G3139 (Genasense) in patients with advanced merkel cell carcinoma

American Journal of Clinical Oncology: Cancer Clinical Trials

Volumn 32, Issue 2, 2009, Pages 174-179

  Shah, Manisha H ^a,e   Varker, Kimberly A ^a   Collamore, Minden ^a   Zwiebel, James A ^b   Coit, Daniel ^c   Kelsen, David ^d   Chung, Ki Y ^d  

^a OHIO STATE UNIVERSITY   (United States)

^b NATIONAL CANCER INSTITUTE   (United States)

^c Gastric and Mixed Tumor Service   (United States)

^d MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^e OHIO STATE UNIVERSITY   (United States)

Author keywords

Bcl 2 antisense therapy; G3139; Merkel cell carcinoma; Phase II trial

Indexed keywords

ANTIHISTAMINIC AGENT; ANTINEOPLASTIC AGENT; CORTICOSTEROID; OBLIMERSEN;

ADULT; ADVANCED CANCER; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALKALINE PHOSPHATASE BLOOD LEVEL; ANEMIA; ANOREXIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; ATAXIA; CANCER CHEMOTHERAPY; CANCER PATIENT; CHEMOTHERAPY INDUCED EMESIS; CHILL; CLINICAL ARTICLE; CLINICAL TRIAL; CONTINUOUS INFUSION; CREATININE BLOOD LEVEL; CYTOPENIA; DIAPHORESIS; DIARRHEA; DIZZINESS; DRUG DOSE REDUCTION; DRUG ERUPTION; DRUG FEVER; DRUG HYPERSENSITIVITY; DRUG TOLERABILITY; DRY SKIN; DYSPEPSIA; FATIGUE; FEMALE; HUMAN; HUMAN TISSUE; HYPERGLYCEMIA; HYPERKALEMIA; HYPERNATREMIA; HYPOALBUMINEMIA; HYPOCALCEMIA; HYPOKALEMIA; HYPONATREMIA; HYPOPHOSPHATEMIA; INFECTION; KARNOFSKY PERFORMANCE STATUS; KIDNEY FAILURE; LEUKOPENIA; LYMPHOCYTOPENIA; MALE; MERKEL CELL TUMOR; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; OUTCOME ASSESSMENT; OUTPATIENT DEPARTMENT; PAIN; PHASE 2 CLINICAL TRIAL; PRURITUS; RIGOR; SIDE EFFECT; TASTE DISORDER; THERAPY DELAY; TREATMENT RESPONSE; TUMOR LOCALIZATION; TUMOR RECURRENCE; WEIGHT REDUCTION;

AGED; CARCINOMA, MERKEL CELL; FEMALE; HUMANS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASM METASTASIS; NEOPLASM STAGING; OLIGONUCLEOTIDES, ANTISENSE; PROGNOSIS; SKIN NEOPLASMS; SURVIVAL RATE; THIONUCLEOTIDES;

EID: 67749106517     PISSN: 02773732     EISSN: 1537453X     Source Type: Journal    
DOI: 10.1097/COC.0b013e31817eebf8     Document Type: Article

References (37)

1. Toker C. Trabecular carcinoma of the skin. Arch Dermatol. 1972;105:107-110.
2. Allen PJ, Bowne WB, Jaques DP, et al. Merkel cell carcinoma: prognosis and treatment of patients from a single institution. J Clin Oncol. 2005;23:2300 -2309.
3. Pectasides D, Pectasides M, Economopoulos T. Merkel cell cancer of the skin. Ann Oncol. 2006;17:1489-1495.
4. Medina-Franco H, Urist MM, Fiveash J, et al. Multimodality treatment of Merkel cell carcinoma: case series and literature review of 1024 cases. Ann Surg Oncol. 2001;8:204-208.
5. Karakousis CP, Balch CM, Urist MM, et al. Local recurrence in malignant melanoma: long-term results of the multiinstitutional randomized surgical trial. Ann Surg Oncol. 1996;3:446-452.
6. Veness MJ, Morgan GJ, Gebski V. Adjuvant locoregional radiotherapy as best practice in patients with Merkel cell carcinoma of the head and neck. Head Neck. 2005;27:208-216.
7. Meeuwissen JA, Bourne RJ, Kearsley JH. The importance of postoperative radiation therapy in the treatment of Merkel cell carcinoma. Int J Radiat Oncol Biol Phys. 1995;31:323-331.
8. Morrison WH, Peters LJ, Silvia EG, et al. The essential role of radiation therapy in securing locoregional control of Merkel cell carcinoma. Int J Radiat Oncol Biol Phys. 1990;19:583-591.
9. Poulsen M, Rischin D, Walpole E, et al. High risk Merkel cell carcinoma of the skin treated with synchronous carboplatin/etoposide and radiation: a Trans-Tasman Radiation Oncology Group study-TROG 96:07. J Clin Oncol. 2003;21:4371-4376.
10. Mojica P, Smith D, Ellenhorn JD. Adjuvant radiation therapy is associated with improved survival in Merkel cell carcinoma of the skin. J Clin Oncol. 2007;25:1043-1047.
11. Pectasides D, Pectasides M, Psyrri A, et al. Cisplatin-based chemotherapy for Merkel cell carcinoma of the skin. Cancer Invest. 2006;24:780-785.
12. Poulsen MG, Rischin D, Porter I, et al. Does chemotherapy improve survival in high-risk Stage I and II Merkel cell carcinoma of the skin? Int J Radiat Oncol Biol Phys. 2006;64:114-119.
13. Feun LF, Savaraj N, Lehga SS, et al. Chemotherapy for metastatic Merkel cell carcinoma. Review of the MD Anderson Hospital's experience. Cancer. 1988;62:683-685.
14. Raaf JH, Urmacher C, Knapper WK, et al. Trabecular (Merkel cell) carcinoma of the skin: treatment of primary, recurrent, and metastatic disease. Cancer. 1986;57:178-182.
15. George TK, di Sant'agnese PA, Bennett JM. Chemotherapy for metastatic Merkel cell carcinoma. Cancer. 1985;56:1034-1048.
16. Sharma D, Flora G, Grunberg SM. Chemotherapy of metastatic Merkel cell carcinoma: case report and review of the literature. Am J Clin Oncol. 1991;14:166-169.
17. Wynne CJ, Kearsley JH. Merkel cell tumor. A chemosensitive skin cancer. Cancer. 1988;62:28-31.
18. Tsujimoto Y, Cossman J, Jaffe E, et al. Involvement of the bcl-2 gene in human follicular lymphoma. Science. 1985;228:1440-1443.
19. Mita M, Tolcher AW. Novel apoptosis inducing agents in cancer therapy. Curr Probl Cancer. 2005;29:8-32.
20. Tolcher AW. Targeting Bcl-2 protein expression in solid tumors and hematologic malignancies with antisense oligonucleotides. Clin Adv Hematol Oncol. 2005;3:635-642.
21. Kim R, Emi M, Matsuura K, et al. Antisense and nonantisense effects of antisense Bcl-2 on multiple roles of Bcl-2 as a chemosensitizer in cancer therapy. Cancer Gene Ther. 2007;14:1-11.
22. Schlagbauer-Wadl H, Klosner G, Heere-Ress E, et al. Bcl-2 antisense oligonucleotides (G3139) inhibit Merkel cell carcinoma growth in SCID mice. J Invest Dermatol. 2000;114:725-730.
23. Morris MJ, Tong WP, Cordon-Cardo C, et al. Phase I trial of BCL-2 antisense oligonucleotide (G3139) administered by continuous intravenous infusion in patients with advanced cancer. Clin Cancer Res. 2002;8:679-683.
24. Jansen B, Wacheck V, Heere-Ress E, et al. Chemosensitization of malignant melanoma by BCL2 antisense therapy. Lancet. 2000;356:1728-1733.
25. Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000;92:205-216.
26. Choi J, Charnsangavej C, de Castro Faria S, et al. CT evaluation of the response of gastrointestinal stromal tumors after imatinib mesylate treatment: a quantitative analysis correlated with FDG PET findings. AJR Am J Roentgenol. 2004;183:1619-1628.
27. Choi H, Chatnsangavej C, Faria SC, et al. 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. 2007;25:1753-1759.
28. Benjamin RS, Choi H, Macapinlac HA, et al. We should desist using RECIST, at least in GIST. J Clin Oncol. 2007;13:1760-1764.
29. Ratain MJ, Eisen T, Stadler WM, et al. Phase II placebo-controlled randomized discontinuation trial of sorafenib in patients with metastatic renal cell carcinoma. J Clin Oncol. 2006;24:2505-2512.
30. O'Brien SM, Cunningham CC, Golenkov AK, et al. Phase I to II multicenter study of oblimersen sodium, a Bcl-2 antisense oligonucleotide, in patients with advanced chronic lymphocytic leukemia. J Clin Oncol. 2005;23:7697-7702.
31. Marcucci G, Stock W, Dai G, et al. Phase I study of oblimersen sodium, an antisense to Bcl-2, in untreated older patients with acute myeloid leukemia: pharmacokinetics, pharmacodynamics, and clinical activity. J Clin Oncol. 2005;23:3404-3411.
32. Marcucci G, Moser B, Blum W, et al. A phase III randomized trial of intensive induction and consolidation chemotherapy ± oblimersen, a proapoptotic Bcl-2 antisense oligonucleotide in untreated acute myeloid leukemia patients > 60 years old. J Clin Oncol 2007 ASCO Annual Meeting Proceedings Part I Vol. 2007;25(18S):7012.
33. Mita MM, Ochoa L, Rowinsky EK, et al. A phase I, pharmacokinetic and biologic correlative study of oblimersen sodium (Genasense™, G3139) and irinotecan in patients with metastatic colorectal cancer. Ann Oncol. 2006;17: 313-321.
34. Marshall J, Chen H, Yang D, et al. A phase I trial of a Bcl-2 antisense (G3139) and weekly docetaxel in patients with advanced breast cancer and other solid tumors. Ann Oncol. 2004;15:1274-1283.
35. Rudin CM, Kozloff M, Hoffman PC, et al. Phase I study of G3139, a bcl-2 antisense oligonucleotide, combined with carboplatin and etoposide in patients with small-cell lung cancer. J Clin Oncol. 2004;22:1110-1117.
36. Bedikian AY, Millward M, Pehamberger J, et al. Bcl-2 antisense (oblimersen sodium) plus dacarbazine in patients with advanced melanoma: the oblimersen melanoma study group. J Clin Oncol. 2006;24:4738-4745.
37. Tolcher AW, Chi K, Kuhn J, et al. A phase II pharmacokinetic and biological correlative study of oblimersen sodium and docetaxel in patients with hormone-refractory prostate cancer. Clin Cancer Res. 2005;11:3854-3861.