A phase 2 trial of sequential temozolomide chemotherapy followed by high-dose interleukin 2 immunotherapy for metastatic melanoma

Cancer

Volumn 113, Issue 7, 2008, Pages 1632-1640

  Tarhini, Ahmad A ^a   Kirkwood, John M ^a   Gooding, William E ^b   Moschos, Stergios ^a   Agarwala, Sanjiv S ^c  

^a UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF PITTSBURGH CANCER INSTITUTE   (United States)

^c St Luke's Health System   (United States)

Author keywords

Chemotherapy; Immunotherapy; Interleukin 2; Metastatic melanoma; Phase 2; Temozolomide

Indexed keywords

ANTINEOPLASTIC AGENT; DACARBAZINE; DRUG DERIVATIVE; INTERLEUKIN 2; TEMOZOLOMIDE;

ADULT; AGED; ARTICLE; CLINICAL TRIAL; DRUG ADMINISTRATION; FEMALE; HUMAN; MALE; MELANOMA; METASTASIS; MIDDLE AGED; PATHOLOGY; PHASE 2 CLINICAL TRIAL; SKIN TUMOR;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; DACARBAZINE; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; INTERLEUKIN-2; MALE; MELANOMA; MIDDLE AGED; NEOPLASM METASTASIS; SKIN NEOPLASMS;

EID: 54049149389     PISSN: 0008543X     EISSN: 10970142     Source Type: Journal    
DOI: 10.1002/cncr.23791     Document Type: Article

References (41)

1. Kirkwood JM, Agarwala SS. Systemic cytotoxic and biologic therapy melanoma. In: DeVita VT Jr, Hellman S, Rosenberg SA, eds. Principles and Practice of Oncology. Philadelphia, Pa: Lippincott Williams and Wilkins; 1993:1-16.
2. Middleton MR, Grob JJ, Aaronson N, et al. Randomized phase III study of temozolomide versus dacarbazine in the treatment of patients with advanced metastatic malignant melanoma. J Clin Oncol. 2000;18:158-166. (Pubitemid 30036349)
3. Chapman PB, Einhorn LH, Meyers ML, et al. Phase III multicenter randomized trial of the Dartmouth regimen versus dacarbazine in patients with metastatic melanoma. J Clin Oncol. 1999;17:2745-2751. (Pubitemid 29415231)
4. Falkson CI, Ibrahim J, Kirkwood JM, Coates AS, Atkins MB, Blum RH. Phase III trial of dacarbazine versus dacarbazine with interferon alpha-2b versus dacarbazine with tamoxifen versus dacarbazine with interferon alpha-2b and tamoxifen in patients with metastatic malignant melanoma: an Eastern Cooperative Oncology Group study. J Clin Oncol. 1998;16:1743-1751.
5. Rusthoven JJ, Quirt IC, Iscoe NA, et al. Randomized, double-blind, placebo-controlled trial comparing the response rates of carmustine, dacarbazine, and cisplatin with and without tamoxifen in patients with metastatic melanoma. National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 1996;14:2083-2090. (Pubitemid 26230110)
6. Agarwala SS, Ferri W, Gooding W, Kirkwood JM. A phase III randomized trial of dacarbazine and carboplatin with and without tamoxifen in the treatment of patients with metastatic melanoma. Cancer. 1999;85:1979-1984. (Pubitemid 29202773)
7. Atkins MB, Lotze MT, Dutcher JP, et al. High-dose recombinant interleukin-2 therapy for patients with metastatic melanoma: analysis of 270 patients treated between 1985 and 1993. J Clin Oncol. 1999;17:2105-2116. (Pubitemid 29318842)
8. Stevens MF, Hickman JA, Stone R, et al. Antitumor imidazotetrazines. 1. Synthesis and chemistry of 8-carbamoyl-3-(2-chloroethyl)imidazo[5,1-d]-1,2,3,5- tetrazin-4(3 H)-1, a novel broad-spectrum antitumor agent. J Med Chem. 1984; 27:196-201. (Pubitemid 14178871)
9. Stevens MF, Hickman JA, Langdon SP, et al. Antitumor activity and pharmacokinetics in mice of 8-carbamoyl-3-methyl-imidazo[5,1-d]-1,2,3,5- tetrazin-4(3H)-1 (CCRG 81045; M&B 39831), a novel drug with potential as an alternative to dacarbazine. Cancer Res. 1987;47:5846-5852. (Pubitemid 18018717)
10. Agarwala SS, Kirkwood JM. Temozolomide, a novel alkylating agent with activity in the central nervous system, may improve the treatment of advanced metastatic melanoma. Oncologist. 2000;5:144-151.
11. Gibson NW, Hickman JA, Erickson LC. DNA cross-linking and cytotoxicity in normal and transformed human cells treated in vitro with 8-carbamoyl-3-(2- chloroethyl)imidazo[ 5,1-d]-1,2,3,5-tetrazin-4(3H)-one. Cancer Res. 1984;44:1772-1775. (Pubitemid 14145712)
12. Hartley JA, Gibson NW, Kohn KW, Mattes WB. DNA sequence selectivity of guanine-N7 alkylation by 3 antitumor chloroethylating agents. Cancer Res. 1986;46(4pt 2):1943-1947. (Pubitemid 16117890)
13. Tsang LL, Quarterman CP, Gescher A, Slack JA. Comparison of the cytotoxicity in vitro of temozolomide and dacarbazine, prodrugs of 3-methyl-(triazen-1-yl)imidazole-4-carboxamide. Cancer Chemother Pharmacol. 1991;27:342-346.
14. Gerson SL, Spiro TP, Reidenberg P, et al. Rapid depletion of O6-alkyguanine DNA alkytransferase with twice daily oral temozolomide (SCH 52365) in patients with advanced cancer [abstract]. Proc Am Soc Clin Oncol. 1996;14:178. Abstract 366.
15. Tolcher AW, Gerson SL, Denis L, et al. Marked inactivation of O6-alkylguanine-DNA alkyltransferase activity with protracted temozolomide schedules. Br J Cancer. 2003;88:1004-1011. (Pubitemid 36560766)
16. Brock CS, Newlands ES, Wedge SR, et al. Phase I trial of temozolomide using an extended continuous oral schedule. Cancer Res. 1998;58:4363-4367. (Pubitemid 28450038)
17. Figueroa J, Tolcher A, Denis L, et al. Protracted cyclic administration of temozolomide is feasible: a phase I, pharmacokinetic and pharmacodynamic study. Proc Am Soc Clin Oncol. 2000:19. Abstract 868.
18. Eton O, Legha SS, Bedikian AY, et al. Sequential biochemotherapy versus chemotherapy for metastatic melanoma: results from a phase III randomized trial. J Clin Oncol. 2002;20:2045-2052. (Pubitemid 34408794)
19. Atkins MB, Lee S, Flaherty LE, Sosman JA, Sondak VK, Kirkwood JM. A prospective randomized phase III trial of concurrent biochemotherapy (BCT) with cisplatin, vinblastine, dacarbazine (CVD), IL-2 and interferon alpha-2b (IFN) versus CVD alone in patients with metastatic melanoma (E3695): an ECOG-coordinated intergroup trial [abstract]. Proc Am Soc Clin Oncol. 2003;22:708. Abstract 2874.
20. Keilholz U, Punt CJ, Gore M, et al. Dacarbazine, cisplatin, and IFN-a2b with or without IL-2 in advanced melanoma: final analysis of EORTC randomized phase III trial 18951. Proc Am Soc Clin Oncol. 2003;22. Abstract 2848.
21. Del Vecchio M, Bajetta E, Vitali M, et al. Multicenter phase III randomized trial of cisplatin, vindesine, and decarbazine (CVD) versus CVD plus subcutaneous (SC) interleukin-2 (IL-2) and interferon-alpha-2b (IFN) in metastatic melanoma patients (PTS). Proc Am Soc Clin Oncol. 2003;22. Abstract 2849.
22. Ives NJ Stowe RL, Lorigan P, Wheatley K. Biochemotherapy versus chemotherapy for metastatic malignant melanoma: a meta-analysis of the randomised trials [abstract]. 2007 ASCO Annual Meeting Proceedings (Post-Meeting Edition). J Clin Oncol. 2007; 2007;25(18S). Abstract 8544.
23. Simon R. Optimal 2-stage designs for phase II clinical trials. Control Clin Trials. 1989;10:1-10. (Pubitemid 19099520)
24. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc. 1958;53:457-481.
25. Balch CM, Buzaid AC, Soong SJ, et al. Final version of the American Joint Committee on Cancer staging system for cutaneous melanoma. J Clin Oncol. 2001;19:3635-3648. (Pubitemid 32786276)
26. Tarhini AA, Kirkwood JM, Gooding WE, Cai C, Agarwala SS. Durable complete responses with high-dose bolus interleukin-2 in patients with metastatic melanoma who have experienced progression after biochemotherapy. J Clin Oncol. 2007;25:3802-3807. (Pubitemid 47477253)
27. McDermott DF, Regan MM, Clark JI, et al. Randomized phase III trial of high-dose interleukin-2 versus subcutaneous interleukin-2 and interferon in patients with metastatic renal cell carcinoma. J Clin Oncol. 2005;23:133-141. (Pubitemid 41702632)
28. Korn EL, Arbuck SG, Pluda JM, Simon R, Kaplan RS, Christian MC. Clinical trial designs for cytostatic agents: are new approaches needed? J Clin Oncol. 2001;19:265-272. (Pubitemid 32063505)
29. Harrison BE, Johnson JL, Clough RW, Halperin EC. Selection of patients with melanoma brain metastases for aggressive treatment. Am J Clin Oncol. 2003;26:354-357. (Pubitemid 36962076)
30. Amer MH, Al-Sarraf M, Baker LH, Vaitkevicius VK. Malignant melanoma and central nervous system metastases: incidence, diagnosis, treatment and survival. Cancer. 1978;42:660-668. (Pubitemid 8405861)
31. Patel JK, Didolkar MS, Pickren JW, Moore RH. Metastatic pattern of malignant melanoma. A study of 216 autopsy cases. Am J Surg. 1978;135:807-810. (Pubitemid 8377329)
32. Bullard DE, Cox EB, Seigler HF. Central nervous system metastases in malignant melanoma. Neurosurgery. 1981;8: 26-30. (Pubitemid 11146127)
33. Budman DR, Camacho E, Wittes RE. The current causes of death in patients with malignant melanoma. Eur J Cancer. 1978;14:327-330. (Pubitemid 8310441)
34. Sampson JH, Carter JH Jr, Friedman AH, Seigler HF. Demographics, prognosis, and therapy in 702 patients with brain metastases from malignantmelanoma. JNeurosurg. 1998; 88:11-20. (Pubitemid 28018958)
35. Patchell RA, Tibbs PA, Walsh JW, et al. A randomized trial of surgery in the treatment of single metastases to the brain. N Engl J Med. 1990;322:494-500. (Pubitemid 20067825)
36. Vecht CJ, Haaxma-Reiche H, Noordijk EM, et al. Treatment of single brain metastasis: radiotherapy alone or combined with neurosurgery? Ann Neurol. 1993;33:583-590. (Pubitemid 23161878)
37. Smalley SR, Laws ER Jr, O'Fallon JR, Shaw EG, Schray MF. Resection for solitary brain metastasis. Role of adjuvant radiation and prognostic variables in 229 patients. J Neurosurg. 1992;77:531-540.
38. Sause WT, Crowley JJ, Morantz R, et al. Solitary brain metastasis: results of an RTOG/SWOG protocol evaluation of surgery + RT versus RT alone. Am J Clin Oncol. 1990;13:427-432. (Pubitemid 20344521)
39. Kondziolka D, Martin JJ, Flickinger JC, et al. Long-term survivors after gamma knife radiosurgery for brain metastases. Cancer. 2005;104:2784-2791. (Pubitemid 41798289)
40. Gaudy-Marqueste C, Regis JM, Muracciole X, et al. Gamma-knife radiosurgery in the management of melanoma patients with brain metastases: a series of 106 patients without whole-brain radiotherapy. Int J Radiat Oncol Biol Phys. 2006;65:809-816. (Pubitemid 43795850)
41. Maker AV, Phan GQ, Attia P, et al. Tumor regression and autoimmunity in patients treated with cytotoxic T lymphocyte-associated antigen 4 blockade and interleukin-2: a phase I/II study. Ann Surg Oncol. 2005;12:1005-1016. (Pubitemid 41660676)