""""""""We continue to follow patients previously treated on our high-risk sarcoma study. We are currently pursuing an immunotherapy approach in an attempt to improve the outcome of metastatic and recurrent sarcoma patients. We are utilizing a peptide vaccination approach in an attempt to generate CTL against tumors bearing the t(2;13) or the t(11;22) translocations seen in alveolar rhabdomyosarcoma (ARMS) and Ewing's tumors (EFT) respectively. We have coupled this approach with an attempt to reconstitute T cell function post-chemotherapy based on studies in our Branch documenting severe T cell depletion for up to 1year following standard high dose chemotherapy for these patients. We have recently opened 2 limited-institution pilot studies. Newly diagnosed patients bearing the t(2;13) or t(11;22) translocation are treated with standard chemotherapy followed by autologous T cell reconstitution and peptide vaccination using peptide-pulsed autologous dendritic cells along with IL-2 therapy. To date, three patients have been entered on this study and all are currently still on treatment. A similar approach is being tested in recurrent patients. A total of 16 patients have been entered on the recurrent study. Of these 16 patients, 15 have completed therapy. One patient had a mixed response, while all other patients developed progressive disease. Immunological end-points have been studied in selected patients and 1 patient out of five generated a proliferative response to the immunizing peptide, and this patient remains NED more than 1 year off therapy following radiation treatment for a progressive lesion in the extremity. All patients are now being assessed for immune responses. In osteosarcoma (OS), we have continued a study using a long-acting somatostatin compound (OncoLar.) in an attempt to determine whether interruption of the GH-IGF-I axis will have salutary effects in patients with recurrent OS based on laboratory and pilot clinical studies previously conducted in our Branch. To date, we have entered 6 patients at 60 mg monthly and 6 patients at 90 mg monthly OncoLar.. The mean reduction of IGF-I levels was 52% at 60mg and 32% for patients treated at 90 mg, suggesting that there is no advantage to the higher dose of the somatostatin analog. We have not seen any objective responses in this group of heavily pretreated patients and are currently entering patients at 60mg plus tamoxifen to determine whether this combination may enhance lowering of IGF-I levels. The treatment has been very well tolerated with no dose-limiting toxicities.""""""""
