A phase I weekly dosing study of brentuximab vedotin in patients with relapsed/refractory CD30-positive hematologic malignancies

Clinical Cancer Research

Volumn 18, Issue 1, 2012, Pages 248-255

  Fanale, Michelle A ^a   Forero Torres, Andres ^b   Rosenblatt, Joseph D ^c   Advani, Ranjana H ^d   Franklin, Anna R ^a   Kennedy, Dana A ^e   Han, Tae H ^e   Sievers, Eric L ^e   Bartlett, Nancy L ^f  

^a UNIVERSITY OF TEXAS   (United States)

^b UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^c UNIVERSITY OF MIAMI MILLER SCHOOL OF MEDICINE   (United States)

^d STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^e SEATTLE GENETICS INC   (United States)

^f WASHINGTON UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BRENTUXIMAB VEDOTIN; CD30 ANTIGEN;

ADOLESCENT; ADULT; AGED; ANEMIA; AREA UNDER THE CURVE; ARTHRALGIA; ARTICLE; BACKACHE; BURNING SENSATION; CANCER REGRESSION; CANCER SURVIVAL; CHEMOTHERAPY INDUCED EMESIS; CHILD; CLINICAL ARTICLE; DECREASED APPETITE; DIARRHEA; DIZZINESS; DRUG ACCUMULATION; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG ERUPTION; DRUG FEVER; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG WITHDRAWAL; FATIGUE; FEMALE; FOLLOW UP; HEMATOLOGIC MALIGNANCY; HODGKIN DISEASE; HUMAN; HYPERGLYCEMIA; HYPESTHESIA; LARGE CELL LYMPHOMA; MALE; MAXIMUM PLASMA CONCENTRATION; MAXIMUM TOLERATED DOSE; MOTOR NEUROPATHY; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MYALGIA; NAUSEA; NEUTROPENIA; OPEN STUDY; OVERALL SURVIVAL; PARESTHESIA; PERIPHERAL EDEMA; PERIPHERAL NEUROPATHY; PERIPHERAL T CELL LYMPHOMA; PHASE 1 CLINICAL TRIAL; POLYNEUROPATHY; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PRURITUS; SCHOOL CHILD; SENSORY NEUROPATHY; SIDE EFFECT; TUMOR REGRESSION; UPPER RESPIRATORY TRACT INFECTION;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTIGENS, CD30; CHILD; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; FOLLOW-UP STUDIES; HEMATOLOGIC NEOPLASMS; HUMANS; IMMUNOCONJUGATES; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; PROGNOSIS; SURVIVAL RATE; TISSUE DISTRIBUTION; YOUNG ADULT;

EID: 84855465227     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-11-1425     Document Type: Article

References (30)

1. Durkop H, Latza U, Hummel M, Eitelbach F, Seed B, Stein H, et al. Molecular cloning and expression of a new member of the nerve growth factor receptor family that is characteristic for Hodgkin's disease. Cell 1992;68:421-7.
2. Falini B, Pileri S, Pizzolo G, Durkop H, Flenghi L, Stirpe F, et al. CD30 (Ki-1) molecule: a new cytokine receptor of the tumor necrosis factor receptor superfamily as a tool for diagnosis and immunotherapy. Blood 1995;85:1-14.
3. Matsumoto K, Terakawa M, Miura K, Fukuda S, Nakajima T, Saito H. Extremely rapid and intense induction of apoptosis in human eosinophils by anti-CD30 antibody treatment in vitro. J Immunol 2004;172:2186-93. (Pubitemid 38182365)
4. Kuruvilla J. Standard therapy of advanced Hodgkin lymphoma. Hematology Am Soc Hematol Educ Program 2009;497-506.
5. Linch DC, Winfield D, Goldstone AH, Moir D, Hancock B, McMillan A, et al. Dose intensification with autologous bone-marrow transplantation in relapsed and resistant Hodgkin's disease: results of a BNLI randomised trial. Lancet 1993;341:1051-4. (Pubitemid 23114397)
6. Schmitz N, Pfistner B, Sextro M, Sieber M, Carella AM, Haenel M, et al. Aggressive conventional chemotherapy compared with high-dose chemotherapy with autologous haemopoietic stem-cell transplantation for relapsed chemosensitive Hodgkin's disease: a randomised trial. Lancet 2002;359:2065-71. (Pubitemid 34680969)
7. Sureda A, Constans M, Iriondo A, Arranz R, Caballero MD, Vidal MJ, et al. Prognostic factors affecting long-term outcome after stem cell transplantation in Hodgkin's lymphoma autografted after a first relapse. Ann Oncol 2005;16:625-33. (Pubitemid 40613330)
8. Majhail NS, Weisdorf DJ, Defor TE, Miller JS, McGlave PB, Slungaard A, et al. Long-term results of autologous stem cell transplantation for primary refractory or relapsed Hodgkin's lymphoma. Biol Blood Marrow Transplant 2006;12:1065-72.
9. Martinez C, Canals C, Alessandrino E, Karakasis D, Leone G, Trneny M, et al. Relapse of Hodgkin's lymphoma (HL) after autologous stem cell transplantation (ASCT): prognostic factors in 462 patients registered in database of the EBMT. J Clin Oncol;28:15s, 2010 (suppl; abstr 8060).
10. Horning S, Fanale M, deVos S, Borchmann P, Illidge T, Engert A, et al. Defining a population of Hodgkin lymphoma patients for novel therapeutics: an international effort. Ann Oncol 2008;19 Suppl 4:abstr 118.
11. Little R, Wittes RE, Longo DL, Wilson WH. Vinblastine for recurrent Hodgkin's disease following autologous bone marrow transplant. J Clin Oncol 1998;16:584-8. (Pubitemid 28135603)
12. Rule S, Tighe M, Davies S, Johnson S. Vinorelbine in the treatment of lymphoma. Hematol Oncol 1998;16:101-5. (Pubitemid 29202168)
13. Zinzani PL, Bendandi M, Stefoni V, Albertini P, Gherlinzoni F, Tani M, et al. Value of gemcitabine treatment in heavily pretreated Hodgkin's disease patients. Haematologica 2000;85:926-9.
14. Bartlett NL, Niedzwiecki D, Johnson JL, Friedberg JW, Jonhson KB, van Biesen K, et al. Gemcitabine, vinorelbine, and pegylated liposomal doxorubicin (GVD), a salvage regimen in relapsed Hodgkin's lymphoma: CALGB 59804. Ann Oncol 2007;18:1071-9. (Pubitemid 47053777)
15. Sureda A, Robinson S, Canals C, Carella AM, Boogaerts MA, Caballero D, et al. Reduced-intensity conditioning compared with conventional allogeneic stem-cell transplantation in relapsed or refractory Hodgkin's lymphoma: an analysis from the Lymphoma Working Party of the European Group for Blood and Marrow Transplantation. J Clin Oncol 2008;26:455-62. (Pubitemid 351171699)
16. Anderlini P, Saliba R, Acholonu S, Giralt SA, Andersson B, Ueno NT, et al. Fludarabine-melphalan as a preparative regimen for reduced-intensity conditioning allogeneic stem cell transplantation in relapsed and refractory Hodgkin's lymphoma: the updated M.D. Anderson Cancer Center experience. Haematologica 2008;93:257-64. (Pubitemid 351397714)
17. Isaacson PG, Chott A, Ott G, et al. Enteropathy-associated T-cell lymphoma. In: Swerdlow SH, Campo E, Harris NL, Jaffe ES, Pileri SA, Stein H, et al., editors. WHO classification of tumours of haematopoietic and lymphoid tissues. 4th ed. Lyon, France: International Agency for Research on Cancer; 2008. p. 289-91.
18. + ALCL and peripheral T-cell lymphoma, not otherwise specified: report from the International Peripheral T-Cell Lymphoma Project. Blood 2008;111:5496-504.
19. Corradini P, Dodero A, Zallio F, Caracciolo D, Casini M, Bregni M, et al. Graft-versus-lymphoma effect in relapsed peripheral T-cell non-Hodgkin's lymphomas after reduced-intensity conditioning followed by allogeneic transplantation of hematopoietic cells. J Clin Oncol 2004;22:2172-6. (Pubitemid 41095152)
20. O'Connor OA, Pro B, Pinter-Brown L, Bartlett N, Popplewell L, Coiffier B, et al. Pralatrexate in patients with relapsed or refractory peripheral T-cell lymphoma: results from the pivotal PROPEL study. J Clin Oncol 2011;29:1182-9.
21. Ansell SM, Horwitz SM, Engert A, Khan KD, Lin T, Strair R, et al. Phase I/II study of an anti-CD30 monoclonal antibody (MDX-060) in Hodgkin's lymphoma and anaplastic large-cell lymphoma. J Clin Oncol 2007;25:2764-9. (Pubitemid 47123185)
22. Forero-Torres A, Leonard JP, Younes A, Rosenblatt JD, Brice P, Bartlett NL, et al. A phase II study of SGN-30 (anti-CD30 mAb) in Hodgkin lymphoma or systemic anaplastic large cell lymphoma. Br J Haematol 2009;146:171-9.
23. Hamblett KJ, Senter PD, Chace DF, Sun MM, Lenox J, Cerveny CG, et al. Effects of drug loading on the antitumor activity of a monoclonal antibody drug conjugate. Clin Cancer Res 2004;10:7063-70. (Pubitemid 39383058)
24. Sun MM, Beam KS, Cerveny CG, Hamblett KJ, Blackmore RS, Torgov MY, et al. Reduction-alkylation strategies for the modification of specific monoclonal antibody disulfides. Bioconjug Chem 2005;16:1282-90. (Pubitemid 41368132)
25. Oflazoglu E, Kissler KM, Sievers EL, Grewal IS, Gerber HP. Combination of the anti-CD30-auristatin-E antibody-drug conjugate (SGN-35) with chemotherapy improves antitumour activity in Hodgkin lymphoma. Br J Haematol 2008;142:69-73. (Pubitemid 351783148)
26. Okeley NM, Miyamoto JB, Zhang X, Sanderson RJ, Benjamin DR, Sievers EL, et al. Intracellular activation of SGN-35, a potent anti-CD30 antibody-drug conjugate. Clin Cancer Res 2010;16:888-97.
27. Younes A, Bartlett NL, Leonard JP, Kennedy DA, Lynch CM, Sievers EL, et al. Brentuximab vedotin (SGN-35) for relapsed CD30-positive lymphomas. N Engl J Med 2010;363:1812-21.
28. Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, et al. Revised response criteria for malignant lymphoma. J Clin Oncol 2007;25:579-86. (Pubitemid 350002966)
29. Lee JJ, Swain SM. Peripheral neuropathy induced by microtubule- stabilizing agents. J Clin Oncol 2006;24:1633-42. (Pubitemid 46638788)
30. Swain SM, Arezzo JC. Neuropathy associated with microtubule inhibitors: diagnosis, incidence, and management. Clin Adv Hematol Oncol 2008;6:455-67.