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Monoclonal Antibody Vaccine Therapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer

2013年6月4日 更新者:Memorial Sloan Kettering Cancer Center

Phase I Trial of the Monoclonal Anti-Idiotype Antibody ACA125 in Patients With Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer

RATIONALE: Vaccines made from monoclonal antibodies combined with tumor cells may make the body build an immune response to kill tumor cells.

PURPOSE: Randomized phase I trial to study the effectiveness of vaccine therapy in treating patients who have ovarian epithelial, fallopian tube, or peritoneal cancer.

研究概览

详细说明

OBJECTIVES:

  • Determine the safety of varying routes and doses of monoclonal antibody ACA125 anti-idiotype vaccine in patients with ovarian epithelial, fallopian tube, or peritoneal cancer.
  • Determine an optimal dose and route of this vaccine for a phase II study.
  • Determine the immune response induced by this vaccination in these patients.
  • Determine the time to development of objective tumor response in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 4 treatment arms.

  • Arm I: Patients receive lower-dose monoclonal antibody ACA125 anti-idiotype vaccine (MOAB ACA125) intramuscularly (IM) on weeks 0, 2, 4, 6, 10, and 14 in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive higher-dose MOAB ACA125 IM as in arm I.
  • Arm III: Patients receive lower-dose MOAB ACA125 subcutaneously (SC) on weeks 0, 2, 4, 6, 10, and 14 in the absence of disease progression or unacceptable toxicity.
  • Arm IV: Patients receive higher-dose MOAB ACA125 SC as in arm III. Patients are followed every 6-12 weeks for 2 years.

PROJECTED ACCRUAL: A total of 40 patients (10 patients per cohort) will be accrued for this study.

研究类型

介入性

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • New York
      • New York、New York、美国、10021
        • Memorial Sloan-Kettering Cancer Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

描述

DISEASE CHARACTERISTICS:

  • Histologically confirmed ovarian epithelial, fallopian tube, or peritoneal cancer

    • Stage II-IV
  • Initially treated with surgery and at least 1 platinum-based chemotherapy regimen
  • Must have relapsed after initial treatment and completed chemotherapy for recurrent disease
  • Asymptomatic residual measurable disease on CT scan and/or an elevated CA 125 allowed
  • Complete clinical remission allowed, defined by the following criteria:

    • CA 125 no greater than 35 IU/mL
    • No objective evidence of disease by CT scan
    • Normal physical examination

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky 70-100%

Life expectancy

  • At least 3 months

Hematopoietic

  • WBC at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL

Hepatic

  • Bilirubin no greater than 2 times normal
  • ALT no greater than 2 times normal
  • Alkaline phosphatase no greater than 2 times normal

Renal

  • Creatinine no greater than 1.5 times normal

Other

  • Not pregnant or nursing
  • No potential for child bearing
  • Human antimurine antibody negative
  • HIV negative
  • No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No active infection
  • No known autoimmune disease (e.g., rheumatoid arthritis or ulcerative colitis)
  • No known immune deficiency (e.g., hypogammaglobulinemia)
  • No known allergy to murine proteins

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 6 weeks since prior interferon
  • At least 6 weeks since prior immunotherapy or biological response modifiers
  • No prior anticancer vaccine

Chemotherapy

  • See Disease Characteristics
  • At least 3 weeks since prior cytotoxic or investigational chemotherapy

Endocrine therapy

  • No concurrent steroids

Radiotherapy

  • At least 4 weeks since prior radiotherapy

Surgery

  • See Disease Characteristics

Other

  • At least 1 week since prior antibiotics
  • No concurrent cyclosporine
  • No other concurrent immunosuppressive therapy

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 屏蔽:无(打开标签)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2002年12月1日

初级完成 (实际的)

2004年3月1日

研究完成 (实际的)

2004年3月1日

研究注册日期

首次提交

2003年4月7日

首先提交符合 QC 标准的

2003年4月8日

首次发布 (估计)

2003年4月9日

研究记录更新

最后更新发布 (估计)

2013年6月5日

上次提交的符合 QC 标准的更新

2013年6月4日

最后验证

2013年6月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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