A phase i study of Folate immune therapy (EC90 vaccine administered with GPI-0100 adjuvant followed by EC17) in patients with renal cell carcinoma

Journal of Immunotherapy

Volumn 36, Issue 4, 2013, Pages 268-275

  Amato, Robert J ^a   Shetty, Aditya ^a   Lu, Yingjuan ^b   Ellis, Ron ^b   Low, Philip S ^b,c  

^a UNIVERSITY OF TEXAS MEDICAL SCHOOL   (United States)

^b Endocyte Inc   (United States)

^c PURDUE UNIVERSITY   (United States)

Author keywords

Folate Immune therapy; renal cell carcinoma; vaccine

Indexed keywords

ANTIBODY; CANCER VACCINE; EC17 VACCINE; EC90 VACCINE; FLUORESCEIN ISOTHIOCYANATE; FLUORESCEIN ISOTHIOCYANATE ANTIBODY; GPI 0100 ADJUVANT; IMMUNOLOGICAL ADJUVANT; UNCLASSIFIED DRUG;

ABDOMINAL PAIN; ADULT; AGED; ANAPHYLAXIS; ANTIBODY TITER; ANTINEOPLASTIC ACTIVITY; ARTICLE; BACKACHE; CANCER IMMUNIZATION; CLINICAL ARTICLE; COUGHING; DRUG DISTRIBUTION; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; FATIGUE; FEMALE; FEVER; HEADACHE; HUMAN; HYPERCALCEMIA; HYPERSENSITIVITY; HYPOTENSION; HYPOXIA; INJECTION SITE ERYTHEMA; INJECTION SITE PRURITUS; INJECTION SITE REACTION; KIDNEY METASTASIS; LUNG TUMOR; MALE; MAXIMUM PLASMA CONCENTRATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; OPEN STUDY; PAIN; PANCREATITIS; PHASE 1 CLINICAL TRIAL; POSTPROCEDURAL PAIN; PRIORITY JOURNAL; PRURITUS; TREATMENT RESPONSE;

ADULT; AGED; CANCER VACCINES; CARCINOMA, RENAL CELL; DRUG ADMINISTRATION SCHEDULE; FEMALE; FOLATE RECEPTORS, GPI-ANCHORED; FOLIC ACID; HUMANS; IMMUNOTHERAPY; KIDNEY NEOPLASMS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASM STAGING; SAPONINS; TREATMENT OUTCOME;

EID: 84876797002     PISSN: 15249557     EISSN: 15374513     Source Type: Journal    
DOI: 10.1097/CJI.0b013e3182917f59     Document Type: Article

References (30)

1. Scott JM, Weir DG. Folate/vitamin B12 inter-relationships. In: Tipton KF, ed. Essays in Biochemistry. Dublin, Ireland: Portland Press; 1994:63-72.
2. Zhao R, Diop-Bove N, Visentin M, et al. Mechanisms of membrane transport of folates into cells and across epithelia. Annu Rev Nutr. 2011;31:177-201.
3. Matherly LH, Goldman DI. Membrane transport of folates. Vitam Horm. 2003;66:403-456. (Pubitemid 137640823)
4. Toffoli G, Cernigoi C, Russo A, et al. Overexpression of folate binding protein in ovarian cancers. Int J Cancer. 1997;74: 193-198. (Pubitemid 27234510)
5. Ross JF, Chaudhuri PK, Ratnam M. Differential regulation of folate receptor isoforms in normal and malignant tissues in vivo and in established cell lines. Physiologic and clinical implications. Cancer. 1994;73:2432-2443. (Pubitemid 24129130)
6. Holm J, Hansen SI, Hoier-Madsen M, et al. Folate receptor of human mammary adenocarcinoma. APMIS. 1994;102: 413-419. (Pubitemid 24266218)
7. Holm J, Hansen SI, Høier-Madsen M, et al. Folate receptor in malignant effusions of ovarian carcinomas. APMIS. 1995; 103:663-670.
8. Holm J, Hansen SI, Hoier-Madsen M, et al. Folate receptors in malignant and benign tissues of human female genital tract. Biosci Rep. 1997;17:415-427. (Pubitemid 27490171)
9. Franklin WA, Waintrub M, Edwards D, et al. New anti-lung-cancer antibody cluster 12 reacts with human folate receptors present on adenocarcinoma. Int J Cancer Suppl. 1994;8:89-95. (Pubitemid 24188966)
10. Li PY, Del Vecchio S, Fonti R, et al. Local concentration of folate binding protein GP38 in sections of human ovarian carcinoma by in vitro quantitative autoradiography. J Nucl Med. 1996;37:665-672. (Pubitemid 126618462)
11. Bueno R, Appasani K, Mercer H, et al. The alpha folate receptor is highly activated in malignant pleural mesothelioma. J Thorac Cardiovasc Surg. 2001;121:225-233. (Pubitemid 32150911)
12. Parker N, Turk MJ, Westrick E, et al. Folate receptor expression in carcinomas and normal tissues determined by a quantitative radioligand binding assay. Anal Biochem. 2005; 338:284-293. (Pubitemid 40312593)
13. Toffoli G, Russo A, Gallo A, et al. Expression of folate binding protein as a prognostic factor for response to platinum-containing chemotherapy and survival in human ovarian cancer. Int J Cancer. 1998;79:121-126. (Pubitemid 28201681)
14. Hartmann LC, Keeney GL, Lingle WL, et al. Folate receptor overexpression is associated with poor outcome in breast cancer. Int J Cancer. 2007;121:938-942. (Pubitemid 47101628)
15. Shia J, Klimstra DS, Nitzkorski JR, et al. Immunohistochemical expression of folate receptor alpha in colorectal carcinoma: patterns and biological significance. Hum Pathol. 2008;39: 498-505. (Pubitemid 351375020)
16. Reddy JA, Dorton R, Westrick E, et al. Preclinical evaluation of EC145, a folate-vinca alkaloid conjugate. Cancer Res. 2007;67:4434-4442. (Pubitemid 46815093)
17. Bettio A, Honer M, Muller C, et al. Synthesis and preclinical evaluation of a folic acid derivative labeled with 18F for PET imaging of folate receptor-positive tumors. J Nucl Med. 2006;47:1153-1160. (Pubitemid 47544910)
18. Choi H, Choi SR, Zhou R, et al. Iron oxide nanoparticles as magnetic resonance contrast agent for tumor imaging via folate receptor-targeted delivery. Acad Radiol. 2004;11:996-1004. (Pubitemid 39220809)
19. Leamon CP, Parker MA, Vlahov IR, et al. Synthesis and biological evaluation of EC20: a new folate-derived, (99m) Tc-based radiopharmaceutical. Bioconjug Chem. 2002;13: 1200-1210. (Pubitemid 35420011)
20. Low PS, Henne WA, Doorneweerd DD. Discovery and development of folic-acid-based receptor targeting for imaging and therapy of cancer and inflammatory diseases. Acc Chem Res. 2008;41:120-129.
21. Lu Y, Sega E, Leamon CP, et al. Folate receptor-targeted immunotherapy of cancer: mechanism and therapeutic potential. Adv Drug Deliv Rev. 2004;56:1161-1176. (Pubitemid 38496513)
22. Lu Y, Low PS. Folate targeting of haptens to cancer cell surfaces mediates immunotherapy of syngeneic murine tumors. Cancer Immunol Immunother. 2002;51:153-162. (Pubitemid 34298111)
23. Lu Y, Sega E, Low PS. Folate receptor-targeted immunother-apy: induction of humoral and cellular immunity against hapten-decorated cancer cells. Int J Cancer. 2005;116:710-719. (Pubitemid 41099702)
24. Kim SK, Ragupathi G, Cappello S, et al. Effect of immunological adjuvant combinations on the antibody and T-cell response to vaccination with MUC1-KLH and GD3-KLH conjugates. Vaccine. 2000;19:530-537.
25. Gupta RK, Siber GR. Adjuvants for human vaccines-current status, problems and future prospects. Vaccine. 1995;13:1263-1276.
26. Slovin SF, Ragupathi G, Fernandez C, et al. A bivalent conjugate vaccine in the treatment of biochemically relapsed prostate cancer: a study of glycosylated MUC-2-KLH and Globo H-KLH conjugate vaccines given with the new semi-synthetic saponin immunological adjuvant GPI-0100 OR QS-21. Vaccine. 2005;23:3114-3122.
27. Coppin C, Porzsolt F, Awa A, et al. Immunotherapy for advanced renal cell cancer. Cochrane Database Syst Rev. 2005; 1:CD001425.
28. Ragupathi G, Meyers M, Adluri S, et al. Induction of antibodies against GD3 ganglioside in melanoma patients by vaccination with GD3-lactone-KLH conjugate plus immuno-logical adjuvant QS-21. Int J Cancer. 2000;85:659-666. (Pubitemid 30080479)
29. Lu Y, Xu LC, Parker N, et al. Preclinical pharmacokinetics, tissue distribution, and antitumor activity of a folate-hapten conjugate-targeted immunotherapy in hapten-immunized mice. Mol Cancer Ther. 2006;5:3258-3267. (Pubitemid 46092069)
30. Lu Y, Klein PJ, Westrick E, et al. Strategy to prevent drug-related hypersensitivity in folate-targeted hapten immuno-therapy of cancer. AAPS J. 2009;11:628-638.