Phase II trial of pegylated interferon and thalidomide in malignant metastatic melanoma

Anti-Cancer Drugs

Volumn 18, Issue 10, 2007, Pages 1221-1226

  Vaishampayan, Ulka N ^a,c   Heilbrun, Lance K ^b   Marsack, Cynthia ^a   Smith, Daryn W ^b   Flaherty, Lawrence E ^a  

^a WAYNE STATE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b WAYNE STATE UNIVERSITY   (United States)

^c Division of Hematology and Oncology   (United States)

Author keywords

Immunotherapy; Melanoma; Pegylated interferon; Phase II clinical trial; Thalidomide

Indexed keywords

PEGINTERFERON; THALIDOMIDE;

ADULT; AGED; ANEMIA; ANOREXIA; ANTIANGIOGENIC ACTIVITY; ARTICLE; BRADYCARDIA; BRAIN METASTASIS; CANCER GROWTH; CANCER STAGING; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL FEATURE; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONSTIPATION; CONTROLLED STUDY; DEHYDRATION; DEPRESSION; DIARRHEA; DISEASE COURSE; DISEASE SEVERITY; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG TOLERABILITY; DYSPNEA; EDEMA; FATIGUE; FEMALE; HEART BLOCK; HUMAN; HYPOTHYROIDISM; IMMUNOMODULATION; LYMPH NODE METASTASIS; MALE; MELANOMA; MYALGIA; NAUSEA; NEUROPATHY; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RASH; SOMNOLENCE; SURVIVAL RATE; THROMBOCYTOPENIA; VISCERAL METASTASIS; VOMITING;

ADMINISTRATION, ORAL; ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; FEMALE; HUMANS; INJECTIONS, SUBCUTANEOUS; INTERFERON ALFA-2B; MALE; MELANOMA; MIDDLE AGED; THALIDOMIDE;

EID: 34748834002     PISSN: 09594973     EISSN: None     Source Type: Journal    
DOI: 10.1097/CAD.0b013e3282eea391     Document Type: Article

References (32)

1. Atallah E, Flaherty L. Treatment of metastatic malignant melanoma. Curr Treat Options Oncol 2005; 6:185-193.
2. Bedikian AY, Millward M, Pehamberger H, Conry R, Gore M, Trefzer U, 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.
3. Kirkwood JM, Strawderman MH, Ernstoff MS, Smith TJ, Borden EC, Blum RH. Interferon alfa-2b adjuvant therapy of high-risk resected cutaneous melanoma: the Eastern Cooperative Oncology Group Trial EST 1684. J Clin Oncol 1996; 14:7-17.
4. Eton O, Legha SS, Bedikian AY, Lee JJ, Buzaid AC, Hodges C, et al. Sequential biochemotherapy versus chemotherapy for metastatic melanoma: results from a phase III randomized trial. J Clin Oncol 2002; 20:2045-2052.
5. Gresser I. Antitumor effects of interferon. Acta Oncol 1989; 28:347-353.
6. Strander H. Interferon treatment of human neoplasia: effects on the immune system. Adv Cancer Res 1986; 46:36-57.
7. Legha SS. The role of interferon alfa in the treatment of metastatic melanoma. Semin Oncol 1997; 24 (Suppl 4):24-34.
8. Schering-Plough PEG-Intron injection investigator's brochure, Kenilworth: Schering-Plough Research Institute; 1999.
9. Manns MP, McHutchison JG, Gordon SC, Rustgi VK, Schiffman M, Reindollar R, et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet 2001; 358:958-965.
10. Bukowski R, Ernstoff M, Gore M, Nemunaitis JJ, Amato R, Gupta SK, et al. Pegylated interferon alfa-2b treatment for patients with solid tumors: a phase I/II study. J Clin Oncol 2002; 20:3841-3849.
11. Sidky YA, Borden EC. Inhibition of angiogenesis by interferons: effects on tumor and lymphocyte induced vascular responses. Cancer 1987; 47:5155-5161.
12. White CW, Sondheimer HM, Crouch EC, Wilson H, Fan LL. Treatment of pulmonary hemangiomatosis with recombinant interferon-alfa 2a. N Engl J Med 1989; 320:1197-1200.
13. Mitsuyasu RT. Interferon alpha in the treatment of AIDS related Kaposi's sarcoma. Br J Hematol 1991; 79:69-73.
14. McCarty MF, Bielenberg DR, Nilsson MB, Gershenwald JE, Barnhill RL, Ahearne P, et al. Epidermal hyperplasia overlying human melanoma correlates with tumour depth and angiogenesis. Melanoma Res 2003; 13:379-387.
15. Singhal S, Mehta J, Desikan R, Roberson P, Eddlemon P, Munshi N, et al. Antitumor activity of thalidomide in refractory multiple myeloma. New Engl J Med 1999; 341:1565-1571.
16. Knight R. IMiDs: a novel class of immunomodulators. Semin Oncol 2005; 32 (4 Suppl 5):S24-S30.
17. D'Amato RJ, Loughnan MS, Flynn E, Folkman J. Thalidomide is an inhibitor of angiogenesis. Proc Natl Acad Sci U S A 1994; 91:4082-4085.
18. Kruse FE, Jousee AM, Rohrschneider K, Becker MD, Volcker HE. Thalidomide inhibits corneal angiogenesis induced by vascular endothelial growth factor. Graefe's Arch Clin Exp Ophthal 1998; 236:461-466.
19. Kenyon BM, Browne F, Damato RJ. Effects of thalidomide and related metabolites in a mouse corneal model of neovascularization. Exp Eye Res 1997; 64:971-978.
20. Eisen T, Boshoff C, Pyle MM, Vaughan L, Smith IE, Johnston SRD, et al. Anti-angiogenic treatment of metastatic melanoma, renal cell, ovarian and breast cancers with thalidomide: a phase II study [abstract]. Proc Am Soc Clin Oncol 1998; 17:441a.
21. Simon R. Optimal two-stage designs for Phase II clinical trials. Controlled Clin Trials 1989; 10:1-10.
22. Casella G. Refining binomial confidence intervals. Can J Stat 1987; 14:113-129.
23. Mehta C, Patel N. StatXact 5: statistical software for exact nonparametric inference, user manual, Cambridge: Cytel; 2004.
24. Lee E. Statistical methods for survival data analysis. 3rd ed. Hoboken: Wiley; 2003.
25. Bauer JA, Morrison BH, Grane RW, Jacobs BS, Borden EC, Lindner DS. IFN-alpha2b and thalidomide synergistically inhibit tumor-induced angiogenesis. J Interferon Cytokine Res 2003; 23:3-10.
26. Dummer R, Garbe C, Thompson JA, Eggermont AM, Yoo K, Maier T, et al. Randomized dose-escalation study evaluating peginterferon alfa-2a in patients with metastatic malignant melanoma. J Clin Oncol 2006; 24:1188-1194.
27. Hwu WJ, Panageas KS, Menell JH, Lamb LA, Aird S, Krown SE, et al. Phase II study of temozolomide plus pegylated interferon-alpha-2b for metastatic melanoma. Cancer 2006; 106:2445-2451.
28. Hwu WJ, Lis E, Menell JH, Panageas K, Lamb LA, Merrell J, et al. Temozolomide plus thalidomide in patients with brain metastases from melanoma: a phase II study. Cancer 2005; 103:2590-2597.
29. Laber DA, Okeke RI, Arce-Lara C, Taft BS, Schonard CL, McMasters KM, et al. A phase II study of extended dose temozolomide and thalidomide in previously treated patients with metastatic melanoma. J Cancer Res Clin Oncol 2006; 132:611-616.
30. Krown SE, Niedzwiecki D, Hwu J, Hodgson L, Houghton AN, Haluska FG. Cancer and Leukemia Group B. Phase II study of temozolomide and thalidomide in patients with metastatic melanoma in the brain: high rate of thromboembolic events (CALGB 500102). Cancer 2006; 107:1883-1890.
31. Vaishampayan U, Abrams J, Darrah D, Jones V, Mitchell MS. Active immunotherapy of metastatic melanoma with allogeneic melanoma lysates and interferon alpha. Clin Cancer Res 2002; 8:3696-3701.
32. Ratain MJ, Eisen T, Stadler WM, Flaherty KT, Kaye SB, Rosner GL, 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.