinomas within the last two years, except cured non-melanoma skin cancer, curatively treated in-situ cervical cancer, or localized prostate cancer with stable prostate-specific antigen (PSA)Xx_NEWLINE_xXHistory of another malignancy; exception: patients who have been disease-free for 3 years, patients with a history of completely resected non-melanoma skin cancer, and/or patients with indolent secondary malignancies, are eligible; MSK can consult the Cancer Therapy Evaluation Program (CTEP) Medical Monitor if unsure whether second malignancies meet the requirements specified aboveXx_NEWLINE_xXEvidence of metastatic disease, unless disease-free for >= 3 years prior to registration, (non-melanomatous skin cancer and in-situ cancers are okay)Xx_NEWLINE_xXAny concurrent malignancy\r\n* Exceptions\r\n** Patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed\r\n** Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (PSA) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performedXx_NEWLINE_xXPrior history of other malignancy with the exclusion of localized prostate cancer, non-melanomatous skin cancer, ductal carcinoma or lobular carcinoma in situ of the breastXx_NEWLINE_xXAny concurrent malignancy with the exception of the following: a) patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed; b) patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (PSA) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performedXx_NEWLINE_xXOther active malignancy requiring therapy; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervixXx_NEWLINE_xXHistory of another malignancy; exception: patients who have been disease-free for 3 years, or patients with a history of completely resected non-melanoma skin cancer or any carcinoma in situ and/or patients with indolent second malignancies, are eligible; consult the Cancer Therapy Evaluation Program (CTEP) medical monitor if unsure whether second malignancies meet the requirementsXx_NEWLINE_xXHistory of other malignancy =< 5 years prior to registration except for non-melanoma skin cancer, carcinoma in situ of the cervix, and ductal carcinoma in situ (DCIS)Xx_NEWLINE_xXOther malignancy within 5 years, except curatively treated non-melanomatous skin cancer, curatively treated carcinoma in situ of the uterine cervix, or early stage (stage I or IIa) prostate cancerXx_NEWLINE_xXHistory of malignancy (other than non-melanoma skin cancer) within 5 years of enrollmentXx_NEWLINE_xXPrior invasive (except non-melanoma skin cancer) malignancy unless disease-free for a minimum of 2 yearsXx_NEWLINE_xXPatients who have a history of another primary malignancy, with the exceptions of: non-melanoma skin cancer, and carcinoma in situ of the cervix, uterus, or breast, unless the patient has been disease free for >= 3 yearsXx_NEWLINE_xXPatients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years are ineligibleXx_NEWLINE_xXPatients with any history of cancer with the exception of non-melanoma skin cancer are excluded if there is any evidence of other malignancy being present within the past five yearsXx_NEWLINE_xXNo other active malignancies (other than treated non-melanoma skin cancer or treated in situ cancer) within the past yearXx_NEWLINE_xXPrior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 yearsXx_NEWLINE_xXPrior or concurrent invasive malignancy (except non-melanomatous skin cancer or lymphomatous/hematogenous malignancy) unless continually disease free for a minimum of 5 yearsXx_NEWLINE_xXPatients with history of prior invasive malignancy (except non-melanomatous skin cancer and glioblastoma diagnosis) must have been disease free for a minimum of 1 yearXx_NEWLINE_xXAny prior external beam radiation will be evaluated to determine radiation field overlaps and appropriateness of protocol radiation, any invasive cancer in the last 5 years (except for a diagnosis of low-risk prostate cancer, treated non-melanoma/melanoma skin cancer, appropriately treated ductal carcinoma in situ or early stage invasive carcinoma of breast and appropriately treated in-situ/early stage cervical/endometrial cancer)Xx_NEWLINE_xXAny concurrent active malignancy other than non-melanoma skin cancers or carcinoma-in-situ of the cervix; patients with previous malignancies but without evidence of disease for > 3 years will be allowed to enter the trial; patients with a history of a T1a or b prostate cancer (detected incidentally at transurethral resection of the prostate [TURP] and comprising less than 5% of resected tissue) may participate if the prostate-specific antigen (PSA) remained within normal limits since TURP removalXx_NEWLINE_xXNo evidence of prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical carcinoma or any surgically- or radiation-cured malignancy continuously disease free for >= 5 years so as not to interfere with interpretation of radiographic responseXx_NEWLINE_xXRANDOMIZED PHASE II (ARMS K AND L): No evidence of prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical carcinoma or any surgically- or radiation-cured malignancy continuously disease free for >= 5 years so as not to interfere with interpretation of radiographic responseXx_NEWLINE_xXNo other cancer in previous 2 years with the exception of non-invasive skin cancersXx_NEWLINE_xXAny other diagnosis of malignancy or evidence of malignancy (except non-melanoma skin cancer, in-situ carcinoma of the cervix) within 2 years prior to screening for this studyXx_NEWLINE_xXPROCUREMENT EXCLUSION CRITERA\r\n* Active infection requiring antibiotics\r\n* No history of other cancer (except non-melanoma skin cancer or in situ breast cancer or cervix cancer) unless the tumor was successfully treated with curative intent at least 2 years before trial entryXx_NEWLINE_xXPrior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for >= 3 years; for example, carcinoma in situ of the breast, oral cavity, and cervix are all permissibleXx_NEWLINE_xXAny concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder cancer, early stage prostate cancer, or carcinoma in situ of the cervix; patients with a previous non-pancreatic, non-periampullary malignancy without evidence of disease for > 5 years will be allowed to enter the trialXx_NEWLINE_xXPrevious or active non-melanoma malignancies (excluding non-melanoma skin cancer or carcinoma in situ of the cervix) diagnosed/treated within the last 5 yearsXx_NEWLINE_xXOther active malignancy: EXCEPTIONS: Non-melanoma skin cancer, localized prostate cancer, or carcinoma-in-situ of the cervix; NOTE: If there is a history or prior malignancy, patient must not be receiving other cytotoxic or molecularly targeted therapeutics treatment for their cancer; patients receiving certain hormonal manipulations as part of their treatment may be allowed to continue at the discretion of the Principal Investigator (PI) (e.g. luteinizing hormone-releasing hormone [LHRH] analogs for prostate cancer)Xx_NEWLINE_xXHistory of a prior malignancy within past 5 years are excluded unless they have been disease free for 3 or more years or unless they have a completely resected non-melanoma skin cancerXx_NEWLINE_xXHistory of secondary malignancy or history of other malignancy within the last three years (patients who have been disease-free for three years, or have a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible)Xx_NEWLINE_xXPatients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years are ineligibleXx_NEWLINE_xXHistory of other invasive malignancies, with the exception of non-melanoma skin cancer and in situ melanoma, who had (or have) any evidence of the other cancer present within the last 5 yearsXx_NEWLINE_xXPrior invasive malignancy (except non-melanomatous skin cancer), unless disease free for a minimum of 3 yearsXx_NEWLINE_xXPatients with other active, current primary malignancies, other than carcinoma in situ of the cervix or non-melanoma skin cancerXx_NEWLINE_xXPrior malignancy; note: subjects who have had another malignancy and have been disease-free for > 3 years, or subjects with a history of completely resected non-melanomatous skin carcinoma, successfully treated in situ carcinoma, or successfully treated bladder cancer are eligibleXx_NEWLINE_xXPatients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years are ineligibleXx_NEWLINE_xXOther malignancy, except non-melanoma skin cancer, with a >= 30% probability of recurrence within 24 monthsXx_NEWLINE_xXHave been diagnosed with another primary malignancy other than NSCLC except for adequately treated non-adequately treated non-melanoma skin cancer or cervical cancer in situ; definitively treated non-metastatic prostate cancer; or patients with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy.Xx_NEWLINE_xXOther malignancy requiring active therapy\r\n* EXCEPTIONS: Non-melanoma skin cancer, ductal carcinoma in situ (DCIS) or carcinoma-in-situ of the cervix\r\n* NOTE: if there is a history of prior malignancy, they must not be receiving other specific treatment for their cancerXx_NEWLINE_xXConcurrent active malignancy, other than adequately treated non-melanoma skin cancer, other noninvasive carcinoma, or in situ neoplasm; a subject with previous history of malignancy is eligible, provided that he/she has been disease-free for > 3 yearsXx_NEWLINE_xXOther active malignancy =< 2 years prior to registration that will interfere with conduct of this trial; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: if there is a history of prior malignancy, patients must not be receiving other specific treatment (chemotherapy, hormonal therapy, radiation) for their cancerXx_NEWLINE_xXPrior invasive malignancy (except non-melanomatous skin cancer), unless disease free for a minimum of 3 yearsXx_NEWLINE_xXSecond malignancies (excluding non-melanoma skin cancer) unless treated with curative intent and disease-free for 3 yearsXx_NEWLINE_xXPatients with any history of cancer with the exception of non-melanoma skin cancer are excluded if there is any evidence of other malignancy being present within the past five yearsXx_NEWLINE_xXPatients with any history of cancer with the exception of non-melanoma skin cancer are excluded if there is any evidence of other malignancy being present within the past five yearsXx_NEWLINE_xXPatients with active non-hematological malignancies (except non-melanoma skin cancers) or those with non-hematological malignancies (except non-melanoma skin cancers) who have been rendered with no evidence of disease, but have a greater than 20% chance of having disease recurrence within 5 years\r\n* This exclusion does not apply to patients with non-hematologic malignancies that do not require therapyXx_NEWLINE_xXPatients with of history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix, unless in complete remission and off therapy for that disease for > 3 years)Xx_NEWLINE_xXNo history of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 yearsXx_NEWLINE_xXOther malignancy, except non-melanomatous skin cancer, < 5 years prior to participation in this study; the disease-free interval from any prior carcinoma must be continuousXx_NEWLINE_xXDONOR: Prior malignancies within the last 5 years except for non-melanoma skin cancersXx_NEWLINE_xXPatients with a past history of malignancy that were treated less than 3 years and have not remained disease free for the past 3 years. (Patients with non metastatic skin cancers will be eligible).Xx_NEWLINE_xXPatients must never have been diagnosed with any malignancy other than the current NSCLC, except for non-metastatic non-melanoma skin cancer, or cancer in situ of the cervix.Xx_NEWLINE_xXNo history of unrelated (non-lymphomatous) neoplasms within past 5 years other than non-melanoma skin cancer or in-situ cancerXx_NEWLINE_xXOther known co-existing malignancies except non-melanoma skin cancer unless definitively treated and proven no evidence of recurrence for 5 years.Xx_NEWLINE_xXAny other malignancy that required treatment (except for non-melanoma skin cancer, or histologically confirmed complete excision of carcinoma in situ), within 2 years prior to study drug administrationXx_NEWLINE_xXHistory of active malignancy in past 5 years (non-melanoma skin cancer or cervical cancer in situ permitted)Xx_NEWLINE_xXPatient with a history of other malignancies within the last 5 years, except for nonmelanoma skin cancer or carcinoma in situ of the cervix.Xx_NEWLINE_xXOther active malignancy than lymphoma\r\n* NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer that could interfere with this protocol therapy; patients on hormonal therapy for treated breast or prostate cancer are permitted if they meet other eligibility criteria; patients with non-melanotic skin cancer may enrollXx_NEWLINE_xXDiagnosed or treated for another malignancy =< 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease; NOTE: Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resectionXx_NEWLINE_xXHistory of prior or concomitant malignancies (other than excised non-melanoma skin cancer or cured in situ cervical carcinoma) within 3 years of study entry.Xx_NEWLINE_xXPrevious malignancies (except non-melanoma skin cancers, in situ bladder cancer, in situ gastric or in situ colon cancers, in situ cervical cancers/dysplasia or breast carcinoma in situ) unless a complete remission was achieved at least 1 year prior to study entry and no additional therapy is required or anticipated to be required during the study periodXx_NEWLINE_xXDiagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease. Participants with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.Xx_NEWLINE_xXActive concurrent malignancy (except non melanoma skin cancer or carcinoma in situ of the cervix) or life-threatening disease.Xx_NEWLINE_xXHistory of another malignancy within the previous 5 years other than curatively treated non-melanoma skin cancerXx_NEWLINE_xXPatients with a history of other malignancies during the past three years. (The following are exempt from the three-year limit: non-melanoma skin cancer, Lymphomatoid papulosis, curatively treated localized prostate cancer, curatively treated localized breast cancer, resected thyroid cancer, biopsy proven cervical intraepithelial neoplasia or cervical carcinoma in situ).Xx_NEWLINE_xXOther active malignancy =< 5 years prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: if there is a history or prior malignancy, they must not be receiving other specific treatment for their cancerXx_NEWLINE_xXPatients with non-melanoma skin cancer or carcinoma in situ of the cervix are eligible, while patients with other prior malignancies must have had at least a 3-year disease-free interval.Xx_NEWLINE_xXConcurrent cancer of any other type except skin cancer (excluding melanoma)Xx_NEWLINE_xXHistory of other malignancies within the past 3 years, other than adequately treated non-melanoma skin cancer, or in situ carcinoma of the cervix, unless the other malignancy is quiescent and medical monitor approval is obtainedXx_NEWLINE_xXHistory of prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, or other treated malignancies with no evidence of disease for at least three yearsXx_NEWLINE_xXKnown history of another primary malignancy that has not been in remission for at least 5 years. Non-melanoma skin cancer and cervical carcinoma in situ or squamous intraepithelial lesions (e.g., cervical intraepithelial neoplasia [CIN] or prostatic intraepithelial/intraductal neoplasia [PIN]) are allowed.Xx_NEWLINE_xXA history of any other primary malignancy that has not been treated with curative intent and that has not been in complete remission for at least 2 years (exempt from the two year limit are non-melanoma skin cancer and cervical carcinoma in-situ on biopsy or a squamous intraepithelial lesion on PAP smear).Xx_NEWLINE_xXKnown history of malignancy diagnosed within 2 years other than non-melanoma skin cancer.Xx_NEWLINE_xXPatients with other active malignancy ? 3 years prior to registration for which active treatment is required must be excluded; patients with composite lymphomas that have a non-B-cell component must be excluded\r\n* EXCEPTIONS: Non-melanotic skin cancers or carcinoma-in-situ of the cervixXx_NEWLINE_xXParticipant has had another active malignancy within the past 3 years except for any cancer considered cured or non-melanoma carcinoma of the skin.Xx_NEWLINE_xXHad prior malignancy other than carcinoma in situ of the cervix or non-melanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 3 years previously with no subsequent evidence of recurrence. If the patient has a medical history of a previous tumor that is not included in this criteria and that the Investigator feels is irrelevant for the objectives of the study, it should be evaluated with the Sponsor or Medical Monitor.Xx_NEWLINE_xXPrior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years, with the exception of those with a negligible risk of metastases or death, such as carcinoma in situ of the breast or cervixXx_NEWLINE_xXPrior additional malignancy within 2 years except for non-melanoma skin cancer, carcinoma in situ of the breast, oral cavity or cervix.Xx_NEWLINE_xXPrevious (within the past 5 years) or concurrent presence of other cancer, except non-melanoma skin cancer and in situ carcinomas.Xx_NEWLINE_xXHPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: Patients with a history of a curatively treated malignancy must be disease-free for at least two years except for carcinoma in situ of cervix, melanoma in-situ (if fully resected), and/or non-melanomatous skin cancerXx_NEWLINE_xXEvidence of invasive anal, vulva, vaginal, or cervical carcinoma; prior loop electrosurgical excision procedure (LEEP) or ablative treatment within 6 months prior to study entry; other invasive malignancies, with the exception of non-melanoma skin cancer, within the last 5 yearsXx_NEWLINE_xXPatients with non-melanoma skin cancer or carcinoma in situ of the cervix are eligible, while patients with other prior malignancies must have had at least a 3-year disease-free interval, or are deemed at low risk for recurrence by his/her treating physician.Xx_NEWLINE_xXREGISTRATION TO TREATMENT (STEP 1): No other active primary malignancy (other than non-melanomatous skin cancer or carcinoma in situ of the cervix) requiring treatment or limiting expected survival to =< 2 years\r\n* NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment (other than hormonal therapy for their cancer)Xx_NEWLINE_xXREGISTRATION TO TREATMENT (STEP 2): No other active primary malignancy (other than non-melanomatous skin cancer or carcinoma in situ of the cervix) requiring treatment or limiting expected survival to =< 2 years; NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment (other than hormonal therapy for their cancerXx_NEWLINE_xXOther active malignancy ? 2 years prior to registration; EXCEPTIONS: Non-melanotic skin cancer, carcinoma-in-situ of the cervix, or early stage prostate cancerXx_NEWLINE_xXPrevious malignancies (except non-melanoma skin cancers, and in situ bladder, gastric, colorectal, endometrial, cervical/dysplasia, melanoma, or breast cancers) unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period. Other active malignancy\r\nrequiring concurrent interventionXx_NEWLINE_xXHistory of other cancer within 3 years (except non-melanoma cutaneous malignancies and cervical carcinoma in situ).Xx_NEWLINE_xXThe subject has had another active malignancy within the past five years except for cervical cancer in situ, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin; questions regarding the inclusion of individual subjects should be directed to the principle investigatorXx_NEWLINE_xXHistory of other malignancy other than glioma\r\n* EXCEPTIONS: non-melanotic skin cancer, carcinoma-in-situ of the cervix, or systemic cancer that has been in documented remission for > 10 years\r\n* NOTE: if there is a history or prior malignancy, they must not be receiving other specific treatment for their cancerXx_NEWLINE_xXOther malignancy within the last 5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), stage 1, grade 1 endometrial carcinoma, or other solid tumors.Xx_NEWLINE_xXHistory of any other malignancy within 3 years, except for adequately treated carcinoma in situ of the cervix or non-melanoma skin cancer and/or subjects with indolent second malignancies are eligibleXx_NEWLINE_xXTreatment for other carcinomas within the last 5 years, except non-melanoma skin cancer and treated cervical carcinoma in-situ (CCIS)Xx_NEWLINE_xXPrior invasive malignancy that is not low-grade glioma (except non-melanomatous skin cancer or carcinoma in situ of the cervix) unless the patient has been disease free and off therapy for that disease for a minimum of 3 yearsXx_NEWLINE_xXPatients with current active malignancies or any remission for < 24 months, except patients with carcinoma in situ or with non-melanoma skin cancer who may have active disease or be in remission for less than 6 monthsXx_NEWLINE_xXPrior malignancy, other than carcinoma in situ of the cervix and non-melanoma skin cancers, unless the prior malignancy was diagnosed and definitively treated >= 5 years previously, there is no subsequent evidence of recurrence, and the patient is considered by a physician to be at < 30% risk of relapseXx_NEWLINE_xXHistory of other malignancy within 2 years prior to screening, except for ductal carcinoma in situ not requiring chemotherapy, appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, low-grade, localized prostate cancer (Gleason score </= 7) not requiring treatment or appropriately treated Stage I uterine cancerXx_NEWLINE_xXParticipant has a history of active malignancies other than SCLC within the past 2 years prior to study entry, with the exception of in situ cancer which was curatively treated.Xx_NEWLINE_xXPrior secondary malignancy < 5 years prior to consent (except non-melanoma skin cancer or carcinoma in situ of the uterine cervix) or receiving other specific treatment for this cancer (monoclonal antibody, small molecule pathway inhibitor)Xx_NEWLINE_xXHistory of another primary cancer within the last 3 years with the exception of non-melanoma skin cancer or curatively-treated cervical carcinoma in-situXx_NEWLINE_xXPrior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).Xx_NEWLINE_xXOther active malignancy =< 2 years prior to registration, unless treated with curative intent; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: if there is a history or prior malignancy, they must not be receiving other specific treatment for their cancerXx_NEWLINE_xXAnother malignancy undergoing active treatment with the exception of non-melanoma skin cancer or in situ cervical cancerXx_NEWLINE_xXAnother diagnosis of malignancy within the 5 years preceding enrollment (excluding non-melanoma skin cancers or in situ cervical lesions, which are permitted)Xx_NEWLINE_xXOther invasive cancer within 5 years before randomization; exceptions are colonic polyps, non-melanoma skin cancer or carcinoma-in-situ of the cervixXx_NEWLINE_xXPatients with a prior diagnosis of cancer must not have received treatment in the last 3 years prior to registration\r\n* NOTE: Patients with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligibleXx_NEWLINE_xXPrior invasive malignancy within the past 3 years (except for non-melanomatous skin cancer, and early stage treated prostate cancer)Xx_NEWLINE_xXPrevious malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study periodXx_NEWLINE_xXPrior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1095 days (3 years); noninvasive cancers (for example, carcinoma in situ of the breast, oral cavity, or cervix) are permitted even if diagnosed and treated < 3 years agoXx_NEWLINE_xXTREATMENT: Patients who have a history of another primary malignancy, with the exceptions of: non-melanoma skin cancer, and carcinoma in situ of the cervix, uteri, or breast from which the patient has been disease free for > 3 yearsXx_NEWLINE_xXPrior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1095 days (3 years); noninvasive cancers (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible) are permitted even if diagnosed and treated < 3 years agoXx_NEWLINE_xXOther active malignancy, except non-melanotic skin cancer or carcinoma-in-situ of the cervix\r\n* Note: If there is a history of prior malignancy, they must not be receiving other specific treatment (other than hormonal therapy) for their cancerXx_NEWLINE_xXHistory of other malignancy; subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinomas are eligibleXx_NEWLINE_xXSubjects with previous malignancies (except non-melanoma skin cancers, and in situ cancers such as the following: bladder, gastric, colon, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry and no additional therapy is required or anticipated to be required during the study periodXx_NEWLINE_xXPrevious malignant disease being disease-free for less than 5 years (except carcinoma in situ [CIS] of the cervix and non-melanoma skin cancer)Xx_NEWLINE_xXOther active malignancy =< 3 years prior to registration; EXCEPTIONS: adequately treated non-melanotic skin cancer (adequate wound healing is required prior to study entry) or carcinoma-in-situ of the cervix; NOTE: if there is a history of prior solid tumor malignancy, it must have been treated curatively with no evidence of recurrence =< 3 years prior to registrationXx_NEWLINE_xXSubjects with a “currently active” second malignancy, other than non-melanoma skin cancer, carcinoma in situ of the cervix, resected incidental prostate cancer (staged pT2 with Gleason score =< 6 and postoperative prostate-specific antigen [PSA] < 0.5 ng/mL), or other adequately treated carcinoma-in-situ are ineligible; patients are not considered to have a “currently active” malignancy if they have completed therapy and are free of disease for >= 1 yearXx_NEWLINE_xXNo prior invasive malignancy in the past 3-years, except non-melanomatous skin cancer unless disease free for a minimum of 2 years; carcinoma in-situ of the bladder or head and neck region is permissibleXx_NEWLINE_xXOther active malignancy within the last 3 years (except for non-melanoma skin cancer, a non-invasive/in situ cancer, or indolent nonmetastatic Gleason 6 prostate cancer)Xx_NEWLINE_xXPatients 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 lesionsXx_NEWLINE_xXPatients with other active invasive malignancies will be excluded; patients with prior malignancies will be excluded (except [1] non-melanoma skin cancer or prior in situ carcinoma of the cervix; [2] patients with other invasive malignancies who had [or have] cancer present within the last five years)Xx_NEWLINE_xXHistory of prior malignancy, with the exception of the following:\r\n* Non-melanoma skin cancers, non-invasive bladder cancer, and carcinoma in situ of the cervix\r\n* Prostate cancer not under active systemic treatment other than hormonal therapy and with documented undetectable prostate-specific antigen (PSA) (< 0.2 ng/mL)\r\n* Chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) provided patient has isolated lymphocytosis (Rai stage O), and does not require systemic treatment (for “B” symptoms, Richter’s transformation, lymphocyte doubling time [< 6 months], lymphadenopathy or hepatosplenomegaly)\r\n* Lymphoma of any type of hairy-cell leukemia provided patient is not on active systemic treatment and is in complete remission, as evidenced by PET/CT scans and bone marrow biopsies for at least 3 months\r\n* History of malignancy provided that patient has completed therapy and is free of disease for >= 2 years; if patient had other malignancy within the last 2 years from which he may have been completely cured by surgery alone, he may be considered to be enrolled on condition that the risk of development of distant metastatic disease based on American Joint Committee on Cancer (AJCC) staging system is less than 30%Xx_NEWLINE_xXPatient with known active invasive malignancy other than NSCLC (exceptions: non-melanoma skin cancer or carcinoma in-situ of the cervix or bladder)Xx_NEWLINE_xXOther active malignancy =< 3 years prior to registration; EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancerXx_NEWLINE_xXNo recent (within 5 years) or concurrent cancers other than non-melanoma skin cancersXx_NEWLINE_xXActive other malignancy, excepting non-melanotic skin cancer or carcinoma-in situ (e.g. of cervix, breast prostate); if there is a history of prior malignancy, they must not be receiving other specific treatment (other than hormonal therapy) for their cancerXx_NEWLINE_xXPrior history of another malignancy (except for non-melanoma skin cancer, in situ cervical or breast cancer, or prostate cancer detectable only by prostate specific antigen [PSA]) unless disease free for over one yearXx_NEWLINE_xXAdequately treated non-melanomatous skin cancer or lentigo maligna melanoma without current evidence of diseaseXx_NEWLINE_xXPatients who have other current malignancies are not eligible; patients with other malignancies are eligible if they have been continuously disease free for > 5 years prior to the time of randomization; patients with prior history at any time of any in situ cancer, lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or melanoma in situ are eligible; patients with prior history of basal or squamous skin cancer are eligible; patients who have had multiple primary melanomas are eligibleXx_NEWLINE_xXOther active malignancy =< 6 months prior to registration\r\n* EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix or or prostate cancer confined to prostate gland or coexistent differentiated thyroid cancer\r\n* NOTE: If there is a history of prior malignancy, they must not be receiving other treatment for their cancer; ongoing adjuvant hormonal treatment for breast cancer is allowedXx_NEWLINE_xXA prior or concurrent malignancy of any other site or histology unless the patient has been disease-free for >= 5 years except for non-melanoma skin cancer and/or stage T1a prostate cancer or carcinoma in situ of the uterine cervixXx_NEWLINE_xXHistory of another malignancy; exception: patients who have been disease-free for > 3 years, or patients with a history of completely resected non-melanoma skin cancer and/or patients with indolent secondary malignancies, are eligible; consult the Cancer Therapy Evaluation Program (CTEP) Medical Monitor if unsure whether second malignancies meet the requirements specified aboveXx_NEWLINE_xXPrior invasive malignancy (except for non-melanoma skin cancer) unless disease free for >= 3 yearsXx_NEWLINE_xXPrior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 yearsXx_NEWLINE_xXPrior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1095 days (3 years) (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)Xx_NEWLINE_xXPrior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)Xx_NEWLINE_xXPatients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapyXx_NEWLINE_xXHistory of another malignancy; exception: patients who have been disease-free for 3 years, or patients with a history of completely resected non-melanoma skin cancer and/or patients with indolent second malignancies, are eligible; consult the Cancer Therapy Evaluation Program (CTEP) medical monitor if unsure whether second malignancies meet the requirements specified aboveXx_NEWLINE_xXPatient with a history of other invasive malignancies, with the exception of non-melanoma skin cancer 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 eligibilityXx_NEWLINE_xXPatient is < 2 years free from a second primary malignancy unless the other malignancy is non-melanomatous skin cancer or an in-situ tumor treated with curative intentXx_NEWLINE_xXPrior invasive malignancy (unless disease free for a minimum of 1095 days [3 years]); non-melanomatous skin cancer and previous early prostate cancer that had a non-rising prostate-specific antigen (PSA) are eligibleXx_NEWLINE_xXPatients with active non-hematological malignancies (except non-melanoma skin cancers) or those with non-hematological malignancies who have been rendered with no evidence of disease, but have a greater than 20% chance of having disease recurrence within 5 years; this exclusion does not apply to patients with non-hematologic malignancies that do not require therapyXx_NEWLINE_xXPatients with second malignancy within 3 years of enrollment; patients treated surgically with a curative intent, such as non-melanoma skin cancers, localized kidney cancer or carcinoma in situ of the bladder, are not excluded; patients with multiple endocrine neoplasia type 2 (MEN2) and a history of pheochromocytoma will also not be excluded; in addition patients with prostate cancer who do not require systemic therapy will not be excluded; (a secondary, minority pathologic focus of another form of thyroid cancer may be coincidentally found in 15-20% of patients with medullary thyroid cancer; in such cases, eligibility is based on the discretion of the investigator)Xx_NEWLINE_xXPatients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment prevents full delivery of this protocol therapyXx_NEWLINE_xXPatients who have other current malignancies are not eligible; patients with other malignancies are eligible if they have been continuously disease free for > 5 years prior to the time of randomization; one exception are patients treated with a curative intent and are continuously disease free for > 3 years; these patients would be considered eligible: \r\n* Patients with prior history at any time of any in situ cancer, lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or Clark I melanoma in situ are eligible\r\n* Patients with prior history of basal or squamous skin cancer are eligibleXx_NEWLINE_xXThey must not have undergone treatment for any other form of cancer (aside from non-melanoma skin cancer) in the past five yearsXx_NEWLINE_xXPrior invasive malignancy (except non-melanomatous skin cancer) unless disease-free for a minimum of 3 yearsXx_NEWLINE_xXPrior head and neck malignancy or history of other prior non-head and neck malignancy (excluding skin cancer and early stage treated prostate cancer) within the past 3 yearsXx_NEWLINE_xXOther active malignancy (with the exception of locally treated non-melanoma skin cancers)Xx_NEWLINE_xXOther active malignancy =< 3 years prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: if there is a history or prior malignancy, they must not be receiving other specific treatment (e.g. hormonal or chemotherapy) for their cancerXx_NEWLINE_xXPrior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)Xx_NEWLINE_xXHistory of a second malignancy within the previous 2 years (except non-melanoma skin cancer and cervical in-situ)Xx_NEWLINE_xXPrior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)Xx_NEWLINE_xXPrior invasive malignancy (except non-melanomatous skin cancer), unless disease free for a minimum of 2 years (e.g., carcinoma in situ of the breast, oral cavity, or cervix are permissible)Xx_NEWLINE_xXPresence of second active tumor, other than non-melanoma skin cancer, carcinoma in situ of the cervix, or Kaposi’s sarcoma (KS) that requires systemic therapyXx_NEWLINE_xXPrior or current non-gynecologic or non-breast malignancy within 5 years except non-melanoma skin cancerXx_NEWLINE_xXPatients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies as noted, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapyXx_NEWLINE_xXPrior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)Xx_NEWLINE_xXPrior head and neck malignancy, or history of other prior non-head and neck malignancy within the past 3 years (excluding skin cancer and early stage treated prostate cancer)Xx_NEWLINE_xXParticipants with any evidence of other invasive malignancy being present within the last 3 years (with the exception of non-melanoma skin cancer). Participants are also excluded if their previous cancer treatment contraindicates this protocol's therapy.Xx_NEWLINE_xXPatients with a history of other invasive malignancies, with the exception of non-melanoma skin cancers are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapyXx_NEWLINE_xXSubject has been diagnosed with another malignancy, unless disease-free for at least 5 years. Subjects with treated nonmelanoma skin cancer, in situ carcinoma or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed. Subjects with organ-confined prostate cancer with no evidence of recurrent or progressive disease are eligible if hormonal therapy has been initiated or the malignancy has been surgically removed or treated with definitive radiotherapy.Xx_NEWLINE_xXKnown concurrent malignancy (except for non-melanoma skin cancer)Xx_NEWLINE_xXPatients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapyXx_NEWLINE_xXHistory of another invasive malignancy that has not been in remission for at least 3 years. Exceptions to the 3 year limit include nonmelanoma skin cancer, curatively treated localized prostate cancer, and cervical cancer in situ on biopsy or squamous intraepithelial lesion on PAP smearXx_NEWLINE_xXHistory of another primary cancer within the last 3 years that required treatment, with the exception of non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical carcinoma in situ.Xx_NEWLINE_xXNo other cancer requiring therapy within the last 3 years (except in situ carcinoma or nonmelanoma skin cancer)Xx_NEWLINE_xXa) Curatively treated non-melanoma skin cancer orXx_NEWLINE_xXCarcinoma in situ or non-melanoma skin cancerXx_NEWLINE_xXAny active malignancy, other than RCC, for which chemotherapy or other anti-cancer therapy is indicated. Patients with adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 3 years will be permitted.Xx_NEWLINE_xXPatients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies are excluded if there is any evidence of other malignancy being present within the last two years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapyXx_NEWLINE_xXPatients with other invasive malignancies, with the exception of non-melanoma skin cancer and in situ melanoma, who had (or have) any evidence of the other cancer present within the last 5 yearsXx_NEWLINE_xXhistory of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 yearsXx_NEWLINE_xXActive second primary malignancy other than non-melanoma skin cancers, nonmetastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy.Xx_NEWLINE_xXHistory of other cancer within 3 years (except non-melanoma cutaneous malignancies and cervical carcinoma in situ).Xx_NEWLINE_xXSubject has no other malignancy within 5 years, except non-melanoma skin cancer, cervical intraepithelial neoplasia, or in-situ cervical cancer or incidental histological finding of prostate cancer (TNM stage of T1a or T1b); all treatments of which should have been completed 6 months prior to signing ICF.Xx_NEWLINE_xXPatients with a second malignancy, other than adequately treated non-melanoma skin cancers, in situ melanoma or in situ cervical cancer. Patients with other non-mammary malignancies must have been disease-free for at least 5yearsXx_NEWLINE_xXThe patient has an active malignancy and/or cancer history (excluding AML, BPDCN, or antecedent MDS) that may confound the assessment of the study endpoints. Patients with a past cancer history (within 2 years of entry) with substantial potential for recurrence and/or ongoing active malignancy must be discussed with the Sponsor before study entry. Patients with the following neoplastic diagnoses are eligible: non-melanoma skin cancer, carcinoma in situ, cervical intraepithelial neoplasia, organ-confined prostate cancer with no evidence of progressive disease.Xx_NEWLINE_xXOther prior malignancies, except for cured non-melanoma skin cancer, curatively treated in situ carcinoma of the cervix, adequately treated malignancies for which there has been no evidence of activity for more than 3 years, or indolent tumors for which observation over three years is a reasonable optionXx_NEWLINE_xXIndividuals with a history of a second malignancy are ineligible except for the following circumstances; individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years or are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers that have been diagnosed and treated within the past 3 years are eligible: cervical/prostate carcinoma in situ, superficial bladder cancer, non-melanoma cancer of the skin; patients with other cancers diagnosed within the past 3 years and felt to be at low risk of recurrence should be discussed with the study sponsor to determine eligibilityXx_NEWLINE_xXPatients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer are excluded if there is any evidence of other malignancy being present within the last three yearsXx_NEWLINE_xXOther clinically significant malignant disease diagnosed within the previous 5 years, excluding intra-epithelial cervical neoplasia or non-melanoma skin cancer.Xx_NEWLINE_xXSecond primary malignancy that has not been in remission for greater than 3 years. Treated non-melanoma skin cancer, cervical carcinoma in situ on biopsy, or squamous intraepithelial lesion on PAP smear, localized prostate cancer (Gleason score < 6), or resected melanoma in situ are exceptions and do not require a 3 year remission.Xx_NEWLINE_xXPrior history of malignancies, other than MM, unless the subject has been free of the disease for ? 5 years with the exception of the following non-invasive malignancies:Xx_NEWLINE_xXHistory of other cancer within 3 years (except non-melanoma cutaneous malignancies and cervical carcinoma in situ). For patients enrolled in Part 2 of the Site-specific Amendment, history of other cancer within 1 year (except non-melanoma cutaneous malignancies and cervical carcinoma in situ. Concurrent active cancers are not allowed).Xx_NEWLINE_xXSecond primary malignancy within the past 2 years (except non-melanoma skin cancer, in situ carcinoma of the cervix, breast cancer)Xx_NEWLINE_xXNon-melanoma skin cancer;Xx_NEWLINE_xXMust not have other invasive malignancies within the past 3 years (with the exception of non-melanoma skin cancers or non-invasive bladder cancer).Xx_NEWLINE_xXPatients with a second malignancy within the last 5 years are not allowed, except for those with non-melanomatous skin cancer and carcinoma-in-situ or the cervix; all prior invasive malignancies must be in complete remissionXx_NEWLINE_xXPatients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are ineligible if there is any evidence of other malignancy being present within the last five years; patients are also ineligible if their previous cancer treatment contraindicates this protocol therapyXx_NEWLINE_xXPrevious history of invasive malignancy (except non-melanoma skin cancer) unless the patient has been disease free for at least 2 years prior to study entry (or first day of chemotherapy for patients having started chemotherapy prior to first step registration); patients with a previous history of carcinoma in situ are eligibleXx_NEWLINE_xXPrior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; noninvasive cancers (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible) are permitted even if diagnosed and treated < 3 years ago; patients with simultaneous primaries or bilateral tumors are excluded, with the exception of patients with bilateral tonsil cancers or patients with primary tumor (T)1-2, nearby lymph nodes (N)0, metastasis (M)0 resected differentiated thyroid carcinoma, who are eligibleXx_NEWLINE_xXHas had a prior malignancy other than the malignancies under study Exception: Subject who has been disease-free for 3 years, or a subject with a history of a completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.Xx_NEWLINE_xXHistory of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or participants who have undergone potentially curative therapy with no evidence of disease and are deemed by the treating physician to be at low risk for recurrenceXx_NEWLINE_xXPrior active secondary malignancy < 5 years prior to consent (except non-melanomatous skin cancer or carcinoma in situ of the uterine cervix) or currently receiving other specific treatment for this cancer (including monoclonal antibody or pathway inhibitor);Xx_NEWLINE_xXHistory of other cancer within 2 years (except non-melanoma cutaneous malignancies and cervical carcinoma in situ)Xx_NEWLINE_xXPrevious malignancy within 3 years other than non-melanomatous skin cancer and non-muscle invasive bladder cancerXx_NEWLINE_xXConcurrent or prior malignancy in the last 5 years other than non-melanoma skin cancer and in-situ carcinoma of the cervix or thymomaXx_NEWLINE_xXPatients with active non-hematologic malignancies (except non-melanoma skin cancers); this exclusion does not apply to patients with non-hematologic malignancies that do not require therapyXx_NEWLINE_xXPatients with a history of non-hematologic malignancies (except non-melanoma skin cancers) currently in a complete remission, who are less than 5 years from the time of complete remission, and have a > 20% risk of disease recurrenceXx_NEWLINE_xXMatched Related Donor: Prior malignancy within the preceding five yrs, with the exception of non-melanoma skin cancersXx_NEWLINE_xXUnrelated Donor: Prior malignancy within the preceding five yrs, with the exception of non-melanoma skin cancersXx_NEWLINE_xXAdequately treated non-melanoma skin cancer or lentigo malignancy without evidence of diseaseXx_NEWLINE_xXHas had a prior malignancy other than the malignancies under study Exception: A subject who has been disease-free for 5 years, or a subject with a history of a completely resected non-melanoma skin cancer or successfully treated in situ carcinoma is eligible.Xx_NEWLINE_xXPrior or current invasive malignancy (except non-melanomatous skin cancer, localized bladder and prostate cancer) unless disease free for a minimum of 2 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)Xx_NEWLINE_xXHave been diagnosed with another primary malignancy other than NSCLC, except for adequately treated non-melanoma skin cancer or cervical cancer in situ; definitively treated non-metastatic prostate cancer; or patients with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy.Xx_NEWLINE_xXActive second primary malignancy other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy determined not be exclusionary.Xx_NEWLINE_xXOther active malignancies besides NSCLC within 3 years prior to Screening. Exceptions: adequately treated malignancies not likely to require therapy (e.g., completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma). Subjects must be in complete remission from prior malignancy in order to be eligible to enter the study.Xx_NEWLINE_xXPatients with known active second malignancy other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer, and ductal or lobular carcinoma in situ of the breast. Patients are not considered to have a currently active malignancy if they have completed anticancer therapy and have been disease free for greater than 2 years prior to screening;Xx_NEWLINE_xXSubjects with a history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; and c) other primary solid tumors (with no known active disease present) that, in the opinion of the investigator, will not affect patient outcome in the setting of the current diagnosisXx_NEWLINE_xXPatients with a history of other invasive malignancies, with the exception of non-melanoma skin, are excluded if:Xx_NEWLINE_xXSubjects with history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the investigator will not affect patient outcome in the setting of current FLC diagnosis.Xx_NEWLINE_xXPrevious (within the past 5 years) or concurrent malignancy diagnosis (expect non-melanoma skin cancer or in situ carcinoma of the cervix)Xx_NEWLINE_xXMalignancies that are expected to alter life expectancy or may interfere with disease assessment. Patients with adequately treated non-melanoma skin cancer and patients with prior history of malignancy who have been disease free for more than 3 years are eligible.Xx_NEWLINE_xXConcurrent malignancies that are expected to alter life expectancy (e.g., NSCLC, etc.) or that may interfere with assessment of prostate cancer (e.g., lymphoma involving the periaortic nodes). Patients with adequately treated non-melanoma skin cancer or non-muscle invasive urothelial carcinoma, and patients with prior history of malignancy who have been disease-free for more than 5 years are eligibleXx_NEWLINE_xXOther invasive malignancies within the last 3 years, except non- melanoma skin cancer and localized cured prostate and cervical cancer;Xx_NEWLINE_xXDiagnosis of another malignancy, with the exception of non-melanoma skin cancers within two years before the first dose, or previously treated for another malignancy with evidence of residual disease, with the exception of a synchronous endometrial cancer and non-melanoma skin cancers; carcinoma in situ will not be considered as malignancyXx_NEWLINE_xXPatients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapyXx_NEWLINE_xXHistory of other carcinomas within the last 5 years except cured non-melanoma skin cancer, curatively treated in-situ cervical cancer, or localized prostate cancer with a current Prostate-specific antigen (PSA) of <1.0 mg/dL on 2 evaluations at least 3 months apart; the most recent evaluation must be no more than 4 weeks prior to Day 1 of the study drug, or other malignancies that were completely resected or treated Stage 1/2 lesions currently in complete remission.Xx_NEWLINE_xXPatients with active non-hematologic malignancies (except non-melanoma skin cancers) or those with non-hematologic malignancies (except non-melanoma skin cancers) who have been rendered with no evidence of disease, but have a greater than 20% chance of having disease recurrence within five years; this exclusion does not apply to patients with non-hematologic malignancies that do not require therapyXx_NEWLINE_xXDONOR: Prior malignancy within the preceding 5 years, with the exception of non-melanoma skin cancersXx_NEWLINE_xXPrior invasive (except non-melanoma skin cancer) malignancy unless disease-free for a minimum of 3 years and not in the pelvis; (for example, carcinoma in situ of the oral cavity is permissible if disease free for a minimum of 3 years; however, patients with prior history of bladder cancer are not allowed no matter the disease free duration); prior hematological (e.g., leukemia, lymphoma, myeloma) malignancy is not allowedXx_NEWLINE_xXSubject who other invasive malignancy within 2 years (5 years for Arm A) except for noninvasive malignancies such as cervical carcinoma in situ, non-melanomatous carcinoma of the skin, ductal carcinoma in situ of the breast, or incidental histologic finding of prostate cancer (T1a or T1b using the TNM [tumor, nodes, metastasis] clinical staging system) that has/have been surgically cured.Xx_NEWLINE_xXActive concurrent malignancy (except non melanoma skin cancer or carcinoma in situ of the cervix) or life-threatening disease.Xx_NEWLINE_xXOther invasive malignancy within 2 years prior to enrollment (localized prostate cancer, cervical carcinoma in situ, non-melanoma skin cancer, or ductal carcinoma in situ of the breast that has/have been surgically cured would not be exclusionary).Xx_NEWLINE_xXHistory of other malignancies, other than non-melanoma skin cancer, Ta or T1 (low grade) bladder carcinomas, or other low grade cancer of very low clinical impact, unless in complete remission and off therapy for that disease for at least 2 yearsXx_NEWLINE_xXNo prior malignancy except for non-melanomatous skin cancer or non-muscle invasive bladder cancer or adequately treated Stage I or II cancer (adequacy at discretion of treating investigator) from which the subject is currently in complete remission, or any other cancer from which the subject has been disease-free for at least 3 years.Xx_NEWLINE_xXPatients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies are excluded if there is any evidence of other malignancy being present within the last three years (2 years for breast cancer); patients are also excluded if their previous cancer treatment contraindicates this protocol therapyXx_NEWLINE_xXSubjects with a history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; c) localized prostate cancer not requiring systemic therapy; and c) other primary tumors with no known active disease present that, in the opinion of the investigator and medical monitor for the sponsor, will not affect patient outcome in the setting of the current diagnosis.Xx_NEWLINE_xXPrior history of invasive cancer within 5 years before screening, except for adequately treated in situ carcinomas or non-melanoma skin cancerXx_NEWLINE_xXDirect evidence of regional or distant metastases after appropriate staging studies, or synchronous primary or prior malignancy in the past 3 years other than nonmelanomatous skin cancer or in situ cancerXx_NEWLINE_xXEvidence of other active, invasive malignancy requiring treatment within the past 5 years; noninvasive cancer history (such as carcinoma-in-situ [CIS] that has been resected) is allowedXx_NEWLINE_xXPrior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 yearsXx_NEWLINE_xXPatients with concomitant invasive malignancy or a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the past five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol.Xx_NEWLINE_xXHistory of or concurrent malignancy of solid tumours, except: subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible. Subjects with second malignancies that are indolent or definitively treated may be enrolled even if less than 5 years have elapsed since treatment. Consult GlaxoSmithKline (GSK) Medical Monitor if unsure whether second malignancies meet requirements specified above.Xx_NEWLINE_xXActive invasive cancer other than the one of the three cancers in this study; patients with active non-invasive cancers (such as non-melanoma skin cancer, superficial cervical and bladder and prostate cancer with PSA level < 1.0) are not excludedXx_NEWLINE_xXHistory of concurrent or previously non-breast malignancies except for appropriately treated (1) non-melanoma skin cancer and (2) in situ carcinomas, including cervix, colon, and skin. A participant with previous invasive non-breast cancer is eligible provided he/she has been disease-free >/= 5 yearsXx_NEWLINE_xXHave a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix or breast), unless in complete remission with no therapy for a minimum of 3 years.Xx_NEWLINE_xXAnother primary malignancy that has not been in remission for at least 2 years; non-melanoma skin cancer, intraepithelial carcinoma of the cervix, or prostate cancer with a current prostate specific antigen (PSA) =< 0.1 ng/mL is allowedXx_NEWLINE_xXPrior malignancy except for prior BRCA-associated cancer as long as there is no current evidence of the prior cancer, carcinoma in situ of the cervix or non-melanoma skin cancer, and a cancer diagnosed and definitively treated >5 years prior to study enrollment with no subsequent evidence of recurrenceXx_NEWLINE_xXHistory 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.Xx_NEWLINE_xXHistory of another primary malignancy that has not been in remission for at least 3 years (the following are exempt from the 3-year limit: non-melanoma skin cancer, fully excised melanoma in situ [stage 0], curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Papanicolaou [PAP] smear)Xx_NEWLINE_xXDiagnosis of non-cutaneous melanoma or melanoma with unknown primary originXx_NEWLINE_xXSubjects who have any history of other malignancy (except non-melanoma skin carcinoma and carcinoma-in-situ of the uterine cervix) within 5 years of study entry.Xx_NEWLINE_xXHistory of non-prostate, primary, malignant cancer, except for non-melanoma skin cancer within previous five yearsXx_NEWLINE_xXA prior or concurrent malignancy of any other site or histology unless the patient has been disease-free for >= 5 years except for non-melanoma skin cancer and/or stage T1a prostate cancer or carcinoma in situ of the uterine cervix or a urothelial carcinoma of the upper urinary tract stage pTa, pTis or pT1 that has not been free of disease after treatment for more than a 2 year periodXx_NEWLINE_xXPrior invasive malignancy (except non-melanomatous skin cancer) or hematological (e.g., leukemia, lymphoma, myeloma) malignancy unless disease free for a minimum of 5 years (prior diagnoses of carcinoma in situ are permitted)Xx_NEWLINE_xXParticipant has a concurrent active malignancy other than breast adenocarcinoma, adequately treated non melanomatous skin cancer, or other non-invasive carcinoma or in situ neoplasm. A participant with previous history of malignancy is eligible, provided that she has been disease free for > 3 yearsXx_NEWLINE_xXPrior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; non-invasive conditions such as carcinoma in situ of the breast, localized prostate cancer, carcinoma in situ of the oral cavity, or cervix are all permissible.Xx_NEWLINE_xXOther active malignancy =< 2 years prior to registration which required systemic treatment\r\n* EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervixXx_NEWLINE_xXDiagnosed with or treated for cancer within the previous two years, other than breast cancer or non-melanoma carcinoma of the skinXx_NEWLINE_xXAdditional active malignancy that may confound the assessment of the study endpoints. Patients with a past cancer history with substantial potential for recurrence must be discussed with the Medical Monitor before study entry. Patients with the following concomitant neoplastic diagnoses are eligible: non-melanoma skin cancer, carcinoma in situ (including transitional cell carcinoma, cervical intraepithelial neoplasia, and melanoma in situ), organ-confined prostate cancer with no evidence of progressive disease.Xx_NEWLINE_xXPast or current history of neoplasm other than Non-small Cell Lung Cancer (NSCLC), except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix, or other cancer curatively treated and with no evidence of disease for at least 5 yearsXx_NEWLINE_xXHave active malignancy within 2 years of entry. Active malignancy is defined as those malignancies requiring treatment with anti-cancer therapy or in the event of indolent malignancies, having measurable disease. Exceptions to this exclusion include: myelodysplastic syndrome, treated non-melanoma skin cancer, completely resected Stage 0 or 1 melanoma no less than 1 year from resection, carcinoma in situ or cervical intraepithelial neoplasia, and successfully treated organ-confined prostate cancer with no evidence of progressive disease based on prostate specific antigen (PSA) levels and are not on active therapyXx_NEWLINE_xXHistory of malignancy other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least 3 yearsXx_NEWLINE_xXNo direct evidence of regional or distant metastases after appropriate staging studies; no synchronous primary or prior malignancy in past 2 years except non-melanoma skin cancer or in situ cancerXx_NEWLINE_xXPatients with a history of another malignancy that progressed or required treatment within the past year prior to registration are not eligible for participation; Note: the exceptions to this include non-melanoma skin cancer or excised carcinoma in situ of the cervixXx_NEWLINE_xXHistory of an invasive secondary primary malignancy diagnosed within the previous 3 years, except for appropriately treated stage I endometrial or cervical carcinoma, prostate carcinoma treated surgically or non-melanoma skin cancerXx_NEWLINE_xXConcurrent malignancy or prior malignancy within the previous 3 years (other than completely resected carcinoma in situ, prostate cancer, or localized non-melanoma skin cancer)Xx_NEWLINE_xXHave a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix or breast), unless in complete remission with no therapy for a minimum of 3 years.Xx_NEWLINE_xXOther prior malignancies within 3 years, except non-melanoma skin cancers and synchronous ovarian primariesXx_NEWLINE_xXDiagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease; patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resectionXx_NEWLINE_xXHistory of other invasive malignancy, with the exception of non-melanoma skin cancer and well-excised cervical carcinoma in situ, =< 3 years prior to enrollment unless assessed by the principal investigator as unlikely to compromise subject safety or to interfere with the study's objectivesXx_NEWLINE_xXOther active malignancy =< 1 year prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervixXx_NEWLINE_xXHistory of another primary invasive malignancy that has not been definitively treated or in remission for at least 2 years; patients with non-melanoma skin cancers or with carcinomas in situ are eligible regardless of the time from diagnosis (including concomitant diagnoses)Xx_NEWLINE_xXPrevious malignancy with diagnosis or suspicion of recurrence within the past 2 years, not including non-melanoma skin cancers or in situ malignanciesXx_NEWLINE_xXPrior invasive malignancy (except non-melanoma skin cancer) unless disease- free or not requiring systemic therapy for a minimum of 3 yearsXx_NEWLINE_xXSecond primary malignancy within 3 years (not including in situ carcinoma of the cervix, non-melanoma skin cancer or low-grade [Gleason score =< 6] localized prostate cancer) at the time of consideration for study enrollmentXx_NEWLINE_xXPatients with other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies as noted in the protocol 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.Xx_NEWLINE_xXPatients with prior history of in situ cancer (e.g., breast, melanoma, squamous cells carcinoma of the skin, cervical).Xx_NEWLINE_xXHistory of another malignancy within 5 years prior to randomisation, except for either non- melanomatous carcinoma of the skin or, adequately treated, non-muscle-invasive urothelial carcinoma of the bladder (Tis, Ta and low grade T1 tumours).Xx_NEWLINE_xXHas a history of other invasive malignancies (with the exception of non-melanoma skin cancer and or in situ cancers that have undergone potentially curative therapy) 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 therapyXx_NEWLINE_xXSubjects with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study periodXx_NEWLINE_xXSecond primary malignancy except most situ carcinoma (e.g. adequately treated non-melanomatous carcinoma of the skin) or other malignancy completely resected with no recurrenceXx_NEWLINE_xXDiagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease; patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection; male patients with incidental histological findings of prostate cancer (T1a or T1b using the TNM [tumor nodes, metastasis]) clinical staging system are not excludedXx_NEWLINE_xXThere has been no evidence of recurrence of any prior malignancies for at least FIVE years (except for successfully treated cervical or non-melanoma skin cancer with no evidence of recurrence), andXx_NEWLINE_xXSubungual melanomaXx_NEWLINE_xXPrior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (e.g., carcinoma in situ of the breast, oral cavity, or cervix are all permissible)Xx_NEWLINE_xXPatient has a history of other malignancy treated with curative intent within the previous 5 years with the exception of adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix. Patients with previous invasive cancers are eligible if the treatment was completed more than 5 years prior to initiating current study treatment, and there is no evidence of recurrent disease.Xx_NEWLINE_xXPatients with a history of another active malignancy within the past two years, with the exception of non-melanoma cutaneous malignancy, cervical carcinoma in situ, or ductal carcinoma in situ which has been successfully treated with curative intent therapyXx_NEWLINE_xXOther active malignancy =< 5 years prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: if there is a history of prior malignancy > 5 years prior to registration, the patient must not be receiving other cancer treatmentXx_NEWLINE_xXPatients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapyXx_NEWLINE_xXOther active malignancy =< 3 years prior to registration; EXCEPTIONS: non-melanoma skin cancer, prostatic intraepithelial neoplasia without evidence of prostate cancer, lobular carcinoma in situ in one breast, or carcinoma-in-situ of the cervix that has been treatedXx_NEWLINE_xXOther active malignancy =< 3 years prior to registration; exceptions: non-melanotic skin cancer or carcinoma-in-situ of the cervix, uterus or breast; note: if there is a history of prior malignancy, they must not be receiving other specific treatment for their cancerXx_NEWLINE_xXHistory of another malignancy except for those who have been disease-free for 24 months; patients with a history of completely resected non-melanoma skin cancer and/or patients with indolent secondary malignancies not requiring active therapy are eligible; consult the study principal investigator if unsure whether second malignancies meet the requirements specified aboveXx_NEWLINE_xXPresence of other active cancers, or history of treatment for invasive cancer within the past 2 years; patients with stage I cancer who have received definitive local treatment, and are considered unlikely to recur are eligible; all patients with previously treated in situ carcinoma (i.e. noninvasive) are eligible, as are patients with history of non-melanoma skin cancer and patients with localized prostate cancer on watch and waitXx_NEWLINE_xXOther coexisting malignancies or malignancies diagnosed within the previous 3 years no evidence of disease for at least 3 years; exceptions to this include non-melanoma skin cancer, cervical cancer in situ, well differentiated thyroid cancer or prostate cancer; other cancers that per assessment of the PI are not prognosis limiting can be allowed after review by the PIXx_NEWLINE_xXPatients who have a history of another primary malignancy from which the patient has been disease free for < 1 year; with the exceptions of non-melanoma skin cancer and carcinoma in situ of the cervix, uteri, or breastXx_NEWLINE_xXPatients who have a history of another primary malignancy within 3 years, with the except non-melanoma skin cancer, and carcinoma in situ of the cervix, uteri, or breast from which the patient has been disease free for >= 3 yearsXx_NEWLINE_xXOther malignancies within the past 5 years other than non-melanoma superficial skin cancer or carcinoma in situ of the cervixXx_NEWLINE_xXHistory of second malignancy, other than non-melanoma skin cancer or in situ carcinoma of the cervix or the breast, unless the tumor was successfully treated at least 2 years before trial entry and with no evidence of relapse or active cancerXx_NEWLINE_xXOther active malignancy =< 5 years prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: patients must not be receiving other active treatment for another cancerXx_NEWLINE_xXPatients must not have other active invasive malignancies within the past 2 years (with the exception of non-melanoma skin cancers) or life threatening illnessesXx_NEWLINE_xXConcomitant malignancies or previous malignancies within the last 3 years; exception: patients who have been disease-free for 3 years, patients with a history of completely resected non-melanoma skin cancer, and/or patients with indolent secondary malignancies, are eligibleXx_NEWLINE_xXPatients who have a history of another primary malignancy, with the exceptions of: non-melanoma skin cancer, and carcinoma in situ of the cervix, uteri, or breast from which the patient has been disease free for greater than or equal to 3 yearsXx_NEWLINE_xXOther past or current malignancy that could interfere with the interpretation of outcome; subjects who have been free of active malignancy for at least 2 years, or have a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma, or whose malignancy will not interfere with the interpretation of study results, are eligibleXx_NEWLINE_xXPresence of other active cancers, or history of treatment for invasive cancer ?5years. Patients with Stage I cancer who have received definitive local treatment at least 3 years previously, and are considered unlikely to recur are eligible. All patients with previously treated in situ carcinoma (i.e., non-invasive) are eligible, as are patients with history of non-melanoma skin cancer.Xx_NEWLINE_xXWith the exception of non-melanoma skin cancer and other specific malignancies as noted above, subjects with other invasive malignancies who had (or have) any evidence of the other cancer present within the last 3 years or whose previous cancer treatment contraindicates this protocol therapy are excludedXx_NEWLINE_xXOther active malignancy =< 3 years prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: if there is a history or prior malignancy, they must not be receiving other specific treatment for their cancerXx_NEWLINE_xXHave inflammatory breast cancer or a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 yearsXx_NEWLINE_xXHave been diagnosed with another primary malignancy within the past 3 years (except for adequately treated non-melanoma skin cancer, cervical cancer in situ, or prostate cancer, which are allowed within 3 years).Xx_NEWLINE_xXPrior malignancy. Patients with nonmelanoma skin cancer or other cancers with greater than 3 years without evidence of disease recurrence are eligibleXx_NEWLINE_xXPatients currently being actively treated or who have been treated within the past 3 years for an unrelated malignancy (except non-melanoma skin cancer, cervical carcinoma in-situ, and low risk prostate cancer)Xx_NEWLINE_xXNo other active primary malignancy (other than non-melanomatous skin cancer or carcinoma in situ of the cervix) requiring treatment or limiting expected survival to =< 2 years; NOTE: if there is a history of prior malignancy, they must not be receiving other specific treatment (other than hormonal therapy for their cancer)Xx_NEWLINE_xXTreatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cancersXx_NEWLINE_xXConcurrent untreated cancer excluding non-melanoma skin cancerXx_NEWLINE_xXParticipants with another cancer, history of another cancer considered uncured on in complete remission for <5 years, or currently under treatment for another suspected cancer except non-melanoma skin cancer or carcinoma in situ of the cervix that has been treated or excised and is considered resolvedXx_NEWLINE_xXSubjects being actively treated for a secondary malignancy or any malignancy within the last 3 years, with the exception of non-melanomatous skin cancer or localized, definitively treated cervical cancer. Men under observation for local prostate cancer are also eligible if they have had stable disease for at least 1 year.Xx_NEWLINE_xXActive concurrent malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix); if there is a history of prior malignancy, the patient must be disease-free for >= 3-years; patients whose lymphoma has transformed from a less aggressive histology remain eligibleXx_NEWLINE_xXHave a concurrent active non-breast malignancy except for non-melanoma skin cancerXx_NEWLINE_xXMelanomaXx_NEWLINE_xXHistory of another malignancy\r\n* Exception: patients who have been disease-free for 3 years, or patients with a history of completely resected non-melanoma skin cancer and/or patients with indolent secondary malignancies, are eligibleXx_NEWLINE_xXHistory of other malignancy including treated lower grade gliomas; EXCEPTIONS: non-melanotic skin cancer, carcinoma-in-situ of the cervix, or lower grade glioma that has never been treated previously; NOTE: if there is a history or prior malignancy, they must not be receiving other specific treatment for their cancerXx_NEWLINE_xXPrior malignancy, unless they have been disease-free for 3 years, or have a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinomaXx_NEWLINE_xXPatients must be disease-free from prior malignancies for >= 3 years, with the exception of non-melanoma skin cancers and superficial urothelial cancersXx_NEWLINE_xXSubjects with invasive malignancy over the previous 2 years except treated early stage carcinomas of the skin, completely resected intraepithelial carcinoma of the cervix, and completely resected papillary thyroid and follicular thyroid cancersXx_NEWLINE_xXHistory of another primary malignancy that has not been in remission for at least 2 years. (The following are exempt from the 2-year limit: nonmelanoma skin cancer, completely resected stage 1 solid tumor with low risk for recurrence, curatively treated localized prostate cancer, cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear, and in situ breast cancer that has been completely resected.)Xx_NEWLINE_xXPrior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 3 years or if cure rate from treatment at 5 years to be 90% or greaterXx_NEWLINE_xXParticipants has a prior history of malignancy, with the exception of non-melanoma skin cancer; participants with history of skin cancer must have 5 years elapse since that diagnosis, be in remission, and must not have received chemotherapy, immunotherapy, or radiation therapyXx_NEWLINE_xXPrevious malignant disease within the last 5 years with the exception of adequately treated non-melanoma skin cancer, in situ cancer, or other cancerXx_NEWLINE_xXOther malignancy, except non-melanoma skin cancer, with a >= 30% probability of recurrence within 24 monthsXx_NEWLINE_xXOther active malignancy =< 5 years prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: if there is a history or prior malignancy, they must not be receiving other specific treatment for their cancerXx_NEWLINE_xXPatients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years are ineligibleXx_NEWLINE_xXPatients with history of prior malignancies (with exception to non-melanoma skin cancer) are ineligible for this study, unless they are documented to be disease-free for at least 5 yearsXx_NEWLINE_xXIndividuals with a history of different malignancy are ineligible except for the following circumstances; individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and non-melanoma cancer of the skinXx_NEWLINE_xXSubjects with history of another primary cancer, including co-existent second malignancy, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the investigator will not affect patient outcome in the setting of current diagnosis.Xx_NEWLINE_xXPatients with a history of a curatively treated malignancy must be disease-free for at least two years except for carcinoma in situ of cervix, melanoma in-situ (if fully resected), and/or non-melanomatous skin cancerXx_NEWLINE_xXPatients with a history of any other cancer (except for non-melanoma skin cancer or carcinoma in-situ of the cervix), are not eligible for participation unless they are in complete remission and have been off of all therapy for that disease for a minimum of 3 yearsXx_NEWLINE_xXPatients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix, unless in complete remission and off all therapy for the disease for a minimum of 3 years)Xx_NEWLINE_xXPrior malignancy except for non-melanoma skin cancer and carcinoma in situ, unless diagnosed and definitively treated more than 5 years prior to enrollmentXx_NEWLINE_xXNo other active malignancies within the past 36 months (with the exception of non-melanoma skin cancers or carcinoma in situ of the bladder) or life-threatening illnessesXx_NEWLINE_xXPatients with second malignancy within 3 years of enrollment; patients curatively treated non-melanoma skin cancers or carcinoma in situ of the bladder, are not excludedXx_NEWLINE_xXPatients must not have other invasive malignancies within the past 5 years (with the exception of non-melanoma skin cancers, non-invasive bladder cancer or localized prostate cancer for whom systemic therapy is not required)Xx_NEWLINE_xXOther active malignancy < 2 years prior to registration; EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancerXx_NEWLINE_xXSubjects with history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the investigator will not affect patient outcome in the setting of current HCC diagnosisXx_NEWLINE_xXHistory of another primary cancer within the last 3 years with the exception of non-melanoma skin cancer, early state prostate cancer, or curatively-treated cervical cancer in-situ.Xx_NEWLINE_xXHistory of another primary malignancy, with the exception of (i) curatively resected non-melanoma skin cancer, (ii) curatively treated in situ cervical cancer, or (iii) other malignancy curatively treated with no evidence of disease and no anticancer therapy administered for 3 years prior to randomization, with the exception of adjuvant hormonal therapy for breast cancerXx_NEWLINE_xXConcurrent malignancy; exception: Subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible; subjects with second malignancies that are indolent or definitively treated may be enrolledXx_NEWLINE_xXSubjects who have had a prior malignancy other than carcinoma in situ of the cervix or nonmelanoma skin cancer, unless the prior malignancy was diagnosed and definitively treated 1.5 or more years before enrollment in this study, with no subsequent evidence of recurrenceXx_NEWLINE_xXPatients must NOT have previous or concurrent malignancy; exceptions are made for patients who meet any of the following conditions:\r\n* Non-melanoma skin cancer, in situ cervical cancer, or breast cancer in situ OR\r\n* Prior malignancy completely excised or removed and patient has been continuously disease free for > 5 years OR\r\n* Prior malignancy cured by non-surgical modalities and patient has been continuously disease free for > 5 yearsXx_NEWLINE_xXNo active invasive malignancy in the past 2 years other than non-melanoma skin cancer; cancers that are in-situ are not considered invasiveXx_NEWLINE_xXOther active malignancy =< 3 years prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervixXx_NEWLINE_xXHistory of other malignancy within the last 5 years except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other non-breast malignancies with a similar outcome to those mentioned aboveXx_NEWLINE_xXHistory of other malignancy in the past 2 years except carcinoma in situ of the cervix or bladder, non-melanomatous skin cancer or localized/early stage prostate cancerXx_NEWLINE_xXPrior invasive malignancies (except non-melanomatous skin cancers and carcinoma in situ of the cervix or bladder) unless disease free for >= 5 yearsXx_NEWLINE_xXOther active malignancy =< 1 year prior to registration\r\n* EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix\r\n* NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancerXx_NEWLINE_xXHistory of another malignancy; exception: subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligibleXx_NEWLINE_xXWithout history of other cancers (excluding non-melanoma skin cancer)Xx_NEWLINE_xXPrior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1 year (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)Xx_NEWLINE_xXDiagnosed with a malignancy in the past two years. However, subjects with non-melanoma skin cancers, melanoma in situ, localized cancer of the prostate with current PSA of <0.1 ng/mL, treated thyroid cancer or cervical carcinoma in situ or ductal/lobular carcinoma in situ of the breast within the past two years may enroll as long as there is no current evidence of disease.Xx_NEWLINE_xXPatients with a history of a prior malignancy are excluded unless they have been disease free for 3 or more years or unless they have a completely resected non-melanoma skin cancer, and/or subjects with indolent second malignanciesXx_NEWLINE_xXPatients with a history of other malignancy; patients who have been disease-free from other malignancy for 5 years or greater, or patients with a history of resected non-melanoma skin cancer, or patients with a history of treated in situ carcinoma will be allowedXx_NEWLINE_xXPatient must not have a history of other malignancy =< 1 year previous with the exception of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinomaXx_NEWLINE_xXPatients must not have other active malignancies other than non-melanoma skin cancers or carcinoma in situ of the bladder; subjects with a history of other cancers who have been adequately treated and have been recurrence-free for >= 3 years are eligibleXx_NEWLINE_xXHistory of another malignancy within the previous 5 years other than non-melanomatous skin cancerXx_NEWLINE_xXOther cancer except that for which the transplant was done < 2 years before study entry, except non-melanoma skin cancer or carcinoma in situ of the uterine cervix or breastXx_NEWLINE_xXPatient must not have a history of prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; noninvasive cancers (for example, carcinoma in situ of the oral cavity, larynx, breast or cervix are all permissible) are permitted even if diagnosed and treated < 3 years agoXx_NEWLINE_xXHistory of another malignancy or concurrent malignancy including prior malignant melanoma. Exceptions to this include: Patients who have been disease-free for 5 years or patients with a history completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible, for example cervical cancer in situ, atypical melanocytic hyperplasia or melanoma in situ, multiple primary melanomas, or other malignancies for which the patient has been disease free for > 5 years.Xx_NEWLINE_xXOther past or current solid tumor malignancy\r\n* Subjects who have been free of malignancy for at least 5 years, or have a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma are eligibleXx_NEWLINE_xXActive concurrent malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix); if there is a history of prior malignancy the patients must be disease free and off treatment for >= 3 yearsXx_NEWLINE_xXPrior invasive malignancy that is not low-grade glioma, glioblastoma or gliosarcoma (except non-melanomatous skin cancer or carcinoma in situ of the cervix) unless the patient has been disease free and off therapy for that disease for a minimum of 3 yearsXx_NEWLINE_xXHistory of malignancy other than non-melanoma skin cancers within 5 years prior to\r\nstudy enrollmentXx_NEWLINE_xXHistory of a previous invasive malignancy within the last 5 years, except adequately treated non-melanoma skin cancer, papillary carcinoma of the thyroid or carcinoma in situ of the uterine cervixXx_NEWLINE_xXOther prior or concomitant malignancies with the exception of:\r\n* Non-melanoma skin cancer\r\n* In-situ malignancy\r\n* Low-risk prostate cancer after curative therapy\r\n* Other cancer for which the patient has been disease free for >= 3 yearsXx_NEWLINE_xXHistory of another malignancy (except subjects who have been disease free for 3 years or with a history of completely resected non-melanoma skin cancer)Xx_NEWLINE_xXPrior malignancy; Note: subjects who have had another malignancy and have been disease-free for 3 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligibleXx_NEWLINE_xXHistory of another malignancy not in remission for at least 2 yrs (except non-melanoma skin cancer, stage 0 melanoma, localized prostate cancer, cervical cancer in situ)Xx_NEWLINE_xXOther active malignancies with the exception of:\r\n* Non-melanoma skin cancer\r\n* Cervical carcinoma in situ without evidence of disease\r\n* Prostatic intraepithelial neoplasia without evidence of prostate cancerXx_NEWLINE_xXOther known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and proven no evidence of recurrence for 5 years.Xx_NEWLINE_xXHistory of another malignancy; exception: subjects who have been disease-free for 3 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligibleXx_NEWLINE_xXPrior malignancy (except non-melanoma skin cancer) within 18 months of study entry NOTE: Patients must be in complete remission from prior malignancy in order to be eligible to enter the study.Xx_NEWLINE_xXPrior or concurrent second invasive malignancy other than non-melanoma skin cancer, unless disease free for a minimum of five yearsXx_NEWLINE_xXOther past or current malignancy; subjects who have been free of malignancy for at least 3 years, or have a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma are eligibleXx_NEWLINE_xXPatients with other untreated, current primary malignancies, other than carcinoma in situ of the cervix or non-melanoma skin cancerXx_NEWLINE_xXOther active malignancy =< 3 years prior to randomization; EXCEPTIONS: non melanotic skin cancer or carcinoma-in-situ of the cervix; Note: if there is a history of prior malignancy, they must not be receiving other specific treatment (i.e. hormonal therapy) for their cancerXx_NEWLINE_xXDiagnosis of another malignancy, unless the patient was diagnosed at least 3 years earlier and has been disease-free for at least 6 months following the completion of curative intent therapy, specifics as follows:\r\n* Curatively resected non-melanomatous skin cancer \r\n* Curatively treated cervical carcinoma in situ\r\n* Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (PSA) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed.\r\n* Other primary solid tumor curatively treated with no known active disease present and no treatment administered for the last 3 yearsXx_NEWLINE_xXWith the exception of non-melanoma skin cancer and other specific malignancies noted above, patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last five years or whose previous cancer treatment contraindicates this therapy are excludedXx_NEWLINE_xXHistory of prior or synchronous malignancy except:\r\n* A malignancy that was treated with curative intent and for which there has been no known active disease for > 3 years prior to randomization\r\n* Curatively treated non-melanoma skin malignancy, cervical cancer in situ, or prostatic intraepithelial neoplasia without evidence of prostate cancerXx_NEWLINE_xXPatients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer within the last five yearsXx_NEWLINE_xXWith the exception of non-melanoma skin cancer and other specific malignancies as noted above, patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last five years or whose previous cancer treatment contraindicates this protocol therapy are excludedXx_NEWLINE_xXNo invasive malignancy within the past 5 years except resected non-melanomatous skin cancer, papillary thyroid cancer, or precancerous cervical dysplasia.Xx_NEWLINE_xXPatients with an active second malignancy (other than non-melanoma skin cancer or cervical cancer in situ) are NOT eligible for participationXx_NEWLINE_xXHistory of another active malignancy; Note: subjects who have had another malignancy and have been disease-free for 5 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligibleXx_NEWLINE_xXPrevious or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured in the opinion of investigator.Xx_NEWLINE_xXConcurrent malignancy (other than non-melanoma skin cancer) diagnosed within the past 3 years or any currently active malignancyXx_NEWLINE_xXOther malignant diseases except non- melanoma skin cancer, in situ carcinoma of the cervix, incidental prostate cancer (T1a, Gleason less than or equal to 6, prostate specific antigen (PSA) less than 0.5 ng/ml) or any other tumour having received adequate treatment and evidencing a disease-free period greater than or equal to 5 yearsXx_NEWLINE_xXOther malignancy, unless the patient has been disease-free for at least 3 years following the completion of curative intent therapy, with the following exceptions: treated non-melanoma skin cancer, any in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed; organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (PSA) values are also eligible for this study if hormonal therapy has been initiated, or radical prostatectomy or definitive prostate irradiation has been performedXx_NEWLINE_xXSubjects with previous malignancies (except non-melanoma skin cancers, in situ bladder cancer, gastric, or colon cancers or cervical cancers/dysplasia, or breast carcinoma in situ) are excluded unless a complete remission was achieved at least 2 years prior to study entry and no additional therapy is required or anticipated to be required during the study periodXx_NEWLINE_xXHistory of another invasive malignancy within 5 years except for curatively resected nonmelanoma skin cancer or carcinoma in situ of the cervixXx_NEWLINE_xXPrior malignancy; Note: subjects who have had another non VHL related malignancy and have been disease-free for 2 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligibleXx_NEWLINE_xXPatients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years, are ineligibleXx_NEWLINE_xXPatients who have a history of another primary malignancy and are off treatment =< 3 years, with the exception of non-melanoma skin cancer and carcinoma in situ of the uterine cervixXx_NEWLINE_xXDONOR: Prior malignancy within the preceding five years, with the exception of non-melanoma skin cancersXx_NEWLINE_xXPrior malignancy, except for non-melanoma skin cancer, in situ carcinoma of any site, or other cancers for which the patient has been adequately treated and disease free for 2 yearsXx_NEWLINE_xXWomen who have completed treatment for other malignancies (except non-melanomatous skin cancer) < 5 years from their new diagnosis of cervical cancerXx_NEWLINE_xXPrior malignancy; exception: subjects who have had another malignancy and have been disease-free for three years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligibleXx_NEWLINE_xXPatient with a history of other malignancies during the past three years; (the following are exempt from the 3-year limit: non-melanoma skin cancer, melanoma in situ, curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Papanicolaou [PAP] smear)Xx_NEWLINE_xXPrior malignancy (except non-melanoma skin cancer) within 3 years.Xx_NEWLINE_xXHistory of another malignancy < 3 years prior to starting study treatment or any malignancy with confirmed activating RAS-mutation; Exceptions: Subjects with any of the following malignancies within 3 years (does not include malignancies with confirmed activating RAS-mutation) are eligible: (a) a history of completely resected skin cancer, (b) successfully treated in situ carcinoma, (c) chronic lymphocytic lymphoma (CLL) in stable remission, or (d) indolent prostate cancer (definition: clinical stage T1 or T2a, Gleason score <= 6, and prostate specific antigen [PSA] < 10 ng/mL) requiring no or only anti-hormonal therapy with histologically confirmed tumour lesions that can be clearly differentiated from lung cancer target and non-target lesions are eligibleXx_NEWLINE_xXPrior malignancy; exceptions: Subjects who have had another malignancy and have been disease free for 3 years or subjects with a history of completely resected non melanomatous skin carcinoma or successfully treated in situ carcinoma are eligibleXx_NEWLINE_xXPatients with a history of other invasive malignancies, with the exception of non-melanoma 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 therapyXx_NEWLINE_xXA second active malignancy except adequately treated non-melanoma skin cancer or other non-invasive or in situ neoplasmXx_NEWLINE_xXHave a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix) unless in complete remission and off all therapy for that disease for a minimum of 3 years. At the discretion of the investigator, hormone-refractory prostate cancer participants who are stable on GnRH agonist therapy and breast cancer participants who are stable on antiestrogen therapy may have that treatment continuedXx_NEWLINE_xXPatients with a history of other primary cancers are eligible if the pathology report confirming the diagnosis of primary breast cancer is available and the other primary cancer was curatively treated with a 5-year disease-free interval\r\n* Patients with non-melanoma skin cancer are eligible; however, patients with squamous cell carcinoma of other sites (except in-situ cervix) are not eligibleXx_NEWLINE_xXPatients who have had a history of non-cutaneous malignancy (other than non-melanoma skin cancer) in the previous 5 years are not eligibleXx_NEWLINE_xXPatients with active non-hematological malignancies (except non-melanoma skin cancers) or those with non-hematological malignancies (except non-melanoma skin cancers) who have been rendered with no evidence of disease, but have a greater than 20% chance of having disease recurrence within 5 years; this exclusion does not apply to patients with non-hematologic malignancies that do not require therapyXx_NEWLINE_xXTreatment for other carcinomas within the last two years, except cured non-melanoma skin, low-risk prostate cancer, non-invasive bladder cancer, or treated in-situ cervical cancerXx_NEWLINE_xXPatients with prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (e.g., carcinoma in situ of the breast, oral cavity, or cervix are all permissible)Xx_NEWLINE_xXPatients with a history of any other cancer (except non-melanoma skin cancer, carcinoma in-situ of the cervix, or low-risk prostate cancer after curative therapy), unless in complete remission and off of all therapy for that disease for a minimum of 3 years are ineligibleXx_NEWLINE_xXThe patient has history of another primary malignancy, with the exception of\r\n* Curatively treated non-melanomatous skin cancer;\r\n* Curatively treated cervical carcinoma in situ; \r\n* Non-metastatic prostate cancer\r\n* Other primary non-hematologic malignancies or solid tumor treated with curative intent, no known active disease, and no treatment administered during the last 3 years prior to registrationXx_NEWLINE_xXParticipants with a history of previous breast cancer are excluded, with the exception of lobular carcinoma in situ (LCIS) or ductal carcinoma in situ (DCIS) treated by locoregional therapy alone ?5 years ago. Participants with a history of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission with no therapy for a minimum of 5 years are excluded.Xx_NEWLINE_xXPatients with non-melanomatous skin cancer, in situ carcinoma, or low-risk prostate cancer can be enrolled.Xx_NEWLINE_xXPatients with another primary malignancy that has not been in remission for at least 3 years, unless approved by the Idera Medical Monitor. The following are exempt from the 3-year limit: non-melanoma skin cancer, curatively treated localized prostate cancer with non-detectable prostate-specific antigen, cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Papanicolaou (Pap) smear, and thyroid cancer (except anaplastic).Xx_NEWLINE_xXSecond primary malignancy that has not been in remission for greater than 3 years. Exceptions that do not require a 3 year remission include: related non-melanoma skin cancer or resected melanoma in situ.Xx_NEWLINE_xXHistory of any prior cancer curatively treated within the last two years except:\r\n* Any non-melanoma skin cancer\r\n* Any cancer excised, not treated with chemotherapy and with less than a 30% chance of recurrence within the next 2 years from registrationXx_NEWLINE_xXConcurrent malignancy except for treated non-melanoma skin cancer, cervical carcinoma in situ and low-risk prostate cancer antigen (CA) being monitored without treatmentXx_NEWLINE_xXOther past or current malignancy. Subjects free of malignancy for at least 5 years or have history of definitively treated non-melanoma skin cancer, or successfully treated in situ carcinoma, are eligibleXx_NEWLINE_xXHistory of other malignancies (except for cured non-melanomatous skin cancer or cured cervical carcinoma in situ, or malignancies with no evidence of disease and no treatment for > 5 years)Xx_NEWLINE_xXNo other diagnosed malignancy (except non-melanoma skin cancer or cervical carcinoma in situ, which are allowable), unless the patient has been disease-free for at least 5 yearsXx_NEWLINE_xXA diagnosis of another active malignancy with the exception of non-melanoma skin cancer or cervical cancer in situXx_NEWLINE_xXConcurrent active malignancy other than non-melanoma skin cancers or carcinoma-in-situ of the cervix, or presence of myelodysplastic or myeloproliferative disease; patients with prior malignancies with a disease-free interval of >= 5 years are eligible; patients who have had prior malignancies within the past 5 years but are considered to be “cured” with a low likelihood of recurrence may be eligible at the discretion of the principal investigatorXx_NEWLINE_xXPatients with active non-hematologic malignancies (except non-melanoma skin cancers) or those with non-hematologic malignancies (except non-melanoma skin cancers) who have been rendered with no evidence of disease, but have a greater than 20% chance of having disease recurrence within five years; this exclusion does not apply to patients with non-hematologic malignancies that do not require therapyXx_NEWLINE_xXNo prior or concurrent malignancies at other sites except for surgically cured carcinoma in situ of the cervix or nonmelanoma skin cancerXx_NEWLINE_xXPatients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix or bladder), unless in complete remission and off of all therapy for that disease for a minimum of 3 years.Xx_NEWLINE_xXOther invasive malignancy; patients treated for solid tumors that have had no evidence of disease for 5 years or more will be eligible; patients with carcinoma in situ of the cervix and nonmelanoma skin cancer will be eligible regardless of when these disorders were diagnosedXx_NEWLINE_xXHistory of an active malignancy or prior malignancy except for the following: patients greater than 5 years out from their diagnosis and or treatment, patients with local malignancies who have undergone localized therapy felt to be curative (e.g., colposcopy resection of in situ cervical carcinoma, surgically resected non-melanoma skin cancer, local irradiation, surgery, or ablative radioactive iodine treatment for local thyroid cancer); patients who have undergone such interventions should be greater than one year from therapy without evidence of recurrenceXx_NEWLINE_xXPatients with active non-hematologic malignancies (except non-melanoma skin cancers); this exclusion does not apply to patients with non-hematologic malignancies that do not require therapyXx_NEWLINE_xXPatients with a history of non-hematologic malignancies (except non-melanoma skin cancers) currently in a complete remission, who are less than 5 years from the time of complete remission, and have a > 20% risk of disease recurrence; this exclusion does not apply to patients with non-hematologic malignancies that do not require therapyXx_NEWLINE_xXPatients with active non-hematologic malignancies (except non-melanoma skin cancers); this exclusion does not apply to patients with non-hematologic malignancies that do not require therapyXx_NEWLINE_xXPatients with a history of non-hematologic malignancies (except non-melanoma skin cancers) currently in a complete remission, who are less than 5 years from the time of complete remission, and have a > 20% risk of disease recurrence; this exclusion does not apply to patients with non-hematologic malignancies that do not require therapyXx_NEWLINE_xXSubject has another past or active malignancy which requires treatment. Prior carcinoma in situ or non-melanoma skin cancer after curative resection are permitted.Xx_NEWLINE_xXHistory of another malignancy; exception: patients who have been disease-free for 3 years, or patients with a history of completely resected non-melanoma skin cancer and/or patients with indolent secondary malignancies, are eligible; consult the Cancer Therapy Evaluation Program (CTEP) Medical Monitor if unsure whether second malignancies meet the requirements specified aboveXx_NEWLINE_xXParticipant has a history of malignancy (other than NHL) within 3 years before the screening period (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, non-muscle invasive bladder cancer (papillary neoplasms of low malignant potential and primary non-invasive tumors), or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 2 years)Xx_NEWLINE_xXHistory of another primary cancer, except:\r\n* Curatively treated cervical carcinoma in situ, or\r\n* Curatively resected non-melanomatous skin cancer, or\r\n* Other primary solid tumor curatively treated with no known active disease present and no treatment administered for >= 3 years prior to enrollmentXx_NEWLINE_xXThe donor has a history of malignancy, including hematologic malignancy, except for appropriately treated non-melanoma skin carcinoma in the last 5 years.Xx_NEWLINE_xXPrior invasive solid tumor or hematological malignancy (except non-melanomatous skin cancer and incidentally discovered prostate cancer at time of cystoprostatectomy) unless disease free for a minimum of 3 yearsXx_NEWLINE_xXThe subject has had another active malignancy within the past three years except for cervical cancer in situ, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin; questions regarding the inclusion of individual subjects should be directed to the principal investigatorXx_NEWLINE_xXCurrently active malignancy (other than MF). Prior malignancies are allowed so long as there is no evidence of disease recurrence within the last 2 years (with the exception of fully excised, non-complicated basal cell carcinoma which can have been active within the prior 2 years, and certain localized, non-invasive fully excised skin, cervical, breast, prostate or bladder tumors).Xx_NEWLINE_xXConcurrent malignancy, unless 1) the subject has been curatively treated and disease free for >= 2 years, or 2) the cancer was non-melanoma skin cancer or early cervical cancerXx_NEWLINE_xXSubject has another past or active malignancy that requires treatment. Prior carcinoma in situ and/or nonmelanoma skin cancer after curative resection are permitted.Xx_NEWLINE_xXSubjects with previous or active malignancies (except non-melanoma skin cancers, and in situ cancers such as the following: bladder, gastric, colon, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to enrollment and no additional therapy is required or anticipated to be required during the study periodXx_NEWLINE_xXPatients with a prior or concurrent malignancy (other than non-melanoma skin cancer or carcinoma in-situ of the cervix) are ineligible unless the previous cancer was treated 5 years or more prior to the current tumor and the patient has remained continually disease freeXx_NEWLINE_xXPrior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 yearsXx_NEWLINE_xXOther active malignancies except cervical carcinomas in situ or clinically insignificant non-melanoma skin cancersXx_NEWLINE_xXOther past or current malignancy; subjects who have been free of malignancy for at least 3 years, or have a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma (any site) are eligible; women with a history of cervical cancers are allowedXx_NEWLINE_xXHistory of other malignancy which could affect compliance with the protocol or interpretation of results. Patients with a history of curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix or breast are allowed. Patients with a malignancy that has been treated with curative intent will also be allowed if the malignancy has been in complete remission without treatment for at least 1 year prior to Cycle 1 Day 1 of study treatment. A recent history of myelodysplastic syndrome in patients with secondary leukemia is allowedXx_NEWLINE_xXPresence of any other malignancy or history of prior malignancy within 5 years of study entry; within 5 years, patients treated for stage I or II cancers are eligible provided they have a life expectancy > 5 years in relation to this prior malignancy; the 5-year exclusion rule does not apply to-non melanoma skin tumors and in situ cervical cancerXx_NEWLINE_xXAdequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.Xx_NEWLINE_xXHistory of another primary cancer within the last 3 years that required treatment, with the exception of non-melanoma skin cancer, early stage prostate cancer, or curatively treated cervical carcinoma in situ.Xx_NEWLINE_xXPatient is free of any prior invasive malignancy (except non-melanomatous skin cancer) for a minimum of the past 3 yearsXx_NEWLINE_xXPatients who have a history of another primary malignancy, with the exceptions of: non-melanoma skin cancer, and carcinoma in situ of the cervix, uteri, or breast from which the patient has been disease free for >= 3 yearsXx_NEWLINE_xXAny other active malignancy. Any other previous malignancy is allowed providing that the tumor was curatively resected and there is no evidence of recurrence within 12 months prior to enrolment to the study. In addition, adequately treated in-situ carcinoma of the cervix, uteri, or non-melanonatous skin cancer are allowed provided that all treatment was completed 6 months prior to enrollment.Xx_NEWLINE_xXHistory of another malignancy except for those who have been disease-free for 3 years, or patients with a history of completely resected non-melanoma skin cancer and/or patients with indolent secondary malignancies not requiring active therapy, are eligible; consult the study principal investigator if unsure whether second malignancies meet the requirements specified aboveXx_NEWLINE_xXHistory of or current neoplasm other than gastric adenocarcinoma, except for curatively treated nonmelanoma skin cancer or in situ carcinoma of the cervix uteri.Xx_NEWLINE_xXHistory of or current neoplasm other than gastric adenocarcinoma, except for curatively treated nonmelanoma skin cancer or in situ carcinoma of the cervix uteri.Xx_NEWLINE_xXPrior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; (note: carcinoma in situ of the breast, oral cavity, or cervix is all permissible)Xx_NEWLINE_xXOther active malignancy =< 3 years prior to registration; EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancerXx_NEWLINE_xX14. History of another invasive malignancy in the last 5 years. Adequately treated noninvasive,non-melanoma skin cancers as well as in situ carcinoma of the cervix within the last 5 years will be allowed.Xx_NEWLINE_xXCuratively resected non-melanomatous skin cancer;Xx_NEWLINE_xXPresence of another primary malignancy within the past 2 years (except for non-melanoma skin cancer or cervical cancer in situ; prior prostate cancer is also permitted if prostate specific antigen [PSA] is now undetectable)Xx_NEWLINE_xXPatients with other active invasive malignancies are excluded; patients with prior malignancies are excluded (except non-melanoma skin cancer or prior in situ carcinoma of the cervix; patients with other invasive malignancies who had [or have] cancer present within the last five years); patients are excluded if they have received prior pelvic radiotherapy for any reason that would contribute radiation dose that would exceed tolerance of normal tissuesXx_NEWLINE_xXPrior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 730 days (2 years) (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)Xx_NEWLINE_xXOther malignancy within 3 years prior to entry into the study, except for treated non-melanoma skin cancer and cervical carcinoma in situ.Xx_NEWLINE_xXPrior malignancy. Note: Subjects who have had another malignancy and have been disease-free for 3 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.Xx_NEWLINE_xXnon-melanoma skin cancerXx_NEWLINE_xXConcurrent malignancy except non-melanomatous skin cancer or prior cancer if disease-free for one year or moreXx_NEWLINE_xXHistory of another invasive malignancy in the last two years; adequately treated non-invasive, non-melanoma skin cancers as well as in situ carcinoma of the cervix will be allowedXx_NEWLINE_xXPrior invasive malignancy except non-melanomatous skin cancers unless patient has been disease free for at least 3 yearsXx_NEWLINE_xXDiagnosed or treated for another malignancy within 3 years prior to study enrollment, with the exception of complete resection of non-melanoma skin cancer, or an in situ malignancyXx_NEWLINE_xXMalignancies within the past 5 years other than non-melanoma skin cancer or in situ cervical cancer status post treatmentXx_NEWLINE_xXAny other malignancy that required treatment or has shown evidence of recurrence (except for nonmelanoma skin cancer, or histologically confirmed complete excision of carcinoma in situ) during the 5 years prior to enrollment in this study.Xx_NEWLINE_xXOther invasive malignancy within 2 years except for noninvasive malignancies such as cervical carcinoma in situ, in situ prostate cancer, non-melanomatous carcinoma of the skin, ductal carcinoma in situ of the breast that has been surgically curedXx_NEWLINE_xXPatients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix) are ineligible for Phase II part of the study unless in complete remission and off of all therapy for that disease for a minimum of 3 years. However, during Phase I part of the study, a patient with second malignancy is eligible if that malignancy has not recurred after appropriate therapy.Xx_NEWLINE_xXOther active malignancy except for non melanoma skin cancer or in situ cervical or breast cancer.Xx_NEWLINE_xXPatient has had an active solid tumor malignancy within the last 5 years from screening, except for cervical carcinoma in situ localized prostate cancer or nonmelanoma skin cancer that has been definitively treated.Xx_NEWLINE_xXConcurrent malignancy; exceptions: patients who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible; subjects with concurrent malignancies that are indolent or definitely treated may be enrolledXx_NEWLINE_xXHistory of another invasive malignancy that has not been in remission for at least 1 year. (Exceptions are nonmelanoma skin cancer, curatively treated localized prostate cancer, ductal carcinoma, and cervical carcinoma or a squamous intraepithelial lesion on PAP smear).Xx_NEWLINE_xXPatients with a history of another malignancy except for those who have been disease-free for 2 years; patients with a history of definitively treated non-melanoma skin cancer or squamous cell carcinoma of the cervix are eligible; patients with definitively treated in-situ cancers are eligible, regardless of timeframeXx_NEWLINE_xXHistory of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancerXx_NEWLINE_xXAdequately treated non-melanoma skin cancer or lentigomaligna without evidence of disease.Xx_NEWLINE_xXThe subject has had another active malignancy within the past five years except for cervical cancer in situ, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin; questions regarding the inclusion of individual subjects should be directed to the Principal InvestigatorXx_NEWLINE_xXHistory of other malignancy within the previous 5 years except for appropriately\n             treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine\n             cancer, or other malignancies with an expected curative outcomeXx_NEWLINE_xXSubjects who have had a prior malignancy other than carcinoma in situ of the cervix, or nonmelanoma skin cancerXx_NEWLINE_xXHistory of other malignancy. Subjects who have been disease-free for 5 years or subjects with a history of completely resected non-melanoma skin cancer (basal or squamous) are eligibleXx_NEWLINE_xXPatients with previous nonmelanoma malignancies are excluded unless a complete resection or remission was achieved at least 2 years prior to study entry and no additional therapy is required or anticipated to be required during the study period (exceptions include, but are not limited to, nonmelanoma skin cancers, in situ bladder cancer, in situ gastric cancer or gastrointestinal stromal tumor, in situ colon cancers, in situ cervical cancers/dysplasia, or breast carcinoma in situ).Xx_NEWLINE_xXPatients who have other current malignancies are not eligible; patients with other malignancies are eligible if they have been continuously disease free for > 2 years prior to the time of registration; patients with prior history at any time of any in situ cancer, lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or melanoma in situ are eligible; patients with prior history of basal or squamous skin cancer are eligible; patients who have had multiple primary melanomas are eligibleXx_NEWLINE_xXNo history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix) unless the patient has been in remission and off all other cancer therapy for at least 3 yearsXx_NEWLINE_xXAny history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix) unless the patient has been in remission and off all other cancer therapy for at least 3 yearsXx_NEWLINE_xXAnother invasive malignancy within 2 years prior to enrollment except for localized prostate cancer, cervical carcinoma in situ, non-melanomatous carcinoma of the skin, or ductal carcinoma in situ of the breast that has/have been surgically curedXx_NEWLINE_xXConcomitant malignancies or previous malignancies treated within the past 3 years. Exception: Patients who have been disease-free for 3 years, patients with a history of completely resected non-melanoma skin cancer, and/or patients with indolent secondary malignancies, are eligible.Xx_NEWLINE_xXConcurrent malignancies other than non-melanoma skin cancer that require active ongoing treatmentXx_NEWLINE_xXCuratively resected non-melanomatous skin cancer;Xx_NEWLINE_xXPatients must not have other invasive malignancies within the past 3 years (with the exception of non-melanoma skin cancers, localized prostate cancer, carcinoma in situ of the cervix and non-invasive bladder cancer that has had successful curative treatment)Xx_NEWLINE_xXPrevious or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured.Xx_NEWLINE_xXAny other malignancy active within 5 years except for non-melanoma skin cancer or carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) of the breastXx_NEWLINE_xXSubjects with history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the investigator will not affect patient outcome in the setting of current HCC diagnosis.Xx_NEWLINE_xXHistory of another primary invasive malignancy that has not been definitively treated or in remission for at least 2 years; patients with non-melanoma skin cancers or with carcinomas in situ are eligible regardless of the time from diagnosis (including concomitant diagnoses)Xx_NEWLINE_xXHistory of another malignancy with exceptions below, or any malignancy with confirmed activating RAS mutation. Exception: (a) Subjects who have been successfully treated and are disease-free for 5 years, (b) a history of completely resected non-melanoma skin cancer, (c) successfully treated in situ carcinoma, (d) chronic lymphocytic leukemia in stable remission, or (e) indolent prostate cancer (definition: clinical stage T1 or T2a, Gleason score <=6, and prostate-specific antigen <10 nanogram per milliliter) requiring no or only anti-hormonal therapy, are eligible. Note: Prospective RAS testing is not required. However, if the results of previous RAS testing are known, they must be used in assessing eligibility.Xx_NEWLINE_xXHistory of another malignancy (Part 3 only). Exception: Subjects who have been disease-free for 3 years, or subjects with a history of completely resected, non-melanoma skin cancer, or subjects with indolent second malignancies are eligible. T1a melanoma and melanoma in situ are permitted. Consult GlaxoSmithKline (GSK) Medical Monitor if unsure whether second malignancies meet requirements specified above.Xx_NEWLINE_xXHistory of an invasive second primary malignancy diagnosed within the previous 3 years, except for appropriately treated stage I endometrial or cervical carcinoma or prostate carcinoma treated surgically, and non-melanoma skin cancerXx_NEWLINE_xXCuratively resected non melanoma skin cancer.Xx_NEWLINE_xXHistory of another malignancy except for those who have been disease-free for 3 years, or patients with a history of completely resected non-melanoma skin cancer and/or patients with indolent secondary malignancies not requiring active therapy, are eligible; consult the study MSK Principal Investigator or the Cancer Therapy Evaluation Program (CTEP) Medical Monitor if unsure whether second malignancies meet the requirements specified aboveXx_NEWLINE_xXSubjects with history of another primary cancer, including co-existent second malignancy, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the Investigator will not affect subject outcome in the setting of breast cancer diagnosis.Xx_NEWLINE_xXSecond primary malignancy with the following exceptions which are allowed:\r\n* Carcinoma in situ of the cervix\r\n* Non-melanoma skin cancer\r\n* History of low-grade (Gleason score =< 6) localized prostate cancer even if diagnosed < 5 years prior to registration\r\n* Treated stage I breast cancer even if diagnosed =< 5 years prior to registration\r\n* Other prior malignancy (including melanoma) allowed if it was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrenceXx_NEWLINE_xXNo active concurrent malignancy with the exception of superficial non-melanoma skin cancer and cervical carcinoma in situXx_NEWLINE_xXCurrent active other malignancy, except non-melanoma skin cancer or carcinoma-in-situ of the cervix; if there is a history of prior malignancy, they must not be receiving other specific treatment (other than hormonal therapy) for their cancerXx_NEWLINE_xXActive malignancy other than the cancer under study. Subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.Xx_NEWLINE_xXConcurrent malignancy except for treated non-melanoma skin cancer and cervical carcinoma in situXx_NEWLINE_xXPatients with another malignancy in the past 3 years except: curatively treated non-melanoma skin cancer, or carcinoma in situ (either cervix or breast) that does not require further treatment.Xx_NEWLINE_xXOther active malignancy < 1 year prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: if there is a history of prior malignancy, they must not be receiving other specific treatment for their cancerXx_NEWLINE_xXPresence of other active malignancy with the exception of non-melanoma skin cancer, cervical cancer, treated early-stage prostate cancer provided that prostate-specific antigen is within normal limits, or any completely resected carcinoma in situXx_NEWLINE_xXHistory of another malignancy (Exception: Subjects who have been disease-free for 3 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible)Xx_NEWLINE_xXMalignancy within last 5 years except non-melanoma skin cancer.Xx_NEWLINE_xXTreated, non-melanoma skin cancersXx_NEWLINE_xXOther active malignancy =< 2 years prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma in-situ of the cervix; NOTE: if there is a history of prior malignancy, they must not be receiving other specific treatment for their cancerXx_NEWLINE_xXSubjects with history of another primary cancer, including co-existent second malignancy, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the investigator will not affect patient outcome in the setting of current cancer diagnosis.Xx_NEWLINE_xXHistory of another malignancy within the previous 5 years, except for appropriately treated and presumed cured carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, and localized prostate cancerXx_NEWLINE_xXOther active malignancy =< 3 years prior to registration; exceptions: non-melanotic skin cancer or carcinoma-in-situ of the cervix; note: if there is a history of prior malignancy, they must not be receiving other specific treatment (other than hormonal therapy) for their cancerXx_NEWLINE_xXOther active malignancy =< 3 years prior to registration; EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment (i.e. other investigational therapy, anti-neoplastic therapy, etc.) for their cancerXx_NEWLINE_xXSubjects with a history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present that, in the opinion of the investigator, will not affect patient outcome in the setting of current hepatocellular carcinoma diagnosis.Xx_NEWLINE_xXPrior malignancy other than CRPC. Subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.Xx_NEWLINE_xXNo current malignancy; subjects who have been free of malignancy for at least 2 years, or have a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma (any site) are eligible; women with a history of cervical cancers are allowedXx_NEWLINE_xXHistory of another malignancy including resected non-melanomatous skin cancer.Xx_NEWLINE_xXPrior invasive malignancy that is not low-grade glioma, high-grade glioma, glioblastoma, or gliosarcoma (except non-melanomatous skin cancer or carcinoma in situ of the cervix) unless the patient has been disease free and off therapy for that disease for a minimum of 3 years.Xx_NEWLINE_xXA history of another invasive malignancy (other than non-melanoma skin cancer or curatively treated in situ carcinoma) with evidence of disease within the past 3 yearsXx_NEWLINE_xXHistory of other malignancy within the past 3 years (except non-melanoma skin cancer)Xx_NEWLINE_xXHistory of another malignancy. Exception: (a) Subjects who have been successfully treated and are disease-free for 3 years, (b) a history of completely resected non-melanoma skin cancer, (c) successfully treated in situ carcinoma, (d) CLL in stable remission are eligible.Xx_NEWLINE_xXPrior invasive malignancy that is not the ependymoma (except non-melanomatous skin cancer or carcinoma in situ of the cervix) unless the patient has been disease free and off therapy for that disease for a minimum of 3 yearsXx_NEWLINE_xXHistory of non-breast malignancies except adequately treated non-melanoma skin cancers, in situ cancers treated by local excision or other cancers curatively treated with no evidence of disease for >= 5 yearsXx_NEWLINE_xXMalignancies other than breast cancer within 5 years prior to treatment initiation (except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer)Xx_NEWLINE_xXOther than ovarian cancer, the patient has been diagnosed or treated for invasive cancer less than 5 years prior to study enrollment. Patients with cervical carcinoma in situ, non melanomatous skin cancer, and ductal carcinoma in situ definitively treated are allowed.Xx_NEWLINE_xXHistory of previous malignancy excluding non-melanoma skin lesions and in-situ cervical cancer; patients with other malignancies are eligible if they have been disease free for >= 3 yearsXx_NEWLINE_xXPrior invasive malignancy other than LACC diagnosed within the past 24 months, excluding anal intraepithelial neoplasia, non-melanoma skin carcinoma, or Kaposi’s sarcoma that has not required systemic chemotherapy within the past 24 monthsXx_NEWLINE_xXHistory of other malignancy within the last 5 years, except for carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, or cancers with a similar curative outcome as those mentioned aboveXx_NEWLINE_xXPreviously diagnosed with another malignancy, within the past two years with the exception of non-melanoma skin cancers or non-invasive bladder cancerXx_NEWLINE_xXOther active malignancy =< 3 years prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: if there is a history or prior malignancy, they must not be receiving other specific treatment (other than hormonal therapy) for their cancerXx_NEWLINE_xXHistory of another primary malignancy not in remission for at least 3 years (the following are exempt from the 3-year limit: nonmelanoma skin cancer and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear)Xx_NEWLINE_xXHistory of another malignancy in the previous 3 years, unless cured by surgery alone and continuously disease free for at least 3 years; participants with prior history of non-invasive cancers are eligibleXx_NEWLINE_xXHistory of other invasive malignancy within 5 years except for localized/in situ, carcinomas such as cervical carcinoma in situ.Xx_NEWLINE_xXHave a secondary malignancy within the last 3 years prior to first dose of study drug, excluding treated non-melanoma skin cancer, carcinoma in situ, or locally-treated prostate cancerXx_NEWLINE_xXHistory of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or patients who have undergone potentially curative therapy with no evidence of disease and are deemed by the treating physician to be at low risk for recurrenceXx_NEWLINE_xXConcurrent (within the last 5 years) second malignancy other than non melanoma skin cancer, cervical carcinoma in situ, or controlled bladder cancerXx_NEWLINE_xXActive other malignancy, excepting non-melanotic skin cancer or carcinoma-in situ of the cervix; if there is a history of prior malignancy, they must not be receiving other specific treatment (other than hormonal therapy) for their cancerXx_NEWLINE_xXPrior malignancy (Note: subjects who have had another malignancy and have been disease-free for 3 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible).Xx_NEWLINE_xXAny malignancy that required treatment, or has shown evidence of recurrence (except for soft tissue sarcoma, non-melanoma skin cancer, or histologically confirmed complete excision of carcinoma in situ) during the 5 years prior to randomization.Xx_NEWLINE_xXPatients must not have other invasive malignancies within the past 5 years (with the exception of non-melanoma skin cancers or non-invasive bladder cancer)Xx_NEWLINE_xXAny malignancy within past 5-years, except non-melanoma skin cancer, cervical intraepithelial neoplasia, or in situ cervical cancerXx_NEWLINE_xXAny malignancy within past 5-years, except non-melanoma skin cancer, cervical intraepithelial neoplasia, or in situ cervical cancerXx_NEWLINE_xXCurrent or previous other malignancy within 2 years of study entry. Exception: Subjects who have been disease-free for 2 years or more, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.Xx_NEWLINE_xXPatients who have other current malignancies are not eligible; patients with other malignancies are eligible if they have been continuously disease free for > 5 years prior to the time of randomization; patients with prior history at any time of any in situ cancer, lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia, or melanoma in situ are eligible; patients with a prior history of basal cell or squamous cell skin cancer are eligible; patients who have had multiple primary melanomas are eligibleXx_NEWLINE_xXPrior or 2nd malignancy, except non-melanoma skin cancer, completely resected cervical or prostate cancer (with PSA of less than or equal to 0.1 ng/ml), or other cancer for which the subject has received curative therapy at least 3 yrs prior to study entryXx_NEWLINE_xXPrior or 2nd malignancy, except non-melanoma skin cancer, completely resected cervical or prostate cancer (with PSA of less than or equal to 0.1 ng/ml), or other cancer for which the subject has received curative therapy at least 3 yrs prior to study entryXx_NEWLINE_xXCurrent or previous other malignancy within 2 years prior to randomization. Subjects who have been free of malignancy for at least 2 years, or have a history of completely resected non-melanoma skin cancer or successfully treated carcinoma in situ, are eligible.Xx_NEWLINE_xXHistory of other malignancy. Subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.Xx_NEWLINE_xXPatients with other cancers (other than non-melanoma skin cancer) within the last five yearsXx_NEWLINE_xXHistory of another malignancy; Note: subjects who have had another malignancy and have been disease-free for 3 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligibleXx_NEWLINE_xXNo history of a previous invasive cancer in the last five years with the exception of minimally invasive non-melanoma skin cancer.Xx_NEWLINE_xXHistory of other invasive cancer in the previous 5 years other than minimally invasive non-melanoma skin cancer.Xx_NEWLINE_xXHistory of another primary malignancy that has not been in remission for at least 3 years (the following are exempt from the 3-year limit: non-invasive nonmelanoma skin cancer, fully excised melanoma in situ [stage 0], curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Papanicolaou [PAP] smear)Xx_NEWLINE_xXHave had a diagnosis of another malignancy, unless the participant has been disease-free for at least 3 years following the completion of curative intent therapy with the following exceptions:\r\n* Participants with treated non-melanoma skin cancer, in situ, carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed\r\n* Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (PSA) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performedXx_NEWLINE_xXActive malignancy, other than NHL, within the past 3 years except for localized prostate cancer treated with hormone therapy, cervical carcinoma in situ, breast cancer in situ, or non-melanoma skin cancer following definitive treatmentXx_NEWLINE_xXPatients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years are ineligibleXx_NEWLINE_xXMalignancy other than breast carcinoma (phase II), except for non-melanoma skin cancer or curatively treated carcinoma in situ of the cervix, diagnosed during the past five yearsXx_NEWLINE_xXPrior malignancy (except non-melanoma skin cancer) within 3 yearsXx_NEWLINE_xXHistory of other malignancy within 5 years prior to screening with the exception of malignancies with a negligible risk of metastasis or death, such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancerXx_NEWLINE_xXPresence of other malignant diseases, except non-melanoma skin careXx_NEWLINE_xXActive malignancy =< 3 years prior to registration; EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix; Note: if there is a history of prior malignancy, they must not be receiving other specific treatment for their cancerXx_NEWLINE_xXConcurrent diagnosis of other active malignancies with the exception of ductal carcinoma in situ, cervical carcinoma in situ, and localized non-melanoma skin cancerXx_NEWLINE_xXActive second malignancy in the last 3 years except for non-melanoma skin cancer or carcinoma-in-situXx_NEWLINE_xXPatients with a history of another active malignancy within the past two years, with the exception of non-melanoma cutaneous malignancy, cervical carcinoma in situ, or ductal carcinoma in situ which has been successfully treated with curative intent therapyXx_NEWLINE_xXOther active malignancy =< 5 years prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix or breast, or prostatic intraepithelial neoplasm; NOTE: if there is a history or prior malignancy, patient must not be receiving other specific treatment (other than hormonal therapy) for their cancerXx_NEWLINE_xXAny other known malignancy within 3 years (with the exception of non-melanoma skin cancer that had undergone curative treatment, cervical cancer in situ, or ductal/lobular carcinoma in situ of the breast that has underwent local treatment); consult the Cancer Therapy Evaluation Program (CTEP) medical monitor if unsure whether second malignancies meet the requirements specified aboveXx_NEWLINE_xXPrior malignancy; note: subjects who have had another malignancy and have been disease-free for 5 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligibleXx_NEWLINE_xXDiagnosis or treatment for any malignancy other than non-Hodgkin lymphoma (NHL) within the 3 years preceding day 1 of the protocol therapy; exceptions are:\r\n* Basal or squamous cell carcinoma of the skin\r\n* In situ malignancy that has been completely resected\r\n* Prostate cancer that was treated with prostatectomy or radiotherapy over 2 years before day 1 of protocol therapy and whose prostate-specific antigen (PSA) is undetectable\r\n* In situ malignancy that was completely resectedXx_NEWLINE_xXHad a malignancy, other than prostate or skin cancer (except malignant melanoma), within 5 years,Xx_NEWLINE_xXPrior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for >= 3 years; for example, carcinoma in situ of the oral cavity and cervix are all permissibleXx_NEWLINE_xXConcurrent active malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix; subjects with previous malignancies are eligible provided that they have been treated with curative intent and remain disease free for 3 years or moreXx_NEWLINE_xXNo concurrently active second invasive malignancies except non-melanoma skin cancerXx_NEWLINE_xXConcomitant invasive malignancy requiring treatment other than non-melanomatous skin cancerXx_NEWLINE_xXPatients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapyXx_NEWLINE_xXPrior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; (for example, carcinoma in situ of the breast, oral cavity or cervix are permissible)Xx_NEWLINE_xXPatient has a concurrent diagnosis of a another cancer (other than non-melanoma skin cancer) and is in active treatment for itXx_NEWLINE_xXPartner is also diagnosed with cancer (other than non-melanoma skin cancer) and is in active treatment for itXx_NEWLINE_xXOther cancers (excluding non-melanoma skin cancer) diagnosed within 5 years prior to index lesion, including concurrent invasive cancer diagnosis and up to the present time of participant’s approach to invitation into the studyXx_NEWLINE_xXPatients with a, “currently active,” second malignancy other than non-melanoma skin cancers or non-invasive bladder cancers or other in-situ or non-invasive malignancies; patients who have completed therapy for a prior malignancy and are free of disease for >= 3 years are eligibleXx_NEWLINE_xXPatients must not have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 yearsXx_NEWLINE_xXHistory of another invasive cancer within 5 years of randomization with the exceptions of (a) non-melanoma skin cancers and (b) American Joint Committee on Cancer (AJCC) stage 0 or 1 cancers that have a remote probability of recurrence, in the opinion of the treating physician, in consultation with the principal investigatorXx_NEWLINE_xXIndividuals with a history of a second malignancy are ineligible except for the following circumstances; individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and non-melanoma cancer of the skin; patients with other cancers diagnosed within the past 5 years and felt to be at low risk of recurrence should be discussed with the study sponsor to determine eligibilityXx_NEWLINE_xXHistory of other malignancy within 5 years, except for treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancerXx_NEWLINE_xXPrior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years. (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).Xx_NEWLINE_xXDevelopment of invasive subsequent malignancy after HCT other than non-melanoma skin cancer, in the past two yearsXx_NEWLINE_xXPartner cannot have cancer diagnosis (other than non-melanoma skin cancer) and be currently receiving treatmentXx_NEWLINE_xXOther concurrent malignancies except skin cancerXx_NEWLINE_xXPersonal diagnosis of any cancer, other than non-melanoma skin cancerXx_NEWLINE_xXOther cancer except that for which the transplant was done < 2 years before study entry, except non-melanoma skin cancer or carcinoma in situ of the uterine cervix or breastXx_NEWLINE_xXAny other cancer present within the last 5 years (other than gynecologic cancer under study and non-melanoma skin cancer)Xx_NEWLINE_xXPatients with another primary cancer diagnosis within 5 years of consent, not including non-melanoma skin cancersXx_NEWLINE_xXAny active malignancy (unrelated, non-hematological malignancy) diagnosed within the past 12 months of starting the study drug (other than curatively treated carcinoma-in-situ of the cervix or non-melanoma skin cancer)Xx_NEWLINE_xXHistory of any other malignancy treated within the past 3 years (other than non-melanoma skin cancer)Xx_NEWLINE_xXHistory of any other malignancy treated within the past 3 years (other than non-melanoma skin cancer)Xx_NEWLINE_xXResearch participants with presence of other active malignancy within 2 years of study entry; participants with history of prior malignancy treated with curative intent who achieved complete remission (CR) more than 2 years before study entry are eligible; this exclusion rule does not apply to non-melanoma skin tumors and in-situ cervical cancerXx_NEWLINE_xXConcomitant malignancy or malignancy within the past five years other than nonmelanomatous skin cancer or carcinoma in situ of the cervixXx_NEWLINE_xXNo prior history of malignancy other than non-melanoma skin cancer (patient)Xx_NEWLINE_xXPrior history of malignancy other than non-melanoma skin cancer (patient)Xx_NEWLINE_xXHave a concurrent active non-breast malignancy except for non-melanoma skin cancerXx_NEWLINE_xXPast history of any cancer other than non-melanoma skin cancerXx_NEWLINE_xXNot have been treated for other cancer (except non-melanoma skin cancer) in the past 5 yearsXx_NEWLINE_xXTreatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancerXx_NEWLINE_xXSubjects with history of another primary cancer, with the exception of: \r\n* Curatively resected non-melanoma skin cancer\r\n* Curatively treated cervical carcinoma in situ\r\n* Other primary solid tumor with no known active disease present in the opinion of the investigator will not affect patient outcome in the setting of current HCCXx_NEWLINE_xXActive malignancy within 2 years of entry, except previously treated non-melanoma skin cancer, carcinoma in situ or cervical intraepithelial neoplasia, and organ confined prostate cancer with no evidence of progressive disease based on PSA levels and are not on active therapy.Xx_NEWLINE_xXParticipants with a history of a different malignancy are ineligible unless they have been disease free for 1 year and considered at low risk for relapse, except for: cervical cancer in situ, ductal carcinoma in situ, localized prostate cancer with no detectable disease by imaging studies, and non-melanoma cancers of the skin, which are eligible at any timeXx_NEWLINE_xXAnother active malignancy =< 3 years prior to registration with the exception of non-melanotic skin cancer or carcinoma-in-situ of any type; NOTE: if there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer; any malignancy considered to be indolent and that has never required therapy may allowed at the discretion of the protocol chairXx_NEWLINE_xXPatient must not have a history of other malignancy that has not been in remission for at least 3 years, with the exception of basal non-melanoma skin cancer which were treated with local resection only or intraepithelial lesions or carcinoma in situ of the cervix or prostate that has been curatively treatedXx_NEWLINE_xXConcurrent other active malignancy (other than non-melanoma skin cancer or in situ cervical cancer)Xx_NEWLINE_xXHistory of, or current active cancer other than NSCLC, with the exception of curatively resected non-melanomatous skin cancer, curatively treated cervical carcinoma in situ, or other primary solid tumors curatively treated with no known active disease present and no curative treatment administered for the last 3 years.Xx_NEWLINE_xXNo active concurrent malignancy is allowed, except inactive non-melanoma skin cancer or in situ carcinoma of the cervix; prior cancer is eligible only if the patient has been disease-free for >= 5 yearsXx_NEWLINE_xXHas a history of other malignant tumors within the last 5 years, except non melanoma skin cancer or in situ cervical carcinoma curatively excisedXx_NEWLINE_xXSecond primary malignancy, except for non-melanoma skin cancer and in situ cervical cancerXx_NEWLINE_xXHistory of malignant tumors other than SCCHN within the last 5 years, except non-melanoma skin cancer or curatively excised in situ cervical carcinomaXx_NEWLINE_xXPatients may not have a history of other invasive malignancies within the last five years, with the exception of non-melanoma skin cancer or stage 1A endometrioid adenocarcinoma of the uterusXx_NEWLINE_xXOther active malignancy =< 5 years prior to pre-registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: if there is a history or prior malignancy, they must not be receiving other specific treatment, i.e., other hormonal therapy, for their cancerXx_NEWLINE_xXParticipants may have a personal history of non-ovarian malignancy, but must: a) be without evidence of disease at enrollment b) remain premenopausal c) have completed treatment (including surgery, chemotherapy, radiotherapy or hormonal therapy) > 3 months prior to enrollment (other than non-melanoma skin cancer)Xx_NEWLINE_xXActive malignancy; exception: non-melanoma skin cancers cancer(s) for which diagnosis and treatment was completed >= 3 years prior to pre-registrationXx_NEWLINE_xXInvasive cancer within the past five years except non-melanoma skin cancerXx_NEWLINE_xXHistory of any malignancy; exceptions: non?melanoma skin cancer or carcinoma in situ (CIS) of the cervixXx_NEWLINE_xXHistory of invasive cancer within the past 2 years, with the exception of excised and cured non-melanoma skin cancer or carcinoma in situ of the cervixXx_NEWLINE_xXWomen with a history of any cancer within the last 3 years, except for non-melanoma skin cancer; history of breast cancer must be at least > 5 years from diagnosisXx_NEWLINE_xXHistory of another primary malignancy that has not been in remission for at least 3 years (the following are exempt from the 3-year limit: non-melanoma skin cancer, fully excised melanoma in situ [stage 0], curatively treated localized prostate cancer, and cervical or breast carcinoma in situ on biopsy or a squamous intraepithelial lesion on Papanicolaou [PAP] smear)Xx_NEWLINE_xXHistory of\r\n* Any invasive malignancy within the past 2 years, with the exception of non-melanoma skin cancer\r\n* Chronic renal diseases or liver cirrhosis\r\n* Diseases such as anemia, peptic ulcer, gastrointestinal bleeding, active colitis and inflammatory bowel disease\r\n* Hemorrhagic stroke or uncontrolled hypertensionXx_NEWLINE_xXPatients with concurrent invasive malignancy other than non-melanoma skin cancer or cervical intraepithelial neoplasia unless the treating physician considers it unlikely to impact the clinical outcome of the patientXx_NEWLINE_xXAny prior diagnosis of gastrointestinal cancer (including esophageal, small intestine, colon, pancreatic), or any diagnosis of other cancers (with the exception of non-melanoma skin) in which there has been any active treatment within the last three yearsXx_NEWLINE_xXParticipants must not have a current or prior invasive malignancy within the past 6 months; participants may enroll prior to biopsy result report, unless there are findings at bronchoscopy suggesting an invasive malignancy; history of the following curatively treated cancers during any time prior to screening is allowed: non-melanoma skin cancer, cervical carcinoma in situ, and bladder carcinoma in situXx_NEWLINE_xXHistory of cancer (except for non-melanoma skin cancer)Xx_NEWLINE_xXPatients with active non-hematological malignancies (except non-melanoma skin cancers) or those with non-hematological malignancies (except non-melanoma skin cancers) who have been rendered with no evidence of disease, but have a greater than 20% chance of having disease recurrence within 5 years; this exclusion does not apply to patients with non-hematologic malignancies that do not require therapyXx_NEWLINE_xXAny personal history of cancer, including ductal carcinoma in situ (DCIS) and not including non-melanoma skin cancersXx_NEWLINE_xXIndividuals with any history of cancer other than non-melanoma skin cancerXx_NEWLINE_xXHave received chemotherapy and/or radiation for any malignancy (excluding non-melanoma skin cancer and cancers confined to organs with removal as only treatment) in the past 2 years; ongoing adjuvant hormonal therapy for breast cancer is allowedXx_NEWLINE_xXEvidence of other cancer(s) (excluding non-melanoma skin cancer) within last 5 yearsXx_NEWLINE_xXOther chronic disease likely to limit lifespan to less than 2-3 years, including any cancer requiring treatment in past 5 years except non-melanoma skin cancerXx_NEWLINE_xXHistory of cancer treatment =< 12 months prior to randomization, excepting hormonal therapy (except treatment for non-melanoma skin cancer or carcinoma-in-situ of the cervix)Xx_NEWLINE_xXNew cancer diagnosis in the last six months (with the exception of non-melanoma skin cancer)Xx_NEWLINE_xXSubjects with current or previous malignancy other than prostate or non-melanoma skin cancer;Xx_NEWLINE_xXSecond primary malignancy that has not been in remission for greater than 3 years, with the exception of non-melanoma skin cancer, cervical carcinoma in situ,or squamous intraepithelial lesion on PAP smear, localized prostate cancer (Gleason score <6), or resected melanoma in situ.Xx_NEWLINE_xXPatients who have a history of another primary malignancy, with the exceptions of: non-melanoma skin cancer, and carcinoma in situ of the cervix, uteri, or breast from which the patient has been disease free for >= 3 yearsXx_NEWLINE_xXOther concurrent clinically active malignant disease, requiring treatment, with the exception of non-melanoma cancers of the skin or carcinoma in-situ of the cervix or non-metastatic prostate cancer.Xx_NEWLINE_xXAny concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder cancer, or carcinoma in situ of the cervix; patients with a previous malignancy without evidence of disease for > 5 years will be allowed to enter the trialXx_NEWLINE_xXHistory of another malignancy\r\n* Exception: patients who have been disease-free for 3 years, or patients with a history of completely resected non-melanoma skin cancer and/or patients with indolent secondary malignancies, are eligible; consult the Cancer Therapy Evaluation Program (CTEP) Medical Monitor if unsure whether second malignancies meet the requirements specified aboveXx_NEWLINE_xXOther active malignancy =< 5 years prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; Note: if there is a history of prior malignancy, they must not be receiving other specific treatment for their cancerXx_NEWLINE_xXSubject has history of a second primary malignancy within the past 2 year except for the following (if appropriately treated and considered cured): stage I endometrial, surgically treated cervical or prostate carcinoma, and non-melanoma skin cancer.Xx_NEWLINE_xXOther cancer that required therapy within the preceding 5 years other than adequately treated: (a) non-melanoma skin cancer or in situ cancer; or (b) following approval by the Medical Monitor, other cancer that has a very low risk of interfering with the safety or efficacy endpoints of the StudyXx_NEWLINE_xXSubjects with prior history of malignancies, other than aggressive R/R NHL, unless the subject has been free of the disease for ? 2 years with the exception of the following non-invasive malignancies:Xx_NEWLINE_xXHave received chemotherapy and/or radiation for any malignancy (excluding non-melanoma skin cancer and cancers confined to organs with removal as only treatment) in the past 5 years (preceding the time of registration)Xx_NEWLINE_xXParticipants may have a personal history of non-ovarian malignancy, but must be without evidence of disease at enrollment and the patient must have completed treatment (including surgery, chemotherapy, or radiotherapy) > 3 months prior to enrollment (other than non-melanoma skin cancer); current or past selective estrogen receptor modulator (SERM) or aromatase inhibitor use is allowedXx_NEWLINE_xXAny type of active invasive cancer (excluding breast and non-melanoma skin cancer) within the preceding 18 monthsXx_NEWLINE_xXWomen who have been treated with chemotherapy for prior malignant disease or currently have an untreated malignancy other than non-melanoma skin cancerXx_NEWLINE_xXDiagnosis of any cancer (except non-melanoma skin cancer)Xx_NEWLINE_xXOther primary or recurrent invasive cancer within the last 10 years (other than nonmelanomic skin cancer or carcinoma of the cervix in situ)Xx_NEWLINE_xXInvasive cancer within the past five years except non-melanoma skin cancerXx_NEWLINE_xXPatients who have a history of another primary malignancy, with the exceptions of: non-melanoma skin cancer, and carcinoma in situ of the cervix, uteri, or breast from which the patient has been disease free for ?3 years;Xx_NEWLINE_xXPatients with a history of any other malignancy within 3 years except non-melanoma skin and cervical carcinoma in situ (CIS)Xx_NEWLINE_xXConcurrent active malignancy other than non-melanomatous skin cancer or carcinoma in-situ of the cervix, unless treatment for the previous cancer was completed > 2 years prior to study entry and patient has remained disease-freeXx_NEWLINE_xXPrior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 yearsXx_NEWLINE_xXWith a history of another cancer, except for non-melanoma skin cancer, as per medical records or patient reportXx_NEWLINE_xXPrior history of any other malignancy within past three years, except melanomatous skin cancer or carcinoma in situ.Xx_NEWLINE_xXHistory of prior malignancy, with the exception of the following:\r\n* Non-melanoma skin cancers, non-invasive bladder cancer, and carcinoma in situ of the cervix \r\n* Prior history of prostate provided patient not under active systemic treatment other than hormonal therapy and with documented undetectable prostate-specific antigen (PSA) (< 0.2 ng/mL)\r\n* Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) provided patient has isolated lymphocytosis (Rai stage 0), and does not require systemic treatment (for “B” symptoms, Richter’s transformation, lymphocyte doubling time [< 6 months], lymphadenopathy or hepatosplenomegaly)\r\n* Lymphoma or any type or hairy-cell leukemia provided patient is not on active systemic treatment and is in complete remission, as evidenced by PET/CT scans and bone marrow biopsies for at least 3 months\r\n* Papillary thyroid cancer; patients with concurrent metastatic melanoma can be enrolled; patients can be enrolled regardless of if they meet any of the following: A) have completed a thyroidectomy within the last 2 years, B) have or have not received adjuvant radioactive iodine therapy, or C) were only recently diagnosed with asymptomatic papillary thyroid cancer and their surgery is pending\r\n* History of malignancy provided patient has completed therapy and is free of disease for >= 2 years; if patient had other malignancy within the last 2 years from which he may have been completely cured by surgery alone, he may considered to be enrolled on condition that the risk of development of distant metastatic disease based on AJCC staging system is less than 30%Xx_NEWLINE_xXHEALTHY VOLUNTEER: A history of neoplastic disease, with the exception of non-melanoma skin cancerXx_NEWLINE_xXPatient with other invasive malignancies, with the exception of non-melanoma skin cancer or cervical carcinoma in-situ, who had (or have) any evidence of the other cancer present within the last 5 yearsXx_NEWLINE_xXPrior history of any other malignancy within last 2 years, other than non-melanoma skin carcinomaXx_NEWLINE_xXFor melanoma patients, if patients have a history of malignancy other than melanoma and other skin cancers in the past five years, their inclusion is up to the discretion of the physicianXx_NEWLINE_xXIf patients have a history of malignancy other than melanoma or malignant brain tumor they must be disease-free (excluding primary cancer for metastatic patients) for >= 5 years at the time of enrollmentXx_NEWLINE_xXHistory of any malignancy (excluding primary cancer for metastatic patients) other than melanoma or malignant brain tumors for which the disease-free interval is < 5 yearsXx_NEWLINE_xXPatients must not have active prior malignancy\r\n* Note: subjects who have had another malignancy and have been disease-free for 3 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligibleXx_NEWLINE_xXConcurrent malignancy other than non-melanoma skin cancerXx_NEWLINE_xXHistory of other malignancy in the past 2 years except non-melanomatous skin cancer, breast ductal carcinoma in situ (DCIS) and low-risk prostate adenocarcinomaXx_NEWLINE_xXHistory of other malignancy in the past 2 years except non-melanomatous skin cancer, breast ductal carcinoma in situ (DCIS) and low-risk prostate adenocarcinomaXx_NEWLINE_xXOther malignancy, except non-melanoma skin cancer, with a >= 30% probability of recurrence within 12 monthsXx_NEWLINE_xXAny malignancy other than non-melanoma cell skin cancer, unless no evidence of disease for a minimum of 5 yearsXx_NEWLINE_xXPatient cannot have received treatment for any malignancy, with the exception of non-melanoma skin cancer, in the past 5 yearsXx_NEWLINE_xXWith the exception of non-melanoma skin cancer and other specific malignancies as noted above, subjects with other invasive malignancies who had (or have) any evidence of the other cancer present within the last 3 years are excludedXx_NEWLINE_xXPatients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 yearsXx_NEWLINE_xXPrior invasive malignancy (except non-melanomatous skin cancer or disease free for at least 3 years)Xx_NEWLINE_xXAdequately treated non-melanoma skin cancer ORXx_NEWLINE_xXOther prior malignancy, active within 3 years, except for localized prostate cancer, cervical carcinoma in situ, non-melanomatous carcinoma of the skin, stage 1 differentiated thyroid cancer or ductal carcinoma in situ of the breast.Xx_NEWLINE_xXHistory of another primary malignancy that has not been in remission for at least 3 years; (Note: The following are exempt for the 3-year limit: nonmelanoma skin cancer, fully excised melanoma in situ [stage 0], curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on papanicolaou [PAP] smear)Xx_NEWLINE_xXHistory of a non-invasive malignancy, such as cervical cancer in situ, non-melanomatous carcinoma of the skin, in situ melanoma, or ductal carcinoma in situ of the breast, is allowed.Xx_NEWLINE_xXMalignancy other than non-melanoma skin cancer, carcinoma in situ, or low grade prostate cancer for which watch-and-wait approach is standard of care, unless disease free for at least 3 yearsXx_NEWLINE_xXPrior malignancy that required treatment, or has shown evidence of recurrence (except for non-melanoma skin cancer or adequately treated cervical carcinoma in situ) during the 5 years prior to randomization.Xx_NEWLINE_xXAny other malignancy known to be active or treated within 3 years of start of screening, except cervical intra-epithelial neoplasia and non-melanoma skin cancerXx_NEWLINE_xXPatients must not have any history of other cancer within 5 years from registration with the exception of in situ carcinoma of the cervix, in situ carcinoma of the breast or completely resected non-melanoma skin cancerXx_NEWLINE_xXAn active malignancy and/or cancer history for at least 2 years with the exception of non-melanoma skin cancer, carcinoma in situ, cervical intraepithelial neoplasia, organ-confined prostate cancer with no evidence of progressive disease.Xx_NEWLINE_xXPresence of other active cancers; patients with stage I cancer who have received definitive local treatment within the last 3 years, and whom are considered unlikely to recur, are eligible; all patients with previously treated in-situ carcinoma (i.e., non-invasive) are eligible, as are patients with prior non-melanoma skin cancersXx_NEWLINE_xXOther malignancy, except non-melanoma skin cancer, with a >= 30% probability of recurrence within 24 monthsXx_NEWLINE_xXPatients must not have other concurrent malignancies (within the past 2 years with the exception of non-melanoma skin cancer and Rai stage 0 chronic lymphocytic leukemia), in situ carcinoma of any site, or life threatening illnesses, including untreated infection (must be at least 1 week off intravenous antibiotic therapy before beginning zolpidem)Xx_NEWLINE_xXHistory of another malignancy within the previous 5 years other than curatively treated non-melanoma skin cancerXx_NEWLINE_xXNo prior treatment within 5 years for another cancer, including chemotherapy, surgery (except for diagnostic biopsy), radiation therapy, hormonal therapy or investigational agents, unless curative treatment of non-melanoma skin cancer or in situ cancerXx_NEWLINE_xXAny previous diagnosis of cancer except for non-melanoma skin cancerXx_NEWLINE_xXDiagnosis of any other invasive cancer (other than non-melanoma skin cancer or carcinoma in situ of the cervix) that requires ongoing treatment or for which there is evidence of active diseaseXx_NEWLINE_xXPatients who have had a history of non-cutaneous malignancy in the previous 5 years are not eligible; exception: patients with history of non-melanoma skin cancer are eligibleXx_NEWLINE_xXHistory of any cancer, other than non-melanoma skin cancer (Arm 4)Xx_NEWLINE_xXExclude any patient who has received treatment for cancer (excluding non-melanoma skin cancers) in the last 6 monthsXx_NEWLINE_xXAny malignancy other than non-melanoma cell skin cancer, unless no evidence of disease for a minimum of 5 yearsXx_NEWLINE_xXPatients must not have other concurrent malignancies (within the past 2 years with the exception of non-melanoma skin cancer and Rai stage 0 chronic lymphocytic leukemia), in situ carcinoma of any site, or life- threatening illnesses, including untreated infection (must be at least 1 week off intravenous antibiotic therapy before beginning enzalutamide)Xx_NEWLINE_xXActive secondary malignancy that requires treatment. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection and are considered disease-free at the time of study entry.Xx_NEWLINE_xXHistory of another invasive malignancy that has not been in remission for at least 3 years. Exceptions: nonmelanoma skin cancer, curatively treated localized prostate cancer, and cervical cancer in situ on biopsy or squamous intraepithelial lesion on PAP smear.Xx_NEWLINE_xXPrior invasive malignancy, except non-melanoma skin cancer, carcinoma in-situ of the bladder or head and neck region, unless disease free for a minimum of 2 yearsXx_NEWLINE_xXActive second primary malignancy other than non-melanoma skin cancers, nonmetastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy determined not be exclusionary.Xx_NEWLINE_xXAny prior history of invasive malignancy within the past 5 years except non-melanoma skin cancer, carcinoma in-situ, localized prostate cancer without biochemical recurrence following definitive treatmentXx_NEWLINE_xX