4. EOT – End of treatment visit: Where feasible, on the day of or within 7 days of the decision to discontinue treatment prematurely before completion of one year of treatment. Does not need to be completed if drug is withheld after one year of treatment. 5. 28 days (+/ - 7 days) after last treatment. If subjects are not willing to come to NIH to FU visit, they will be contacted by phone to assess adverse events. 6. Participants who have come off treatment for disease progression will be followed by phone annually for survival. Participants who have not progressed on treatment will continue to be followed and scanned per investigator discretion until progression. Those that completed one year of treatment will be invited for an additional year of treatment at the time of progression. Initial and follow up courses of treatment may extend beyond a year per investigator discretion. 7. As indicated in S ection 12.3, all subjects will be offered the opportunity to complete an NIH advanced directives form. This should be done preferably at baseline but can be done at any time during the study as long as the capacity to do so is retained. The completion of the form is strongly recommended, but is not required.