Phase 2 study of weekly @entity2600 in adults with recurrent XXXX : final report of NABTT 97-11.

@entity1 @entity137 @entity2600 @entity294 @entity11 @entity281 @entity1398 @entity1576
The primary objective of this study was to determine the proportion of @entity1 exhibiting a radiographic response in a cohort of @entity1 with recurrent @entity11 who were treated with @entity2600 . Secondary objectives were to determine progression-free survival, overall survival, and @entity137 . The trial was terminated after the first 18 @entity1 were enrolled in this multicenter, 2-stage, phase 2 study. Twelve @entity1 received concurrent enzyme-inducing antiepileptic drugs, and 6 did not. Each cycle consisted of a 90-min i.v. infusion of @entity2600 every week for 4 consecutive weeks, followed by 2 weeks off. One @entity1 had a complete response, 5 @entity1 had stable disease, 5 @entity1 had radiographic progression, 6 @entity1 were removed from the study because of @entity137 , and 1 @entity1 refused further therapy and was removed from the study. The response rate in this study was 6% (1/18), and 28% (5/18) of these @entity1 progressed while receiving @entity2600 . Dose-limiting @entity137 consisted of @entity294 in 5 @entity1 , @entity1398 in 1 @entity1 , @entity281 in 1 @entity1 , and @entity1576 in 1 @entity1 . @entity2600 had minimal efficacy in this cohort of 18 @entity1 with recurrent @entity11 . @entity137 was significant but similar to that reported in other @entity1 populations.
