Phase II trial of @entity2600 ( @entity2600 ) in relapsed or XXXX .

@entity1 @entity137 @entity2600 @entity66 @entity390 @entity882 @entity5 @entity294 @entity1503 @entity1398 @entity9800 @entity74 @entity14 @entity1893 @entity1210
@entity2600 , a @entity9800 analogue, is a specific DNA topoisomerase I inhibitor, with activity in @entity5 cell lines with MDR expression. @entity2600 has a broad spectrum of activity in solid @entity5 (especially in @entity14 ). Early reports have shown that @entity2600 could be active in @entity1893 ( @entity1893 ) with low-dose schedules. To further evaluate the efficacy and @entity137 of @entity2600 in @entity1 with refractory or relapsed NHLs, we conducted a phase II trial with escalated doses. @entity1 AND THERAPY: From 04/98 to 05/01, 28 @entity1 with @entity1893 were enrolled. @entity1 CHARACTERISTICS: M/F 21/7; median age: 56 years (range 28-72); Ann Arbor stage at the time of the study I/II and III/IV in 6 and 21 @entity1 , respectively. Sixteen @entity1 had @entity66 when they were enrolled in this phase II study and 8 @entity1 were previously treated with high-dose therapy and stem-cell transplantation. @entity2600 was administrated at the doses of 350 mg/m2 every 3 weeks. Six courses were given in @entity1 who achieved CR, PR or stable disease. @entity1 were evaluated every 2 courses. If no grade II or more @entity137 was observed after the first course, escalated dose (500 mg/m2) was then undertaken. RESULTS: 19/28 @entity1 received more than 2 courses of @entity2600 and were evaluated for response. Nine @entity1 received one course of therapy because of either @entity74 (n = 6), @entity137 (n = 2) or refusal (n = 1). Ten @entity1 received escalated dose (500 mg/m2). Complete remission and partial was achieved in 2/19 @entity1 , stable disease in 7/19, and @entity74 in 10/19 @entity1 . Median duration of responses was short (3 months, range 1-8 months). Seventy-five courses were evaluated for @entity137 according to the WHO criteria. @entity294 grade 2 or 3 occurred in 9/75 courses; cholinergic syndrome grade 2 in 3/75 courses; @entity390 grade 3 in 7/75 courses. @entity1503 : @entity1210 grade 3 or 4 in 21/75 courses; @entity882 grade 3 in 8/75 courses; infectious episodes grade 2 or 3 in 7/75 courses. In 2/7 courses with escalated doses, grade I/IV @entity1398 occurred withoutother major @entity137 . CONCLUSION: @entity2600 has low activity in heavily pretreated NHLs. Responses were of short duration.
