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Clinical Trials |
Departments of Obstetrics and Gynecology [R. D. A., W. K. H., E. E. P., L. C. K., J. M. A., M. N. B.], Radiation Oncology [M. B. K., R. F. M., S. S.], Pathology [W. E. G.], Biostatistics [D. C.], and Medicine [A. F. L.], University of Alabama at Birmingham Cancer Center, Birmingham, Alabama 35233, and National Cancer Institute, Bethesda, Maryland 20892 [J. S.]
Purpose: The purpose of this study was to determine the feasibility and maximum tolerated dose of 90Yttrium-CC49 (90Y-CC49) as the radioimmunotherapy (RIT) component of an i.p. combined modality treatment for recurrent ovarian cancer.
Experimental Design: A Phase I trial of 90Y-CC49 RIT was conducted in ovarian cancer patients who had persistent or recurrent intra-abdominal disease, had failed one or two prior chemotherapy regimens, and demonstrated TAG-72 expression. Patients were treated with a previously established combined modality treatment protocol of s.c. IFN 
2b, i.p. paclitaxel, and increasing dosages of i.p. 90Y-CC49. Patients were monitored for toxicity, generation of human antimouse antibody response, and clinical efficacy.
Results: Twenty eligible patients were treated per study specifications. All patients had been treated with debulking and paclitaxel/carboplatin-based chemotherapy at initial diagnosis. The patients included 11 patients with persistent disease at the time of second look laparotomy and 9 patients with delayed recurrence. Patients were treated with i.p. 90Y-CC49 given in combination with s.c. IFN 2b (dose of 3 x 106 units for a total of four doses) and i.p. paclitaxel (dose of 100 mg/m2). RIT treatment was associated with primarily hematological toxicity. The maximum tolerated dose of i.p. 90Y-CC49 was established at 24.2 mCi/m2 in this combined regimen. Of nine patients with measurable disease, two had partial responses lasting 2 and 4 months. Of 11 patients with nonmeasurable disease, median time to progression was 6 months in 7 patients who recurred; 4 of these patients remain no evidence of disease at 9+, 18+, 19+, and 23+ months.
Conclusions: 90Yttrium-CC49-based RIT in combination with IFN 2b and i.p. paclitaxel is feasible and well tolerated at a dose of 
24.2 mCi/m2.
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