The role of hematopoietic growth factors in support of XXXX / @entity3003 / @entity2879 chemotherapy.

@entity1 @entity650 @entity137 @entity1261 @entity882 @entity3003 @entity1149 @entity2879 @entity1398 @entity2772 @entity1260
The @entity1260 / @entity3003 / @entity2879 (ICE) combination represents an active chemotherapy regimen across a wide variety of disease types. The most common limiting @entity137 for all three of these agents individually and in combination is myelosuppression. Thus, this regimen represents an ideal model to evaluate the role of @entity2772 support in amelioration of hematologic @entity137 , maintenance of dose intensity, and dose escalation. While chemotherapy strategies using colony-stimulating factors have abrogated @entity1398 , cumulative @entity882 is common with many chemotherapy regimens, including ICE chemotherapy. In preclinical and phase II trials, monotherapy with recombinant @entity1 @entity650 ( @entity650 ) has demonstrated substantial thrombopoietic activity, but with little enhancement of neutrophil recovery. Thus, this study was designed to evaluate combination cytokine therapy with both recombinant @entity650 and @entity1261 ( @entity1261 ) after ICE chemotherapy. Previously untreated @entity1 with inoperable @entity1149 are eligible. Treatment includes two monthly cycles of @entity1260 2,000 mg/m2 with mesna 1,600 mg/m2 intravenously on days 1, 2, and 3, @entity3003 350 mg/m2 intravenously on day 1 only, and @entity2879 75 mg/m2 intravenously on days 1, 2, and 3. All @entity1 then receive @entity1261 at a dose of 5 micrograms/kg/d subcutaneously beginning on day 4 until a postnadir absolute neutrophil count of more than 10 x 10(9)/L. Cohorts of @entity1 (n = 15) are randomized to receive 0, 1, 2.5, or 5 micrograms/kg/d of @entity650 subcutaneously on days 4 to 13 in successive cohorts. This study has now reached its target accrual in all cohorts. The final data analysis is in progress. It is hoped that this trial will define the safety and tolerability of the simultaneous administration of @entity650 and @entity1261 following ICE chemotherapy in @entity1 with @entity1149 . In addition, this trial should determine the biologic activity and hematopoietic recovery observed during the simultaneous administration of these two cytokines in this setting.
