A Safety and Feasibility Study of an Allogeneic Colon Cancer Cell Vaccine Administered with a Granulocyte–Macrophage Colony Stimulating Factor–Producing Bystander Cell Line in Patients with Metastatic Colorectal Cancer

Annals of Surgical Oncology

Volumn 21, Issue 12, 2014, Pages 3931-3937

  Zheng, Lei ^a,b   Edil, Barish H ^c   Soares, Kevin C ^a,b   El Shami, Khaled ^d   Uram, Jennifer N ^a,b   Judkins, Carol ^a,b   Zhang, Zhe ^a,b   Onners, Beth ^a,b   Laheru, Daniel ^a,b   Pardoll, Drew ^a,b   Jaffee, Elizabeth M ^a,b   Schulick, Richard D ^c  

^a JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b JOHNS HOPKINS UNIVERSITY   (United States)

^c UNIVERSITY OF COLORADO SCHOOL OF MEDICINE   (United States)

^d GEORGE WASHINGTON UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CYCLOPHOSPHAMIDE; GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR; IMMUNOGLOBULIN G; MUCIN 1; PROTEIN ANTIBODY; TUMOR CELL VACCINE; ALKYLATING AGENT; CANCER VACCINE; COLONY STIMULATING FACTOR 1;

ADULT; AGED; ANTIBODY PRODUCTION; ARTICLE; CANCER CELL LINE; CANCER IMMUNIZATION; CANCER IMMUNOTHERAPY; CANCER PATIENT; CANCER RECURRENCE; CANCER STAGING; CANCER SURVIVAL; CHILL; CLINICAL ARTICLE; COLORECTAL CARCINOMA; COLORECTAL LIVER METASTASIS; CYTOKINE PRODUCTION; DISEASE FREE SURVIVAL; DRUG DOSE ESCALATION; DRUG FEVER; DRUG SAFETY; FATIGUE; FEASIBILITY STUDY; FEMALE; FOLLOW UP; HEADACHE; HUMAN; HUMAN CELL; IMMUNOGLOBULIN PRODUCTION; INJECTION SITE ERYTHEMA; INJECTION SITE INDURATION; INJECTION SITE PRURITUS; INJECTION SITE REACTION; INOPERABLE CANCER; K562 CELL LINE; LOW DRUG DOSE; LUNG METASTASIS; LYMPH NODE METASTASIS; LYMPHOCYTOPENIA; MALE; MEDICAL HISTORY; METASTASIS RESECTION; METASTATIC COLORECTAL CANCER; MIDDLE AGED; MYALGIA; NAUSEA; OVERALL SURVIVAL; PARTIAL HEPATECTOMY; PHASE 1 CLINICAL TRIAL; SINGLE DRUG DOSE; SURVIVAL TIME; TUMOR IMMUNITY; ADENOCARCINOMA; COLORECTAL NEOPLASMS; IMMUNOLOGY; IMMUNOTHERAPY; LEUKEMIA, MYELOGENOUS, CHRONIC, BCR-ABL POSITIVE; MORTALITY; MULTIMODALITY CANCER THERAPY; PATHOLOGY; PHASE 1 CLINICAL TRIAL (TOPIC); PROGNOSIS; SAFETY; SECONDARY; SURVIVAL RATE; TUMOR CELL CULTURE; TUMOR RECURRENCE;

ADENOCARCINOMA; ADULT; AGED; ANTINEOPLASTIC AGENTS, ALKYLATING; CANCER VACCINES; CLINICAL TRIALS, PHASE I AS TOPIC; COLORECTAL NEOPLASMS; COMBINED MODALITY THERAPY; CYCLOPHOSPHAMIDE; FEASIBILITY STUDIES; FEMALE; FOLLOW-UP STUDIES; HUMANS; IMMUNOTHERAPY; LEUKEMIA, MYELOGENOUS, CHRONIC, BCR-ABL POSITIVE; LYMPHATIC METASTASIS; MACROPHAGE COLONY-STIMULATING FACTOR; MALE; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; NEOPLASM STAGING; PROGNOSIS; SAFETY; SURVIVAL RATE; TUMOR CELLS, CULTURED;

EID: 84918783663     PISSN: 10689265     EISSN: 15344681     Source Type: Journal    
DOI: 10.1245/s10434-014-3844-x     Document Type: Article

References (32)

1. Jemal A, Center MM, DeSantis C, Ward EM. Global patterns of cancer incidence and mortality rates and trends. Cancer Epidemiol Biomark Prev. 2010;19:1893–907.
2. Benson AB 3rd, Bekaii-Saab T, Chan E, et al. Localized colon cancer, version 3.2013: featured updates to the NCCN guidelines. J Natl Compr Cancer Netw. 2013;11:519–28.
3. Benson AB 3rd, Bekaii-Saab T, Chan E, et al. Metastatic colon cancer, version 3.2013: featured updates to the NCCN guidelines. J Natl Compr Cancer Netw. 2013;11:141–52.
4. Rothbarth J, van de Velde CJ. Treatment of liver metastases of colorectal cancer. Ann Oncol. 2005;16 Suppl 2:ii144–9.
5. Hodi FS, O’Day SJ, McDermott DF, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010;363:711–23.
6. Kantoff PW, Higano CS, Shore ND, et al. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010;363:411–22.
7. Mosolits S, Nilsson B, Mellstedt H. Towards therapeutic vaccines for colorectal carcinoma: a review of clinical trials. Expert Rev Vaccines. 2005;4:329–50.
8. Jain A, Slansky JE, Matey LC, et al. Synergistic effect of a granulocyte–macrophage colony-stimulating factor–transduced tumor vaccine and systemic interleukin-2 in the treatment of murine colorectal cancer hepatic metastases. Ann Surg Oncol. 2003;10:810–20.
9. Uyl-de Groot CA, Vermorken JB, Hanna MG Jr, et al. Immunotherapy with autologous tumor cell-BCG vaccine in patients with colon cancer: a prospective study of medical and economic benefits. Vaccine. 2005;23:2379–87.
10. Laheru D, Jaffee EM. Immunotherapy for pancreatic cancer—science driving clinical progress. Nat Rev Cancer. 2005;5:459–67.
11. Jaffee EM, Hruban RH, Biedrzycki B, et al. Novel allogeneic granulocyte–macrophage colony-stimulating factor–secreting tumor vaccine for pancreatic cancer: a phase I trial of safety and immune activation. J Clin Oncol. 2001;19:145–56.
12. Laheru D, Lutz E, Burke J, et al. Allogeneic granulocyte macrophage colony-stimulating factor–secreting tumor immunotherapy alone or in sequence with cyclophosphamide for metastatic pancreatic cancer: a pilot study of safety, feasibility, and immune activation. Clin Cancer Res. 2008;14:1455–63.
13. Lutz E, Yeo CJ, Lillemoe KD, et al. A lethally irradiated allogeneic granulocyte–macrophage colony stimulating factor-secreting tumor vaccine for pancreatic adenocarcinoma. A phase II trial of safety, efficacy, and immune activation. Ann Surg. 2011;253:328–35.
14. Thomas MC, Greten TF, Pardoll DM, Jaffee EM. Enhanced tumor protection by granulocyte–macrophage colony-stimulating factor expression at the site of an allogeneic vaccine. Hum Gene Ther. 1998;9:835–43.
15. Dranoff G, Jaffee E, Lazenby A, et al. Vaccination with irradiated tumor cells engineered to secrete murine granulocyte–macrophage colony-stimulating factor stimulates potent, specific, and long-lasting anti-tumor immunity. Proc Natl Acad Sci USA. 1993;90:3539–43.
16. Borrello I, Sotomayor EM, Cooke S, Levitsky HI. A universal granulocyte–macrophage colony-stimulating factor–producing bystander cell line for use in the formulation of autologous tumor cell-based vaccines. Hum Gene Ther. 1999;10:1983–91.
17. Drake CG, Jaffee E, Pardoll DM. Mechanisms of immune evasion by tumors. Adv Immunol. 2006;90:51–81.
18. Banham AH, Powrie FM, Suri-Payer E. FOXP3 + regulatory T cells: current controversies and future perspectives. Eur J Immunol. 2006;36:2832–6.
19. Zheng L, Xue J, Jaffee EM, Habtezion A. Role of immune cells and immune-based therapies in pancreatitis and pancreatic ductal adenocarcinoma. Gastroenterology. 2013;144:1230–40.
20. Ercolini AM, Ladle BH, Manning EA, et al. Recruitment of latent pools of high-avidity CD8(+) T cells to the antitumor immune response. J Exp Med. 2005;201:1591–602.
21. Leao IC, Ganesan P, Armstrong TD, Jaffee EM. Effective depletion of regulatory T cells allows the recruitment of mesothelin-specific CD8 t cells to the antitumor immune response against a mesothelin-expressing mouse pancreatic adenocarcinoma. Clin Transl Sci. 2008;1:228–239.
22. Emens LA, Asquith JM, Leatherman JM, et al. Timed sequential treatment with cyclophosphamide, doxorubicin, and an allogeneic granulocyte–macrophage colony-stimulating factor–secreting breast tumor vaccine: a chemotherapy dose-ranging factorial study of safety and immune activation. J Clin Oncol. 2009;27:5911–8.
23. Shawler DL, Bartholomew RM, Garrett MA, et al. Antigenic and immunologic characterization of an allogeneic colon carcinoma vaccine. Clin Exp Immunol. 2002;129:99–106.
24. Yamamoto Y, Hirakawa E, Mori S, et al. Cleavage of carcinoembryonic antigen induces metastatic potential in colorectal carcinoma. Biochem Biophys Res Commun. 2005;333:223–9.
25. Takenaga K, Nakanishi H, Wada K, et al. Increased expression of S100A4, a metastasis-associated gene, in human colorectal adenocarcinomas. Clin Cancer Res. 1997;3:2309–16.
26. Simons JW, Jaffee EM, Weber CE, et al. Bioactivity of autologous irradiated renal cell carcinoma vaccines generated by ex vivo granulocyte–macrophage colony-stimulating factor gene transfer. Cancer Res. 1997;57:1537–46.
27. Lubaroff DM. Prostate cancer vaccines in clinical trials. Expert Rev Vaccines. 2012;11:857–68.
28. Simons JW, Sacks N. Granulocyte–macrophage colony-stimulating factor–transduced allogeneic cancer cellular immunotherapy: the GVAX vaccine for prostate cancer. Urol Oncol. 2006;24:419–24.
29. Dittmann J, Keller-Matschke K, Weinschenk T, et al. CD8 + T-cell response against MUC1-derived peptides in gastrointestinal cancer survivors. Cancer Immunol Immunother. 2005;54:750–8.
30. Mukherjee P, Pathangey LB, Bradley JB, et al. MUC1-specific immune therapy generates a strong anti-tumor response in a MUC1-tolerant colon cancer model. Vaccine. 2007;25:1607–18.
31. Schimanski CC, Mohler M, Schon M, et al. LICC: L-BLP25 in patients with colorectal carcinoma after curative resection of hepatic metastases: a randomized, placebo-controlled, multicenter, multinational, double-blinded phase II trial. BMC Cancer. 2012;12:144.
32. Morse MA, Niedzwiecki D, Marshall JL, et al. A randomized phase II study of immunization with dendritic cells modified with poxvectors encoding CEA and MUC1 compared with the same poxvectors plus GM-CSF for resected metastatic colorectal cancer. Ann Surg. 2013;258:879–86.