Phase I pharmacokinetic and pharmacodynamic study of recombinant human endostatin in patients with advanced solid tumors

Journal of Clinical Oncology

Volumn 21, Issue 2, 2003, Pages 223-231

  Thomas, James P ^a   Arzoomanian, Rhoda Z ^a   Alberti, Dona ^a   Marnocha, Rebecca ^a   Lee, Fred ^a   Friedl, Andreas ^a   Tutsch, Kendra ^a   Dresen, Amy ^a   Geiger, Peter ^a   Pluda, James ^a   Fogler, William ^a   Schiller, Joan H ^a   Wilding, George ^a  

^a UNIVERSITY OF WISCONSIN   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ENDOSTATIN; GROWTH FACTOR; VASCULOTROPIN; ANGIOGENESIS INHIBITOR; COLLAGEN; ENDOTHELIAL CELL GROWTH FACTOR; FIBROBLAST GROWTH FACTOR 2; LYMPHOKINE; PEPTIDE FRAGMENT; RECOMBINANT PROTEIN; SIGNAL PEPTIDE; VASCULOTROPIN A;

ADVANCED CANCER; ANTINEOPLASTIC ACTIVITY; ARTICLE; CANCER PATIENT; CLINICAL TRIAL; COMPUTER ASSISTED TOMOGRAPHY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG ERUPTION; DRUG METABOLISM; HUMAN; MASS SPECTROMETRY; MICROVASCULATURE; MULTIPLE CYCLE TREATMENT; NUCLEAR MAGNETIC RESONANCE IMAGING; PHASE 1 CLINICAL TRIAL; POSITRON EMISSION TOMOGRAPHY; PRIORITY JOURNAL; SOLID TUMOR; TREATMENT RESPONSE; TUMOR VASCULARIZATION; ULTRASOUND; WESTERN BLOTTING; ADULT; AGED; BLOOD; DIAGNOSTIC IMAGING; DOSE RESPONSE; FEMALE; INTRAVENOUS DRUG ADMINISTRATION; MALE; METABOLISM; MIDDLE AGED; NEOPLASM; NEOVASCULARIZATION (PATHOLOGY); TISSUE DISTRIBUTION; VASCULARIZATION;

ADULT; AGED; ANGIOGENESIS INHIBITORS; BLOTTING, WESTERN; COLLAGEN; DIAGNOSTIC IMAGING; DOSE-RESPONSE RELATIONSHIP, DRUG; ENDOSTATINS; ENDOTHELIAL GROWTH FACTORS; FEMALE; FIBROBLAST GROWTH FACTOR 2; HUMANS; INFUSIONS, INTRAVENOUS; INTERCELLULAR SIGNALING PEPTIDES AND PROTEINS; LYMPHOKINES; MALE; MIDDLE AGED; NEOPLASMS; NEOVASCULARIZATION, PATHOLOGIC; PEPTIDE FRAGMENTS; RECOMBINANT PROTEINS; TISSUE DISTRIBUTION; VASCULAR ENDOTHELIAL GROWTH FACTOR A; VASCULAR ENDOTHELIAL GROWTH FACTORS;

EID: 0037440123     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2003.12.120     Document Type: Article

References (60)

1. Hagedorn M, Bikfalvi A: Target molecules for anti-angiogenic therapy: From basic research to clinical trials. Crit Rev Oncol Hematol 34:89-110, 2000
2. Harris AL: Anti-angiogenesis therapy and strategies for integrating it with adjuvant therapy. Recent Results Cancer Res 152:341-352, 1998
3. Saphir A: Angiogenesis: The unifying concept in cancer? J Natl Cancer Inst 89:1658-1659, 1997
4. Folkman J: Fighting cancer by attacking its blood supply. Sci Am 275:150-154, 1996
5. Folkman J: New perspectives in clinical oncology from angiogenesis research. Eur J Cancer 32A:2534-2539, 1996
6. Shibuya M: Structure and function of VEGF/VEGF-receptor system involved in angiogenesis. Cell Struct Funct 26:25-35, 2001
7. Cross MJ, Claesson-Welsh L: FGF and VEGF function in angiogenesis: Signalling pathways, biological responses and therapeutic inhibition. Trends Pharmacol Sci 22:201-207, 2001
8. Potgens AJ, Westphal HR, de Waal RM, et al: The role of vascular permeability factor and basic fibroblast growth factor in tumor angiogenesis. Biol Chem Hoppe-Seyler 376:57-70, 1995
9. Sim BK, MacDonald NJ, Gubish ER: Angiostatin and endostatin: Endogenous inhibitors of tumor growth. Cancer Metastasis Rev 19:181-190, 2000
10. O'Reilly MS, Boehm T, Shing Y, et al: Endostatin: An endogenous inhibitor of angiogenesis and tumor growth. Cell 88:277-285, 1997
11. Zatterstrom UK, Felbor U, Fukai N, et al: Collagen XVIII/endostatin structure and functional role in angiogenesis. Cell Struct Funct 25:97-101, 2000
12. Boehm T, Folkman J, Browder T, et al: Antiangiogenic therapy of experimental cancer does not induce acquired drug resistance. Nature 390:404-407, 1997
13. Rehn M, Veikkola T, Kukk-Valdre E, et al: Interaction of endostatin with integrins implicated in angiogenesis. Proc Natl Acad Sci U S A 98:1024-1029, 2001
14. Ding I, Sun JZ, Fenton B, et al: Intratumoral administration of endostatin plasmid inhibits vascular growth and perfusion in MCa-4 murine mammary carcinomas. Cancer Res 61:526-531, 2001
15. Bloch W, Huggel K, Sasaki T, et al: The angiogenesis inhibitor endostatin impairs blood vessel maturation during wound healing. FASEB J 14:2373-2376, 2000
16. Kim YM, Jang JW, Lee OH, et al: Endostatin inhibits endothelial and tumor cellular invasion by blocking the activation and catalytic activity of matrix metalloproteinase. Cancer Res 60:5410-5413, 2000
17. Yokoyama Y, Green JE, Sukhatme VP, et al: Effect of endostatin on spontaneous tumorigenesis of mammary adenocarcinoma in a transgenic mouse model. Cancer Res 60:4362-4365, 2000
18. Bertolini F, Fusetti L, Mancuso P, et al: Endostatin, an antiangiogenic drug, induces tumor stabilization after chemotherapy or anti-CD20 therapy in a NOD/SCID mouse model of human high-grade non-Hodgkin lymphoma. Blood 96:282-287, 2000
19. Dixelius J, Larsson H, Sasaki T, et al: Endostatin-induced tyrosine kinase signaling through the Shb adaptor protein regulates endothelial cell apoptosis. Blood 95:3403-3411, 2000
20. Perletti G, Concari P, Giardini R, et al: Antitumor activity of endostatin against carcinogen-induced rat primary mammary tumors. Cancer Res 60:1793-1796, 2000
21. Kruger EA, Duray PH, Tsokos MG, et al: Endostatin inhibits microvessel formation in the ex vivo rat aortic ring angiogenesis assay. Biochem Biophys Res Commun 268:183-191, 2000
22. Yoon SS, Eto H, Lin CM, et al: Mouse endostatin inhibits the formation of lung and liver metastases. Cancer Res 59:6251-6256, 1999
23. Sasaki T, Larsson H, Kreuger J, et al: Structural basis and potential role of heparin/heparan sulfate binding to the angiogenesis inhibitor endostatin. EMBO J 18:6240-6248, 1999
24. Taddei L, Chiarugi P, Brogelli L, et al: Inhibitory effect of full-length human endostatin on in vitro angiogenesis. Biochem Biophys Res Commun 263:340-345, 1999
25. Yamaguchi N, Anand-Apte B, Lee M, et al: Endostatin inhibits VEGF-induced endothelial cell migration and tumor growth independently of zinc binding. EMBO J 18:4414-4423, 1999
26. Chang Z, Choon A, Friedl A: Endostatin binds to blood vessels in situ independent of heparan sulfate and does not compete for fibroblast growth factor-2 binding. Am J Pathol 155:71-76, 1999
27. Dhanabal M, Volk R, Ramchandran R, et al: Cloning, expression, and in vitro activity of human endostatin. Biochem Biophys Res Commun 258:345-352, 1999
28. Dhanabal M, Ramchandran R, Waterman MJ, et al: Endostatin induces endothelial cell apoptosis. J Biol Chem 274:11721-11726, 1999
29. Dhanabal M, Ramchandran R, Volk R, et al: Endostatin: Yeast production, mutants, and antitumor effect in renal cell carcinoma. Cancer Res 59:189-197, 1999
30. Boehm T, O'Reilly MS, Keough K, et al: Zinc-binding of endostatin is essential for its antiangiogenic activity. Biochem Biophys Res Commun 252:190-194, 1998
31. Hanna NN, Seetharam S, Mauceri H, et al: Antitumor interaction of short-course endostatin and ionizing radiation. Cancer J 6:287-293, 2000
32. Scappaticci FA, Smith R, Pathak A, et al: Combination angiostatin and endostatin gene transfer induces synergistic antiangiogenic activity in vitro and antitumor efficacy in leukemia and solid tumors in mice. Mol Ther J Am Soc Gene Ther 3:186-196, 2001
33. Yokoyama Y, Dhanabal M, Griffioen AW, et al: Synergy between angiostatin and endostatin: Inhibition of ovarian cancer growth. Cancer Res 60:2190-2196, 2000
34. Yamagata M, Shiratori Y, Dan Y, et al: Serum endostatin levels in patients with hepatocellular carcinoma. Ann Oncol 11:761-762, 2000
35. Feldman AL, Pak H, Yang JC, et al: Serum endostatin levels are elevated in patients with soft tissue sarcoma. Cancer 91:1525-1529, 2001
36. Kuroi K, Tanaka C, Toi M: Circulating levels of endostatin in cancer patients. Oncol Rep 8:405-409, 2001
37. Feldman AL, Tamarkin L, Paciotti GF, et al: Serum endostatin levels are elevated and correlate with serum vascular endothelial growth factor levels in patients with stage IV clear cell renal cancer. Clin Cancer Res 6:4628-4634, 2000
38. John H, Preissner KT, Forssmann WG, et al: Novel glycosylated forms of human plasma endostatin and circulating endostatin-related fragments of collagen XV. Biochemistry 38:10217-10224, 1999
39. Hefler L, Tempfer C, Kainz C, et al: Serum concentrations of endostatin in patients with vulvar cancer. Gynecol Oncol 74:151-152, 1999
40. Nagashima M, Asano G, Yoshino S: Imbalance in production between vascular endothelial growth factor and endostatin in patients with rheumatoid arthritis. J Rheumatol 27:2339-2342, 2000
41. Hebbar M, Peyrat JP, Hornez L, et al: Increased concentrations of the circulating angiogenesis inhibitor endostatin in patients with systemic sclerosis. Arthritis Rheum 43:889-893, 2000
42. Wen W, Moses MA, Wiederschain D, et al: The generation of endostatin is mediated by elastase. Cancer Res 59:6052-6056, 1999
43. Feibor U, Dreier L, Bryant RA, et al: Secreted cathepsin L generates endostatin from collagen XVIII. EMBO J 19:1187-1194, 2000
44. Ferreras M, Felbor U, Lenhard T, et al: Generation and degradation of human endostatin proteins by various proteinases. FEBS Lett 486:247-251, 2000
45. Jiang L, Jha V, Dhanabal M, et al: Intracellular Ca(2+) signaling in endothelial cells by the angiogenesis inhibitors endostatin and angiostatin. Am J Physiol Cell Physiol 280:C1140-C1150, 2001
46. Shichiri M, Hirata Y: Antiangiogenesis signals by endostatin. FASEB J 15:1044-1053, 2001
47. MacDonald N, Shivers W, Narum D, et al: The role of tropomyosin and the cytoskeleton in the antitumor activity of endostatin. NCI-EORTC-AACR International Conference, Miami, FL, October 2001
48. Endostatin Investigational Drug Brochure, EntreMed, Rockville, MD, 1999.
49. Berger AC, Feldman AL, Gnant MF, et al: The angiogenesis inhibitor, endostatin, does not affect murine cutaneous wound healing. J Surg Res 91:26-31, 2000
50. Fogler WE, Song M, Supko JG, et al: Recombinant human endostatin demonstrates consistent and predictable pharmacokinetics following intravenous bolus administration to cancer patients. Proc Am Soc Clin Oncol 20:274, 2001
51. Miles KA: Tumour angiogenesis and its relation to contrast enhancement on computed tomography: A review. Eur J Radiol 30:198-205, 1999
52. Cao Y: Endogenous angiogenesis inhibitors and their therapeutic implications. Int J Biochem Cell Biol 33:357-369, 2001
53. Gibaldi M: Regulating angiogenesis: A new therapeutic strategy. J Clin Pharmacol 38:898-903, 1998
54. Rowe PM: What is all the hullabaloo about endostatin? Lancet 353:732, 1999
55. Cohen J: Behind the headlines of endostatin's ups and downs. Science 283:1250-1251, 1999
56. Marshall E: The power of the front page of The New York Times. Science 280:996-997, 1998
57. Phillips P: Cancer experts offer healthy dose of skepticism toward hype over antiangiogenesis agents. JAMA 279:1936-1937, 1998
58. Ryan CJ, Wilding G: Angiogenesis inhibitors: New agents in cancer therapy. Drugs Aging 17:249-255, 2000
59. Mundhenke C, Thomas JP, Wilding G, et al: Tissue examination to monitor antiangiogenic therapy: A phase I clinical trial of endostatin. Clin Cancer Res 7:3366-3374, 2001
60. Ding YH, Javaherian K, Lo KM, et al: Zinc-dependent dimers observed in crystals of human endostatin. Proc Natl Acad Sci U S A 95:10443-10448, 1998