A multicenter open-label study to assess the safety of a new formulation of BLP25 liposome vaccine in patients with unresectable stage III non-small-cell lung cancer

Clinical Lung Cancer

Volumn 11, Issue 6, 2010, Pages 391-395

  Butts, Charles ^a   Murray, R Nevin ^b   Smith, Colum ^c   Ellis, Peter ^d   Jasas, Kevin ^e   Maksymiuk, Andrew ^f   Goss, Glenwood ^g   Ely, Guy ^h   Beier, Frank ^h   Soulières, Denis ⁱ  

^a CROSS CANCER INSTITUTE   (Canada)

^b Vancouver Cancer Centre   (Canada)

^c TOM BAKER CANCER CENTRE   (Canada)

^d JURAVINSKI CANCER CENTRE   (Canada)

^e SIR CHARLES GAIRDNER HOSPITAL   (Australia)

^f CANCERCARE MANITOBA   (Canada)

^g OTTAWA REGIONAL CANCER CENTRE   (Canada)

^h MERCK KGAA   (Germany)

ⁱ NOTRE DAME HOSPITAL   (Canada)

Author keywords

Immunotherapy; Lipid A; MUC1; Phase II study

Indexed keywords

BLP25 LIPOSOME VACCINE; CANCER VACCINE; CYCLOPHOSPHAMIDE; IMMUNOLIPOSOME; MUCIN 1; UNCLASSIFIED DRUG;

ADULT; ANOREXIA; ARTICLE; BREAST CANCER; CANCER STAGING; CHILL; CLINICAL ARTICLE; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; DIARRHEA; DISEASE COURSE; DIZZINESS; DRUG EFFICACY; DRUG FORMULATION; DRUG SAFETY; DYSPNEA; FATIGUE; FEMALE; FLU LIKE SYNDROME; FOLLOW UP; HUMAN; HUMAN CELL; IMMUNE RESPONSE; INJECTION SITE BLEEDING; INJECTION SITE CONTUSION; INJECTION SITE ERYTHEMA; INJECTION SITE IRRITATION; INJECTION SITE NODULE; INJECTION SITE PAIN; INSOMNIA; ISCHEMIC HEART DISEASE; LUNG NON SMALL CELL CANCER; MALE; MULTICENTER STUDY; NAUSEA; OPEN STUDY; PHASE 2 CLINICAL TRIAL; PNEUMONIA; SIDE EFFECT; SINUSITIS; SURVIVAL RATE; THORAX PAIN; TREATMENT DURATION; TREATMENT RESPONSE; UPPER RESPIRATORY TRACT INFECTION; VOMITING; WEIGHT GAIN;

AGED; CANCER VACCINES; CARCINOMA, NON-SMALL-CELL LUNG; DISEASE PROGRESSION; FEMALE; FOLLOW-UP STUDIES; HUMANS; LIPOSOMES; LUNG NEOPLASMS; MALE; MEMBRANE GLYCOPROTEINS; MIDDLE AGED; MUCIN-1; SURVIVAL RATE; TIME FACTORS;

EID: 78649235731     PISSN: 15257304     EISSN: None     Source Type: Journal    
DOI: 10.3816/CLC.2010.n.101     Document Type: Article

References (30)

1. Ferlay J, Autier P, Boniol M, et al. Estimates of the cancer incidence and mortality in Europe in 2006. Ann Oncol 2007; 18:581-92.
2. Jemal A, Siegel R, Ward E, et al. Cancer Statistics, 2009. CA Cancer J Clin 2009; 59:225-49.
3. Yang P, Allen MS, Aubry MC, et al. Clinical features of 5,628 primary lung cancer patients: experience at the Mayo Clinic from 1997 to 2003. Chest 2005; 128:452-62.
4. NCCN. 2008. NCCN clinical practice guidelines in oncology: non-small cell lung cancer. V.2.2008. Available at: http://www.nccn.org/professionals/physi- cian-gls/PDF/nscl.pdf. Accessed: November 19, 2009.
5. Robinson LA, Ruckdeschel JC, Wagner H Jr, et al. Treatment of non-small cell lung cancer-stage IIIA: ACCP evidence-based clinical practice guidelines (2nd edition). Chest 2007; 132(3 suppl):243S-65S.
6. Furuse K, Fukuoka M, Kawahara M, et al. Phase III study of concurrent versus sequential thoracic radiotherapy in combination with mitomycin, vindesine, and cisplatin in unresectable stage III non-small-cell lung cancer. J Clin Oncol 1999; 17:2692-9.
7. Fournel P, Robinet G, Thomas P, et al. Randomized phase III trial of sequential chemoradiotherapy compared with concurrent chemoradiotherapy in locally advanced non-small-cell lung cancer: Groupe Lyon-Saint-Etienne d'Oncologie Thoracique-Groupe Français de Pneumo-Cancérologie NPC 95-01 Study. J Clin Oncol 2005; 23:5910-7.
8. Curran WJ, Scott CB, Langer CJ, et al. Long-term benefit is observed in a phase III comparison of sequential vs. concurrent chemo-radiation for patients with unresectable stage III NSCLC: RTOG 9410. Am Soc Clin Oncol 2003; 22:621.
9. Gandara DR, Chansky K, Albain KS, et al. Consolidation docetaxel after concurrent chemoradiotherapy in stage IIIB non-small-cell lung cancer: phase II Southwest Oncology Group Study S9504. J Clin Oncol 2003; 21:2004-10.
10. Hanna N, Neubauer M, Yiannoutsos C, et al. Phase III study of cisplatin, etopo-side, and concurrent chest radiation with or without consolidation docetaxel in patients with inoperable stage III non-small-cell lung cancer: the Hoosier Oncology Group and U.S. Oncology. J Clin Oncol 2008; 26:5755-60.
11. Kelly K, Chansky K, Gaspar LE, et al. Phase III trial of maintenance gefitinib or placebo after concurrent chemoradiotherapy and docetaxel consolidation in inoperable stage III non-small-cell lung cancer: SWOG S0023. J Clin Oncol 2008; 26:2450-6.
12. Hirschowitz EA, Yannelli JR. Immunotherapy for lung cancer. Proc Am Thorac Soc 2009; 6:224-32.
13. Ho SB, Niehans GA, Lyftogt C, et al. Heterogeneity of mucin gene expression in normal and neoplastic tissues. Cancer Res 1993; 53:641-51.
14. Takahashi T, Makiguchi Y, Hinoda Y, et al. Expression of MUC1 on myeloma cells and induction of HLA-unrestricted CTL against MUC1 from a multiple myeloma patient. J Immunol 1994; 153:2102-9.
15. Zotter S, Hageman PC, Lossnitzer A, et al. Tissue and tumor distribution of human polymorphic epithelial mucin. Cancer Rev 1988; 11-12:55-101.
16. Carraway KL III, Funes M, Workman HC, et al. Contribution of membrane mucins to tumor progression through modulation of cellular growth signaling pathways. Curr Top Dev Biol 2007; 78:1-22.
17. Devine PL, McKenzie I F. Mucins: structure, function, and associations with malignancy. Bioessays 1992; 14:619-25.
18. Sangha R, Butts C. L-BLP25: a peptide vaccine strategy in non-small cell lung cancer. Clin Cancer Res 2007; 13:4652s.
19. Tang CK, Apostolopoulos V. Strategies used for MUC1 immunotherapy: preclini-cal studies. Expert Rev Vaccines 2008; 7:951-62.
20. Apostolopoulos V, Pietersz GA, McKenzie I F. MUC1 and breast cancer. Curr Opin Mol Ther 1999; 1:98-103.
21. Hull SR, Bright A, Carraway KL, et al. Oligosaccharide differences in the DF3 sialomucin antigen from normal human milk and the BT-20 human breast carcinoma cell line. Cancer Commun 1989; 1:261-7.
22. de Roos MA, van der Vegt B, Peterse JL, et al. The expression pattern of MUC1 (EMA) is related to tumour characteristics and clinical outcome in 'pure' ductal carcinoma in situ of the breast. Histopathology 2007; 51:227-38.
23. Reddish MA, MacLean GD, Poppema S, et al. Pre-immunotherapy serum CA27.29 (MUC-1) mucin level and CD69+ lymphocytes correlate with effects of Theratope® sialyl-Tn-KLH cancer vaccine in active specific immunotherapy. Cancer Immunol Immunother 1996; 42:303-9.
24. Van der Vegt B, de Roos MA, Peterse JL, et al. The expression pattern of MUC1 (EMA) is related to tumour characteristics and clinical outcome of invasive ductal breast carcinoma. Histopathology 2007; 51:322-35.
25. Butts C, Murray N, Maksymiuk A, et al. Randomized phase IIB trial of BLP25 liposome vaccine in stage IIIB and IV non-small-cell lung cancer. J Clin Oncol 2005; 23:6674-81.
26. Palmer M, Parker J, Modi S, et al. Phase I study of the BLP25 (MUC1 peptide) liposomal vaccine for active specific immunotherapy in stage IIIB/IV non-small-cell lung cancer. Clin Lung Cancer 2001; 3:49-57.
27. Butts C, Maksymiuk A, Goss G, et al. A multi-centre phase IIB randomized controlled study of L-BLP25 liposome vaccine (L-BLP25 or Stimuvax) for active specific immunotherapy of non-small cell lung cancer (NSCLC): updated survival analysis: B1-01. J Thorac Oncol 2007; 2:s332-3.
28. Jaffee EM, Thomas MC, Huang AY, et al. Enhanced immune priming with spatial distribution of paracrine cytokine vaccines. J Immunother Emphasis Tumor Immunol 1996; 19:176-83.
29. Brode S, Cooke A. Immune-potentiating effects of the chemotherapeutic drug cyclophosphamide. Crit Rev Immunol 2008; 28:109-26.
30. Soulieres D, Smith C, Ellis PM, et al. A multi-centre, open-label study to assess the safety of Stimuvax (BLP25 liposome vaccine or L-BLP25) in non-small cell lung cancer (NSCLC) patients (pts) with unresectable stage III disease. J Clin Oncol 2007; 25(18 suppl):136s (abstract 3075).