The objective was to study the effects of @entity1 -specific vaccine immunotherapy administered with either @entity379 ( @entity379 ) or @entity2841 ( @entity2841 ) in @entity1 with @entity5 . Short-term cell lines were established from @entity5 tissue resected from @entity1 with @entity5 for use as @entity5 cell vaccines. Successful cultures were expanded to 1 to 2 x 108 cells, irradiated, and cryopreserved in aliquots of 106 cells for intradermal testing of delayed @entity5 hypersensitivity and 107 cells for subcutaneous vaccinations. The study design was that of a randomized phase 2 trial. @entity1 were stratified by @entity5 type and by whether they had measurable disease at the time vaccination was to commence, and then randomized to receive either 100 MIU @entity379 subcutaneously or 500 microg @entity2841 subcutaneously at the time of each @entity5 cell vaccination. Following a baseline test of @entity56 ( @entity56 ) to an intradermal injection of 106 irradiated @entity5 cells, @entity1 received 3 weekly subcutaneous injections of 107 cells, had a repeat @entity56 test at week 4, then received monthly vaccinations for 5 months. A positive @entity56 test was defined as at least 10 mm of induration; survival was determined from the first @entity56 test. There were 98 @entity1 enrolled with a median follow-up of over 4 years. The most prevalent diagnoses were @entity320 (51), @entity1358 (18), and soft-tissue @entity242 (14). There were 49 @entity1 (26 @entity1 , 23 @entity1 , average age 50.4 years) randomized to @entity379 and 49 (28 @entity1 , 21 @entity1 , average age 54.1 years) to @entity2841 . The average numbers of vaccine and adjuvant injections were 6.3 and 5.9, respectively. For the @entity1 who received @entity379 , the objective response rate was 0 of 21; for @entity1 who received @entity2841 the response rate was 1 of 26. Only eight @entity1 (four from each arm) had a positive baseline @entity56 reaction to @entity5 . The @entity5 @entity56 test converted from negative to positive in 13 of 45 of the @entity379 group and 11 of 43 of the @entity2841 group. With 29 @entity1 deceased in the @entity379 arm and 31 in the @entity2841 arm, the 2-year and 5-year survival rates were 45% and 29% for the @entity379 arm and 41% and 23% for the @entity2841 arm ( @entity168 ). Both adjuvants were well tolerated and results were similar in both arms of the study. Both adjuvants were associated with a 25% to 30% rate of @entity56 conversion and a 25% 5-year survival rate. Immune recognition of @entity5 can be induced with this approach.

@entity379 or granulocyte-macrophage colony-stimulating factor administered as adjuvants with a vaccine of irradiated XXXX cells from short-term cell line cultures: a randomized phase 2 trial of the @entity5 biotherapy research group.

@entity1 :: ('9606', 'Species') :: ['men', 'women', 'Patients', 'patients', 'patient'] @entity242 :: ('MESH:D012509', 'Disease') :: ['sarcoma'] @entity5 :: ('MESH:D009369', 'Disease') :: ['tumor', 'autologous tumor', 'cancer', 'metastatic cancer'] @entity168 :: ('MESH:D029461', 'Disease') :: ['NSD'] @entity1358 :: ('MESH:D002292', 'Disease') :: ['renal cell carcinoma'] @entity56 :: ('MESH:D004342', 'Disease') :: ['DTH', 'delayed-type hypersensitivity'] @entity379 :: ('3458', 'Gene') :: ['IFNgamma', 'interferon-gamma'] @entity2841 :: ('1437', 'Gene') :: ['granulocyte-macrophage colony stimulating factor', 'GM-CSF'] @entity320 :: ('MESH:D008545', 'Disease') :: ['melanoma']
@entity5 :: (MESH:D009369,Disease) :: ['autologous tumor']
