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

NCT00393783 | Active Not Recruiting Phase 1

• 1 other identifier: 04-101
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Metastatic; HER2; 04-101

Outcome Measures

Primary Outcomes (1)

• The maximum tolerated dose over four dose levels

  13 weeks

Secondary Outcomes (1)

• A secondary endpoint is to observe patients for any evidence of anti-tumor effect.

  at week 19 or at the discretion of the physician

Study Arms (1)

1

EXPERIMENTAL

HER2 ECD DNA.

Biological: MAB HER 2 (HERCEPTIN)

Interventions

MAB HER 2 (HERCEPTIN) BIOLOGICAL

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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Mark Robson, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2006
• First Posted: October 30, 2006
• Study Start: May 1, 2006
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: June 5, 2025

Record last verified: 2025-06

Locations

US (1)