History of other malignancy, unless the patient has been disease free for at least years. Adequately treated basal cell carcinoma or squamous cell skin cancer is acceptable regardless of time, as well as localized prostate carcinoma or cervical carcinoma in situ after curative treatment History of other malignancy within years with the exception of prior SCCHN, adequately treated basal cell or squamous cell skin cancer, or carcinoma of the cervix Diagnosis of other malignancy within years prior to enrollment except adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the bladder, breast, or cervix, or low grade (Gleason ?) prostate cancer Other malignancy diagnosed or requiring treatment within the past years with the exception of adequately treated basal cell carcinoma, squamous cell skin cancer, carcinoma in-situ of the cervix or breast or very low and low risk prostate cancer in active surveillance. Diagnosis of any other malignancy within years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix. Previous or current systemic malignancy within the past years other than breast cancer or adequately treated cervical carcinoma in situ or basal/squamous carcinoma of the skin Other active malignancy within years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ Subjects diagnosed with another malignancy within years prior to study start with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma, non-melanomatous skin cancer or carcinoma in situ of the uterine cervix. Patients with an active second malignancy other than adequately treated squamous or basal cell carcinoma of the skin Diagnosis or treatment for another malignancy within years of enrollment, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer Prior invasive malignancy of other histology, with the exception of adequately treated basal or squamous cell carcinoma of the skin, or any other malignancy for which the patient does not currently require treatment, and/or has no evidence of disease for >= years Other malignancy diagnosed or requiring treatment within the past years with the exception of adequately treated basal cell carcinoma, squamous cell skin cancer, carcinoma in-situ of the cervix or breast or very low and low risk prostate cancer in active surveillance History of another active cancer within years prior to study drug dosing, excluding adequately treated basal cell or squamous cell carcinoma of the skin, cervical cancer in situ, or other adequately treated in situ carcinoma Diagnosis of other malignancy within years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or cervix, or low-grade (Gleason ?) prostate cancer Prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin Other malignancy diagnosed or requiring treatment within the past years with the exception of adequately treated basal cell carcinoma, squamous cell skin cancer, carcinoma in-situ of the cervix or breast, or low-risk Gleason grade =< localized prostate cancer not requiring therapy History of another primary malignancy within years prior to starting study treatment, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ Patients must not have had another primary malignancy within years prior to starting study treatment with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma or other non-melanomatous skin cancer, or in-situ carcinoma of the uterine cervix, or any local cancers that are deemed to be cured from investigators point of view Patients with prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin Malignancy within the years prior to entry in study, excluding adequately treated squamous cell skin cancer, basal cell carcinoma, and carcinoma in situ; treatment must have been completed (with the exception of hormonal therapy for breast cancer) with cure/remission status verified for at least years prior to entry in this study Any concurrent or previous malignancy within years prior to enrollment except for basal or squamous skin cancer, or carcinoma in situ of the cervix, or other non-invasive/in-situ neoplasm, all of which must have been adequately and radically treated. A subject with previous history of invasive malignancy (other than adequately and radically treated basal or squamous skin cancer) is eligible provided that she has been disease free for more than years. Patients with prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin History of another primary malignancy within years prior to starting study treatment, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ; patients with an early stage cancer, now off therapy for at least years may be enrolled with permission of the principal investigator (PI) if that disease is unlikely to interfere with the primary endpoints of this study Subject has a concurrent active malignancy under treatment, with the exception of:\r\n* Adequately treated carcinoma in situ of the breast or cervix uteri\r\n* Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin\r\n* Low-grade, early-stage prostate cancer with no requirement for therapy\r\n* Previous malignancy confined Any other malignancy within years prior to registration, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix adequately treated local basal cell or squamous cell carcinoma of the skin; Prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin Patient has a history of other malignancy, unless the patient has been disease free for at least years. Adequately treated basal cell carcinoma or squamous cell skin cancer is acceptable regardless of time, as well as localized prostate carcinoma or cervical carcinoma in situ, after curative treatment. Prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin Any other malignancy within years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or localized papillary carcinoma of the thyroid Patients with another primary malignancy within years prior to starting study treatment with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma or other non-melanomatous skin cancer, or in-situ carcinoma of the uterine cervix History of other malignancy within the last years, except for adequately treated carcinoma in situ of the cervix or basal cell, or squamous cell carcinoma of the skin Prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin Myelodysplasia or any active malignancy other than HL, or < years remission from any other prior malignancy, except adequately treated basal cell or squamous cell carcinoma Previous history of cancer, other than adequately treated basal cell or Stage squamous cell carcinoma of the skin; Diagnosis of any other malignancy within years prior to study enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast, bladder, or cervix, or low-grade prostate cancer or other early-stage low-risk cancers. Diagnosis of another malignancy within years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix. History of a malignancy, excluding adequately treated squamous cell skin cancer, basal cell carcinoma, and carcinoma in situ DONOR: Malignancy within years prior to donation of marrow, excluding adequately treated squamous cell skin cancer and basal cell carcinoma; treatment must have been completed (with the exception of hormonal therapy for breast cancer) with cure/remission status verified for at least years at time of marrow harvest Subjects must be at least years from any prior malignancy and have no evidence of the malignancy at the time of enrollment; subjects with adequately treated squamous cell or basal cell carcinomas of the skin, multiple primary melanomas, or any carcinoma in situ will be allowed Diagnosis of any other malignancy within years prior to registration, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix. Adequately treated basal cell or squamous cell carcinoma (adequate wound healing is required prior to study entry) Diagnosis of any other malignancy within years prior to registration, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix or melanoma in-situ or low grade (Gleason or below) prostate cancer on surveillance with no plans for treatment intervention (eg, surgery, radiation or castration) History of another invasive malignancy (except non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin or cervical carcinoma in situ adequately treated) unless in remission for >= years, or a non - invasive malignancy requiring ongoing therapy Other malignancy within the past years with the exception of adequately treated basal cell carcinoma, squamous cell skin cancer, carcinoma in-situ of the cervix For part patients only: History of other clinically active malignancy within years of enrollment, except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix or breast, or early stage endometrial cancer (stage IA/B, grade or , endometrioid histology) Other malignancy within the last years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer Patients with a prior history of a second malignancy are eligible provided they have been treated with curative intent and have been free of disease greater than three years; there will be no exclusion for patients with a history of basal cell carcinoma, squamous cell skin cancer, or other in situ carcinoma that has been adequately treated History of prior invasive malignant cancer(s) within the last years except adequately treated or controlled basal cell or squamous cell carcinoma of the skin History of other malignancy except for adequately treated non-invasive cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix Malignancies other than the cervical cancer within years prior to cycle , day , with the exception of those with a negligible risk of metastasis or death, such as adequately controlled basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the breast Prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin; (treatment with tamoxifen or aromatase inhibitors or other hormonal therapy that may be indicated in prevention of prior cancer disease recurrence, are not considered current active treatment) Diagnosis of any non-RCC malignancy occurring within years prior to the date of randomization except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix or low grade prostate cancer with no plans for treatment intervention History of another malignancy within years with the exception of basal cell carcinoma or cervical carcinoma in situ or stage or cancer that is considered adequately treated and currently in complete remission for at least l months. Diagnosis of any second malignancy within the last years, except for adequately treated basal cell or squamous cell skin cancer, or for in situ carcinoma of the cervix uteri or breast Patients with prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin History of prior invasive malignant cancer(s) within the last years except adequately treated or controlled basal cell or squamous cell carcinoma of the skin Patients with a prior history of a second malignancy are eligible provided they have been treated with curative intent and have been free of disease greater than three years; there will be no exclusion for patients with a history of basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma that has been adequately treated History of other malignancy (i.e., excluding disease under study) within years of randomization. Exceptions include: adequately-treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or breast, or adequately treated non-metastatic prostate cancer. Diagnosis of any second malignancy within the last years, except for adequately treated basal cell carcinoma, or squamous cell skin carcinoma or in situ cervical carcinoma. Adequately treated basal cell carcinoma, squamous cell carcinoma, or in situ cervical cancer Malignancy within the years prior to treatment, excluding adequately treated squamous cell skin cancer, basal cell carcinoma, and carcinoma in situ; treatment must have been completed (with the exception of hormonal therapy for breast cancer) with cure/remission status verified for at least years at time of treatment Concurrent active malignancy other than adequately treated basal cell or squamous cell carcinoma of the skin or pre-invasive carcinoma of the cervix. Adequately treated basal cell carcinoma, squamous cell carcinoma, or in situ cervical cancer Prior malignancy or secondary malignancy within the prior years (except in situ cervical cancer, squamous cell carcinoma or basal cell carcinoma of the skin). Patients with evidence of other cancer within years, excluding adequately treated basal cell carcinoma or squamous cell carcinoma of the skin Diagnosis of any other malignancy within years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the breast or of the cervix, low grade prostate cancer on surveillance without any plans for treatment intervention, or prostate cancer that has been adequately treated with prostatectomy or radiotherapy and currently with no evidence of disease or symptoms. Other malignancy within the last years, except for adequately treated carcinoma in situ of the cervix, squamous carcinoma of the skin, adequately controlled limited basal cell skin cancer, or synchronous primary endometrial cancer or prior primary endometrial cancer if protocol criteria are met A history of another primary cancer that has been active or treated within the past years prior to start of study treatment, with the exception of adequately treated/resected: basal cell or squamous cell skin carcinoma or actinic keratoses; or carcinoma in situ of the breast or of the cervix; or non-invasive malignant colon polyps Patients with another primary malignancy within years prior to starting study drug, with the exception of adequately treated in-situ carcinoma of the uterine cervix, or skin cancer (such as basal cell carcinoma, squamous cell carcinoma, or non-melanomatous skin cancer) Diagnosis of any second malignancy within the last years, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma of the cervix uteri that has been adequately treated with no evidence of recurrent disease for months Phase II: Diagnosis of any second malignancy within the last years except for adequately treated basal cell carcinoma, or squamous cell skin carcinoma or in-situ cervical carcinoma Another primary malignancy =< years prior to starting study treatment, with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma or other non-melanomatous skin cancer, or in-situ carcinoma of the uterine cervix Has a history of other malignancy within the years prior to screening, except adequately treated basal cell or squamous cell carcinoma of the skin, or carcinoma in-situ; History of invasive malignancy =< years prior to pre-registration; exception: adequately treated carcinoma of the cervix, carcinoma in situ, or basal or squamous cell carcinomas of the skin Prior history of or current malignancy other than adequately treated skin cancer (squamous cell cancer or basal cell carcinoma) History of prior malignancy other than ovarian that has not been in remission for > years, with the exception of basal cell or squamous cell carcinoma or cervical carcinoma in situ on biopsy Any concurrent or previous malignancy within years prior to enrollment except for adequately and radically treated basal or squamous skin cancer, or carcinoma in situ of the cervix, or other non-invasive/in-situ neoplasm. A subject with previous history of invasive malignancy (other than adequately and radically treated basal or squamous skin cancer or carcinomas in situ) is eligible provided that she has been disease free for more than years. Patients diagnosed with another primary malignancy within years prior to study start, with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma, or other non-melanomatous skin cancer, or carcinoma in situ of the uterine cervix