An open phase I study to assess the biological effects of a continuous intravenous infusion of interleukin-3 followed by granulocyte macrophage- colony stimulating factor

European Journal of Cancer Part A

Volumn 32, Issue 7, 1996, Pages 1171-1178

  Bretti, S ^a   Gilleece, M H ^a   Kamthan, A ^a   Fitzsimmons, L ^a   Hicks, F ^a   Rowlands, M ^a   Bishop, P ^a   Picardo, A M ^a   Dexter, T M ^a   Scarffe, J H ^a  

^a CHRISTIE HOSPITAL   (United Kingdom)

Author keywords

GM CSF; IL 3; phase I clinical trial

Indexed keywords

GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR; INTERLEUKIN 3;

ADULT; AGED; ANTINEOPLASTIC ACTIVITY; ARTICLE; BONE PAIN; CLINICAL ARTICLE; CLINICAL TRIAL; DOSE RESPONSE; DRUG POTENTIATION; FEMALE; FEVER; HUMAN; INFLUENZA; INTRAVENOUS DRUG ADMINISTRATION; LEUKOCYTE COUNT; MALE; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RASH; THROMBOCYTE COUNT;

EID: 0030176257     PISSN: 09598049     EISSN: None     Source Type: Journal    
DOI: 10.1016/0959-8049(96)00027-5     Document Type: Article

References (58)

1. 1. Yang Y, Ciarletta AB, Temple PA, et al. Human IL-3 (multiCSF): identification by expression cloning of a novel haematopoietic growth factor related to murine IL-3. Cell 1986, 47, 3-10.
2. 2. Sieff C, Emerson SG, Donahue RE, Nathen DG. Human recombinant granulocyte/macrophage colony stimulating factor: a multilineage haematopoietin. Science 1985, 230, 1171-1173.
3. 3. Migliaccio AR, Bruno M, Migliaccio G. Evidence for direct action of human biosynthetic (recombinant) GM-CSF on erythroid progenitors in serum-free culture. Blood 1987, 70, 1867-1871.
4. 4. Mazer EM, Cohen JL, Wong G, Clark SC. Stimulant effect of human recombinant granulocyte/macrophage colony stimulating factor (rGM-CSF) on colony growth from human megakaryocyte progenitor cells (CFU-Meg). Blood 1986, 68(Suppl. 1), 1712.
5. 5. Coutinho LH, Will A, Radford J, Schiro R, Testa NG, Dexter TM. Effects of recombinant human Granulocyte-Colony Stimulating Factor (CSF), human Granulocyte Macrophage-CSF, and gibbon Interleukin-3 on haematopoiesis in human long-term bone marrow culture. Blood 1990, 75, 2118-2129.
6. 6. McNiece IK, McGrath HE, Quesenberry PJ. Granulocyte colony stimulating factor augments in vitro megakaryocyte colon formation by interleukin-3. Exp Hematol 1988, 16, 807-810.
7. 7. Sonoda Y, Yang YC, Wong GG, et al. Erythroid burst-promoting activity of purified recombinant human GM-CSF and interleukin-3: studies with anti-GM-CSF and IL-3 sera and studies in serum-free cultures. Blood 1988, 72, 1381-1386.
8. 8. Leary AG, Yang Y-C, Clark SC, Gasson JC, Golde DW, Ogawa M. Recombinant gibbon interleukin 3 supports formation of human multilineage colonies and blast cell colonies in culture: comparison with recombinant human granulocyte-macrophage colony stimulating factor. Blood 1987, 70, 1343-1348.
9. 9. Robinson BE, McGrath HE, Quesenberry PJ. Recombinant murine granulocyte macrophage colony-stimulating factor has megakaryocyte colony-stimulating activity and augments megakaryocyte colony stimulation by interleukin 3. J Clin Invest 1987, 79, 1648-1652.
10. 10. Sonada Y, Yang YC, Wong GG, Clark SC, Ogawa M. Analysis in serum-free culture of the targets of recombinant human hematopoietic growth factors: interleukin 3 and granulocyte macrophage-colony stimulating factor are specific for early developmental stages. Proc Natl Acad Sci USA 1988, 85, 4360-4364.
11. 11. Tomonaga M, Golde DW, Gasson JC. Biosynthetic (recombinant) human granulocyte-macrophage colony stimulating factor: effect on normal bone marrow and leukaemia cell lines. Blood 1986, 67, 31-36.
12. 12. Long MW, Hutchinson RJ, Gragowski LL, Heffher CH, Emerson SG. Synergystic regulation of human megakaryocyte development. J Clin Invest 1988, 82, 1779-1786.
13. 13. Donahue RE, Emerson SG, Wang EA, Wong GG, Clark SC, Nathan DG. Demonstration of burst-promoting activity of recombinant human GM-CSF on circulating erythroid progenitors using an assay involving the delayed addition of erythropoietin. Blood 1985, 66, 1479-1481.
14. 14. Bruno E, Miller ME, Hoffman R. Interacting cytokines regulate in vitro human megakaryocytopoiesis. Blood 1989, 73, 671-677.
15. 15. Emerson SG, Sieff CA, Wang EA, Wong GG, Clark SC, Nathan DG. Purification of fetal hematopoietic progenitors and demonstration of recombinant multipotential colony stimulating activity. J Clin Invest 1985, 76, 1286-1290.
16. 16. Bonnem EM, Morstyn G. Granulocyte macrophage colony stimulating factor (GM-CSF) current status and future development. Semin Oncol 1988, 15, 46-51.
17. 17. Lopez AF, Nicola NA, Burgess AW, et al. Activation of granulocyte cytotoxic function by purified mouse colony-stimulating factors. J Immunol 1983, 131, 2983-2988.
18. 18. Leary AG, Ikebuchi K, Hiarai Y, et al. Synergism between interleukin-6 and interleukin-3 in supporting proliferation of human haemopoietic stem cells: comparison with interleukin-1. Blood 1988, 71, 1759-1763.
19. 19. Broxmeyer HE, Cooper S, Williams DE, Hangoc G, Gutterman JU, Vadhan RS. Growth characteristics of marrow hematopoietic progenitor/precursor cells from patients on a phase I clinical trial with purified recombinant human granulocyte-macrophage colony-stimulating factor. Exp Hematol 1988, 16, 594-602.
20. 20. Socinski MA, Cannistra SA, Elias A, Antman KH, Schnipper L, Griffin JD. Granulocyte-macrophage colony stimulating factor expands the circulating haemopoietic progenitor cell compartment in man. Lancet 1988, 1, 1194-1198.
21. 21. Vadas MA, Nicola NA, Metcalf D. Activation of antibody dependent cell mediated cytotoxicity of human neutrophils and eosinophils by separate colony stimulating factors. J Immunol 1983, 130, 795-799.
22. 22. Metcalf D, Begley CG, Johnson GR. Biologic properties in vitro of a recombinant human granulocyte-macrophage colony stimulating factor. Blood 1986, 67, 37-45.
23. 23. Champlin RE, Nimer SD, Oette DH, Golde DW. Granulocyte-macrophage colony stimulating factor (GM-CSF) treatment for aplastic anaemia. Clin Res 1988, 36, 563A.
24. 24. Coffey RG. Mechanism of GM-CSF stimulating of neutrophils. Immunol Res 1989, 8, 236-248.
25. 25. Wang JM, Collela S, Allavena P, Mantovani A. Chemotactic activity of human recombinant granulocyte-macrophage colony stimulating factor. Immunology 1987, 60, 439-444.
26. 26. Ruef C, Coleman DL. Granulocyte-macrophage colony stimulating factor: pleiotropic cytokine with potential clinical usefulness. Rev Infect Dis 1990, 12, 41-62.
27. 27. Kleinerman ES, Knowles RD, Lachman LB, Gutterman JU. Effect of recombinant granulocyte/macrophage colony stimulating factor on human monocyte activity in vitro and following intravenous administration. Cancer Res 1988, 48, 2604-2609.
28. 28. Charak BS, Sadowski RM, Mazumder A. Granulocyte-macrophage colony stimulating factor in autologous bone marrow transplantation: augmentation of graft versus tumor effect via antibody dependent cellular cytotoxicity. Leuk Lymphoma 1993, 9, 453-457.
29. 29. Steward WP, Scarffe JH, Austin R, et al. Recombinant human granulocyte macrophage colony stimulating factor (rhGM-CSF) given as daily short infusions - a phase I dose-toxicity study. Br J Cancer 1989, 59, 142-145.
30. 30. Donahue RE, Seehra J, Metzger M, et al. Human IL-3 and GM-CSF act synergistically in stimulating hematopoiesis in primates. Science 1988, 241, 1820-1923.
31. 31. Krumwieh D, Seiler FR. In vivo effects of recombinant colony stimulating factors on hematopoiesis in cynamolgus monkeys. Transplant Proc 1989, 21, 2964-2967.
32. 32. Geissler K, Valent P, Mayer P, et al. Recombinant human interleukin-3 expands the pool of circulating hematopoietic progenitor cells in primates - synergism with recombinant human granulocyte/macrophage colony-stimulating factor. Blood 1990, 75, 2305-2310.
33. 33. Mayer P, Valent P, Schmidt G, Liehl E, Bettelheim P. The in vivo effects of recombinant human interleukin-3: demonstration of basophil differentiation factor, histamine-producing activity, and priming of GM-CSF responsive progenitors in nonhuman primates. Blood 1989, 74, 613-621.
34. 34. Naparstek E, Hardan Y, Ben-Shahar M, et al. Enhanced marrow recovery by short preincubation of marrow allografts with human recombinant interleukin-3 and granulocyte-macrophage colony stimulating factor. Blood 1992, 80, 1673-1678.
35. 35. Morstyn G, Lieschke GJ, Sheridan W, Layton J, Cebon J, Fox RM. Clinical experience with recombinant human granulocyte colony-stimulating factor. Semin Hematol 1989, 26, 9-13.
36. 36. Maekawa T, Metcalfe D, Gearing DP. Enhanced suppression of human myeloid leukemic cell lines by combinations of IL-6, LIF, GM-CSF and G-CSF. Int J Cancer 1990, 45, 353-358.
37. 37. Frei EI, Canellos G. Dose: a critical factor in cancer chemotherapy. Ann J Med 1980, 69, 585-594.
38. 38. Miller AB, Hoogstraten G, Staquet M, Winkler A. Reporting results of cancer treatment. Cancer 1981, 47, 207-214.
39. 39. Steward WP, Scarffe JH, Dirix LY, et al. Granulocyte-macrophage colony stimulating factor (GM-CSF) after high-dose melphalan in patients with advanced colon cancer. Br J Cancer 1990, 61, 749-754.
40. 40. Antman KH, Griffin JD, Elias A, et al. Effect of recombinant human granulocyte-macrophage colony stimulating factor on chemotherapy induced myelosupression. N Engl J Med 1988, 319, 594-598.
41. 41. D'Hondt V, Weynants P, Humblet Y, et al. Dose-dependent interleukin-3 stimulation of thrombopoiesis and neutropoiesis in patients with small-cell lung carcinoma before and following chemotherapy: a placebo-controlled randomized phase Ib study. J Clin Oncol 1993, 11, 2063-2071.
42. 42. Ganser A, Lindemann A, Speipelt G, et al. Effects of recombinant human interleukin-3 in patients with normal hematopoiesis and in patients with bone marrow failure. Blood 1990, 76, 666-676.
43. 43. Ottmann OG, Ganser A, Seipelt G, Eder M, Schulz G, Hoelzer D. Effects of recombinant human interleukin-3 on human hematopoietic progenitor and precursor cells in vivo. Blood 1990, 76, 1494-1502.
44. 44. Postmus PE, Gietema JA, Damsma G, et al. Effects of recombinant human interleukin-3 in patients with relapsed small cell lung cancer treated with chemotherapy: a dose-finding study. J Clin Oncol 1992, 10, 1131-1140.
45. 45. Devereux S, Linch DC, Campos CD, Spitle MF, Jelliffe AM. Transient leukopenia induced by granulocyte macrophage colony stimulating factor. Lancet 1987, 2, 1523-1524.
46. 46. Herrmann F, Schulz G, Lindemann A, et al. Hematopoietic responses in patients with advanced malignancy treated with recombinant human granulocyte-macrophage colony stimulating factor. J Clin Oncol 1989, 7, 159-167.
47. 47. Lieschke GJ, Maher D, Cebon J, et al. Effects of bacterially synthesized recombinant human granulocyte-macrophage colony-stimulating factor in patients with advanced malignancy. Ann Intern Med 1989, 110, 357-364.
48. 48. Steward WP, Scarffe JH, Bonnem E, Crowther D. Clinical studies with recombinant human granulocyte-macrophage colony stimulating factor. Int J Cell Cloning 1990, 8, 335-346.
49. 49. Klingemann HG, Eaves CJ. Colony stimulating factors. Bone Marrow Transplant 1988, 3, 177-184.
50. 50. Krumwieh D, Weinmann E, Seiler FR. Human recombinant derived IL-3 and GM-CSF in hematopoiesis of normal cynomolgus monkeys. Behring Inst Mitt 1988, 83, 250-257.
51. 51. Groopman JE, Molina JM, Scadden DT. Hematopoietic growth factors. Biology and clinical applications. N Engl J Med 1989, 321, 1449-1459.
52. 52. Vadhan-Raj S, Keating M, LeMaistre A, et al. Effects of recombinant human granulocyte-macrophage colony-stimulating factor in patients with myelodysplastic syndromes. N Engl J Med 1987, 317, 1545-1552.
53. 53. Lieschke GJ, Cebon J, Morstyn G. Characterisation of the clinical effects after the first dose of bacterially synthesised recombinant human granulocyte colony-stimulating factor. Blood 1989, 74, 2634-2643.
54. 54. Lord BI, Molineux G, Pojda Z, Souza LM, Mermod JJ, Dexter TM. Myeloid cell kinetics in mice treated with recombinant interleukin-3, granulocyte colony stimulating factor (CSF) or granulocyte-macrophage CSF in vitro. Blood 1991, 77, 2154-2159.
55. 55. Lord BI, Gurney H, Chang J, Thatcher N, Crowther N, Dexter TM. Haemopoietic cell kinetics in humans treated with rGM-CSF. Int J Cancer 1992, 50, 26-31.
56. 56. Lord BI, Testa NG, Bretti S, et al. Haemopoietic progenitor and myeloid cell kinetics in humans treated with interleukin-3 and granulocyte-macrophage colony-stimulating factor in combination. Int J Cancer 1994, 59, 483-490.
57. 57. Bruno E, Cooper RJ, Briddell RA, Hoffman R. Further examination of the effects of recombinant cytokines on the proliferation of human megakaryocyte progenitor cells. Blood 1991, 77, 2339-2346.
58. 58. Fay JW, Lazarus H, Herzig R, et al. Sequential administration of recombinant human interleukin-3 and granulocyte macrophage-colony stimulating factor after autologous bone marrow transplantation for malignant lymphoma: a phase I/II multicenter study. Blood 1994, 76, 2151-2157.