Known history of another primary malignancy that has not been in remission for ?1 year In patients with a prior history of invasive malignancy, less than five years in complete remission Patients with a history of any other malignancy, except patients with a secondary brain tumor if the patient’s first malignancy has been in remission for at least 5 years from the end of treatment History of another primary malignancy that has not been in remission for at least 2 years. Subjects must be in primary remission Second primary invasive malignancy that has not been in remission for greater than 2 years. Subjects who have an uncontrolled systemic malignancy that is not in remission History of another primary invasive cancer, hematologic malignancy, or myelodysplastic syndrome that has not been in remission for at least 1 year History of another invasive malignancy that has not been in remission for at least 3 years A primary malignancy which has been completely resected and in complete remission for ? 5 years Known history of another primary malignancy that has not been in remission for ?2 years History of a primary invasive malignancy not listed in the inclusion criteria, which has not been in remission for at least 3 years. The following are exempt from the 3 year limit: History of another primary invasive cancer, hematologic malignancy, or myelodysplastic syndrome that has not been in remission for at least 3 years other effectively treated malignancy that has been in remission for more than 5 years and is considered to be cured Patients with another primary malignancy that has not been in remission for at least 3 years. History of another primary invasive malignancy that has not been in remission for at least 3 years Patients who have had a previous malignancy that is not in remission Participants with history of another primary malignancy not in remission for at least 3 years Patients who have had a previous malignancy that is not in remission Second 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. History of another primary malignancy that has not been in remission for at least 3 years Prior malignancy (excluding nonmelanoma carcinomas of the skin) unless in remission for 2 years. History of a concurrent or second malignancy, except for specified exceptions in the protocol or any other cancer that has been in complete remission for ? 5 years the malignancy has been in remission without treatment for ? 5 years prior to enrollment, or History of another primary malignancy that has not been in remission for 3 years Second primary malignancy that has not been in remission for more than 3 years History of another primary malignancy that has not been in remission for at least 3 years Has history of a diagnosed and/or treated hematologic or primary solid tumor malignancy, unless in remission for at least 5 years prior to randomization Subject has other prior malignancy that is not in complete remission. Second primary invasive malignancy that has not been in remission for greater than 2 years.