Pegylated liposomal mitomycin C prodrug enhances tolerance of mitomycin C: A phase 1 study in advanced solid tumor patients

Cancer Medicine

Volumn 4, Issue 10, 2015, Pages 1472-1483

  Golan, Talia ^a   Grenader, Tal ^b   Ohana, Patricia ^c   Amitay, Yasmine ^c   Shmeeda, Hilary ^b   La Beck, Ninh M ^d   Tahover, Esther ^b   Berger, Raanan ^a   Gabizon, Alberto A ^b,c,e  

^a SHEBA MEDICAL CENTER   (Israel)

^b SHAARE ZEDEK MEDICAL CENTER   (Israel)

^c Lipomedix Pharmaceuticals Ltd   (Israel)

^d TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER   (United States)

^e HEBREW UNIVERSITY OF JERUSALEM   (Israel)

Author keywords

Clinical trial; Liposome; Mitomycin C; Prodrug

Indexed keywords

BILIRUBIN; GAMMA GLUTAMYLTRANSFERASE; MITOMYCIN; ANTINEOPLASTIC ANTIBIOTIC; LIPOSOME; MACROGOL DERIVATIVE; PRODRUG;

ADULT; AGED; ANEMIA; AREA UNDER THE CURVE; ARTICLE; BILE DUCT CARCINOMA; BILIRUBIN BLOOD LEVEL; BLADDER CANCER; BREAST CANCER; CLINICAL ARTICLE; COLORECTAL CANCER; COMPLEMENT ACTIVATION; DECREASED APPETITE; DRUG CLEARANCE; DRUG CYTOTOXICITY; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG HALF LIFE; DRUG RESPONSE; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; FATIGUE; FEMALE; GALLBLADDER CANCER; GAMMA GLUTAMYL TRANSFERASE BLOOD LEVEL; HEMOLYTIC UREMIC SYNDROME; HEPATOBILIARY DISEASE; HOT FLUSH; HUMAN; HYPOPHARYNX CANCER; INFUSION RELATED REACTION; LUNG EMBOLISM; LUNG INFECTION; MALE; MAXIMUM PLASMA CONCENTRATION; MAXIMUM TOLERATED DOSE; MELANOMA; MULTIPLE CYCLE TREATMENT; OVARY CANCER; PANCREAS CANCER; PERITONEUM CANCER; PRIORITY JOURNAL; REPEATED DRUG DOSE; SIDE EFFECT; SINGLE DRUG DOSE; SOLID TUMOR; STOMACH CANCER; THROMBOCYTOPENIA; TREATMENT OUTCOME; TREATMENT RESPONSE; UTERINE CERVIX CANCER; VERY ELDERLY; VOMITING; CHEMICALLY INDUCED; CLINICAL TRIAL; MIDDLE AGED; NEOPLASMS; PHASE 1 CLINICAL TRIAL; RESPONSE EVALUATION CRITERIA IN SOLID TUMORS;

ADULT; AGED; ANEMIA; ANTIBIOTICS, ANTINEOPLASTIC; FATIGUE; FEMALE; HUMANS; LIPOSOMES; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; MITOMYCIN; NEOPLASMS; POLYETHYLENE GLYCOLS; PRODRUGS; RESPONSE EVALUATION CRITERIA IN SOLID TUMORS; THROMBOCYTOPENIA;

EID: 85006184578     PISSN: None     EISSN: 20457634     Source Type: Journal    
DOI: 10.1002/cam4.491     Document Type: Article

References (23)

1. Crooke, S. T., and W. T. Bradner. 1976. Mitomycin C: a review. Cancer Treat. Rev. 3:121-139.
2. Verweij, J., and H. M. Pinedo. 1990. Mitomycin C: mechanism of action, usefulness and limitations. Anticancer Drugs 1:5-13.
3. Sartorelli, A. C., W. F. Hodnick, M. F. Belcourt, M. Tomasz, B. Haffty, J. J. Fischer, et al. 1994. Mitomycin C: a prototype bioreductive agent. Oncol. Res. 6:501-508.
4. Tomasz, M. 1995. Mitomycin C: small fast and deadly (but very selective). Chem. Biol. 2:575-579.
5. James, R. D., R. Glynne-Jones, H. M. Meadows, D. Cunningham, A. S. Myint, M. P. Saunders, et al. 2013. Mitomycin or cisplatin chemoradiation with or without maintenance chemotherapy for treatment of squamous-cell carcinoma of the anus (ACT II): a randomised, phase 3, open-label, 2 × 2 factorial trial. Lancet Oncol. 14:516-524.
6. Ihnat, M. A., J. P. Lariviere, A. J. Warren, N. La Ronde, J. R. Blaxall, K. M. Pierre, et al. 1997. Suppression of P-glycoprotein expression and multidrug resistance by DNA cross-linking agents. Clin. Cancer Res. 3:1339-1346.
7. Maitra, R., P. A. Halpin, K. H. Karlson, R. L. Page, D. Y. Paik, M. O. Leavitt, et al. 2001. Differential effects of mitomycin C and doxorubicin on P-glycoprotein expression. Biochem J. 355:617-624.
8. Gabizon, A., H. Shmeeda, and T. Grenader. 2012. Pharmacological basis of pegylated liposomal doxorubicin: impact on cancer therapy. Eur. J. Pharm. Sci. 45:388-398.
9. Lyseng-Williamson, K. A., S. T. Duggan, and G. M. Keating. 2013. Pegylated liposomal doxorubicin: a guide to its use in various malignancies. BioDrugs 27:533-540.
10. Bertrand, N., J. Wu, X. Xu, N. Kamaly, and O. C. Farokhzad. 2014. Cancer nanotechnology: the impact of passive and active targeting in the era of modern cancer biology. Adv. Drug Deliv. Rev. 66:2-25.
11. Gabizon, A. A., D. Tzemach, A. T. Horowitz, H. Shmeeda, J. Yeh, and S. Zalipsky. 2006. Reduced toxicity and superior therapeutic activity of a mitomycin C lipid-based prodrug incorporated in pegylated liposomes. Clin. Cancer Res. 12:1913-1920.
12. Powis, G., and D. L. Kirkpatrick. 2007. Thioredoxin signaling as a target for cancer therapy. Curr. Opin. Pharmacol. 7:392-397.
13. Stern, S. T., J. B. Hall, L. L. Yu, L. J. Wood, G. F. Paciotti, L. Tarmarkin, et al. 2010. Translational considerations for cancer nanomedicine. J. Controlled Release 146:164-174.
14. Gabizon, A., Y. Amitay, D. Tzemach, J. Gorin, H. Shmeeda, and S. Zalipsky. 2012. Therapeutic efficacy of a lipid-based prodrug of mitomycin C in pegylated liposomes: studies with human gastro-entero-pancreatic ectopic tumor models. J. Controlled Release 160:245-253.
15. ®): possible role in hypersensitivity reactions. Ann. Oncol. 14:1430-1437.
16. Zalipsky, S., M. Saad, R. Kiwan, E. Ber, N. Yu, and T. Minko. 2007. Antitumor activity of new liposomal prodrug of mitomycin C in multidrug resistant solid tumor: insights of the mechanism of action. J. Drug Target. 15:518-530.
17. Szebeni, J., F. Muggia, A. Gabizon, and Y. Barenholz. 2011. Activation of complement by therapeutic liposomes and other lipid excipient-based therapeutic products: prediction and prevention. Adv. Drug Deliv. Rev. 63:1020-1030.
18. Buyon, J. P., J. Tamerius, H. M. Belmont, and S. Abramson. 1992. Assessment of disease activity and impending flare in patients with systemic lupus erythematosus. Comparison of the use of complement split products and conventional measurements of complement. Arthritis Rheum. 35:1028-1037.
19. Chong, G., J. L. Dickson, D. Cunningham, A. R. Norman, S. Rao, M. E. Hill, et al. 2005. Capecitabine and mitomycin C as third-line therapy for patients with metastatic colorectal cancer resistant to fluorouracil and irinotecan. Br. J. Cancer 93:510-514.
20. Verweij, J., M. E. L. van der Burg, and H. M. Pinedo. 1987. Mitomycin C-induced hemolytic uremic syndrome. Six case reports and review of the literature on renal, pulmonary and cardiac side effects of the drug. Radiother. Oncol. 8:33-41.
21. Arnér, E. S., and A. Holmgren. 2006. The thioredoxin system in cancer. Semin. Cancer Biol. 16:420-426.
22. Dennis, I. F., J. R. Ramsay, P. Workman, and N. M. Bleehen. 1993. Pharmacokinetics of BW12C and mitomycin C, given in combination in a phase 1 study in patients with advanced gastrointestinal cancer. Cancer Chemother. Pharmacol. 32:67-72.
23. Gabizon, A., R. Isacson, O. Rosengarten, D. Tzemach, H. Shmeeda, and R. Sapir. 2008. An open-label study to evaluate dose and cycle dependence of the pharmacokinetics of pegylated liposomal doxorubicin. Cancer Chemother. Pharmacol. 61:695-702.