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Journal of Clinical Oncology, Vol 15, 3266-3274, Copyright © 1997 by American Society of Clinical Oncology

ARTICLES

IDEC-C2B8: results of a phase I multiple-dose trial in patients with relapsed non-Hodgkin's lymphoma

DG Maloney, AJ Grillo-Lopez, DJ Bodkin, CA White, TM Liles, I Royston, C Varns, J Rosenberg and R Levy
Department of Medicine, Stanford University, CA, USA. dmaloney@fhcrc.org

PURPOSE: To evaluate the safety, pharmacokinetics, and biologic effect of multiple doses of the chimeric anti-CD20 monoclonal antibody (mAb) IDEC-C2B8 in patients with relapsed B-cell lymphoma. PATIENTS AND METHODS: Twenty patients with relapsed low-grade (n = 15) or intermediate-/high-grade (n = 5) lymphoma received weekly infusions times four of 125 mg/m2 (n = 3), 250 mg/m2 (n = 7), or 375 mg/m2 (n = 10) of IDEC-C2B8. RESULTS: Infusional side effects during the initial infusion were mainly grade I/II fever, asthenia, chills, nausea, rash, and urticaria. More serious events were rare. Peripheral-blood B cells were rapidly depleted and slowly recovered over 3 to 6 months. There was no change in mean immunoglobulin (Ig) levels. Antibody serum half- life (and maximum concentration [Cmax]) generally increased between the first and fourth infusions (33.2 hours v 76.6 hours, respectively) following the 375-mg/m2 doses. Six of 18 assessable patients had a partial remission (PR), with a median time to disease progression of 6.4 months (range, 3 to 21.7). Minor responses (MRs) were observed in five patients and progressive disease (PD) in seven. Tumor responses occurred in peripheral blood, bone marrow (BM), spleen, bulky lymph nodes, and extranodal sites, and in patients who had relapsed following high-dose myeloablative chemotherapy. Six of 14 patients (40%) with a low-grade histology responded. Four of six with bulky disease had a PR. CONCLUSION: IDEC-C2B8 chimeric anti-CD20 mAb therapy is well tolerated and has clinical activity in patients with relapsed B-cell lymphoma. The 375-mg/m2 dose has been selected for a phase II trial in patients with relapsed low-grade or follicular B-cell lymphoma.
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Expression of complement inhibitors CD46, CD55, and CD59 on tumor cells does not predict clinical outcome after rituximab treatment in follicular non-Hodgkin lymphoma
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Rituximab chimeric anti-CD20 monoclonal antibody treatment for adults with chronic idiopathic thrombocytopenic purpura
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Synergistic Effects of the Fenretinide (4-HPR) and Anti-CD20 Monoclonal Antibodies on Apoptosis Induction of Malignant Human B Cells
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Rituximab Using A Thrice Weekly Dosing Schedule in B-Cell Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma Demonstrates Clinical Activity and Acceptable Toxicity
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J. C. W. Edwards and G. Cambridge
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Characterization of Epstein-Barr virus-infected B cells in patients with posttransplantation lymphoproliferative disease: disappearance after rituximab therapy does not predict clinical response
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Rituximab Anti-CD20 Monoclonal Antibody Therapy in Non-Hodgkin's Lymphoma: Safety and Efficacy of Re-Treatment
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T. A. Davis, D. G. Maloney, A. J. Grillo-López, C. A. White, M. E. Williams, G. J. Weiner, S. Dowden, and R. Levy
Combination Immunotherapy of Relapsed or Refractory Low-Grade or Follicular Non-Hodgkin's Lymphoma with Rituximab and Interferon-{{alpha}}-2a
Clin. Cancer Res., July 1, 2000; 6(7): 2644 - 2652.
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Arch Dermatol, March 1, 2000; 136(3): 374 - 378.
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J. M. Foran, A. Z. S. Rohatiner, D. Cunningham, R. A. Popescu, P. Solal-Celigny, M. Ghielmini, B. Coiffier, P. W. M. Johnson, C. Gisselbrecht, F. Reyes, et al.
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T. E. Witzig, C. A. White, G. A. Wiseman, L. I. Gordon, C. Emmanouilides, A. Raubitschek, N. Janakiraman, J. Gutheil, R. J. Schilder, S. Spies, et al.
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Low-Grade Stage III-IV Follicular Lymphoma: Multivariate Analysis of Prognostic Factors in 484 Patients--A Study of the Groupe d'Etude des Lymphomes de l'Adulte
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The Importance of Antibody-Specificity in Determining Successful Radioimmunotherapy of B-Cell Lymphoma
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Rituximab (Anti-CD20 Monoclonal Antibody) for the Treatment of Patients With Relapsing or Refractory Aggressive Lymphoma: A Multicenter Phase II Study
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