Interleukin-2 liposome inhalation therapy is safe and effective for dogs with spontaneous pulmonary metastases

Cancer

Volumn 79, Issue 7, 1997, Pages 1409-1421

  Khanna, Chand ^a   Anderson, Peter M ^b   Hasz, Diane E ^c   Katsanis, Emmanuel ^c   Neville, Mary ^d   Klausner, Jeffrey S ^a  

^a UNIVERSITY OF MINNESOTA   (United States)

^b MAYO CLINIC   (United States)

^c UNIVERSITY OF MINNESOTA MEDICAL SCHOOL   (United States)

^d Biomira USA Inc   (United States)

Author keywords

dogs; inhalation; interleukin 2; liposome; lung carcinoma; pulmonary metastases

Indexed keywords

LIPOSOME; RECOMBINANT INTERLEUKIN 2; TECELLEUKIN; UNCLASSIFIED DRUG;

AEROSOL; ANIMAL CELL; ANIMAL MODEL; ANTINEOPLASTIC ACTIVITY; ARTICLE; CANCER IMMUNOTHERAPY; DRUG EFFICACY; DRUG FORMULATION; DRUG RESPONSE; IMMUNOGENICITY; INHALATIONAL DRUG ADMINISTRATION; LUNG CARCINOMA; LUNG METASTASIS; LYMPHOCYTE; NONHUMAN; OSTEOSARCOMA; PRIORITY JOURNAL;

AEROSOLS; ANIMALS; BRONCHOALVEOLAR LAVAGE; DOG DISEASES; DOGS; DRUG HYPERSENSITIVITY; IMMUNITY, CELLULAR; IMMUNOPHENOTYPING; INTERLEUKIN-2; LIPOSOMES; LUNG NEOPLASMS; MALE; OSTEOSARCOMA; RESPIRATORY THERAPY; TIME FACTORS;

EID: 0030982904     PISSN: 0008543X     EISSN: None     Source Type: Journal    
DOI: 10.1002/(SICI)1097-0142(19970401)79:7<1409::AID-CNCR19>3.0.CO;2-3     Document Type: Article

References (66)

1. Potter DA, Glenn S, Kinsella T, Glatstein E, Lack EE, Restrepo C, et al. Patterns of recurrence in patients with high grade soft tissue sarcomas. J Clin Oncol 1985;3:353-6.
2. Elias AD, Antman KH. Adjuvant chemotherapy of soft tissue sarcoma: an approach in search of an effective regime. Semin Oncol 1989;16:305-11.
3. Kleinerman ES, Gano JB, Johnston DA, Benjamin RS, Jaffe N. Efficacy of liposomal muramyl tripeptide (CGP 19835A) in the treatment of relapsed osteosarcoma. Am J Clin Oncology 1995;18(2):93-9.
4. Kintzel PE, Calis KA. Recombinant interleukin-2: a biological response modifier. Clin Pharmacy 1991;10:110-28.
5. Rosenberg SA, Lotze MT, Muul LM, Chang AE, Avis FP, Leitman S, et al. Observations on the systemic administration of autologous lymphokine activated killer cells and recombinant interleukin-2 to patients with metastatic cancer. N Engl J Med 1985;313:1485-92.
6. Smith KA. Interleukin-2: inception, impact, and implications. Science 1988;240:1169-76.
7. Sznol M, Dutcher JP, Atkins MB, Rayner AR, Margolin KA, Gaynor ER, et al. Review of interleukin-2 alone and interleukin-2/LAK clinical trials in metastatic malignant melanoma. Cancer Treat Rev 1989;15:29-38.
8. Espinoza-Delgadro I, Bosca MC, Musso T, Gusella L, Longo DL, Varesio L. Interleukin-2 and human monocyte activation. J Leukoc Biol 1995;57:13-9.
9. Grimm EA, Owen-Schaub L. The IL-2 mediated amplification of cellular cytotoxicity. J Cell Biochem 1991;45:335-9.
10. Rubin JT. Interleukin-2: its biological and clinical applications in patients with cancer. Cancer Invest 1993;11(4):460-72.
11. Kaplan DR. Delivery of interleukin-2 for immunotherapy. J Chromatogr B Biomed Appl 1994;662:315-23.
12. Maas RA, Dullens HF, Den Otter W. Interleukin-2 in cancer treatment: disappointing or (still) promising? A review. Cancer Immunol Immunother 1993;36(3):141-8.
13. Marincola FM, White DE, Wise AP, Rosenberg SA. Combination therapy with interferon alfa-2a and interleukin-2 for the treatment of metastatic cancer. J Clin Oncol 1995; 13(5):1110-22.
14. Anderson PM, Hasz D, Dickerell L, Sencer S. Interleukin-2 in liposomes: increased intravenous potency and less pulmonary toxicity in the rat. Drug Devel Res 1992;27:15-31.
15. Guida M, Abbate I, Casamassima A, Muci MD, Latorre A, Lorusso V, et al. Long-term subcutaneous recombinant interleukin-2 as maintenance therapy: biological effects and clinical implications. Cancer Biother 1995;10(3):195-203.
16. Menzel T, Schomburg A, Korfer A, Haydam M, Meffert M, Dallman I, et al. Clinical and preclinical evaluation of recombinant PEG-IL-2 in human. Cancer Biother 1993;8(3):199-212.
17. Siegal J, Puri R. Interleukin toxicity. J Clin Oncol 1991;9:694-704.
18. Smith KA. Lowest dose interleukin-2 immunotherapy. Blood 1993;81(6):1414-23.
19. Anderson PM, Sorenson MA. Effects of route and formulation on clinical pharmacokinetics of interleukin-2 Drug Disposition 1994;27(1):19-31.
20. Helfand S, Soergel SA, MacWilliams PS, Hank JA, Sondel PM. Clinical and immunological effects of human recombinant IL-2 given by repetitive weekly infusion to normal dogs. Cancer Immunol Immunother 1994;39:84-92.
21. Waldrep JC, Scherer PW, Hess GH, Black M, Knight V. Nebulized glucocorticoids in liposomes: aerosol characteristics and human dose estimates. J Aerosol Med 1994;7(2):135-45.
22. Knight V, Yu CP, Gilbert BE, Divine GW. Estimating the dosage of ribravirin aerosol according to age and other variables. J Infect Dis 1988;158(2):443-8.
23. Hodson ME. Aerosolized dornase alpha (rhDNase) for therapy of cystic fibrosis. Am J Respir Crit Care Med 1995;151:S70-4.
24. Malone R, Hollie MC, Berhart AG, Nelson H. Optimal duration of nebulized albuterol therapy. Chest 1993;104:114-8.
25. Maasilta P, Maija H, Mattson K, Cantell K. Pharmacokinetics of inhaled recombinant and natural alpha interferon. Lancet 1991;337(9):371.
26. Dowling RD, Zenati M, Burckart GJ, Yousman SA, Schaper M, Simmons RL, et al. Aerosolized cyclosporine as a single-agent immunotherapy in canine lung allografts. Surgery 1990;108:198-205.
27. Gilbert BE, Wilson SZ, Garcon NM, Wyde PR, Knight V. Characterization and administration of cyclosporine liposomes as a small particle aerosol. Transplantation 1993;56:974-7.
28. Knight V, Waldrep JC. New approaches in aerosol drug delivery for the treatment of asthma. In: Kay B, editor. Allergy and allergic disease. London: Blackwell Scientific, 1995.
29. Newman SP, Clarke SW. Therapeutic aerosols. 1. Physical and practical considerations. Thorax 1983;38:881-6.
30. Huland E, Huland H, Heinzer H. Interleukin-2 by inhalation: local therapy for metastatic renal carcinoma. J Urol 1992;147:344-8.
31. Huland E, Heinzer H, Huland H. Inhaled interleukin-2 in combination with low-dose systemic interleukin-2 and interferon alpha in patients with pulmonary metastatic renal-cell carcinoma: effectiveness and toxicity of mainly local treatment. J Cancer Res Clin Oncol 1994;120:221-8.
32. Khanna C, Anderson PM, Hasz D, Klausner J. Aerosol delivery of interleukin-2 liposomes is non-toxic and effective: murine and canine studies. Proc Am Assoc Cancer Res 1994;35:414.
33. Zhang YH, Liu XY. Inhibition of lung metastases of mouse mammary tumor by aerosolized interleukin-2 in bacillus Calmette-Geurin primed mice. Proc Am Assoc Cancer Res 1994;35:519.
34. Juliano RL, McCullough HN. Controlled delivery of an anti-tumor drug: localized action of liposome encapsulated cytosine arabinoside administered via the respiratory system. J Pharmacol Exp Ther 1980;214(2):381-7.
35. Ostro MJ, Peiter RC. Use of liposomes as injectable-drug delivery systems. Am J Hosp Pharm 1989;46:1576-87.
36. Anderson PM, Hasz DE, Blazar BR, Ochoa AC. Cytokines in liposomes: preliminary studies with IL-1, IL-2, IL-6, GM-CSF, and interferon-γ. Cytokines 1994;6(1):1-10.
37. Kedar E, Rutkowski Y, Braun E, Emanuel N, Berenholz Y. Delivery of cytokines by liposomes. I. Preparation and characterization of interleukin-2 encapsulated in long-circulating sterically stabilized liposomes. J Immunother 1994; 16:47-59.
38. Bergers JJ, Den Otter W, Dullens HFJ, Kerkvliet TM, Crommelin DJA. Interleukin-2-containing liposomes: interaction of interleukin-2 with liposomal bilayers and preliminary studies on application in cancer vaccines. Pharmacol Res 1993;10(12):1715-21.
39. Loeffler CM, Platt JL, Anderson PM, Katsanis E, Ochoa JB, Urba WJ, et al. Increased local anti-tumor effects of IL-2 liposomes in mice with MCA 106 sarcoma pulmonary metastases. Cancer Res 1990;50:1853-6.
40. Niven RW, Speir M, Schreier H. Nebulization of liposomes I. Effects of size and modeling of solute release profiles. Pharmacol Res 1991(8):217-21.
41. Martin F. Development of liposomes for aerosol delivery: recent preclinical and clinical results. J Lipid Res 1990; 1(4):407-29.
42. Schreier H, Gonzalez-Rothi RJ, Stecenko AA. Pulmonary delivery of liposomes. J Control Release 1993;24:209-23.
43. Khanna C, Hasz D, Klausner JS, Anderson PM. Aerosols of interleukin-2 liposomes are non-toxic and biologically active: canine studies. Clin Cancer Res 1996;4:719-36.
44. Anderson PM, Katsanis E, Leonard AS, Schow D, Loeffler CM, Goldstein MD, et al. Increased local anti-tumor effects of interleukin 2 liposomes in mice with MCA-106 sarcoma pulmonary metastases. Cancer Res 1990;50:1853-6.
45. Moore PF, Rossitto PV, Danilenko DM, Wielenga J, Raff RF, Sevems E. Monoclonal antibodies specific for canine CD4 and CD8 define functional T-lymphocyte subsets and high-density expression of CD4 by canine neutrophils. Tissue Antigens 1992;40:75-85.
46. Anderson PM, Blazer BR, Bach FH, Ochoa AC. Anti-CD3 IL-2 stimulated murine killer cells: in vitro generation and in vivo anti-tumor activity. J Immunol 1989;142(4):1383-94.
47. Wee SL, Wu S, Alter BJ, Bach FH. Early detection and specificity analysis of human cytolytic T lymphocytes (CTL) colonies generated in soft agarose culture: a potential assay for definition of CTL defined (CD) determinants. Hum Immunol 1981;3:45-56.
48. Gong JH, Maki G, Klingemann HG. Characterization of human cell line (NK92) with phenotypical and functional characteristics of activated natural killer cells. Leukemia 1994; 8(4):652-8.
49. Owen LN, editor. TNM classification of tumors in domestic animals. 1st edition. Geneva: World Health Organization, 1980.
50. Ogilvie GK, Straw RC, Jameson VJ. Evaluation of single-agent chemotherapy for treatment of clinically evident osteosarcoma metastases in dogs: 45 cases (1987-1991). J Am Vet Med Assoc 1993;202:304-6.
51. Withrow SJ, Powers BE, Straw RC, Wilkins RM. Comparative aspects of osteosarcoma. Dog versus man. Clin Orthop 1991;270:159-68.
52. Brodey RS, Abt DA. Results of surgical treatment in 65 dogs with osteosarcoma. J Am Vet Med Assoc 1977;168:1032-5.
53. Spodnick GJ, Berg J, Rand WM, Schelling SH, Couto G, Harvey HJ, et al. Prognosis for dogs with appendicular osteosarcoma treated by amputation alone: 162 cases (1978-1988). J Am Vet Med Assoc 1992;200:995-9.
54. Powers BE, Withrow SJ, Thrall DE, Straw RC, LaRue SM, Page RL, et al. Percent tumor necrosis as a predictor of treatment response in canine osteosarcoma. Cancer 1993;71:2484-90.
55. Shapiro W, Fossum TW, Kitchel BE. Use of cisplatin for treatment of appendicular osteosarcomas in dogs. J Am Vet Med Assoc 1988;192:507-11.
56. MacEwen EG, Kurzamn ID, Rosenthal RC. Therapy for osteosarcoma in dogs with intravenous injection of liposome encapsulated muramyl tripeptide. J Natl Cancer Inst 1989;81:935-8.
57. Kurzman ID, MacEwen EG, Rosenthal RC, Fox LS, Keller ET, Helfand SC, et al. Adjuvant therapy for osteosarcoma in dogs: results of randomized clinical trials using combined liposome encapsulated muramyl tripeptide and cisplatin. Clin Cancer Res 1995;1:1595-601.
58. Foon KA. Biological response modifiers: the new immunotherapy. Cancer Res 1989;49:1621-39.
59. Lorenz J, Wilhelm K, Kessler M, Perschel C, Schwulera U, Lissner R, et al. Phase I trial of inhaled natural interleukin 2 for treatment of pulmonary malignancy: toxicity, pharmacokinetics, and biological effects. Clin Cancer Res 1996; 2:1115-22.
60. Fabian I, Kravtsov V, Elis A, Gurevitch O, Ackerstein A, Slavin S, et al. Eosinophils activation in post-autologous bone marrow transplanted patients treated with subcutaneous interleukin-2 and interferon-alpha 2a immunotherapy. Leukemia 1994;8(8):1379-84.
61. Milne AAY, Teixeira MM, Hellewell PG, Piper PJ. Induction of leukocyte recruitment and bronchial hyper responsiveness in the guinea pig by aerosol administration of interleukin-2. Int Arch Allergy Immunol 1995;108:60-7.
62. Rivoltini L, Viggiano V, Spinazze S, Santoro A, Colombo MP, Takatsu K, et al. In vitro anti-tumor activity of eosinophils from cancer patients treated with subcutaneous administration of interleukin 2. Role of interleukin 5. Int J Cancer 1993;54:8-15.
63. Ishimitsu T, Torisu M. The role of eosinophils in interleukin-2/lymphokine-activated killer cell therapy. Surgery 1993; 113(2):192-9.
64. Sencer S, Rsich HL, Katsanis E, Ochoa AC, Anderson PM. Anti-tumor vaccine adjuvant effects of IL-2 liposomes in mice immunized against MCA-102 sarcoma. Eur Cytokine Netw 1991;2(5):311-8.
65. Kilbourn RG, Owen-Schaub LB, Cromeens DM, Gross SS, Flaherty MJ, Santee SM, et al. NG-methyl-L-arginine, an inhibitor of nitric oxide formation, reverses IL-2 mediated hypotension in dogs. J Appl Physiol 1994;76(3):1130-7.
66. Knapp DW, Williams JS, Andrisani OM. Cloning of the canine interleukin-2-encoding cDNA. Gene 1995;159(2):281-2.