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

Trial ID or NCT#

NCT00485277

Status

not recruiting iconNOT RECRUITING

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

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  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)

Robert W. Carlson

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Contact

Mary Chen
6507238686