A Phase I study of combined modality (90)Yttrium-CC49 intraperitoneal radioimmunotherapy for XXXX .

@entity43 @entity1 @entity137 @entity3003 @entity1311 @entity4020 @entity1320 @entity2797
PURPOSE: The purpose of this study was to determine the feasibility and maximum tolerated dose of (90)Yttrium-CC49 ((90)Y-CC49) as the radioimmunotherapy (RIT) component of an i.p. combined modality treatment for recurrent @entity43 . EXPERIMENTAL DESIGN: A Phase I trial of (90)Y-CC49 RIT was conducted in @entity43 @entity1 who had persistent or recurrent @entity1320 , had failed one or two prior chemotherapy regimens, and demonstrated @entity2797 expression. @entity1 were treated with a previously established combined modality treatment protocol of s.c. IFN alpha2b, i.p. @entity1311 , and increasing dosages of i.p. (90)Y-CC49. @entity1 were monitored for @entity137 , generation of human antimouse antibody response, and clinical efficacy. RESULTS: Twenty eligible @entity1 were treated per study specifications. All @entity1 had been treated with debulking and @entity1311 / @entity3003 -based chemotherapy at initial diagnosis. The @entity1 included 11 @entity1 with persistent disease at the time of second look laparotomy and 9 @entity1 with delayed recurrence. @entity1 were treated with i.p. (90)Y-CC49 given in combination with s.c. IFN alpha2b (dose of 3 x 10(6) units for a total of four doses) and i.p. @entity1311 (dose of 100 mg/m(2)). RIT treatment was associated with primarily hematological @entity137 . The maximum tolerated dose of i.p. (90)Y-CC49 was established at 24.2 mCi/m(2) in this combined regimen. Of nine @entity1 with measurable disease, two had partial responses lasting 2 and 4 months. Of 11 @entity1 with nonmeasurable disease, median time to progression was 6 months in 7 @entity1 who recurred; 4 of these @entity1 remain no evidence of disease at 9+, 18+, 19+, and 23+ months. CONCLUSIONS: (90)Yttrium-CC49-based RIT in combination with @entity4020 b and i.p. @entity1311 is feasible and well tolerated at a dose of < or =24.2 mCi/m(2).
