A PILOT STUDY OF YTTRIUM-90-LABELED ANTI-CD20 MONOCLONAL

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这项研究的目的是1；评估使用与放射性物质结合的抗体(IDEC-Y2B8)结合大剂量化疗(药物为BCNU、依托泊苷、Ara-C和Melphalan，或BEAM)然后进行自体干细胞移植(ASCT)的治疗方案的安全性和有效性；以及2；评估该方案在诊断为非霍奇金淋巴瘤患者中的短期和长期并发症。非霍奇金淋巴瘤是一种B淋巴细胞的恶性肿瘤，B淋巴细胞是正常情况下制造抗体的白细胞，有助于对抗感染。虽然常规化疗和/或放射治疗可以缓解(通过标准临床测试没有疾病的证据)，但缓解的时间通常很短，而且会复发(疾病复发)。复发淋巴瘤患者的前景黯淡。最近的研究表明，在复发的淋巴瘤患者中，强化、大剂量化疗和自体干细胞移植(ASCT)可以产生长期缓解。BEAM是制备ASCT最常用的大剂量方案之一。ASCT包括在治疗前收集受试者的干细胞(可成为血细胞的未成熟细胞)，并在治疗结束后将这些细胞返回受试者(通过静脉)。然而，这种治疗方案也会复发。Rituximab(Rituxan或IDEC-C2B8)抗体已被证明在接受治疗的B细胞淋巴瘤受试者中约有一半产生缓解。在以前的研究中，这种抗体被证明可以选择性地定位和破坏B细胞，包括B细胞淋巴瘤，并导致耐药淋巴瘤细胞对化疗变得敏感。在IDEC-Y2B8中添加一种名为Yttrium的放射性物质(产生一种称为IDEC-Y2B8的放射性化合物)，可以将辐射直接携带到肿瘤部位，从而提高抗肿瘤效果。在IDEC-Y2B8过去的一项研究中，大约三分之二的B细胞淋巴瘤患者在治疗后肿瘤缩小超过50%，其中四分之一的肿瘤全部消失。回应期约为12个月。目前的研究将使用强化、大剂量化疗(BEAM)和IDEC-Y2B8，然后进行ASCT。这项研究将试图确定这种联合方案的安全性和有效性。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The purposes of this study are to 1> evaluate the safety and effectiveness of a treatment regimen using an antibody attached to a radioactive substance (IDEC-Y2B8) in combination with high-dose chemotherapy (with the drugs BCNU, Etoposide, Ara-C and Melphalan, or BEAM) followed by autologous stem cell transplant (ASCT); and 2> to evaluate the short-term and long-term complications of this regimen in patients diagnosed with non-Hodgkin's lymphoma. Non-Hodgkin's lymphoma is a malignancy of B lymphocytes, which are the white blood cells that normally make antibodies that help fight infections. Although remission (no evidence of disease by standard clinical tests) can occur with conventional chemotherapy and/or radiation therapy, the length of remission is usually short and relapses (return of disease) occur. The outlook for patients with relapsed lymphoma is poor. Recent studies have shown that intensive, high-dose chemotherapy followed by autologous stem cell transplantation (ASCT), can produce long-term remission in patients with relapsed lymphoma. BEAM is one of the most commonly used high-dose regimens for preparation of ASCT. ASCT involves collection of the subject's stem cells (immature cells that can become blood cells) before therapy and return of these cells to the subject (through a vein) after therapy is over. However, relapses also occur with this treatment regimen. The antibody, Rituximab (Rituxan or IDEC-C2B8) has been shown to produce remission in about half of the B-cell lymphoma subjects treated. In previous studies, this antibody has been shown to selectively locate and destroy B-cells, including B-cell lymphoma, and to cause drug-resistant lymphoma cells to become sensitive to chemotherapy. Adding a radioactive substance called Yttrium to IDEC-Y2B8, (creating a radioactive combination called IDEC-Y2B8) allows radiation to be carried directly to tumor sites which can increase the anti-tumor effect. In a past study of IDEC-Y2B8, about two-thirds of the subjects with B-cell lymphoma had shown greater than 50% shrinkage of the tumor after treatment and in one-fourth of them all the tumor was gone. The duration of response was about 12 months. The present study will use intensive, high-dose chemotherapy (BEAM) and IDEC-Y2B8, followed by ASCT. This study will try to determine the safety and effectiveness of this combination regimen.