Phase 1 study of the antimesothelin immunotoxin SS1P in combination with pemetrexed and cisplatin for front-line therapy of pleural mesothelioma and correlation of tumor response with serum mesothelin, megakaryocyte potentiating factor, and cancer antigen 125

Cancer

Volumn 120, Issue 21, 2014, Pages 3311-3319

  Hassan, Raffit ^a   Sharon, Elad ^a   Thomas, Anish ^a   Zhang, Jingli ^b   Ling, Alexander ^a   Miettinen, Markku ^a   Kreitman, Robert J ^a   Steinberg, Seth M ^a   Hollevoet, Kevin ^a   Pastan, Ira ^a  

^a NATIONAL CANCER INSTITUTE   (United States)

^b NONE

Author keywords

immunotoxin; mesothelin; pleural mesothelioma; SS1P

Indexed keywords

ANTINEOPLASTIC AGENT; BIOLOGICAL MARKER; CA 125 ANTIGEN; CELL PROTEIN; CISPLATIN; IMMUNOTOXIN SS1P; MEGAKARYOCYTE POTENTIATING FACTOR; MESOTHELIN; PEMETREXED; UNCLASSIFIED DRUG; BACTERIAL TOXIN; EXOTOXIN; GLUTAMIC ACID DERIVATIVE; GLYCOSYLPHOSPHATIDYLINOSITOL ANCHORED PROTEIN; GUANINE; MONOCLONAL ANTIBODY; NICOTINAMIDE ADENINE DINUCLEOTIDE ADENOSINE DIPHOSPHATE RIBOSYLTRANSFERASE; SS1(DSFV)PE38; TOXA PROTEIN, PSEUDOMONAS AERUGINOSA; VIRULENCE FACTOR;

ADULT; AGED; ANEMIA; ANOREXIA; ARTICLE; BACKACHE; BLOOD LEVEL; CANCER CHEMOTHERAPY; CANCER FATIGUE; CANCER STAGING; CAUSE OF DEATH; CLINICAL EFFECTIVENESS; CONTROLLED STUDY; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG MECHANISM; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EDEMA; FATIGUE; FEMALE; FEVER; HUMAN; HYPOALBUMINEMIA; HYPONATREMIA; HYPOTENSION; IMMUNOGENICITY; LEG EDEMA; LEUKOPENIA; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; MIDDLE AGED; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; PLEURA MESOTHELIOMA; PRIORITY JOURNAL; PROTEIN DETERMINATION; PROTEIN EXPRESSION; PROTEIN FUNCTION; ANALOGS AND DERIVATIVES; BLOOD; CLINICAL TRIAL; LUNG NEOPLASMS; MAXIMUM TOLERATED DOSE; MESOTHELIOMA; PATHOLOGY; PLEURAL NEOPLASMS;

ADP RIBOSE TRANSFERASES; AGED; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BACTERIAL TOXINS; CA-125 ANTIGEN; CISPLATIN; EXOTOXINS; FEMALE; GLUTAMATES; GPI-LINKED PROTEINS; GUANINE; HUMANS; LUNG NEOPLASMS; MALE; MAXIMUM TOLERATED DOSE; MESOTHELIOMA; MIDDLE AGED; NEOPLASM STAGING; PLEURAL NEOPLASMS; VIRULENCE FACTORS;

EID: 84925032574     PISSN: 0008543X     EISSN: 10970142     Source Type: Journal    
DOI: 10.1002/cncr.28875     Document Type: Article

References (28)

1. Vogelzang NJ, Rusthoven JJ, Symanowski J, 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: 2636-2644.
2. Hassan R, Schweizer C, Lu KF, et al., Inhibition of mesothelin-CA-125 interaction in patients with mesothelioma by the anti-mesothelin monoclonal antibody MORAb-009: Implications for cancer therapy. Lung Cancer. 2010; 68: 455-459.
3. Chang K, Pai LH, Batra JK, Pastan I, Willingham MC,. Characterization of the antigen (CAK1) recognized by monoclonal antibody K1 present on ovarian cancers and normal mesothelium. Cancer Res. 1992; 52: 181-186.
4. Chang K, Pastan I,. Molecular cloning of mesothelin, a differentiation antigen present on mesothelium, mesotheliomas, and ovarian cancers. Proc Natl Acad Sci U S A. 1996; 93: 136-140.
5. Hassan R, Kreitman RJ, Pastan I, Willingham MC,. Localization of mesothelin in epithelial ovarian cancer. Appl Immunohistochem Mol Morphol. 2005; 13: 243-247.
6. Argani P, Iacobuzio-Donahue C, Ryu B, et al., Mesothelin is overexpressed in the vast majority of ductal adenocarcinomas of the pancreas: identification of a new pancreatic cancer marker by serial analysis of gene expression (SAGE). Clin Cancer Res. 2001; 7: 3862-3868.
7. Kelly RJ, Sharon E, Pastan I, Hassan, R,. Mesothelin-targeted agents in clinical trials and in preclinical development. Mol Cancer Ther. 2012; 11: 517-525.
8. Hassan R, Bera T, Pastan I,. Mesothelin: a new target for immunotherapy. Clin Cancer Res. 2004; 10: 3937-3942.
9. Hassan R, Remaley AT, Sampson ML, et al., Detection and quantitation of serum mesothelin, a tumor marker for patients with mesothelioma and ovarian cancer. Clin Cancer Res. 2006; 12: 447-453.
10. Robinson BW, Creaney J, Lake R, et al., Mesothelin-family proteins and diagnosis of mesothelioma. Lancet. 2003; 362: 1612-1616.
11. Hollevoet K, Nackaerts K, Thimpont J, et al., Diagnostic performance of soluble mesothelin and megakaryocyte potentiating factor in mesothelioma. Am J Respir Crit Care Med. 2010; 181: 620-625.
12. Onda M, Nagata S, Ho M, et al., Megakaryocyte potentiation factor cleaved from mesothelin precursor is a useful tumor marker in the serum of patients with mesothelioma. Clin Cancer Res. 2006; 12: 4225-4231.
13. Hollevoet K, Reitsma JB, Creaney J, et al., Serum mesothelin for diagnosing malignant pleural mesothelioma: an individual patient data meta-analysis. J Clin Oncol. 2012; 30: 1541-1549.
14. Hassan R, Bullock S, Premkumar A, et al., Phase I study of SS1P, a recombinant anti-mesothelin immunotoxin given as a bolus I.V. infusion to patients with mesothelin-expressing mesothelioma, ovarian, and pancreatic cancers. Clin Cancer Res. 2007; 13: 5144-5149.
15. Zhang Y, Pastan I,. High shed antigen levels within tumors: an additional barrier to immunoconjugate therapy. Clin Cancer Res. 2008; 4: 7981-7986.
16. Zhang Y, Xiang L, Hassan R, et al., Synergistic antitumor activity of taxol and immunotoxin SS1P in tumor-bearing mice. Clin Cancer Res. 2006; 12: 4695-4701.
17. Hassan R, Broaddus VC, Wilson S, Liewehr DJ, Zhang J,. Anti-mesothelin immunotoxin SS1P in combination with gemcitabine results in increased activity against mesothelin-expressing tumor xenografts. Clin Cancer Res. 2007; 13: 7166-7171.
18. Zhang Y, Xiang L, Hassan R, Pastan I,. Immunotoxin and Taxol synergy results from a decrease in shed mesothelin levels in the extracellular space of tumors. Proc Natl Acad Sci USA. 2007; 104: 17099-17104.
19. Byrne MJ, Nowak AK,. Modified RECIST criteria for assessment of response in malignant pleural mesothelioma. Ann Oncol. 2004; 15: 257-260.
20. National Cancer Institute Cancer Therapy Evaluation Program. Common Terminology Criteria for Adverse Events, version 4.0 (CTCAE). Available at: http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE-4.03-2010-06-14-QuickReference-5x7.pdf. Accessed January 26, 2014.
21. Kreitman RJ, Squires DR, Stetler-Stevenson M, et al., Phase I trial of recombinant immunotoxin RFB4(dsFv)-PE38 (BL22) in patients with B-cell malignancies. J Clin Oncol. 2005; 23: 6719-6729.
22. Hollander M, Wolfe DA, eds. Nonparametric Statistical Methods. 2nd ed. New York: John Wiley & Sons, Inc.; 1999.
23. Mossoba ME, Onda M, Taylor J, et al., Pentostatin plus cyclophosphamide safely and effectively prevents immunotoxin immunogenicity in murine hosts. Clin Cancer Res. 2011; 17: 3697-3705.
24. Liu W, Onda M, Lee B, et al., Recombinant immunotoxin engineered for low immunogenicity and antigenicity by identifying and silencing human B-cell epitopes. Proc Natl Acad Sci U S A. 2012; 109: 11782-11787.
25. Hassan R, Miller AC, Sharon E, et al., Major cancer regressions in mesothelioma after treatment with an anti-mesothelin immunotoxin and immune suppression [serial online]. Sci Transl Med. 2013; 5: 208ra147.
26. Wheatley-Price P, Yang B, Patsios D, et al., Soluble mesothelin-related peptide and osteopontin as markers of response in malignant mesothelioma. J Clin Oncol. 2010; 28: 3316-3322.
27. Hollevoet K, Nackaerts K, Gosselin R, et al., Soluble mesothelin, megakaryocyte potentiating factor, and osteopontin as markers of patient response and outcome in mesothelioma. J Thorac Oncol. 2011; 6: 1930-1937.
28. Baratti D, Kusamura S, Martinetti A, et al., Circulating CA-125 in patients with peritoneal mesothelioma treated with cytoreductive surgery and intraperitoneal hyperthermic perfusion. Ann Surg Oncol. 2007; 14: 500-508.