A phase I study of combined modality90Yttrium-CC49 intraperitoneal radioimmunotherapy for ovarian cancer

Ronald D. Alvarez, Warner K. Huh, M. B. Khazaeli, Ruby F. Meredith, Edward E. Partridge, Larry Kilgore, William E. Grizzle, Sui Shen, J. Max Austin, Mack N. Barnes, Delicia Carey, Jeffrey Schlom, Albert F. LoBuglio

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Abstract

Purpose: The purpose of this study was to determine the feasibility and maximum tolerated dose of9OYttrium-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 of90Y-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 α2b, 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 α2b (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 α2b and i.p. paclitaxel is feasible and well tolerated at a dose of ≤24.2 mCi/m2.

Original languageEnglish (US)
Pages (from-to)2806-2811
Number of pages6
JournalClinical Cancer Research
Volume8
Issue number9
StatePublished - Jan 1 2002

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Radioimmunotherapy
Ovarian Neoplasms
Paclitaxel
Maximum Tolerated Dose
Drug Therapy
Carboplatin
Clinical Protocols
Laparotomy
Antibody Formation

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Alvarez, R. D., Huh, W. K., Khazaeli, M. B., Meredith, R. F., Partridge, E. E., Kilgore, L., ... LoBuglio, A. F. (2002). A phase I study of combined modality90Yttrium-CC49 intraperitoneal radioimmunotherapy for ovarian cancer. Clinical Cancer Research, 8(9), 2806-2811.

A phase I study of combined modality90Yttrium-CC49 intraperitoneal radioimmunotherapy for ovarian cancer. / Alvarez, Ronald D.; Huh, Warner K.; Khazaeli, M. B.; Meredith, Ruby F.; Partridge, Edward E.; Kilgore, Larry; Grizzle, William E.; Shen, Sui; Austin, J. Max; Barnes, Mack N.; Carey, Delicia; Schlom, Jeffrey; LoBuglio, Albert F.

In: Clinical Cancer Research, Vol. 8, No. 9, 01.01.2002, p. 2806-2811.

Research output: Contribution to journalArticle

Alvarez, RD, Huh, WK, Khazaeli, MB, Meredith, RF, Partridge, EE, Kilgore, L, Grizzle, WE, Shen, S, Austin, JM, Barnes, MN, Carey, D, Schlom, J & LoBuglio, AF 2002, 'A phase I study of combined modality90Yttrium-CC49 intraperitoneal radioimmunotherapy for ovarian cancer', Clinical Cancer Research, vol. 8, no. 9, pp. 2806-2811.
Alvarez RD, Huh WK, Khazaeli MB, Meredith RF, Partridge EE, Kilgore L et al. A phase I study of combined modality90Yttrium-CC49 intraperitoneal radioimmunotherapy for ovarian cancer. Clinical Cancer Research. 2002 Jan 1;8(9):2806-2811.
Alvarez, Ronald D. ; Huh, Warner K. ; Khazaeli, M. B. ; Meredith, Ruby F. ; Partridge, Edward E. ; Kilgore, Larry ; Grizzle, William E. ; Shen, Sui ; Austin, J. Max ; Barnes, Mack N. ; Carey, Delicia ; Schlom, Jeffrey ; LoBuglio, Albert F. / A phase I study of combined modality90Yttrium-CC49 intraperitoneal radioimmunotherapy for ovarian cancer. In: Clinical Cancer Research. 2002 ; Vol. 8, No. 9. pp. 2806-2811.
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abstract = "Purpose: The purpose of this study was to determine the feasibility and maximum tolerated dose of9OYttrium-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 of90Y-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 α2b, 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 α2b (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 α2b and i.p. paclitaxel is feasible and well tolerated at a dose of ≤24.2 mCi/m2.",
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AU - Partridge, Edward E.

AU - Kilgore, Larry

AU - Grizzle, William E.

AU - Shen, Sui

AU - Austin, J. Max

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