Randomized, blinded, placebo-controlled phase I trial of pegylated recombinant human megakaryocyte growth and development factor with filgrastim after dose-intensive chemotherapy in patients with advanced cancer

Blood

Volumn 89, Issue 9, 1997, Pages 3118-3128

  Basser, Russell L ^a   Rasko, John E J ^b   Clarke, Kerrie ^b   Cebon, Jonathan ^b   Green, Michael D ^b   Grigg, Andrew P ^b   Zalcberg, John ^b   Cohen, Brian ^b   O'Byrne, Joan ^b   Menchaca, Dora M ^b   Fox, Richard M ^b   Begley, C Glenn ^b  

^a ROYAL MELBOURNE HOSPITAL   (Australia)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

CARBOPLATIN; MEGAKARYOCYTE GROWTH AND DEVELOPMENT FACTOR; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR;

ADULT; ADVANCED CANCER; AGED; ANALYTIC METHOD; ARTICLE; CANCER CHEMOTHERAPY; CELL MATURATION; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFECT; DRUG SAFETY; FEMALE; HUMAN; IMMUNE RESPONSE; MAJOR CLINICAL STUDY; MALE; MEGAKARYOPOIESIS; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SINGLE BLIND PROCEDURE; SUBCUTANEOUS DRUG ADMINISTRATION; THROMBOCYTE AGGREGATION; THROMBOCYTOPENIA;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BLOOD PLATELETS; CARBOPLATIN; CYCLOPHOSPHAMIDE; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; DRUG THERAPY, COMBINATION; FEMALE; FILGRASTIM; HUMANS; INJECTIONS, SUBCUTANEOUS; MALE; MIDDLE AGED; NEOPLASMS; PLACEBOS; PLATELET AGGREGATION; PLATELET COUNT; POLYETHYLENE GLYCOLS; RECOMBINANT PROTEINS; THROMBOPOIETIN;

EID: 17944389931     PISSN: 00064971     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (40)

1. Wood WC, Budman DR, Korzus AH, Cooper MR, Younger J, Hart RD, Moore A, Ellerton JA, Norton L, Ferree CR, Ballow AC, Frei E III, Henderson IC: Dose and dose intensity of adjuvant chemotherapy for stage II, node-positive breast carcinoma. N Engl J Med 330:1253, 1994
2. Philip T, Guglielmi C, Hagenbeek A, Somers R, Van der Lelie H, Bron D, Sonneveld P, Gisselbrecht C, Cahn JY, Harousseau JL, Coiffier B, Biron P, Mandelli F, Chauvin F: Autologous bone marrow transplantation as compared with salvage chemotherapy in relapses of chemotherapy-sensitive non Hodgkin's lymphoma. N Engl J Med 333:1540, 1995
3. Kaye SB, Lewis CR, Paul J, Duncan ID, Gordon HK, Kitchener HC, Cruickshank DJ, Atkinson RJ, Soukop M, Rankin EM, Cassidy J, Davis JA, Reed NS, Crawford SM, MacLean A, Swapp GA, Sarkar TK, Kennedy JH, Symonds RP: Randomised study of two doses of cisplatin with cyclophosphamide in epithelial ovarian cancer. Lancet 340:329, 1992
4. Morstyn G, Campbell L, Souza LM, Alton NK, Keech J, Green M, Sheridan W, Metcalf D, Fox R: Effect of granulocyte colony stimulating factor on neutropenia induced by cytotoxic chemotherapy. Lancet 1:667, 1988
5. Lieschke GJ, Maher D, Cebon J, O'Connor M, Green M, Sheridan W, Boyd A, Rallings M, Bonnem E, Metcalf D, Burgess AW, McGrath K, Fox RM, Morstyn G: Effects of bacterially synthesized recombinant human granulocyte-macrophage colony-stimulating factor in patients with advanced malignancy. Ann Intern Med 110:357, 1989
6. Smith JW, Longo DL, Alvord WG, Janie JE, Sharfman WH, Cause BL, Curti BD, Creekmore SP, Holmlund JT, Fenton RG, Sznol M, Miller LL, Shimizu M, Oppenheim JJ, Fiem SJ, Hursey JC, Powers GC, Urba WJ: The effects of treatment with interleukin-1α on platelet recovery after high-dose carboplatin. N Engl J Med 328:756, 1993
7. D'Hondt V, Humblet Y, Guillaume T, Baatout S, Chatelain C, Berlière M, Longueville J, Feyens AM, De Greve J, Van Oosterom A, Von Graffenried B, Donnez J, Symann M: Thrombopoietic effects and toxicity of interleukin-6 in patients with ovarian cancer before and after chemotherapy: A multicentric placebo-controlled, randomized phase Ib study. Blood 85:2347, 1995
8. Gordon MS, McCaskill-Stevens WJ, Battiato LA, Loewy J, Loesch D, Breedon E, Hoffman R, Beach KJ, Kuca B, Kaye J, Sledge GW Jr: A phase I trial of recombinant human interleukin-11 (Neumega rhIL-11 growth factor) in women with breast cancer receiving chemotherapy. Blood 87:3615, 1996
9. Ulich TR, Del Castillo J, Yin S, Swift S, Padilla D, Senaldi G, Bennett L, Shutter J, Bogenberger J, Sun D, Samal B, Shimamoto G, Lee R, Steinbrink R, Boone T, Sheridan WT, Hunt P: Megakaryocyte growth and development factor ameliorates carboplatin-induced thrombocytopenia in mice. Blood 86:971, 1995
10. Hokom MM, Lacey D, Kinstler OB, Choi E, Kaufman S, Faust J, Rowan C, Dwyer E, Nichol JL, Grasel T, Wilson J, Steinbrink R, Hecht R, Winters D, Boone T, Hunt P: Pegylated megakaryocyte growth and development factor abrogates the lethal thrombocytopenia associated with carboplatin and irradiation in mice. Blood 86:4486, 1995
11. Kaushansky K: Thrombopoietin: The primary regulator of platelet production. Blood 86:419, 1995
12. Bartley TD, Bogenberger J, Hunt P, Li PS, Lu HS, Martin F, Chang M-S, Samal B, Nichol JL, Swift S, Johnson MJ, Hsu R-Y, Parker VP, Suggs S Skrine JD, Merewether LA, Clogston C, Hsu E, Hokom MM, Hornkohl A, Choi E, Pangelinan M, Sun Y, Mar J, McNinch J, Simonet L, Jacobsen F, Xie C, Shutter J, Chute H, Basu R, Selander L, Trollinger D, Sieu L, Padilla D, Trail G, Elliott G, Izumi R, Covey T, Crouse J, Garcia A, Xu W, Del Castillo J, Biron J, Cole S, Hu MC-T, Pacifici R, Ponting I, Saris C, Wen D, Yung YP, Lin H, Bosselman RA: Identification and cloning of a megakaryocyte growth and development factor that is a ligand for the cytokine receptor mpl. Cell 77:1117, 1994
13. Nichol JL, Hokom MM, Hornkohl A, Sheridan WP, Ohashi H, Kato T, Li YS, Bartley TD, Choi E, Bogenberger J, Skrine JD, Knudten A, Chen J, Trail G, Sleeman L, Cole S, Grampp G, Hunt P: Megakaryocyte growth and development factor. Analyses of in vitro effects on human megakaryopoiesis and endogenous serum levels during chemotherapy-induced thrombocytopenia. J Clin Invest 95:2973, 1995
14. Farese AM, Hunt P, Boone T, Mac Vittie TJ: Recombinant human megakaryocyte growth and development factor stimulates thrombocytopoiesis in normal nonhuman primates. Blood 86:54, 1995
15. Harker LA, Hunt P, Marzec UM, Kelly AB, Tomer A, Hanson SR, Stead RB: Regulation of platelet production and function by megakaryocyte growth and development factor (MGDF) in nonhuman primates. Blood 87:1833, 1996
16. Basser RL, Rasko JEJ, Clarke K, Cebon J, Green MD, Hussein S, Menchaca D, Tomita D, Marty J, Fox RM, Begley CG: Thrombopoietic effects of pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF) in patients with advanced cancer. Lancet 348:1279, 1996
17. Mangioni C, Bolis G, Pecorelli S, Bragman K, Epis A, Favalli G, Gambino A, Landoni F, Presti M, Torri W, Vassena L, Zanaboni F, Marsoni S: Randomized trial in advanced ovarian cancer comparing cisplatin and carboplatin. J Natl Cancer Inst 81:1464, 1989
18. Aisner J, Sinibaldi V, Eisenberger M: Carboplatin in the treatment of squamous cell head and neck cancers. Semin Oncol 19:60, 1992 (suppl 2)
19. Bunn PA Jr: Clinical experience with carboplatin (paraplatin) in lung cancer. Semin Oncol 19:1, 1992 (suppl 2)
20. Martin M, Diaz Rubio E, Casado A, Santabarbara P, Lopez Vega JM, Adrover E, Lenaz L: Carboplatin: An active drug in metastatic breast cancer. J Clin Oncol 10:433, 1992
21. Shea TC, Flaherty M, Elias A, Eder JP, Antman K, Begg C, Schnipper L, Frei E III, Henner WD: A phase I clinical and pharmacokinetic study of carboplatin and autologous bone marrow support. J Clin Oncol 7:651, 1989
22. Shea TC, Mason JR, Storniolo AM, Newton B, Breslin M, Mullen M, Ward DM, Miller L, Christian M, Taetle R: Sequential cycles of high-dose carboplatin administered with recombinant human granulocyte-macrophage colony-stimulating factor and repeated infusions of autologous peripheral blood progenitor cells: A novel and effective method for delivering multiple courses of dose-intensive therapy. J Clin Oncol 10:464, 1992
23. Toner G, Green M, Bishop J, McKendrick J, Sheridan W, Maher D, McKeever S, Lockbaum P, Dziem G, Hoffman E, Fox R: Dose escalation of carboplatin (CBDCA) and cylophosphamide (CTX) with filgrastim (r-metHuG-CSF) in advanced solid tumors. Proc Am Soc Clin Oncol 12:274, 1993 (abstr)
24. Toombs CF, Young CH, Glaspy JA, Varnum BC: Megakaryocyte growth and development factor (MGDF) moderately enhances in-vitro platelet aggregation. Thromb Res 80:23, 1995
25. Montrucchio G, Brizzi MF, Calosso G, Marengo S, Pegoraro L, Camussi G: Effects of recombinant human megakaryocyte growth and development factor on platelet activation. Blood 87:2762, 1996
26. O'Malley CJ, Rasko JEJ, Basser RL, McGrath KM, Hopkins W, Grigg A, Cebon J, Green M, Fox R, Berndt MC, Begley CG: Administration of pegylated recombinant human megakaryocyte growth and development factor to humans stimulates the production of functional platelets that show no evidence of in vivo activation. Blood 88:3288, 1996
27. Dale GL, Friese P, Hynes LA, Burstein SA: Demonstration that thiazole-orange-positive platelets in the dog are less than 24 hours old. Blood 85:1822, 1995
28. Grigg AP, Roberts AW, Raunow H, Houghton S, Layton JE, Boyd AW, McGrath KM, Maher D: Optimizing dose and scheduling of filgrastim (granulocyte colony-stimulating factor) for mobilization and collection of peripheral blood progenitor cells in normal volunteers. Blood 86:4437, 1995
29. Crawford J, Ozer H, Stoller R, Johnson D, Lyman G, Tabbara I, Kris M, Grous J, Picozzi V, Rausch G, Smith R, Gradishar W, Yahanda A, Vincent M, Stewart M, Glaspy J: Reduction by granulocyte colony-stimulating factor of fever and neutropenia induced by chemotherapy in patients with small-cell lung cancer. N Engl J Med 325:164, 1991
30. Alexander WS, Roberts AW, Nicola NA, Li R, Metcalf D: Deficiencies in progenitor cells of multiple hematopoietic lineages and defective megakaryopoiesis in mice lacking the thrombopoietin receptor c-mpl. Blood 87:2162, 1996
31. Sitnicka E, Lin N, Priestley GV, Fox N, Broudy VC, Wolf NS, Kaushansky K: The effect of thrombopoietin on the proliferation and differentiation of murine hematopoietic cells. Blood 87:4998, 1996
32. De Haan G, Dontje B, Engel C, Loeffler M, Nijhof W: Prophylactic pretreatment of mice with hematopoietic growth factors induces expansion of primitive cell compartments and results in protection against 5-fluorouracil-induced toxicity. Blood 87:4581, 1996
33. Ginsburg AD: Platelet function in patients with high platelet counts. Ann Intern Med 82:506, 1975
34. Buss DH, Cashell AW, O'Connor ML, Richards F 2d, Case LD: Occurrence, etiology, and clinical significance of extreme thrombocytosis. Am J Med 96:247, 1994
35. Bunn PA Jr, Ridgway EC: Paraneoplastic syndromes, in DeVita VT Jr, Hellman S, Rosenberg SA (eds): Cancer: Principles and Practice of Oncology. Philadelphia, PA, Lippincott, 1993, p 2026
36. Rasko JEJ, Basser RL, Boyd J, Mansfield R, O'Malley CJ, Hussein S, Berndt MC, Clarke K, O'Byrne J, Sheridan WP, Grigg AJ, Begley CG: Multilineage mobilization of peripheral blood progenitor cells in humans following administration of PEG-rHuMGDF. Br J Haematol 1997 (in press)
37. Basser RL, Begley CG, Mansfield R, To B, Juttner C, Maher D, Fox R, Cebon J, Szer J, Grigg A, Clarke K, Marty J, Menchaca D, Thompson B, Russell I, Collins J, Green M: Mobilization of PBPC by priming with stem cell factor (SCF) before filgrastim compared to concurrent administration. Blood 86:687a, 1995 (abstr, suppl 1)
38. Geissler K, Peschel C, Niederwieser D, Strobl H, Goldschmitt J. Öhler L, Bettelheim P, Kalhs P, Huber C, Lechner K, Höcker P, Kolbe K: Potentiation of granulocyte colony-stimulating factor-induced mobilization of circulating progenitor cells by seven-day pretreatment with interleukin-3. Blood 87:2732, 1996
39. Roberts AW, DeLuca E, Begley CG, Basser R, Grigg AP, Metcalf D: Broad inter-individual variations in circulating progenitor cell numbers induced by granulocyte colony-stimulating factor therapy. Stem Cells 13:512, 1995
40. Sheridan WP, Begley CG, Juttner CA, Szer J, To LB, Maher D, McGrath KM, Morstyn G, Fox RM: Effect of peripheral-blood progenitor cells mobilised by filgrastim (G-CSF) on platelet recovery after high-dose chemotherapy. Lancet 339:640, 1992