Status:
COMPLETED
Vaccine Therapy in Treating Patients Receiving Trastuzumab For HER2-Positive Stage IIIB-IV Breast Cancer
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
HER2-positive Breast Cancer
Male Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial is studying how well vaccine therapy works in treating patients receiving trastuzumab for HER2-positive stage IIIB- IV breast cancer. Vaccines made from peptides may help the body ...
Detailed Description
PRIMARY OBJECTIVES: 1\. To estimate the RFS in patients with HER2 positive locally advanced breast cancer vaccinated with a HER2 ICD peptide-based vaccine. SECONDARY OBJECTIVES: 1. To assess the sa...
Eligibility Criteria
Inclusion
- Stage IIIB or Stage IIIC breast cancer who are within 1 year of diagnosis and initiating treatment with chemotherapy and trastuzumab; and are in complete remission
- Stage IV breast cancer in first complete remission and defined as NED (no evidence of disease) or with stable bone only disease who are within 6 months of initiating maintenance trastuzumab
- NED status should be documented by chest/abdominal CT, PET or PET/CT within the last 90 days
- Bone only disease documented as stable or healed by PET, PET/CT, or MRI within the last 90 days; stable bone-only disease must be documented with bone scan performed within the last 6 months
- HER2 overexpression by IHC of 2+ or 3+, in the primary tumor or metastasis or documented gene amplification by FISH analysis; if overexpression is 2+ by IHC, then patients must have HER2 gene amplification documented by FISH
- Eligible subjects must have been treated to NED or stable bone only disease status with trastuzumab and/or chemotherapy and be off cytotoxic chemotherapy or immunosuppressive agents (e.g. systemic steroids) for at least 30 days prior to enrollment (concurrent hormonal therapy allowed; concurrent bisphosphonate therapy allowed)
- Patients on trastuzumab should continue trastuzumab monotherapy per standard of care (the dosing and schedule of trastuzumab should follow standard guidelines as described below: trastuzumab 2mg/kg IV weekly or trastuzumab 6mg/kg IV every 3 weeks)
- Subjects must have an ECOG Performance Status Score =\< 1
- Non-menopausal female subjects must agree to contraception for the remainder of their childbearing years
- Male subjects must use an acceptable form of contraception throughout the course of the study
- Hematocrit \>= 30,000
- Platelet count \>= 100,000
- WBC \>= 3000/mcl
- Stable creatinine =\< 2.0 mg/dl or a creatinine clearance greater than 60 ml/min
- Serum bilirubin \< 1.5 mg/dl
- SGOT \< 2x ULN
- Laboratory tests should be performed within 60 days of enrollment
- Subjects must have recovered from major infections and/or surgical procedures and, in the opinion of the investigator, not have any significant active concurrent medical illnesses precluding protocol treatment
- Patients on trastuzumab monotherapy must have adequate cardiac function as demonstrated by normal ejection fraction (EF) on MUGA scan or echocardiogram performed within last 6 months
Exclusion
- Subjects cannot be simultaneously enrolled in other treatment studies
- Patients cannot be receiving any other concurrent immunomodulators besides trastuzumab
- Any contraindication to receiving GM-CSF based vaccine products
- Cardiac disease, specifically restrictive cardiomyopathy, unstable angina within the last 6 months prior to enrollment, New York Heart Association functional class III-IV heart failure on active treatment with normalized LVEF on therapy, and symptomatic pericardial effusion
- Active autoimmune disease
- Subjects can not have active immunodeficiency disorder, e.g. HIV
- Cannot be pregnant or breast feeding
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00343109
Start Date
March 1 2004
Last Update
February 12 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109