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

NCT01152398 | Completed Phase 1

• 1 other identifier: BNIT-BR-003
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The current trial, BNIT-BR-003, will evaluate the safety and biological activity of a fixed dose of MVA-BN®-HER2 following adjuvant chemotherapy in patients with HER-2-positive breast cancer. The intent of vaccination is to induce a combined antibody and T-cell anti-HER-2 immune response, which is intended to target HER-2-expressing tumor cells, 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 Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Number and type of adverse events as a measure of safety and tolerability of multiple vaccinations

  18 months

Secondary Outcomes (1)

• Type and duration of immune response measured over time to repeat vaccine administrations

  18 months

Study Arms (1)

MVA-BN-HER2

EXPERIMENTAL

Biological: MVA-BN-HER2

Interventions

MVA-BN-HER2 BIOLOGICAL

experimental vaccine, subcutaneous injection q4weeks x6

MVA-BN-HER2

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-positive breast cancer without metastatic disease. Hormone receptor (ER/PR) status may be either positive or negative. HER-2 (+) status may be determined by one of the following measurements:
• Immunohistochemistry 3+ or FISH/CISH+ (HER-2 gene signal to centromere 17 signal \> 2). NOTE: HER-2 assessment may have been on initial diagnosis and need not be repeated.
• Patients should be assessed as having no evidence of disease (NED) at the end of adjuvant chemotherapy. In addition, these patients must have a clinical evaluation and lab work as standard of care disease assessment without evidence of recurrence within 28 days of the first planned dose of MVA-BN®-HER2.
• Completed adjuvant and/or neoadjuvant chemotherapy for breast cancer at least 3 months previously (measured from the date of the last dose of chemotherapy) and prior to the first planned dose of MVA-BN®-HER2).
• ECOG Performance Score of 0, 1.
• Predicted life expectancy ≥ 12 months
• Left ventricular ejection fraction (LVEF) by ECHO ≥ LLN as defined by institutional standards
• 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.
• A negative virology screen for HIV, HBsAg, and HCV

You may not qualify if:

• 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 cardiac toxicity secondary to chemotherapy or Herceptin immunotherapy (LVEF decline of 15% or greater from baseline)
• 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
• Any breast cancer metastases beyond the lymph nodes
• Known allergy to eggs, egg products, or aminoglycoside antibiotics, e.g., gentamicin or tobramycin
• Chronic administration (defined as 6 or more consecutive days of use) of systemic corticosteroids within 14 days of the first planned dose of MVA-BN®-HER2. Limited use of inhaled steroids, nasal sprays, eye drops, and topical creams for small body areas is allowed.
• 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 14 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:
• Live (attenuated) vaccine (e.g., FluMist®) Vaccination with a live vaccine within 28 days of the first planned dose of MVA-BN®-HER2, or plans to receive a live vaccine within 28 days after the last dose of MVA-BN®-HER2 is not allowed Killed (inactivated) vaccine (e.g.,PneumoVax®) Vaccination with a killed vaccine within 14 days of the first planned dose of MVA-BN®-HER2, or plans to receive a killed vaccine within 14 ' days after the last dose of MVA-BN®-HER2 is not allowed
• A maximum cumulative dose of prior doxorubicin \> 360 mg/m2 or epirubicn \> 720 mg/m2
• Radiation therapy within 14 days of the first planned dose of MVA-BN®-HER2 or plans for radiation therapy after enrollment. Prior to initiating palliative radiation during the treatment phase of the study, the Sponsor's medical monitor or designee must be contacted.

Sponsors & Collaborators

• Bavarian Nordic: lead

Study Sites (1)

Alta Bates Comprehensive Cancer Center

Berkeley, California, 94704, 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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2010
• First Posted: June 29, 2010
• Study Start: June 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: March 14, 2019

Record last verified: 2011-08

Locations

US (1)