VACCINATION WITH CONJUGATED FOLLICULAR LYMPHOMA-DERIVED IDIOTYPE PLUS GM-CSF

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。在这项由NCI赞助的III期随机试验中，患者必须患有III/IV期滤泡性淋巴瘤。他们必须有2厘米的淋巴结，用于切除和收获淋巴瘤，以生产自体疫苗。所有患者将接受标准化疗(PACE)。如果患者对PACE有临床反应，他们将被随机接受KLH疫苗(第1天)+GM-CSF(第1-4天)或KLH对照疫苗(第1天)+GM-CSF(第1-4天)。因此，研究人员将确定在对这种肿瘤进行标准的初步治疗后，与单独使用KLH相比，使用与KLH结合的自体滤泡性淋巴瘤来源的免疫球蛋白免疫对诱导和维持临床完全缓解和消除亚临床残留肿瘤细胞的能力的影响。临床前和临床非随机数据支持这项研究的设计。将为每个患者制作一种单独的自体疫苗。小剂量GMCSF将作为辅助治疗。疫苗将由NCI生产。在佩斯化疗后至少六个月开始免疫接种。将在6个月内进行5次免疫接种(1、2、3、4、6个月注射)。

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. In this NCI-sponsored phase III randomized trial, patients must have stage III/IV follicular lymphoma. They must have lymph nodes 2 cm for resection and harvest of lymphoma for the production of an autologous vaccine. All patients will receive the standard chemotherapy (PACE). If patients attain a clinical response with PACE they will be randomized to receive either KLH vaccine (day 1) + GM-CSF (days 1-4) or KLH control vaccine (day 1) + GM-CSF (days 1-4). Thus, the investigators will determine the effects of immunization with autologous, follicular lymphoma-derived immunoglobulin conjugated to KLH as compared with KLH alone on the ability to induce and sustain clinical complete remission and to eliminate subclinical residual tumor cells, as detected by PCR, following standard initial therapy for this tumor. Preclinical and clinical nonrandomized data support the design of this study. A separate autologous vaccine will be made for each patient. Low-dose GMCSF will be used as adjuvant therapy. The vaccines will be made by the NCI. Immunizations start at least six months after PACE chemotherapy. Five immunizations will be done over 6 months (1, 2, 3, 4, 6 month injections).