Trial Search Results

A Safety and Immunology Study of a Modified Vaccinia Vaccine for HER-2(+) Metastatic Breast Cancer

The current trial, BNIT-BR-002, will evaluate the safety and biological activity of a fixed dose of MVA-BN®-HER2, with and without Herceptin, following 1st- or 2nd-line chemotherapy in patients with Her-2-positive metastatic breast cancer.

The intent of vaccination is to induce anti-Her-2 immune responses, both antibody and T cell, that will then attack the Her-2 expressing tumors, and may induce tumor regression or slow progression of disease.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Bavarian Nordic

Stanford Investigator(s):

Intervention(s):

  • Biological: MVA-BN-HER2

Phase:

Phase 1

Eligibility


Inclusion Criteria:

   - Signed Informed Consent

   - Women, ≥ 18 years of age

   - Histologically documented, HER-2 (+) breast cancer with metastatic disease.

   - Evaluable or measurable disease. PATIENTS MAY BE NED. Patients must be assessed as
   having stable disease or better at the end of 1st- or 2nd-line chemotherapy. In
   addition, patients must have a tumor assessment within 28 days of the first planned
   dose of MVA-BN®-HER2, and have a response status of SD or better.

   - Prior chemotherapy for metastatic breast cancer

   - Completed 1st- or 2nd-line chemo for mBrCA at least 3 weeks (from the date of the last
   dose) prior to the first dose of MVA-BN®-HER2

   - ECOG Performance Score of 0, 1, or 2

   - Life expectancy ≥ 6 months

   - Left ventricular ejection fraction (LVEF) by ECHO or MUGA ≥ LLN

   - Women of childbearing potential must have a negative serum or urine pregnancy test,
   and must agree to use a medically acceptable barrier and/or chemical method of
   contraception throughout the study treatment period and for 28 days after the last
   dose of MVA-BN®-HER2

   - No significant cardiac, bone marrow dysfunction, or coagulopathy. No significant
   hepatic or renal dysfunction.

   - A negative virology screen for HIV, hepatitis B surface antigen, hepatitis C, and
   HTLV-1

Exclusion Criteria:

Patients may not have:

   - Known history of metastasis to the central nervous system

   - Congestive heart failure (NYHA Class III or IV), unstable angina, or cardiovascular
   disease such as stroke or myocardial infarction (current or within the past 6 months)

   - History of prior malignancies other than breast cancer within the past 5 years,
   excluding basal or squamous cell carcinoma of the skin or carcinoma in situ of the
   cervix

   - Known allergy to eggs, egg products, or aminoglycoside antibiotics, e.g., gentamicin
   or tobramycin

   - Chronic administration (5 or more consecutive days) of systemic corticosteroids within
   14 days of the first planned dose of MVA-BN®-HER2.

   - History of or active autoimmune disease. Persons with vitiligo or thyroid disease
   taking thyroid replacement hormones are not excluded.

   - Prior solid organ or hematopoietic allogenic transplant(s)

   - Prior use of hematopoietic growth factors (e.g., GM-CSF) within 28 days of the first
   planned dose of MVA-BN®-HER2

   - Receipt of an investigational agent within 28 days of the first planned dose of
   MVA-BN®-HER2

   - Prior "vaccine" therapy for breast cancer at any time

   - Vaccination: Vaccinations with a live (attenuated) vaccine within 28 days of the first
   or last dose of study drug; or vaccinations with a killed (inactivated) vaccine within
   14 days of the first or last dose of study drug.

   - A maximum cumulative dose of prior doxorubicin > 360 mg/m2 or epirubicin > 720 mg/m2

   - Radiation therapy within 28 days of the first planned dose of MVA-BN®-HER2 or plans
   for radiation therapy after enrollment.

   - Pregnant, lactating, or nursing

   - Any condition which, in the opinion of the investigator, would prevent full
   participation in this trial or the long-term follow-up study, or would interfere with
   the evaluation of the trial endpoints

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mary Chen
6507238686
Not Recruiting