A phase i trial of repeated intrapleural adenoviral-mediated interferon-β gene transfer for mesothelioma and metastatic pleural effusions

Molecular Therapy

Volumn 18, Issue 4, 2010, Pages 852-860

  Sterman, Daniel H ^a   Recio, Adri ^a   Haas, Andrew R ^a   Vachani, Anil ^a   Katz, Sharyn I ^a   Gillespie, Colin T ^a   Cheng, Guanjun ^a   Sun, Jing ^a   Moon, Edmund ^a   Pereira, Luana ^a   Wang, Xinzhong ^b   Heitjan, Daniel F ^a   Litzky, Leslie ^a   June, Carl H ^a   Vonderheide, Robert H ^a   Carroll, Richard G ^a   Albelda, Steven M ^a,c  

^a HOSPITAL OF THE UNIVERSITY OF PENNSYLVANIA   (United States)

^b BIOGEN   (United States)

^c Allergy   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADENOVIRUS VECTOR; BETA INTERFERON; BEVACIZUMAB; BG 00001; CP 870893; CRS 207; CYCLOPHOSPHAMIDE; DOCETAXEL; DOXORUBICIN; ERLOTINIB; GEMCITABINE; LISTERIA MESOTHELIN VACCINE; NEUTRALIZING ANTIBODY; PEMETREXED; TAMOXIFEN; TUMOR ANTIGEN; UNCLASSIFIED DRUG; VACCINE;

ADULT; AGED; ANEMIA; ANTIBODY RESPONSE; ARTICLE; CHILL; CLINICAL ARTICLE; CLINICAL TRIAL; CYTOKINE RELEASE; DRUG RESPONSE; FEMALE; FEVER; GENE TRANSFER; HUMAN; HYPOALBUMINEMIA; HYPOCALCEMIA; HYPOTENSION; IMMUNE RESPONSE; INDWELLING CATHETER; LYMPHOCYTOPENIA; MALE; MALIGNANT MESOTHELIOMA; NAUSEA; PHASE 1 CLINICAL TRIAL; PLEURA EFFUSION; PLEURA FLUID; POSITRON EMISSION TOMOGRAPHY; REPEATED DRUG DOSE; RIGOR; SIDE EFFECT; SURVIVAL TIME; TACHYCARDIA;

ADENOVIRIDAE; AGED; AGED, 80 AND OVER; FEMALE; GENE THERAPY; GENE TRANSFER TECHNIQUES; GENETIC VECTORS; HUMANS; INTERFERON-BETA; LUNG NEOPLASMS; MALE; MESOTHELIOMA; MIDDLE AGED; OVARIAN NEOPLASMS; PLEURAL CAVITY; PLEURAL EFFUSION, MALIGNANT;

EID: 77950517811     PISSN: 15250016     EISSN: 15250024     Source Type: Journal    
DOI: 10.1038/mt.2009.309     Document Type: Article

References (27)

1. Fennell, DA, Gaudino, G, O'Byrne, KJ, Mutti, L and van Meerbeeck, J (2008). Advances in the systemic therapy of malignant pleural mesothelioma. Nat Clin Pract Oncol 5: 136-147. (Pubitemid 351330666)
2. Vogelzang, NJ, Rusthoven, JJ, Symanowski, J, Denham, C, Kaukel, E, Ruffe, P et al. (2003). Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol 21: 2636-2644. (Pubitemid 46606305)
3. Ruckdeschel, JC (1995). Management of malignant pleural effusions. Semin Oncol 22 (2 suppl. 3): 58-63.
4. Sterman, DH, Gillespie, CT, Carroll, RG, Coughlin, CM, Lord, EM, Sun, J et al. (2006). Interferon beta adenoviral gene therapy in a patient with ovarian cancer. Nat Clin Pract Oncol 3: 633-639. (Pubitemid 44669718)
5. Sterman, DH, Recio, A, Carroll, RG, Gillespie, CT, Haas, A, Vachani, A et al. (2007). A phase I clinical trial of single-dose intrapleural IFN-beta gene transfer for malignant pleural mesothelioma and metastatic pleural effusions: high rate of antitumor immune responses. Clin Cancer Res 13 (15 Pt 1): 4456-4466. (Pubitemid 47219714)
6. Lambright, ES, Force, SD, Lanuti, ME, Wasf, DS, Amin, KM, Albelda, SM et al. (2000). Effcacy of repeated adenoviral suicide gene therapy in a localized murine tumor model. Ann Thorac Surg 70: 1865-1870; discussion 1870-1871.
7. Suzuki, E, Kapoor, V, Jassar, AS, Kaiser, LR and Albelda, SM (2005). Gemcitabine selectively eliminates splenic Gr-1+/CD11b+ myeloid suppressor cells in tumor-bearing animals and enhances antitumor immune activity. Clin Cancer Res 11: 6713-6721. (Pubitemid 41339014)
8. Sterman, DH, Recio, A, Vachani, A, Sun, J, Cheung, L, DeLong, P et al. (2005). Long-term follow-up of patients with malignant pleural mesothelioma receiving high-dose adenovirus herpes simplex thymidine kinase/ganciclovir suicide gene therapy. Clin Cancer Res 11: 7444-7453. (Pubitemid 41507705)
9. Ben-Gary, H, McKinney, RL, Rosengart, T, Lesser, ML and Crystal, RG (2002). Systemic interleukin-6 responses following administration of adenovirus gene transfer vectors to humans by different routes. Mol Ther 6: 287-297. (Pubitemid 36336138)
10. Tolcher, AW, Hao, D, de Bono, J, Miller, A, Patnaik, A, Hammond, LA et al. (2006). Phase I, pharmacokinetic, and pharmacodynamic study of intravenously administered Ad5CMV-p53, an adenoviral vector containing the wild-type p53 gene, in patients with advanced cancer. J Clin Oncol 24: 2052-2058. (Pubitemid 46622114)
11. Pan, JJ, Zhang, SW, Chen, CB, Xiao, SW, Sun, Y, Liu, CQ et al. (2009). Effect of recombinant adenovirus-p53 combined with radiotherapy on long-term prognosis of advanced nasopharyngeal carcinoma. J Clin Oncol 27: 799-804.
12. Fujiwara, T, Tanaka, N, Kanazawa, S, Ohtani, S, Saijo, Y, Nukiwa, T et al. (2006). Multicenter phase I study of repeated intratumoral delivery of adenoviral p53 in patients with advanced non-small-cell lung cancer. J Clin Oncol 24: 1689-1699. (Pubitemid 46622140)
13. Keedy, V, Wang, W, Schiller, J, Chada, S, Slovis, B, Coffee, K et al. (2008). Phase I study of adenovirus p53 administered by bronchoalveolar lavage in patients with bronchioloalveolar cell lung carcinoma: ECOG 6597. J Clin Oncol 26: 4166-4171.
14. Pagliaro, LC, Keyhani, A, Williams, D, Woods, D, Liu, B, Perrotte, P et al. (2003). Repeated intravesical instillations of an adenoviral vector in patients with locally advanced bladder cancer: a phase I study of p53 gene therapy. J Clin Oncol 21: 2247-2253. (Pubitemid 46621859)
15. Wolf, JK, Bodurka, DC, Gano, JB, Deavers, M, Ramondetta, L, Ramirez, PT et al. (2004). A phase I study of Adp53 (INGN 201; ADVEXIN) for patients with platinum-and paclitaxel-resistant epithelial ovarian cancer. Gynecol Oncol 94: 442-448. (Pubitemid 39024551)
16. Dong, M, Li, X, Hong, LJ, Xie, R, Zhao, HL, Li, K et al. (2008). Advanced malignant pleural or peritoneal effusion in patients treated with recombinant adenovirus p53 injection plus cisplatin. J Int Med Res 36: 1273-1278.
17. Tsai, V, Johnson, DE, Rahman, A, Wen, SF, LaFace, D, Philopena, J et al. (2004). Impact of human neutralizing antibodies on antitumor effcacy of an oncolytic adenovirus in a murine model. Clin Cancer Res 10: 7199-7206. (Pubitemid 39487706)
18. Tong, AW, Nemunaitis, J, Su, D, Zhang, Y, Cunningham, C, Senzer, N et al. (2005). Intratumoral injection of INGN 241, a nonreplicating adenovector expressing the melanoma-differentiation associated gene-7 (mda-7/IL24): biologic outcome in advanced cancer patients. Mol Ther 11: 160-172. (Pubitemid 40012010)
19. Molnar-Kimber, KL, Sterman, DH, Chang, M, Kang, EH, ElBash, M, Lanuti, M et al. (1998). Impact of preexisting and induced humoral and cellular immune responses in an adenovirus-based gene therapy phase I clinical trial for localized mesothelioma. Hum Gene Ther 9: 2121-2133. (Pubitemid 28463929)
20. Hemminki, A, Wang, M, Desmond, RA, Strong, TV, Alvarez, RD and Curiel, DT (2002). Serum and ascites neutralizing antibodies in ovarian cancer patients treated with intraperitoneal adenoviral gene therapy. Hum Gene Ther 13: 1505-1514.
21. Harvey BG, Leopold PL, Hackett NR, Grasso TM, Williams PM, Tucker AL et al. (1999). Airway epithelial CFTR mRNA expression in cystic fbrosis patients after repetitive administration of a recombinant adenovirus. J Clin Invest 104:1245-1255.
22. Ceresoli, GL, Chiti, A, Zucali, PA, Rodari, M, Lutman, RF, Salamina, S et al. (2006). Early response evaluation in malignant pleural mesothelioma by positron emission tomography with [18F]fuorodeoxyglucose. J Clin Oncol 24: 4587-4593. (Pubitemid 46630956)
23. Flores, RM, Akhurst, T, Gonen, M, Zakowski, M, Dycoco, J, Larson, SM et al. (2006). Positron emission tomography predicts survival in malignant pleural mesothelioma. J Thorac Cardiovasc Surg 132: 763-768. (Pubitemid 44415880)
24. Choi, H, Charnsangavej, C, Faria, SC, Macapinlac, HA, Burgess, MA, Patel, SR et al. (2007). Correlation of computed tomography and positron emission tomography in patients with metastatic gastrointestinal stromal tumor treated at a single institution with imatinib mesylate: proposal of new computed tomography response criteria. J Clin Oncol 25: 1753-1759. (Pubitemid 46797957)
25. Van den Abbeele, AD (2008). The lessons of GIST-PET and PET/CT: a new paradigm for imaging. Oncologist 13 Suppl 2: 8-13.
26. Kruklitis, RJ, Singhal, S, Delong, P, Kapoor, V, Sterman, DH, Kaiser, LR et al. (2004). Immuno-gene therapy with interferon-beta before surgical debulking delays recurrence and improves survival in a murine model of malignant mesothelioma. J Thorac Cardiovasc Surg 127: 123-130. (Pubitemid 38160475)
27. Byrne, MJ and Nowak, AK (2004). Modifed RECIST criteria for assessment of response in malignant pleural mesothelioma. Ann Oncol 15: 257-260. (Pubitemid 38262625)