 - Patients must not currently be receiving any other investigational agents or any other systemic anti-cancer therapy including radiation, excluding RANKL inhibitors and bisphosphonates; in event patient recently received any other systemic anti-cancer therapy, patient must be off therapy at least 7 days prior to registration and any therapy-induced toxicity must have recovered to grade 1, except alopecia and grade 2 neuropathy which are allowed; any planned radiation therapy must be completed before enrollment onto S1609 