Phase I trial of interferon γ retroviral vector administered intratumorally with multiple courses in patients with metastatic melanoma

Human Gene Therapy

Volumn 10, Issue 8, 1999, Pages 1289-1298

  Nemunaitis, John ^a,b   Fong, Timothy ^c   Burrows, Francis ^c   Bruce, Janet ^a   Peters, Gloria ^c   Ognoskie, Nadine ^a   Meyer, Wally ^a   Wynne, Dee ^c   Kerr, Ronald ^a   Pippen, John ^a   Oldham, Fred ^c   Ando, Dale ^c  

^a University of South Carolina   (United States)

^b BAYLOR UNIVERSITY MEDICAL CENTER   (United States)

^c NOVARTIS PHARMA AG   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

CANCER ANTIBODY; GAMMA INTERFERON; VIRUS VECTOR;

ADULT; AGED; ANTIBODY RESPONSE; ANTINEOPLASTIC ACTIVITY; ARTICLE; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL TRIAL; ENZYME LINKED IMMUNOSORBENT ASSAY; FEMALE; GENE THERAPY; HUMAN; HUMAN CELL; MALE; MELANOMA; METASTASIS; PHASE 1 CLINICAL TRIAL; POLYMERASE CHAIN REACTION; RETROVIRUS;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, NEOPLASM; ANTINEOPLASTIC AGENTS; COHORT STUDIES; FEMALE; GENE THERAPY; GENETIC VECTORS; HUMANS; INJECTIONS; INTERFERON TYPE II; MALE; MELANOMA; MIDDLE AGED; MOLONEY MURINE LEUKEMIA VIRUS; TUMOR CELLS, CULTURED;

UNIDENTIFIED RETROVIRUS;

EID: 0033587072     PISSN: 10430342     EISSN: None     Source Type: Journal    
DOI: 10.1089/10430349950017978     Document Type: Article

References (46)

1. ABDEL-WAHAB, Z., DAR, M.M., HESTER, D., VERVAERT, C., GANGAVALLI, R., BARBER, J., DARROW, T.L., and SEIGLER, H.F. (1996). Effect of irradiation on cytokine production, MHC antigen expression, and vaccine potential of IL-2 and gamma-interferon gene-modified melanoma cells. Cell. Immunol. 171(2), 246-254.
2. ABDEL-WAHAB, Z., DAR, M., OSANTO, S., FONG, T., VERVAERT, C.E., HESTER, D., JOLLY, D., and SIEGLER, H.F. (1997a). Eradication of melanoma pulmonary metastases by immunotherapy with tumor cells engineered to secrete IL-2 or gamma-interferon. Cancer Gene Ther. 4(1), 33-41.
3. ABDEL-WAHAB, Z., WELTZ, C., HESTER, D., PICKETT, N., VERVAERT, C., BARBER, J.R., JOLLY, D., and SEIGLR, H.F. (1997b). A phase I clinical trial of immunotherapy with gamma-interferon gene-modified autologous melanoma cells: Monitoring the humoral immune response. Cancer 80(3), 410-412.
4. BALCH, C.M., HOUGHTON, A.N., MILTON, G.W., SOBER, A.J., and SOONG, S.J. (eds.). (1992). Cutaneous Melanoma, 2nd ed., Vol. 38. (J.B. Lippincott, Philadelphia, PA) pp. 498-508.
5. BATEMAN, W.J., FIERA, R., MATTHEWS, N., and MORRIS, A.G. (1991). Inducibility of class II major histocompatibility complex antigens by interferon-γ is associated with reduced tumorigenicity in C3H mouse fibroblasts transformed by v-KI-ras. J. Exp. Med. 173, 193-196.
6. BOUCHER, Y., BAXTER, L.T., and JAIN, R.K. (1990). Interstitial pressure gradients in tissue-isolated and subcutaneous tumors: Implications for therapy. Cancer Res. 50, 4478-4484.
7. COLOMBO, M.P., and FORNI, G. (1994). Cytokine gene transfer in tumor inhibition and tumor therapy: Where are we now? Immunol. Today 15(2), 48-51.
8. CULVER, D.W. (1994). Clinical applications of gene therapy for cancer. Clin. Chem. 40(4), 510-512.
9. CUSACK, J.C., SPITZ, F.R., NGUYEN, D., ZHANG, W.W., CRISTIANO, R.J., and ROTH, J.A. (1996). High levels of gene transduction in human lung tumors following intralesional injection of recombinant adenovirus. Cancer Gene Ther. 4(4), 245-249.
10. DEL PRETTE, S.A., MAURER, L.H., O'DONNELL, J., FORCIER, R.I., and LEMARBRE, P. (1984). Combination chemotherapy with cisplatin, carmustine, decarbazine and tamoxifen in metastatic melanoma. Cancer Treat. Rep. 68(11), 1403-1405.
11. FONG, T.C., CHONG, K., and ROBBINS, J.M. (1996). Regional and systemic cancer therapy by direct intralesional administration of γ-IFN retroviral vector. Cancer Gene Ther. 3(6), S12.
12. GANSBACHER, B., ZIER, K., DANIELS, B., CRONIN, K., BANNERJI, R., and GILBOA, E. (1990a). Interleukin-2 gene transfer into tumor cells abrogates tumorigenicity and induces protective immunity. J. Exp. Med. 172, 1217-1224.
13. GANSBACHER, B., BANNERJI, R., DANIELS, B., ZIER, K., CRONIN, K., and GILBOA, E. (1990b). Retroviral vector-mediated gamma-interferon gene transfer into tumor cells generates potent and long lasting anti-tumor immunity. Cancer Res. 50, 7820-7825.
14. HARRIS, M.P., SUTJIPTO, S., WILLIS, K.N., HANCOCK, W., CORNELL, D., JOHNSON, D.E., GREGORY, R.J., SHEPARD, H.M., and MANEVAL, D.C. (1996). Adenovirus-mediated p53 gene transfer inhibits growth of human tumor cells expressing mutant p53 protein. Cancer Gene Ther. 2, 121-129.
15. HOWARD, B., BURRASCANO, M., McCALLISTER, T., CHONG, K., GANGAVALLI, R., SEVERINSSON, L., JOLLY, D.F., DARROW, T., VERVAERT, C., and ADBEDL-WAHAB, Z. (1994). Retrovirus-mediated gene transfer of the human γ-IFN gene: A therapy for cancer. Gene Ther. Neoplastic Dis. 716, 167-187.
16. KARAVODIN, L., ROBBINS, J., CHONG, K., HSU, D., IBAÑEZ, C., MENTO, S., JOLLY, D., and FONG, T.C. (1998). Generation of a strong systemic anti-tumor response with direct regional intratumoral injections of IFN-γ retroviral vector. Hum. Gene Ther. 9, 2231-2241.
17. KIRKWOOD, J.M., STRAWDERMAN, M.H., ERNSTOFF, M.S., SMITH, T.J., BORDEN, E.C., and BLUM, R.H. (1996). Interferon alfa-2b adjuvant therapy of high-risk resected cutaneous melanoma: The Eastern Cooperative Oncology Group Trial EST 1684. J. Clin. Oncol. 14(1), 7-17.
18. KOH, H.K. (1991). Cutaneous melanoma. N. Engl. J. Med. 325, 171-182.
19. KWONG, Y.L., CHEN, S.H., KOSAJ, K., FINEGOLD, M.J., and WOO, S.L. (1996). Adenoviral-mediated suicide gene therapy for hepatic metastases of breast cancer. Cancer Gene Ther. 3, 399-344.
20. McADAM, A.J., PULASKI, B.A., STOROZYNSKY, E., YEH, K.Y., SICKEL, J.Z., FELINGER, J.G., and LORT, E.M. (1995). Analysis of the effect of cytokines (IL-2, IL-3, IL-4, IL-6, granulocyte-macrophage colony stimulating factor, and γ-IFN) on generation of primary cytotoxic T-lymphocytes against a weakly immunogenic tumor. Cell. Immunol. 165(2), 183-192.
21. NABEL, G., NABEL, E., and YANG, Z. (1993). Direct gene transfer with DNA-liposome complexes in melanoma: Expression, biologic activity, and lack of toxicity in humans. Proc. Natl. Acad. Sci. USA 90(23), 11307-11311.
22. NABEL, G., GORDON, D., and BISHOP, D.K. (1996). Immune response in human melanoma after transplant of an allogeneic class I major histocompatibility complex gene with DNA-liposome complex. Proc. Natl. Acad. Sci. U.S.A. 93(26), 15388-15393.
23. NEMUNAITIS, J., KLEMOW, S., and JAIN, V. (1996). Gene therapy: Clinical application in hematology and oncology. Part II. J. Oncol. Manage. 5(5), 30-38.
24. NEMUNAITIS, J., BOHART, C., FONG, T., MEYER, W., EDELMAN, G., PAULSON, R.S., ORR, D., JAIN, V., KOWAL, K.J., BURKEHOLDER, S., BRUCE, J., OGNOSKIE, N., WYNNE, D., and ANDO, D. (1998). Phase I trial of retroviral vector-mediated gamma-interferon gene transfer into autologous tumor cells in patients with metastatic melanoma. Cancer Gene Ther. 5(5), 292-300.
25. NEMUNAITIS, J., FONG, T., EDELMAN, G., PAULSON, R.S., BRUCE, J., OGNOSKIE, N., WYNN, D., MERRITT, J., and ANDO, D. (1999a). Phase I trial of gamma-interferon retroviral vector administered intra-tumorally to patients with metastatic melanoma. Cancer Gene Ther. (in press).
26. NEMUNAITIS, J., SWISHER, S.G., CONNORS, D., OGNOSKIE, N., TIMMONS, T., DOERKSEN, L., SAVIN, M., WEILL, D., MACK, M., WAIT, J., MERRITT, J., and ROTH, J. (1999b). Adenovirus-mediated p53 gene transfer in sequence with cisplatin to tumors of patients with non-small cell lung cancer (NSCLC). Submitted.
27. NESTLE, F.O., ALIJAGIC, S., GILLIEE, M., SUN, Y., GRABBE, S., DUMMER, R., BURG, G., and SCHADENDORF, D. (1998). Vaccination of melanoma patients with peptide-or tumor lysate-pulsed dendritic cells. Nature Med. 4, 328-332.
28. O'MALLEY, B.W., COPE, K.A., CHEN, S.H., LI, D., SCHWARTA, M.R., and WOO, S.L. (1996). Combination gene therapy for oral cancer in a murine model. Cancer Res. 56, 1737-1741.
29. PANELLY, M.C., WANG, E., SHEN, S., SCHLUTER, S.F., BERNSTEIN, R.M., HERSH, E.M., STOPECK, A., GANGAVALLI, R., BARBER, J., JOLLY, D., and AKPORIAYE, E.T. (1996). Interferon gamma (IFN-γ) gene transfer of an EMT6 tumor that is poorly responsive to γ-IFN stimulation: Increase in tumor immunogenicity is accompanied by induction of a mouse class II transactivator and class II MHC. Cancer Immunol. Immunother. 42(2), 99-107.
30. PENN, I. (1991). Principles of tumor immunity: Immunocompetence and Cancer. In Biology Therapy of Cancer. V.T. DeVita, S. Hellman, and S.A. Rosenberg, eds. (Lippincott, Philadelphia, PA) pp. 53-66.
31. PORGADOR, A., BANNERJI, R., WATANABE, Y., FELDMAN, M., GILBOA, E., and EISENBACH, L. (1993). Antimetastatic vaccination of tumor-bearing mice with two types of IFN-γ gene inserted tumor cells. J. Immunol. 150(4), 1458-1370.
32. RESTIFO, N.P., SPIESS, P.J., KARP, S.E., MULE, J.J., and ROSENBERG, S.A. (1992). A nonimmunogenic sarcoma transduced with the cDNA for Interferon gamma elicits CD8+ T-cells against the wild type tumor: Correlation with antigen presentation capability. J. Exp. Med. 175, 1423-1431.
33. ROSENBERG, S.A., LOTZKE, M.T., MUUL, L.M., CHANG, A.E., AVIS, F.P., LEITMAN, S., LINEHAN, W.M., ROBERTSON, C.N., LEE, R.E., and BUBIN, J.T. (1987). A progress report on the treatment of 157 patients with advanced cancer using lymphokine-activated killer cells and interleukin-2 or high-dose interleukin-2 alone. N. Engl. J. Med. 316(15), 889-897.
34. ROSENBERG, S.A., PACKARD, B.S., AEBERSOLD, P.M., SOLOMON, D., TOPALIAN, S.L., TOY, S.T., SIMON, P., LOTZE, M.T., YANG, J.C., and SEIPP, C.A. (1988). Use of tumor-infiltrating lymphocytes and interleukin-2 in the immunotherapy of patients with metastatic melanoma. N. Engl. J. Med. 316, 889-897.
35. ROSENBERG, S.A., YANG, J.C., SCHWARTZENTRUBER, D.J., HWU, P., MARINCOLA, F.M., TOPALIAN, S.L., RESTIFO, N.P., DUDLEY, M.E., SCHWARTZ, S.L., SPIESS, P.J., WUNDERLICH, J.R., PARKHURST, M.R., KAWAKAMI, Y., SEIPP, C.A., EINHORN, J.H., and WHITE, D.E. (1998). Immunologic and therapeutic evaluation of a synthetic peptide vaccine for the treatment of patients with metastatic melanoma. Nature Med. 4, 321-327.
36. ROSENTHAL, F.M., CRONIN, K., BANNERJI, R., GOLDE, D.W., and GANSBACHER, B. (1994). Augmentation of antitumor immunity by tumor cells transduced with a retroviral vector carrying the IL-2 and γ-IFN cDNAs. Blood 83(5), 1289-1298.
37. ROTH, J.A., NGUYEN, D., LAWERENCE, D.D., KEMP, B.L., CARRASCO, C.H., FERSON, D.Z., HONG, W.K., KOMAKI, R., LEE, J.J., NESBITT, J.C., PISTERS, K.M., PUTMAN, J.B., SCHEA, R., SHIN, D.M., WALSH, G.L., DOLORMENTE, M.M., HAN, C.I., MARTIN, F.D., YEN, N., XU, K., STEPHENS, L.C., McDONNELL, T.K., MUKHOPADHYAY, T., and CAY, D. (1996). Retroviral mediated wildtype p53 gene transfer to tumors of patients with lung cancer. Nature Med. 2(9), 985-991.
38. SCHMIDT-WOLF, G.D., and SCHMIDT-WOLF, G.H. (1995). Cytokines and gene therapy. Immunol. Today 16, 173-175.
39. SILVER, H.K.B., KLASA, R.J., and BALLY, M.B. (1996). Proc. A.A.C.R. 37, 342. [Abstract 2337]
40. SMILEY, W.R., LAUBERT, B., HOWARD, B.D., IBANEZ, C., FONG, T.C., SUMMERS, W.S., and BURROWS, F. (1997). Establishment of parameters for optimal transduction efficiency and anti-tumor effects with purified high-titer HSV-TK retroviral vector in established solid tumors. Hum. Gene Ther. 8, 965-977.
41. SOSMAN, J.A., WEISS, G.R., MARGOLIN, K.A., ARONSON, F.R., SZNOL, M., ATKINS, M.B., O'BYLE, K., FISHER, R.I., BOLDT, D.H., and DOROSHOW, J. (1993). Phase IB clinical trial of anti-CD3 followed by high-dose bolus interleukin-2 in patients with metastatic melanoma and advanced renal cell carcinoma: Clinical and immunologic effects. J. Clin. Oncol. 1(8), 1496-1505.
42. SPARANO, J.A., and DUTCHER, J.P. (1993). Interleukin-2 for the treatment of advanced melanoma. Melanoma 1(4), 189-295.
43. SUGITA, K., MIYAZAKI, J.I., APPELA, E., and OZATO, K. (1987). Interferons increase transcription of a major histocompatibility class I gene via a 5′ interferon consensus sequence. Mol. Cell. Biol. 7, 2625-2630.
44. SUTTON, M.A., BERKMAN, S.A., CHEN, S.H., BLOCK, A., DANG, T.D., KATTAN, M.W., WHEELER, T.M., ROWLEY, D.R., WOO, S.L., and LERNER, S.P. (1997). Adenovirus-mediated suicide gene therapy for experimental bladder cancer. Urology 49, 173-180.
45. WALSH, P., DORNER, A., DUKE, R.C., SU, L.J., and GLODE, L.M. (1995). Macrophage colony-stimulating factor complementary DNA: A candidate for gene therapy in metastatic melanoma. J. Natl. Cancer Inst. 87(11), 806-816.
46. WATANABE, Y., KURIBAYASHI, K., MIYATAKE, S., NISHIHARA, K., NAKAYAMA, E., TANIYAMA, T., and SAKATA, T. (1989). Exogenous expression of mouse interferon gamma cDNA in mouse neuroblastoma CI300 cells results in reduced tumorigenicity by augmented antitumor immunity. Proc. Natl. Acad. Sci. U.S.A. 89, 9456-9460.