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临床试验/NCT00003067
NCT00003067暂停2 期

Intracavitary Interleukin-2 (IL-2) and Lymphokine-Activated Killer (LAK) Cell Therapy for Malignant Gliomas

Weill Medical College of Cornell University2 个研究点 分布在 1 个国家开始时间: 1997年7月最近更新:
适应症

试验速览

阶段
2 期
状态
暂停
试验地点
2

研究概览

简要总结

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells in patients with primary or advanced glioma.

PURPOSE: Clinical trial to study the effectiveness of biological therapy with interleukin-2 and lymphokine-activated killer cells in treating patients who have primary, recurrent, or refractory malignant glioma.

详细描述

OBJECTIVES:

  • Confirm the antitumor efficacy of intracavitary interleukin-2 plus autologous lymphokine-activated killer cells in patients with primary, recurrent or refractory malignant gliomas.
  • Determine whether the induction of a regional, intracavitary, eosinophilia is a prognosticator of response to immunotherapy and long term survival in these patients.

OUTLINE: Patients receive cytoreductive tumor surgery and/or biopsy and implantation of intracavitary Ommaya reservoir prior to therapy induction.

Patients undergo outpatient leukapheresis on day -4 or -5, and cells are incubated ex vivo with interleukin-2 (IL-2). Lymphokine-activated killer (LAK) cells and IL-2 are infused on day 1. Bolus infusions of low-dose IL-2 are administered on days 3, 5, 8, 10, and 12, followed by a rest period on days 13-24. The course is repeated on day 25 starting with leukapheresis. Therapy courses are repeated for up to 1 year for stable disease or response to therapy. Maintenance doses repeat every 4-6 months thereafter.

Disease restaging is done every 8-12 weeks.

研究设计

研究类型
Interventional
主要目的
Treatment

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究者

申办方类型
Other

研究点 (2)

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