Phase I/II radioimmunotherapy trial with iodine-131-labeled monoclonal antibody G250 in metastatic renal cell carcinoma

Clinical Cancer Research

Volumn 4, Issue 11, 1998, Pages 2729-2739

  Divgi, Chaitanya R ^a   Bander, Neil H ^a,b,c   Scott, Andrew M ^a,b   O'Donoghue, Joseph A ^a   Sgouros, George ^a   Welt, Sydney ^a,b   Finn, Ronald D ^a   Morrissey, Francesca ^a   Capitelli, Peter ^a   Williams, Jeanne M ^a   Deland, Devie ^a   Nakhre, Aparna ^a   Oosterwijk, Egbert ^a,d   Gulec, Seza ^a   Graham, Martin C ^a   Larson, Steven M ^a   Old, Lloyd J ^a,b  

^a MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^b LUDWIG INSTITUTE FOR CANCER RESEARCH   (Australia)

^c WEILL CORNELL MEDICAL CENTER   (United States)

^d RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBODY CONJUGATE; MONOCLONAL ANTIBODY; MONOCLONAL ANTIBODY G 250 I 131; MONOCLONAL ANTIBODY G250; UNCLASSIFIED DRUG;

ADULT; ARTICLE; BLOOD TOXICITY; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED STUDY; DRUG DISTRIBUTION; DRUG SAFETY; FEMALE; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; KIDNEY CARCINOMA; LIVER FUNCTION TEST; MALE; MAXIMUM PERMISSIBLE DOSE; METASTASIS; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RADIATION DOSE; RADIOIMMUNOTHERAPY; SINGLE PHOTON EMISSION COMPUTER TOMOGRAPHY; TREATMENT OUTCOME; WHOLE BODY SCINTISCANNING;

ADULT; AGED; ANTIBODIES, MONOCLONAL; BLOOD CELL COUNT; CARCINOMA, RENAL CELL; FEMALE; HUMANS; IMMUNOCONJUGATES; IODINE RADIOISOTOPES; KIDNEY NEOPLASMS; LIVER; MALE; MIDDLE AGED; RADIOIMMUNOTHERAPY; RADIOMETRY; RADIONUCLIDE IMAGING; WHOLE-BODY IRRADIATION;

EID: 0031724558     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (39)

1. Garnick, M. B., and Richie, J. P. Renal neoplasia. In: B. M. Brenner, and F. C. Rector Jr. (eds.), The Kidney, pp. 1809-1827. Philadelphia: W. B. Saunders, 1991.
2. DeKiernion, J. B. Renal tumors. In: M. F. Campbell, A. B. Retik, E. darraco Vaughan, and P. C. Walsh (eds.), Campbell's Urology, Ed. 6, pp. 1294-1342. Philadelphia: W. B. Saunders, 1993.
3. Parker, S. L., Tong, T., Bolden, S., and Wingo, P. A. Cancer statistics, 1996. CA Cancer J. Clin., 46: 5-27, 1996.
4. De Kiernion, J. B., Ramming, K. P., and Smith, R. B. The natural history of metastatic renal cell carcinoma: a computer analysis. J. Urol., 120; 1978:148-152.
5. Waters, W. B., and Richie, J. P. Aggressive surgical approach to renal cell carcinoma. Review of 130 cases. J. Urol., 122: 306-309, 1979.
6. Finney, R. The value of radiotherapy in the treatment of hypernephroma: a clinical trial. Br. J. Urol., 45: 258-269, 1973.
7. Yagoda, A., Abi-Rached, B., and Petrylak, D. Chemotherapy for advanced renal-cell carcinoma: 1983-1993. Semin. Oncol., 22: 42-60, 1995.
8. Rosenberg, S. A. Clinical immunotherapy studies in the Surgery Branch of the U.S. National Cancer Institute: brief review. Cancer Treat. Rev., 16 (Suppl. A): 115-121, 1989.
9. Bukowski, R. M., Goodman, P., Crawford, E. D., Sergi, J. S., Redman, B. G., and Whitehead, R. P. Phase II trial of high-dose intermittent interleukin-2 in metastatic renal cell carcinoma: a Southwest Oncology Group Study. J. Natl. Cancer Inst. (Bethesda), 82: 143-146, 1990.
10. Neidhart, J. A., Anderson, S. A., Harris, J. E., Rinehart, J. J., Lazlo, J., Dexeus, F. H., Einhorn, L. H., Trump, D. L., Benedetto, P. W., Tuttle, R. L., et al. Vinblastine fails to improve response of renal cancer to interferon α-n1: high response rates in patients with pulmonary metastases. J. Clin. Oncol., 9: 832-837, 1991.
11. Otto, U., Schneider, A. W., Conrad, S., and Klosterhalfen, H. Recombinant α-2 or γ interferon in the treatment of metastatic renal cell carcinoma: results of two Phase II/III trials. Prog. Clin. Biol. Res., 350: 275-282, 1990.
12. Quesada, J. R., Evans, L., Saks, S. R., and Gutterman, J. U. Recombinant interferon α and γ in combination as treatment for metastatic renal cell carcinoma. J. Biol. Response Modif., 7: 234-239, 1988.
13. Debruyne, F. M. J., Franssen, M. P. H., Beniers, A. J. M. C., Schalken, J. A., and deMulder, P. H. New prospects in the management of metastatic renal cell carcinoma. Experimental and clinical data. Prog. Clin. Biol. Res., 350: 243-255, 1990.
14. Kellokumpo-Lehtinen, P., and Nordman, E. Recombinant interferon α2a and vinblastine in advance renal cell cancer: a clinical Phase I-II study. J. Biol. Response Modif., 9: 439-444, 1990.
15. Hercend, T., Farace, F., Baume, D. M., Charpentier, F., Droz, J. P., Triebel, F., and Escudier, B. Immunotherapy with lymphokine-activated natural killer cells and recombinant interleukin-2: a feasibility trial in metastatic renal cell carcinoma. J. Biol. Response Modif., 9: 546-555, 1990.
16. Kohler, G., and Milstein, C. Continuous cultures of fused cells secreting antibody of predefined specificity. Nature (Lond.), 256: 495-497, 1975.
17. Scott, A. M., and Welt, S. Antibody-based immunological therapies. Curr. Opin. Immunol., 9: 717-722, 1997.
18. Houghton, A. N., Mintzer, D., Cordon-Cardo, C., Welt, S., Fliegel, B., Vadhan, S., Carswell, E., Melamed, M. R., Oettgen, H. F., and Old, L. J. Mouse monoclonal IgG3 antibody detecting GD3 ganglioside: a Phase I trial in patients with malignant melanoma. Proc. Natl. Acad. Sci. USA, 82: 1242-1246, 1985.
19. HER2 monoclonal antibody in patients with her2/neu-overexpressing metastatic breast cancer. J. Clin. Oncol., 14: 737-744, 1996.
20. Welt, S., Divgi, C. R., Kemeny, N., Finn, R. D., Scott, A. M., Graham, M., Germain, J. S., Richards, E. C., Larson, S. M., Oettgen, H. F., et al. Phase I/II study of iodine-131-labeled monoclonal antibody A33 in patients with advanced colon cancer. J. Clin. Oncol., 12: 1561-1571, 1994.
21. Pai, L. H., Wittes, R., Sester, A., Willingham, M. C., and Pastan, I. Treatment of advanced solid tumors with immunotoxin LMB-1: an antibody linked to Pseudomonas exotoxin. Nat. Med., 2: 350-353, 1996.
22. Avner, B., Swindell, L., Sharp, E., Liao, S. K., Ogden, J. R., Avner, B. P., and Oldham, R. K. Evaluation and clinical relevance of patient immune responses to intravenous therapy with murine monoclonal antibodies conjugated to Adriamycin. Mol. Biother., 3: 14-21, 1991.
23. Oosterwijk, E., Ruiter, D. J., Hoedemaeker, P. J., Pauwels E. K., Jonas, U., Zwartendijk, J., and Warnaar, S. O. Monoclonal antibody G250 recognizes a determinant present in renal-cell carcinoma and absent from normal kidney. Int. J. Cancer, 38: 489-494, 1986.
24. Oosterwijk, E., Bander, N. H., Divgi, C. R., Welt, S., Wakka, J. C., Finn, R. D., Carswell, E. A., Larson, S. M., Warnaar, S. O., Fleuren, G. J., et al. Antibody localization in human renal cell carcinoma: a Phase I study of monoclonal antibody G250. J. Clin. Oncol., 11: 738-750, 1993.
25. Oosterwijk, E., de Weijert, M., van Bokhoven, A., Brakenhoff, R. H., Peelen, W. P., and Debruyne, F. M. Molecular characterization of the renal cell carcinoma-associated antigen G250. Proc. Am. Urol. Assoc., 155: 542, 1996.
26. Pastorek, J., Pastorekova, S., Callebaut, I., Mornon, J. P., Zelnik, V., Opavsky, R., Zat'ovicova, M., Liao, S., Portetelle, D., Stanbridge, E. J., et al. Cloning and characterization of MN, a human tumor-associated protein with a domain homologous to carbonic anhydrase and a putative helix-loop-helix DNA binding segment. Oncogene. 9: 2877-2888, 1994.
27. 131I labeled human growth hormone of high specificity. Nature (Lond.), 194: 495-498, 1962.
28. Loh, A, Sgouros, G, O'Donoghue, J. A., Deland, D., Puri, D., Capitelli, P., Humm, J. L., Larson, S. M., Old, L. J., and Divgi, C. R. Pharmacokinetic model of I-131-G250 antibody in patients with renal cell carcinoma. J. Nucl. Med., 39: 484-489, 1998.
29. Loevinger, R., Budinger, T. F., and Watson, E. E. MIRD Primer for Absorbed Dose Calculations. New York: The Society of Nuclear Medicine, 1988.
30. Thomas, S. R., Maxon, H. R., and Kereiakes, J. G. In vivo quantitation of lesion radioactivity using external counting methods. Med. Phys., 3: 253-255, 1976.
31. Brownell, G. L., Ellet, W. H., and Reddy, A. R. MIRD pamphlet 3: absorbed fractions for photon dosimetry. J. Nucl. Med., 9: 27-39, 1968.
32. Divgi, C. R., Scott, A. M., Dantis, L., Capitelli, P., Siler, K., Hilton, S., Finn, R. D., Kemeny, N., Kelsen, D., Kostakoglu, L., et al. Phase I radioimmunotherapy trial with 1-131 CC49 in metastatic colon carcinoma. J. Nucl. Med., 36: 586-592, 1995.
33. Yu, B., Carrasquillo, J., Milenic, D., Chung, Y., Perentesis, P., Feuerestein, I., Eggensperger, D., Qi, C. F., Paik, C., Reynolds, J., Grem, J., Curt, G., Siler, K., Schlom, J., and Allegra, C. Phase I trial of iodine 131-labeled COL-1 in patients with gastrointestinal malignancies: influence of serum carcinoembryonic antigen and tumor bulk on pharmacokinetics. J. Clin. Oncol., 14: 1798-1809, 1996.
34. 131I-G250 antibody therapy in patients with renal-cell carcinoma. J. Nucl. Med., 38: 252P, 1997.
35. Vessella, R. L. Radioimmunoconjugates in renal cell carcinoma. In: F. M. S. Dubruyne (ed.). Immunotherapy of Renal Cell Carcinoma, pp. 38-46. Heidelberg, Germany: Springer-Verlag. 1991.
36. Surtus, J. E., Hank, J. A., Oosterwijk, E., Welt, S., Lindstrom, M. J., Albertini, M. R., Schiller, J. H., and Sondel, P. M. Anti-renal-cell carcinoma chimeric antibody G250 facilitates antibody-dependent cellular toxicity with in vitro and in vivo interleukin-2-activated effectors. J. Immunother., 79: 184-191, 1996.
37. Steffens, M. G., Boerman, O. C., Oosterwijk-Wakka, J. C., Oosterhof, G. O., Witjes, J. A., Koenders, E. B., Oyen, W. J., Buijs, W. C., Debruyne, F. M., Corstens, F. H., and Oosterwijk, E. Targeting of renal cell carcinoma with iodine-131-labeled chimeric monoclonal antibody G250. J. Clin. Oncol., 15: 1529-1537, 1997.
38. Schlom, J., Molinolo, A., Simpson, J. F., Siler, K., Roselli, M., Hinkle, G., Houchens, D. P., and Colcher, D. Advantage of dose fractionation in monoclonal antibody-targeted radioimmunotherapy. J. Natl. Cancer Inst. (Bethesda), 82: 763-771, 1990.
39. 131I-labeled monoclonal antibody CC49. Cancer Res., 55 (Suppl.): 5881s-5887s, 1995.