- Active second malignancy within 2 years prior to randomization. Exceptions that do not require a 2-year remission include: nonmelanoma skin cancer; cervical carcinoma in situ on biopsy; squamous intraepithelial lesion on Papanicolaou (PAP) smear; localized prostate cancer (Gleason score less than 6); resected melanoma in situ; or ductal carcinoma in situ