specific toxicity of the a-emitting radioimmunoconjugate At-rituximab against non-Hodgkin’s lymphoma cells. Br J Cancer 2000; 83: 1375–1379. 9 Ma D, McDevitt MR, Barendswaard E, Lai L, Curcio MJ, Pellegrini V, et al. Radioimmunotherapy for model B cell malignancies using Y-labeled anti-CD19 and anti-CD20 monoclonal antibodies. Leukemia 2002; 16:60–66. 10 DeNardo GL, DeNardo SJ, Goldstein DS, Kroger LA, Lamborn KR, Levy NB, et al. Maximum-tolerated dose, toxicity, and efficacy of I-Lym-1 antibody for fractionated radioimmunotherapy of non-Hodgkin’s lymphoma. J Clin Oncol 1998; 16:3246–3256. 11 Knop S, Jakob A, Kanz L, Hebart H, Bares R, Dohmen B. Rheniumlabeled anti-CD20 antibody radioimmunotherapy followed by autologous peripheral blood stem cell transplantation in patients with relapsed or refractory non-Hodgkin lymphoma [letter]. Blood 2004; 103:1175. 12 Otte A, Thompson SL. Practical and health economic aspects of radioimmunotherapy for the treatment of patients with non-Hodgkin’s lymphoma. Editorial. Nucl Med Comm 2006; 27:753–756.

2007-08-01·Cancer Biotherapy and Radiopharmaceuticals4区 · 医学

Effect of Antilymphoma Antibody,¹³¹I-Lym-1, on Peripheral Blood Lymphocytes in Patients with Non-Hodgkin's Lymphoma

4区 · 医学

Article

作者: DeNardo, Gerald L. ; Schillaci, Orazio ; DeNardo, Sally J. ; O'Donnell, Robert T. ; Kroger, Linda A. ; Lamborn, Kathleen R. ; Goldstein, Desiree S.

Anti-CD20 monoclonal antibodies (mAbs), unlabeled rituximab (Rituxan, Biogen Idec Inc., Cambridge, MA; and Genentech Inc., South San Francisco, CA) or radiolabeled 90Y-ibritumomab (Zevalin, Biogen Idec Inc., Cambridge, MA) and 131I-tositumomab (Bexxar; Glaxo Smith Kline, Research Triangle Park, NC), have proven to be effective therapy for non-Hodgkin's lymphoma (NHL), but also induce immediate and persistent decreases in normal peripheral blood lymphocytes (PBLs). Lym-1, a mAb that selectively targets malignant lymphocytes, also has induced therapeutic responses and prolonged survival in patients with NHL when labeled with iodine-131 (131I). We have retrospectively examined its effect on PBLs in 41 NHL patients that had received 131I-Lym-1 therapy. Absolute lymphocyte counts (ALCs) were evaluated before and after the first and last 131I-Lym-1 infusion. Modest decreases in PBLs were observed in most of the patients. Using strict criteria to define recovery, time to recovery was determined for 19 patients, with the remainder censored because of insufficient follow-up (median follow up for censored patients: 22 days). Using Kaplan-Meier estimates, it would be predicted that 31% of patients would recover by 28 days and that median time to recovery would be 44 days after the last 131I-Lym-1 infusion. No predictors were found for time to recovery, considering such factors as the administered Lym-1 or 131I dose, spleen volume, or radiation doses to the body, marrow, or spleen. The data suggest that the effect of 131I-Lym-1 on ALC is the result of a nonspecific radiation effect, rather than a specific Lym-1 mAb effect. The shorter time required for ALC recovery after 131I-Lym-1 when compared to that reported for anti-CD20 mAbs, whether radiolabeled or otherwise, is probably related to differing mechanisms for lymphocytotoxicity and lesser Lym-1 antigenic density on normal B-lymphocytes.

2004-10-01·Cancer Biotherapy and Radiopharmaceuticals4区 · 医学

Phase I Clinical Trial of Targeted Therapy Using ¹³¹I-Hepama-1 mAb in Patients with Hepatocellular Carcinoma

4区 · 医学

Article

作者: Xie, Hong ; Xu, Li ; Niu, Guangjun ; Li, Beilei ; Fan, Qingxia ; Chen, Shaoliang ; Fan, Kuisheng

OBJECTIVESThe aim of this study was to evaluate the response- and treatment-related toxicity for patients with unresectable hepatocellular carcinoma (HCC) treated with 131I-Hepama-1 mAb (DGDK-1).MATERIALS AND METHODSSeeking approval for the use of 131I-hepama-1 mAb, 32 patients with unresectable HCC were divided into 5 groups to take part in the Phase I clinical trial study. Systemic reactions and acute toxicity were evaluated weekly for at least 45 days following treatment with an intravenous injection of 10 mg of antibody radiolabeled with 740-3700 MBq (20-100 mCi), divided into 5 groups.RESULTSNo patients demonstrated any evidence of fever, severe side effects, or impairments of important organs, such as the lung, liver, and heart. During, and for 45 days after, the treatment, most of their routine examinations of blood, functions of liver and kidneys, and the thyroid hormone were all normal. Hypothyroidism was not observed during the course of monitoring. None of the 32 patients developed human antimurine antibodies (HAMA) within 15 days of therapy; however, 82% of patients were HAMA-positive by 45 days of therapy. According to the pilot study of prognosis, survival from the start of radioimmunotherapy (RIT) was a median of 4 months, and the 1-year survival rate was 31%. The median survival time of 15 patients without metastases was 10 months, and the 1-year survival rate was 60%. Of alpha-fetoprotein (AFP)-positive patients, 75% of AFP levels decreased by at least 50% or became normal. Of all patients, 84% showed an improved Eastern Cooperative Oncology Group (ECOG) performance status.CONCLUSIONThis phase I clinical trial demonstrated that it was safe to use 131I-hepama- 1 mAb by peripheral intravenous administration. The recommended dose of DGDK-1 for clinical use is 1480-2960 MBq/10 mg.

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适应症	最高研发状态	国家/地区	公司	日期
非霍奇金淋巴瘤	临床2期	美国	Avid Bioservices, Inc.	-
非霍奇金淋巴瘤	临床2期	-	Schering Plough A/S	-
非霍奇金淋巴瘤	临床2期	-	Northwest University	-
非霍奇金淋巴瘤	临床2期	-	Peregrine Holdings Ltd.	-