Xenogeneic HER2/Neu DNA Immunization for Patients With Metastatic and High Risk Breast Cancer: A Phase I Study to Assess Safety and Immunogenicity

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00393783
First received: October 26, 2006
Last updated: February 5, 2014
Last verified: February 2014

October 26, 2006
February 5, 2014
May 2006
May 2015   (final data collection date for primary outcome measure)
The maximum tolerated dose over four dose levels [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
  • The maximum tolerated dose over four dose levels
  • The primary objectives of this trial are to determine the following endpoints after injection with
  • rat HER2 DNA:
  • The toxicities
  • The IgG and IgM antibody response and T cell response to HER2
Complete list of historical versions of study NCT00393783 on ClinicalTrials.gov Archive Site
A secondary endpoint is to observe patients for any evidence of anti-tumor effect. [ Time Frame: at week 19 or at the discretion of the physician ] [ Designated as safety issue: No ]
A secondary endpoint is to observe patients for any evidence of anti-tumor effect.
Not Provided
Not Provided
 
Xenogeneic HER2/Neu DNA Immunization for Patients With Metastatic and High Risk Breast Cancer: A Phase I Study to Assess Safety and Immunogenicity
Xenogeneic HER2/Neu DNA Immunization for Patients With Metastatic and High Risk Breast Cancer: A Phase I Study to Assess Safety and Immunogenicity

The purpose of this study is to evaluate whether the injection of HER2/neu DNA is safe and stimulates an immune response.

The immune system consists of different kinds of cells and substances which help fight against infections and inflammation in the body. These antibodies and T-cells are part of the immune system that may also help to fight against tumor cells. One way to make antibodies and stimulate T-cells is to inject the patient with a preparation which contains material that may stimulate the immune system. This process is called an immunization. We are trying to immunize the patient against HER2/neu. In order to participate in this trial, the tumor must have a large amount of HER2/neu on its surface. The injection that the patient will receive in this trial is a piece of DNA made in bacteria which contains the gene for rat HER2. DNA is material which contains the information needed to produce many substances in the body. The HER2 gene encodes for a protein known as HER2.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
Biological: MAB HER 2 (HERCEPTIN)
Rat HER2 DNA will be delivered intramuscularly at four different dose levels (0.5mg, 1mg, 3mg, or 6mg) during weeks 1, 4, 7, 10 and 13 for five injections.
Experimental: 1
HER2 ECD DNA.
Intervention: Biological: MAB HER 2 (HERCEPTIN)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12
May 2015
May 2015   (final data collection date for primary outcome measure)

Breast cancer patients with AJCC Stage III or metastatic (AJCC Stage IV) disease that over-express HER2 will potentially be eligible for this trial. Patients may have measurable disease, evaluable disease or be without evidence of disease. They may be receiving hormonal therapy and they may have already received trastuzumab (Herceptin) or be receiving trastuzumab during this study.

Inclusion Criteria:

Patients must have ALL of the features listed below:

  • AJCC Stage IV breast cancer (histologically confirmed) with no evidence of disease or stable disease. Patients may be either off therapy or on hormone therapy and/or trastuzumab.

OR AJCC Stage III breast cancer < or = to 36 months post completion of adjuvant therapy.

  • Pathology slides must be reviewed by the Department of Pathology at MSKCC.
  • HER2 over-expression by FISH or by staining 3+ on immunohistochemistry in either the primary or metastatic tumor.
  • Karnofsky performance status > or = to 80%.
  • Patients must have recovered from the toxicity of any prior therapy, and not received major surgery, radiation therapy, or chemotherapy for at least 4 weeks prior to entry into the trial. (Ongoing hormonal therapy and/or trastuzumab administration is permitted.)
  • Age > 18 years

Exclusion Criteria:

  • Pregnancy (Women of child bearing potential must not be pregnant and have a normal pregnancy test within 2 weeks of starting treatment.) Woman who may yet bear children and sexually active men must be using appropriate contraception during the course of this study. Patients must be counseled not to become pregnant during the study. Patients must also be counseled that injection of HER2 may have unknown affects on the viability of a future fetus.
  • Nursing
  • Prior cumulative doxorubicin dose > 360 mg/m2
  • Prior cumulative epirubicin dose > 600 mg/m2
  • Other active cancers (within the prior five years, excluding non-melanoma skin cancer).
  • Inadequate organ function as defined by any of the following:

    • total white blood cell count of < 3,000 cells/mm3
    • platelet count < 100,000/mm3
    • serum creatinine > 1.5 x upper limit of normal
    • aspartate aminotransferase (AST) > 2 x the upper limit of normal
  • History of cardiac disease as defined by any of the following:

    • any prior myocardial infarction
    • history of documented congestive heart failure
    • left ventricular ejection fraction below the normal institutional range
    • use of medications for treatment of angina pectoris
    • any prior arrhythmia or cardiac valvular disease requiring medication or clinically significant
  • History of known immunodeficiency or autoimmune disease.
  • Any use of medication (e.g., corticosteroids) which might make it difficult for the patient to complete the full course of treatments or to respond immunologically to vaccines is grounds for exclusion, at the discretion of the Principal Investigator or co-Principal Investigators.
  • Previous breast cancer vaccine exposure
  • Active CNS or leptomeningeal tumor
  • Active infection requiring antibiotic treatment
  • Anticipated survival of less than 6 months
Female
18 Years and older
No
Contact: Teresa Gilewski,, MD 646-888-4557
Contact: Alan Houghton, MD 646 888-2330
United States
 
NCT00393783
04-101
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Teresa Gilewski, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP