Phase I study of NGR-hTNF, a selective vascular targeting agent, in combination with cisplatin in refractory solid tumors

Clinical Cancer Research

Volumn 17, Issue 7, 2011, Pages 1964-1972

  Gregorc, Vanesa ^a   De Braud, Filippo G ^b   De Pas, Tommaso M ^b   Scalamogna, Roberto ^b   Citterio, Giovanni ^a   Milani, Alessandra ^b   Boselli, Sabrina ^b   Catania, Chiara ^b   Donadoni, Giovanni ^a   Rossoni, Gilda ^a   Ghio, Domenico ^a,d   Spitaleri, Gianluca ^b   Ammannati, Cristina ^c   Colombi, Scialini ^c   Caligaris Cappio, Federico ^a,d   Lambiase, Antonio ^c   Bordignon, Claudio ^c,d  

^a SAN RAFFAELE HOSPITAL   (Italy)

^b EUROPEAN INSTITUTE OF ONCOLOGY   (Italy)

^c MOLMED S P A   (Italy)

^d VITA SALUTE SAN RAFFAELE UNIVERSITY   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

ALKALINE PHOSPHATASE; ANTINEOPLASTIC AGENT; ASPARAGINYLGLYCYLARGININE HUMAN TUMOR NECROSIS FACTOR; ASPARTATE AMINOTRANSFERASE; CISPLATIN; CREATININE; GAMMA GLUTAMYLTRANSFERASE; PLATINUM COMPLEX; TUMOR NECROSIS FACTOR ALPHA; TUMOR NECROSIS FACTOR RECEPTOR; UNCLASSIFIED DRUG;

ADULT; AGED; ALKALINE PHOSPHATASE BLOOD LEVEL; ANOREXIA; ANTINEOPLASTIC ACTIVITY; APPLICATION SITE REACTION; AREA UNDER THE CURVE; ARTICLE; ASCITES; ASTHENIA; ATELECTASIS; CANCER RESISTANCE; CARCINOID; CHEMOTHERAPY INDUCED EMESIS; CHILL; CLINICAL ARTICLE; COHORT ANALYSIS; CONSTIPATION; COUGHING; CREATININE BLOOD LEVEL; DIARRHEA; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG DOSE ESCALATION; DRUG FEVER; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TARGETING; DYSPHAGIA; DYSPNEA; DYSURIA; ESOPHAGUS STENOSIS; FATIGUE; FEMALE; HEART ATRIUM FLUTTER; HEART VENTRICLE EXTRASYSTOLE; HUMAN; HYPERBILIRUBINEMIA; HYPERGLYCEMIA; HYPERKALEMIA; HYPERMAGNESEMIA; HYPERTENSION; HYPERURICEMIA; HYPOALBUMINEMIA; HYPOCALCEMIA; HYPOKALEMIA; HYPOMAGNESEMIA; HYPONATREMIA; HYPOTENSION; HYPOXIA; KIDNEY FAILURE; LEUKOPENIA; LOW DRUG DOSE; LUNG CANCER; LUNG NON SMALL CELL CANCER; LYMPHOCYTOPENIA; MALE; MAXIMUM PLASMA CONCENTRATION; MESOTHELIOMA; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MUSCLE WEAKNESS; NAUSEA; NEUTROPENIA; OLIGURIA; PAIN; PERIPHERAL EDEMA; PHASE 1 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; RESPIRATORY FAILURE; SIDE EFFECT; SOLID TUMOR; THROMBOCYTE; TIME TO MAXIMUM PLASMA CONCENTRATION; TINNITUS; TOXIC SHOCK SYNDROME; TUMOR VASCULARIZATION; URETER OBSTRUCTION; VEIN OCCLUSION; WEIGHT REDUCTION;

AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CISPLATIN; DISEASE-FREE SURVIVAL; FEMALE; HUMANS; MALE; MIDDLE AGED; NEOPLASMS; RECEPTORS, TUMOR NECROSIS FACTOR; RECOMBINANT FUSION PROTEINS; TREATMENT OUTCOME; TUMOR NECROSIS FACTOR-ALPHA;

EID: 79953306455     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-10-1376     Document Type: Article

References (29)

1. Carswell EA, Old LJ, Kassel RL, Green S, Fiore N, Williamson B. An endotoxin-induced serum factor that causes necrosis of tumors. Proc Natl Acad Sci U S A 1975;72:3666-70.
2. Balkwill F. Tumour necrosis factor and cancer. Nat Rev Cancer AOP , published online 3 April 2009; doi:10.1038/nrc2628.
3. Lejeune FJ, Lienard D, Matter M, Ruegg C. Efficiency of recombinant human TNF in human cancer therapy. Cancer Immun. 2006;6:6.
4. Creaven PJ, Brenner DE, Cowens JW, Huben RP, Wolf RM, Takita H, et al. A phase I clinical trial of recombinant human tumor necrosis factor given daily for five days. Cancer Chemother Pharmacol 1989;23:186-91. (Pubitemid 19076605)
5. Gamm H, Lindemann A, Mertelsmann R, Herrmann F. Phase I trial of recombinant human tumour necrosis factor alpha in patients with advanced malignancy. Eur J Cancer 1991;27:856-63.
6. Mittelman A, Puccio C, Gafney E, Coombe N, Singh B, Wood D, et al. A phase I pharmacokinetic study of recombinant human tumor necrosis factor administered by a 5-day continuous infusion. Invest New Drugs 1992;10:183-90.
7. Schwartz JE, Scuderi P, Wiggins C, Rudolph A, Hersh EM. A phase I trial of recombinant tumor necrosis factor (rTNF) administered by continuous intravenous infusion in patients with disseminated malignancy. Biotherapy 1989;1:207-14. (Pubitemid 20196464)
8. Wiedenmann B, Reichardt P, Rath U, Theilmann L, Sch€ule B, Ho AD, et al. Phase-I trial of intravenous continuous infusion of tumor necrosis factor in advanced metastatic carcinomas. J Cancer Res Clin Oncol 1989;115:189-92. (Pubitemid 19109379)
9. Fraker DL, Alexander HR, Pass HI. Biologic therapy with TNF: systemic administration and isolation-perfusion. In: De Vita V, Hellman S, Rosenberg S, editors. Biologic Therapy of Cancer: Principles and Practice. Philadelphia, PA: JB Lippincott Co.;1995:329-45.
10. Lienard D, Eggermont AM, Schraffordt Koops H, Kroon BB, Rosenkaimer F, Autier P, et al. Isolated perfusion of the limb with high-dose tumour necrosis factor-alpha (TNF-alpha), interferon-gamma (IFN-gamma) and melphalan for melanoma stage III. Results of a multicentre pilot study. Melanoma Res 1994;4 (Suppl 1):21-6. (Pubitemid 24144669)
11. Eggermont AM, Schraffordt Koops H, Lienard D, Kroon BB, van Geel AN, Hoekstra HJ, et al. Isolated limb perfusion with high-dose tumor necrosis factor-alpha in combination with interferon-gamma and melphalan for nonresectable extremity soft tissue sarcomas: a multicenter trial. J Clin Oncol 1996;14:2653-65. (Pubitemid 26329649)
12. Alexander HR, Brown CK, Bartlett DL, Libutti SK, Figg WD, Raje S, et al. Augmented capillary leak during isolated hepatic perfusion (IHP) occurs via tumor necrosis factor-independent mechanisms. Clin Cancer Res 1998;4:2357-62. (Pubitemid 28477899)
13. Curnis F, Sacchi A, Borgna L, Magni F, Gasparri A, Corti A. Enhancement of tumor necrosis factor alpha antitumor immunotherapeutic properties by targeted delivery to aminopeptidase N (CD13). Nat Biotechnol 2000;18:1185-90.
14. Corti A, Ponzoni M. Tumor vascular targeting with tumor necrosis factor alpha and chemotherapeutic drugs. Ann N Y Acad Sci 2004;1028:104-12. (Pubitemid 40361814)
15. Colombo G, Curnis F, De Mori GM, Gasparri A, Longoni C, Sacchi A, et al. Structure-activity relationships of linear and cyclic peptides containing the NGR tumor-homing motif. J Biol Chem 2002;277:47891-7. (Pubitemid 36159317)
16. Curnis F, Arrigoni G, Sacchi A, Fischetti L, Arap W, Pasqualini R, et al. Differential binding of drugs containing the NGR motif to CD13 isoforms in tumor vessels, epithelia, and myeloid cells. Cancer Res 2002;62:867-74. (Pubitemid 34126966)
17. Rangel R, Sun Y, Guzman-Rojas L, Ozawa MG, Sun J, Giordano RJ, et al. Impaired angiogenesis in aminopeptidase N-null mice. PNAS 2007;104:4588-93. (Pubitemid 47186269)
18. Curnis F, Sacchi A, Corti A. Improving chemotherapeutic drug penetration in tumors by vascular targeting and barrier alteration. J Clin Invest 2002;110:475-82. (Pubitemid 34919701)
19. Sacchi A, Gasparri A, Gallo-Stampino C, Toma S, Curnis F, Corti A, et al. (Synergistic antitumor activity of cisplatin, paclitaxel, and gemcitabine with tumor vasculature-targeted tumor necrosis factor-alpha. Clin Cancer Res 2006;12:175-82.
20. van Hensbergen Y, Broxtermann HJ, Rana S, van Diest PJ, Duyndam MC, Hoekman K, et al. Reduced growth, increased vascular area, and reduced response to cisplatin in CD13-overexpressing human ovarian cancer xenografts. Clin Cancer Res 2004;10:1180-91. (Pubitemid 38198920)
21. van Laarhoven HWM, Fiedler W, Desar IME, van Asten JJ, Marréaud S, Lacombe D, et al. Phase I clinical and magnetic resonance imaging study of the vascular agent NGR-hTNF in patients with advanced cancers (European Organization for Research and Treatment of Cancer Study 16041). Clin Cancer Res 2010;16:1315-23.
22. Gregorc V, Citterio C, Vitali G, Spreafico A, Scifo P, Borri A, et al. Defining the optimal biological dose of NGR-hTNF, a selective vascular targeting agent, in advanced solid tumours. Eur J Cancer 2010;46, 198-206.
23. Socinski MA, Langer CJ, Huang JE, Kolb MM, Compton P, Wang L, et al. Safety of bevacizumab in patients with non-small cell lung cancer and brain metastases. J Clin Oncol 2009;27:5255-61.
24. Sandler AB, Nemunaitis J, Denham C, von Pawel J, Cormier Y, Gatzemeier U, et al. Phase III trial of gemcitabine plus cisplatin versus cisplatin alone in patients with locally advanced or metastatic non-small-cell lung cancer. J Clin Oncol 2000;18:122-30. (Pubitemid 30036345)
25. Vogelzang NJ, Rusthoven JJ, Symanowsky J, Denham C, Kaukel E, Ruffie P, et al. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol 2003;21:2636-44. (Pubitemid 46606305)
26. van Heeckeren WJ, Bhakta S, Ortis J, Duerk J, Cooney MM, Dowlati A, et al. Promise of new vascular-disrupting agents balanced with cardiac toxicity: is it time for oncologists to get to know their cardiologists? J Clin Oncol 24:1485-8.
27. Kwak EL, Clark JW, Chabner B. Targeted agents: the rules of combination. Clin Cancer Res 13:5232-7.
28. Horsman MR, Siemann DW. Pathophysiologic effects of vascular targeting agents and the implications for combination with conventional therapies. Cancer Res 66:11520-39.
29. Aderka D, Sorkine P, Abu-Abid S, Lev D, Setton A, Cope AP, et al. Shedding kinetics of soluble tumor necrosis factor (TNF) receptors after sys-temic TNF leaking during isolated limb perfusion. J Clin Invest 101:650-9.