BACKGROUND: A significant percentage of @entity1 with @entity2971 will not respond to standard salvage regimens. Thus there is a need for new active agents. @entity1311 has demonstrated activity against a variety of solid @entity5 in both laboratory and clinical studies. METHODS: Eighteen @entity1 with @entity2971 who failed initial @entity900 -based chemotherapy and a maximum of 2 salvage regimens were enrolled into a Phase II trial of @entity1311 at a dose of 170 mg/m2 by intravenous infusion over 24 hours every 21 days without growth factor support. The median age of the @entity1 was 32.5 years (range, 18-49 years). The testis was the primary site of @entity5 for 13 @entity1 (72%) and the @entity5 was extragonadal in 5 @entity1 (28%). Six @entity1 (33%) were late recurrences. Twelve @entity1 (67%) had > or = 2 metastatic sites. The median number of previous chemotherapy cycles was six (range, four to nine). Three @entity1 (17%) previously had undergone autologous bone marrow transplantation. RESULTS: Two @entity1 (11%) responded to @entity1311 . Major @entity137 were Grade 3-4 @entity1398 (55% of @entity1 ) and Grade 3-4 @entity2359 (2 @entity1 ). @entity221 occurred in 3 @entity1 (17%). CONCLUSIONS: @entity1311 demonstrated minimal activity in heavily pretreated @entity1 with multiple, poor risk clinical features. These results in part may be due to the unfavorable characteristics of the @entity1 in the current study, specifically the high percentage of @entity1 with late recurrences and extragonadal @entity5 , both of which are known to respond poorly to salvage therapy. Other trials with different @entity1 populations and doses of @entity1311 reported response rates ranging from 13.3%-26%. The role of @entity1311 in the treatment of @entity1 with @entity2971 remains to be defined in future studies.

A phase II trial of @entity1311 in XXXX .

@entity1 :: ('9606', 'Species') :: ['patients', 'patient'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicities'] @entity2971 :: ('MESH:D009373', 'Disease') :: ['refractory germ cell tumors'] @entity5 :: ('MESH:D009369', 'Disease') :: ['tumor', 'primary tumors', 'tumors'] @entity900 :: ('MESH:D002945', 'Chemical') :: ['cisplatin'] @entity1311 :: ('MESH:D017239', 'Chemical') :: ['paclitaxel', 'Paclitaxel'] @entity1398 :: ('MESH:D009503', 'Disease') :: ['neutropenia'] @entity221 :: ('MESH:D005334', 'Disease') :: ['Neutropenic fever'] @entity2359 :: ('MESH:D020258', 'Disease') :: ['neurotoxicity']
@entity2971 :: (MESH:D009373,Disease) :: ['refractory germ cell tumors']
