A Safety and Immunology Study of a Modified Vaccinia Vaccine for HER-2(+) Metastatic Breast Cancer
Trial ID or NCT#
Status
Purpose
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.
Official Title
A Phase I Trial of a Fixed Dose of MVA-BN-HER2 Following 1st- or 2nd-Line Chemotherapy for HER-2-Positive Metastatic Breast Cancer
Eligibility 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
- 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
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Mary Chen
6507238686
View on ClinicalTrials.gov