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

NCT00485277 | Completed Phase 1 DMC

• 1 other identifier: BNIT-BR-002
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Breast cancer; Vaccine; Metastatic; HER-2-positive; Phase I; HER-2 Positive Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

  2years, 3 months

Secondary Outcomes (1)

• Immune response

  2 yrs 3 mo

Interventions

MVA-BN-HER2 BIOLOGICAL

Experimental vaccine, subcutaneous injection q3weeks x 3

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bavarian Nordic: lead

Study Sites (2)

Alta Bates Herrick Hospital Comprehensive Cancer Center

Berkeley, California, 94705, United States

Location

Stanford Cancer Center

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

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

Study Officials

• Olga Bandman

  Bavarian Nordic

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: June 8, 2007
• First Posted: June 12, 2007
• Study Start: June 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: March 14, 2019

Record last verified: 2010-09

Locations

US (2)