NCT00081809已完成2 期
A Phase II Trial of Active Specific Immunotherapy in Patients With Indolent Lymphoma Using Autologous Lymphoma-Derived Heat Shock Protein-Peptide Complex (HSPPC-96)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Agenus Inc.
- 入组人数
- 35
- 试验地点
- 2
研究概览
简要总结
Primary Objectives:
- To document the efficacy of treatment with autologous lymphoma-derived HSPPC-96 of selected patients with indolent lymphoma. The efficacy endpoints are:
- the rate of complete and partial responses
- the time to progression.
Secondary Objectives:
- To evaluate the safety and tolerability of autologous tumor-derived heat-shock protein peptide complex (HSPPC-96) administered intradermally once weekly for four consecutive weeks, followed by HSPPC-96 administered once every two weeks.
- To evaluate the feasibility of autologous HSPPC-96 preparation from lymphoma specimens.
- To assess approximately the composition of the tissue source of the autologous HSPPC-96 for each patient.
- To study the effect of autologous lymphoma-derived HSPPC-96 vaccine therapy on the expression of Fas ligand and TRAIL death proteins in peripheral blood lymphocytes of patients with indolent lymphoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with previously treated or newly diagnosed follicular center cell grade I or grade II lymphoma, small lymphocytic lymphoma, MALT lymphoma, monocytoid B-cell lymphoma, Waldenstrom's macroglobulinemia, or marginal zone lymphoma with bidimensionally measurable disease;
- •Part of the resected specimen must undergo routine pathologic examination to confirm the diagnosis of lymphoma. The remaining tissue must be used for the preparation of autologous HSPPC-96;
- •Autologous HSPPC-96 vaccine must be successfully prepared and provided by the sponsor;
- •A minimum of 2 grams of non-necrotic, resectable malignant lymphoma for HSPPC-96 preparation;
- •Bidimensionally measurable disease in at least one location other than the resected lymphoid tissue;
- •Life expectancy of at least 16 weeks;
- •Zubrod performance status of less then or equal to 2;
- •Adequate bone marrow function;
- •Adequate hepatic function;
- •Adequate renal function;
- •Signed written informed consent;
- •Patients of child-bearing potential must practice contraception, which is adequate in the opinion of the Principal Investigator;
- •Patients of child-bearing potential must have a negative serum pregnancy test prior to entry into the study and must not be lactating;
- •Patients must be willing to be followed at the M. D. Anderson Cancer Center during the course of treatment and follow-up;
- •Electrocardiogram if none performed in the prior six months;
- •Patients must have no chemotherapy, immunotherapy, radiotherapy, or experimental anti-cancer therapy within six weeks prior to starting autologous HSPPC-96 administration;
- •Patients must have fully recovered from prior anti-cancer therapy;
- •Tumor measurements and staging no more than 4 weeks prior to receiving the first dose of autologous HSPPC-96.
排除标准
- •Patients with active or prior history of central nervous system lymphoma;
- •Patients with serious intercurrent medical illnesses, requiring hospitalization;
- •Patients with a history of primary or secondary immunodeficiency (other than related to the malignant lymphoma because treatment is dependent on functional immune system) or patients taking immunosuppressive drugs such as systemic corticosteroids;
- •Women who are pregnant or lactating;
- •Patients participating in another clinical trial;
- •Patients receiving growth factors of any kind, including G-CSF, GM-CSF, or Epogen;
- •Patients with bulky disease, defined as greater than 10 cm in diameter;
- •Patients with positive HIV antibody;
- •Patients with more than 4 previous treatment regimens will be excluded.
研究者
研究点 (2)
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