跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/NCT00343109
NCT00343109已完成2 期

Phase II Study of a HER-2/Neu (HER2) Intracellular Domain (ICD) Peptide-Based Vaccine Administered to Patients With Locally Advanced or Stage IV HER2 Positive Breast Cancer

University of Washington2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2004年3月最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
38
试验地点
2
主要终点
Relapse-free survival
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This phase II trial is studying how well vaccine therapy works in treating patients receiving trastuzumab for HER2-positive stage IIIB- IV breast cancer. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells

详细描述

PRIMARY OBJECTIVES:

  1. To estimate the RFS in patients with HER2 positive locally advanced breast cancer vaccinated with a HER2 ICD peptide-based vaccine.

SECONDARY OBJECTIVES:

  1. To assess the safety of a HER2 ICD peptide-based vaccine administered concurrently with trastuzumab.

  2. To determine the immunogenicity of the HER2 ICD peptide based vaccine when given within one year of initiating standard treatment which includes trastuzumab.

  3. To determine the incidence of the development of T cell immunity specific for the HER2 ICD.

  4. To determine the incidence of the development of intramolecular epitope spreading.

  5. To determine the magnitude of the HER2 ICD specific CD4+ and CD8+ immune response generated with immunization.

  6. To assess whether there is an association between RFS and the development of an immune response (HER2 specific T cell immunity and/or the development of intramolecular epitope spreading).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • •Stage IIIB or Stage IIIC breast cancer who are within 1 year of diagnosis and initiating treatment with chemotherapy and trastuzumab; and are in complete remission
  • •Stage IV breast cancer in first complete remission and defined as NED (no evidence of disease) or with stable bone only disease who are within 6 months of initiating maintenance trastuzumab
  • •NED status should be documented by chest/abdominal CT, PET or PET/CT within the last 90 days
  • •Bone only disease documented as stable or healed by PET, PET/CT, or MRI within the last 90 days; stable bone-only disease must be documented with bone scan performed within the last 6 months
  • •HER2 overexpression by IHC of 2+ or 3+, in the primary tumor or metastasis or documented gene amplification by FISH analysis; if overexpression is 2+ by IHC, then patients must have HER2 gene amplification documented by FISH
  • •Eligible subjects must have been treated to NED or stable bone only disease status with trastuzumab and/or chemotherapy and be off cytotoxic chemotherapy or immunosuppressive agents (e.g. systemic steroids) for at least 30 days prior to enrollment (concurrent hormonal therapy allowed; concurrent bisphosphonate therapy allowed)
  • •Patients on trastuzumab should continue trastuzumab monotherapy per standard of care (the dosing and schedule of trastuzumab should follow standard guidelines as described below: trastuzumab 2mg/kg IV weekly or trastuzumab 6mg/kg IV every 3 weeks)
  • •Subjects must have an ECOG Performance Status Score =< 1
  • •Non-menopausal female subjects must agree to contraception for the remainder of their childbearing years
  • •Male subjects must use an acceptable form of contraception throughout the course of the study
  • •Hematocrit >= 30,000
  • •Platelet count >= 100,000
  • •WBC >= 3000/mcl
  • •Stable creatinine =< 2.0 mg/dl or a creatinine clearance greater than 60 ml/min
  • •Serum bilirubin < 1.5 mg/dl
  • •SGOT < 2x ULN
  • •Laboratory tests should be performed within 60 days of enrollment
  • •Subjects must have recovered from major infections and/or surgical procedures and, in the opinion of the investigator, not have any significant active concurrent medical illnesses precluding protocol treatment
  • •Patients on trastuzumab monotherapy must have adequate cardiac function as demonstrated by normal ejection fraction (EF) on MUGA scan or echocardiogram performed within last 6 months

排除标准

  • •Subjects cannot be simultaneously enrolled in other treatment studies
  • •Patients cannot be receiving any other concurrent immunomodulators besides trastuzumab
  • •Any contraindication to receiving GM-CSF based vaccine products
  • •Cardiac disease, specifically restrictive cardiomyopathy, unstable angina within the last 6 months prior to enrollment, New York Heart Association functional class III-IV heart failure on active treatment with normalized LVEF on therapy, and symptomatic pericardial effusion
  • •Active autoimmune disease
  • •Subjects can not have active immunodeficiency disorder, e.g. HIV
  • •Cannot be pregnant or breast feeding

结局指标

主要结局

Relapse-free survival

时间窗: At 4 years

次要结局

  • Immune response as assessed by HER2 specific T cell immunity and/or intramolecular epitope spreading(Baseline, midpoint in the immunization schedule (prior to the 4th vaccine), 1 month after the 6th and last immunization and at 4, 8 and 12 months after the end of vaccinations)
  • Correlation of RFS to the generation of an immune response(Prior to the 4th vaccine, 1 month after the 6th and last immunization and at 4, 8 and 12 months after the end of vaccinations)
  • Safety as assessed by NCI CTCAE version 3.0(Baseline and 1 month following last vaccination)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

终止
2 期
Vaccine Therapy in Treating Patients With Stage IV Hormone Receptor Positive Breast CancerHER2-positive Breast CancerRecurrent Breast CancerStage IV Breast CancerMale Breast Cancer
NCT01729884University of Washington3
已完成
2 期
Phase II Neoadjuvant Trial of Trastuzumab in Combination With Dose-Dense ABI-007 (Abraxane™)Breast Cancer
NCT00503750Emory University27
已完成
2 期
Viral Therapy in Treating Patients With Metastatic MelanomaRecurrent MelanomaStage IV Melanoma
NCT00651157National Cancer Institute (NCI)23
招募中
2 期
TPIV100 and Sargramostim for the Treatment of HER2 Positive, Stage II-III Breast Cancer in Patients With Residual Disease After Chemotherapy and SurgeryBreast AdenocarcinomaStage II Breast Cancer AJCC v6 and v7Stage IIA Breast Cancer AJCC v6 and v7Stage IIB Breast Cancer AJCC v6 and v7Stage III Breast Cancer AJCC v7Stage IIIA Breast Cancer AJCC v7Stage IIIB Breast Cancer AJCC v7Stage IIIC Breast Cancer AJCC v7
NCT04197687Academic and Community Cancer Research United480
招募中
1 期
A Vaccine (H2NVAC) Before Surgery for the Treatment of HER2-Expressing Ductal Carcinoma In SituBreast Ductal Carcinoma In Situ
NCT04144023Mayo Clinic43