Phase II study of temozolomide plus thalidomide for the treatment of metastatic melanoma

Journal of Clinical Oncology

Volumn 21, Issue 17, 2003, Pages 3351-3356

  Hwu, Wen Jen ^a   Krown, Susan E ^a   Menell, Jennifer H ^a   Panageas, Katherine S ^a   Merrell, Janene ^a   Lamb, Lynne A ^a   Williams, Linda J ^a   Quinn, Carolyn J ^a   Foster, Theresa ^a   Chapman, Paul B ^a   Livingston, Philip O ^a   Wolchok, Jedd D ^a   Houghton, Alan N ^a  

^a MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

TEMOZOLOMIDE; THALIDOMIDE; ANTINEOPLASTIC AGENT; DACARBAZINE; DRUG DERIVATIVE;

ADULT; AGED; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER STAGING; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEEP VEIN THROMBOSIS; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG WITHDRAWAL; DYSPNEA; EDEMA; FATIGUE; FEVER; FOLLOW UP; GASTROINTESTINAL HEMORRHAGE; HUMAN; LYMPHOCYTOPENIA; MELANOMA; METASTASIS; MULTIPLE CYCLE TREATMENT; NEUROTOXICITY; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; RASH; THROMBOCYTOPENIA; TREATMENT RESPONSE; BRAIN TUMOR; DOSE RESPONSE; FEMALE; MALE; MIDDLE AGED; PATHOLOGY; SURVIVAL; TREATMENT OUTCOME;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BRAIN NEOPLASMS; DACARBAZINE; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; MALE; MELANOMA; MIDDLE AGED; SURVIVAL ANALYSIS; THALIDOMIDE; TREATMENT OUTCOME;

EID: 0141688331     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2003.02.061     Document Type: Article

References (26)

1. Balch CM, Buzaid AC, Soong S-J, et al: Final version of the American Joint Committee on Cancer staging system for cutaneous melanoma. J Clin Oncol 19:3635-3648, 2001
2. Jemal A, Thomas A, Murray T, et al: Cancer statistics, 2002. CA Cancer J Clin 52:23-47, 2002
3. Serrone L, Zeuli M, Sega FM, et al: Dacarbazine-based chemotherapy for metastatic melanoma: Thirty-year experience overview. J Exp Clin Cancer Res 19:21-34, 2000
4. 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 17:2745-2751, 1999
5. Rosenberg SA, Yang JC, Schwartzentruber DJ, et al: Prospective randomized trial of the treatment of patients with metastatic melanoma using chemotherapy with cisplatin, dacarbazine, and tamoxifen alone or in combination with interleukin-2 and interferon alfa-2b. J Clin Oncol 17:968-975, 1999
6. Dorval T, Negrier S, Chevreau C, et al: Randomized trial of treatment with cisplatin and interleukin-2 either alone or in combination with interferon-alpha-2a in patients with metastatic melanoma: A Federation Nationale des Centres de Lutte Contre le Cancer Multicenter, parallel study. Cancer 85:1060-1066, 1999
7. 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 20:2045-2052, 2002
8. Agarwala SS, Reyderman L, Statkevich P, et al: Pharmacokinetic study of temozolomide penetration into CSF in a patient with dural melanoma. Ann Oncol 9:138, 1998 (abstr 659)
9. Stupp R, Ostermann S, Leyvraz S, et al: Cerebrospinal fluid levels of temozolomide as a surrogate marker for brain penetration. Proc Am Soc Clin Oncol 20:59a, 2001 (abstr 232)
10. 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 18:158-166, 2000
11. Paul MJ, Summers Y, Calvert AH, et al: Effect of temozolomide on central nervous system relapse in patients with advanced melanoma. Melanoma Res 12:175-178, 2002
12. Atkins MB, Gollob JA, Sosman JA, et al: A phase II pilot trial of concurrent biochemotherapy with cisplatin, vinblastine, temozolomide, interleukin 2, and IFN-alpha 2B in patients with metastatic melanoma. Clin Cancer Res 8:3075-3081, 2002
13. Brock CS, Newlands ES, Wedge SR, et al: Phase I trial of temozolomide using an extended continuous oral schedule. Cancer Res 58:4363-4367, 1998
14. D'Amato RJ, Loughnan MS, Flynn E, et al: Thalidomide is an inhibitor of angiogenesis. Proc Natl Acad Sci U S A 91:4082-4085, 1994
15. Geitz H, Handt S, Zwingenberger K: Thalidomide selectively modulates the density of cell surface molecules involved in the adhesion cascade. Immunopharmacology 31:213-221, 1996
16. Haslett PA, Corral LG, Albert M, et al: Thalidomide costimulates primary human T lymphocytes, preferentially inducing proliferation, cytokine production, and cytotoxic responses in the CD8+ subset. J Exp Med 187:1885-1892, 1998
17. Rajkumar SV: Current status of thalidomide in the treatment of cancer. Oncology (Huntingt) 15:867-874, 2001
18. Eisen T, Boshoff C, Mak I, et al: Continuous low dose Thalidomide: A phase II study in advanced melanoma, renal cell, ovarian and breast cancer. Br J Cancer 82:812-817, 2000
19. Hwu W-J, Krown SE, Panageas KS, et al: Temozolomide plus thalidomide in patients with advanced melanoma: Results of a dose-finding trial. J Clin Oncol 20:2610-2615, 2002
20. Anderson JR, Cain KC, Gelber RD: Analysis of survival by tumor response. J Clin Oncol 1:710-719, 1983
21. Amer MH, Al-Sarraf M, Baker LH, et al: Malignant melanoma and central nervous system metastases: incidence, diagnosis, treatment and survival. Cancer 42:660-668, 1978
22. Patel JK, Didolkar MS, Pickren JW, et al: Metastatic pattern of malignant melanoma: A study of 216 autopsy cases. Am J Surg 135:807-810, 1978
23. Bafaloukos D, Gogas H, Georgoulias V, et al: Temozolomide in combination with docetaxel in patients with advanced melanoma: A phase II study of the Hellenic Cooperative Oncology Group. J Clin Oncol 20:420-425, 2002
24. Hwu W-J, Raizer J, Panageas KS, et al: Treatment of metastatic melanoma in the brain with temozolomide and thalidomide. Lancet Oncol 2:634-635, 2001
25. Dardoufas C, Miliadou A, Skarleas C, et al: Concomitant temozolomide (TMZ) and radiotherapy (RT) followed by adjuvant treatment with temozolomide in patients with brain metastases from solid tumours. Proc Am Soc Clin Oncol 20:75b, 2001 (abstr 2048)
26. Agarwala SS, Kirkwood JM: Temozolomide in combination with interferon alfa-2b in patients with metastatic melanoma: A phase I dose-escalation study. Cancer 97:121-127, 2003