A Multicenter Phase II Study of Vaccines to Prevent Recurrence in Patients With HER-2 Positive Breast Cancer
Overview
- Phase
- Phase 2
- Intervention
- DC1 Vaccine
- Conditions
- Breast Cancer Female
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Enrollment
- 119
- Locations
- 7
- Primary Endpoint
- Immunogenicity
- Status
- Active, not recruiting
- Last Updated
- last month
Overview
Brief Summary
The main purpose of this study is to evaluate the safety of each study vaccine and to evaluate the effect on the time to disease recurrence (assessed by disease free survival).
Participants will be assigned to receive one of two study vaccines (DC1 study vaccine vs. WOKVAC). The study vaccine will be administered in two phases: a study vaccination phase and a booster phase.
Detailed Description
The total duration of the study will be 6 years (4 years of patient enrollment and 2 additional years of clinical follow-up). Assessment for disease recurrence and survival will be conducted every 6 months (with a phone call/secure email, medical records or follow up visit) from the end of treatment for a total of 2 years, until the completion of the trial or until documented disease recurrence.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Clinical stage I-III HER2 positive breast cancer treated with neoadjuvant chemotherapy including HER-2 directed treatment for at least 12 weeks.
- •Residual invasive carcinoma in the breast or axillary nodes in the final pathology from resected tumor following neoadjuvant chemotherapy.
- •Completed last cycle of cytotoxic chemotherapy (excluding ado-trastuzumab emtansine \[T-DM1\]) or radiation \> 30 days with resolution of all acute toxic effects of prior therapy to grade ≤ 2 (except alopecia)
- •Currently on HER-2 targeted therapy (eg; trastuzumab +/- pertuzumab or T-DM1) per standard of care or has completed HER-2 targeted therapy less than 6 months ago
- •Age ≥ 18 years.
- •Eastern Cooperative Group (ECOG) performance status 0 or
- •Must have normal organ and marrow function as defined below:
- •Absolute neutrophil count (ANC) ≥ 1,000/ μL
- •Platelets ≥ 75,000/ μL
- •Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN), except patients with Gilbert's syndrome in whom total bilirubin must be \<3.0 mg/dL
Exclusion Criteria
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, congenital prolonged QT syndrome, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Uncontrolled autoimmune disease requiring active systemic treatment.
- •Known hypersensitivity reaction to the Granulocyte-macrophage colony stimulating factor (GM-CSF) adjuvant; any known contraindication to GM-CSF.
- •Pregnant or breast feeding.
- •Known HIV-positive.
- •Known current or a history of hepatitis B or C virus, including chronic and dormant states, unless disease has been treated and confirmed cleared.
- •Major surgery within 4 weeks of initiation of study drug.
- •Current extended use of immunosuppressive agents or systemic corticosteroids. Topical, ocular, intra-articular, intranasal, inhalational corticosteroids (with minimal systemic absorption) are allowed. A brief course of corticosteroids for prophylaxis (eg., for contrast dye allergy) or for treatment of non-autoimmune conditions (eg., delayed-type hypersensitivity reaction caused by a contact allergen) is permitted.
- •Potential participant is currently on active treatment in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices, or investigational drug.
Arms & Interventions
Dendritic Cell (DC1) Vaccine
The vaccine will be administered in two phases: a vaccination phase and a booster phase. Approximately 6 months from the initiation of the first vaccine, patients will receive the first of 3 booster vaccines.
Intervention: DC1 Vaccine
pUMVC3-IGFBP2-HER2-IGF1R (WOKVAC)
The vaccine will be administered in two phases: a vaccination phase and a booster phase. Approximately 6 months from the initiation of the first vaccine, patients will receive the first of 3 booster vaccines.
Intervention: WOKVAC Vaccine
Outcomes
Primary Outcomes
Immunogenicity
Time Frame: Up to 3 years
The primary immunogenicity outcome for both arms of this trial will be the summation of spots (ELISPOT) for 6 distinct peptides and reported as total SFC/10\^6 cells. A value \>150 defines an immune response.
Secondary Outcomes
- Disease-free Survival (DFS)(Up to 3 years)