Mammaglobin-A DNA Vaccine for Metastatic Breast Cancer

NCT00807781 | Completed Phase 1

• 1 other identifier: 06-0298 / 201110267
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety of mammaglobin-A DNA vaccine in metastatic breast cancer patients.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Evaluate safety of mammaglobin-A DNA vaccine, WUSM-MGBA-01

  30 days after completion of treatment

Secondary Outcomes (1)

• To evaluate the immunogenicity of the mammaglobin-A DNA vaccine, WUSTL-MGBA-01. Immunogenicity will be measured by ELISPOT analysis, a surrogate for CD8 T cell function.

  52 weeks

Study Arms (1)

Mammaglobin-A DNA vaccine

EXPERIMENTAL

Patients will receive vaccine day 1 (week 1), week 4 (day 29 +/- 7), week 8 (day 57 +/- 7) with at least 21 days between injection days. All injections will be given intramuscularly using a jet delivery device. Patients will be administered the vaccine in lateral shoulder and buttocks positions that will be rotated with each administration in the above order.

Biological: Mammaglobin-A DNA vaccine

Interventions

Mammaglobin-A DNA vaccine BIOLOGICAL

Mammaglobin-A DNA vaccine

Eligibility Criteria

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

You may qualify if:

• Patient must have a histologically confirmed diagnosis of invasive breast cancer. Paraffin-embedded tissue or tissue sections must be available for immunohistochemistry analysis to confirm mammaglobin-A expression.
• Patient must have metastatic breast cancer that has been stable for at least 30 days. This may include patients with measurable or evaluable disease by RECIST criteria, and those without evidence of disease.
• Patient must not have had chemotherapy, radiation therapy, or biologic therapy within 30 days of initiating therapy on study, and have resolved all toxicities experienced from these treatments. Patients receiving hormonal therapy and supportive therapy with bisphosphonates will be allowed. Patients currently on trastuzumab will be allowed.
• Patient must be 18 years or older.
• Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• Patient must have a life expectancy of ≥ 24 weeks.
• Patient must have adequate organ and marrow function as defined below:
• WBC ≥3,000/μL
• absolute neutrophil count ≥1,500/μL
• platelets ≥100,000/μL
• total bilirubin ≤2.5 X institutional upper limit of normal
• AST/ALT ≤2.5 X institutional upper limit of normal
• creatinine ≤1.5 X institutional upper limit of normal
• Women of reproductive potential must have a negative urine or serum β-HCG pregnancy test prior to enrollment to confirm that they are not pregnant.
• Women of reproductive potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for 21 days prior to study entry and for the duration of study participation (until Week 52).

You may not qualify if:

• Patient has evidence of progressive breast cancer within the last 30 days.
• Patient is currently receiving other investigational agent(s) or has received an investigational agent within the last 30 days.
• Patient has known brain metastases.
• Patient with known allergy, or history of serious adverse reaction to vaccines such as anaphylaxis, hives, or respiratory difficulty.
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements.
• Patient with prior or currently active autoimmune disease requiring management with immunosuppression. This includes inflammatory bowel disease, ulcerative colitis, crohn's disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia, immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjögren's syndrome, sarcoidosis, or other rheumatologic disease or any other medical condition or use of medication (e.g., corticosteroids) which might make it difficult for the patient to complete the full course of treatments or to generate an immune response to vaccines. Asthma or chronic obstructive pulmonary disease that does not require daily systemic corticosteroids is acceptable. Any patients receiving steroids should be discussed with the PI to determine if eligible.
• Patient is pregnant.
• Patients known to be HIV-positive are ineligible because of the potential inability to generate an immune response to vaccines.
• Patients has failed greater than two chemotherapy regimens for metastatic disease.
• Subjects with a strong likelihood of non-adherence such as difficulties in adhering to follow-up schedule due to geographic distance from the Siteman Cancer Center, should not knowingly be registered.
• Patients who have known seropositivity for hepatitis B antigen or hepatitis C antibody. Testing will be done prior to study entry to confirm.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• William Gillanders, M.D.

  Washington Univerisity School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 11, 2008
• First Posted: December 12, 2008
• Study Start: October 1, 2009
• Primary Completion: March 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 5, 2015

Record last verified: 2015-01

Locations

US (1)