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Cancer Vaccine
Cancer Vaccine for Breast Cancer Remission (WOKVAC Trial)
Phase 1
Waitlist Available
Led By Kari Wisinski
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with non-metastatic, node positive, HER2 negative breast cancer, confirmed by pathology report, who are in remission and defined as having no evidence of disease (NED)
Patients must have Eastern Cooperative Oncology Group (ECOG) performance status score of =< 2
Must not have
Patients with any of the following cardiac conditions: Symptomatic restrictive cardiomyopathy, Dilated cardiomyopathy, Unstable angina within 4 months prior to enrollment, New York Heart Association functional class III-IV heart failure on active treatment, Symptomatic pericardial effusion
Patients with any contraindication or known hypersensitivity to receiving sargramostatin (recombinant human granulocyte macrophage colony stimulating factor [rhuGM-CSF]) or other yeast based products
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 9 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a DNA vaccine called WOKVAC in patients with a specific type of breast cancer to see if it can help prevent the cancer from returning by boosting the immune system.
Who is the study for?
This trial is for patients with non-metastatic, node-positive, HER2 negative breast cancer in remission. Participants must have stable health without major recent surgeries or infections and agree to use contraception if applicable. They should not be on other investigational drugs, have certain heart conditions, allergies to similar vaccines or yeast products, uncontrolled autoimmunity, diabetes, or known HIV/hepatitis B/C.
What is being tested?
The trial tests a DNA vaccine's safety and optimal dosage designed to prevent breast cancer recurrence by strengthening the immune response against tumor cells. It involves multiple vaccinations and includes laboratory biomarker analysis alongside the administration of Sargramostim and pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine.
What are the potential side effects?
Potential side effects may include typical vaccine reactions such as soreness at injection site, fever, fatigue; allergic responses; autoimmune reactions where the body attacks its own cells; plus any specific issues related to sargramostim like bone pain or weakness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is not spread, HER2 negative, in remission, and shows no signs of disease.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
My kidney function is normal or only slightly impaired.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have serious heart conditions, including unstable chest pain or heart failure.
Select...
I am not allergic to sargramostatin or yeast-based products.
Select...
I have a history of diabetes.
Select...
I have a history of HIV, hepatitis B, or hepatitis C.
Select...
My autoimmune disease has not been under control despite treatment in the past year.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 9 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Adverse Events Per Common Terminology Criteria for Adverse Events Version 4.0
Secondary study objectives
Assessment of IgG Antibodies
Assessment of T Helper Th1:Th2 Ratio
Assessment of the Immunogenicity of WOKVAC by Generation of IGFBP-2, HER2, and IGF-1R Specific Type 1 (Th1) T- Cells
+3 moreOther study objectives
Change in mammographic density assessed using clinically available images and the automated Cumulus software program
Side effects data
From 2022 Phase 1 trial • 32 Patients • NCT0278040190%
Injection site reaction
70%
Hypertension
70%
Lymphocyte count decreased
60%
Nausea
50%
Fatigue
50%
Flu like symptoms
50%
Myalgia
50%
White blood cell decreased
40%
Chills
40%
Headache
40%
Hypokalemia
40%
Postnasal drip
40%
Cough
30%
Non-cardiac chest pain
30%
Constipation
20%
Upper respiratory infection
20%
Diarrhea
20%
Alkaline phosphatase increased
20%
Hypothyroidism
20%
Arthralgia
20%
Flushing
20%
Abdominal pain
20%
Surgical and medical procedures - Other
10%
Muscle weakness lower limb
10%
Somnolence
10%
Glucose
10%
Hypotension
10%
Oral dysesthesia
10%
Urinary tract infection (UTI)
10%
Chest wall pain
10%
Sore throat
10%
Anxiety
10%
Aspartate aminotransferase increased
10%
Breast pain
10%
Phantom pain
10%
Investigations - Other
10%
Hyperthyroidism
10%
Alanine aminotransferase increased
10%
Bloating
10%
Dyspnea
10%
Hyponatremia
10%
Hypoxia
10%
Respiratory, thoracic and mediastinal disorders - Other
10%
Vomiting
10%
Erythema multiforme
10%
Hypocalcemia
10%
Lymphedema
10%
Neutrophil count decreased
10%
Renal calculi
10%
Skin and subcutaneous tissue disorders - Other
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (WOKVAC With Sargramostim) - Dose 150 mcg + 100 mcg Sargramostim
Treatment (WOKVAC With Sargramostim) - Dose 300 mcg + 100 mcg Sargramostim
Treatment (WOKVAC With Sargramostim) - Dose 600 mcg + 100 mcg Sargramostim
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (WOKVAC with sargramostim)Experimental Treatment3 Interventions
Patients receive WOKVAC with sargramostim ID on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Patients with ALND will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sargramostim
2006
Completed Phase 4
~850
pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine
2016
Completed Phase 1
~40
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for breast cancer that stimulate the immune response include immunotherapy and targeted therapy. Immunotherapy, such as checkpoint inhibitors, works by enhancing the body's immune system to recognize and attack cancer cells.
Targeted therapies, like HER2 inhibitors, specifically target cancer cell proteins that promote tumor growth. The DNA vaccine being studied aims to stimulate an immune response to kill tumor cells by using DNA to produce antigens that trigger the immune system.
These treatments are crucial for breast cancer patients as they offer more personalized and potentially less toxic options compared to traditional chemotherapy, improving outcomes and quality of life.
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,824 Previous Clinical Trials
1,913,323 Total Patients Enrolled
20 Trials studying Breast Cancer
3,253 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,023,138 Total Patients Enrolled
943 Trials studying Breast Cancer
1,443,257 Patients Enrolled for Breast Cancer
University of Wisconsin, MadisonOTHER
1,234 Previous Clinical Trials
3,200,259 Total Patients Enrolled
36 Trials studying Breast Cancer
38,481 Patients Enrolled for Breast Cancer
Kari WisinskiPrincipal InvestigatorUniversity of Wisconsin, Madison
1 Previous Clinical Trials
11 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My breast cancer is not spread, HER2 negative, in remission, and shows no signs of disease.I have serious heart conditions, including unstable chest pain or heart failure.You have enough platelets in your blood, at least 75,000 per cubic millimeter.I am not allergic to sargramostatin or yeast-based products.I have a history of diabetes.I can take care of myself but might not be able to do heavy physical work.I have a history of HIV, hepatitis B, or hepatitis C.My autoimmune disease has not been under control despite treatment in the past year.Your white blood cell count is at least 3000 per cubic millimeter.Your total bilirubin level must be less than or equal to 1.5 mg/dl.Your glycosylated hemoglobin level is less than 5.7%.Your heart's pumping function must be within the normal range based on a test called MUGA or ECHO done before the study.I finished my last cancer treatment at least 28 days ago.I haven't taken systemic steroids in the last 28 days.I have recovered from major infections or surgeries and don't have other serious illnesses.I agree not to have any elective surgery with anesthesia for 1 month after vaccination.Your hemoglobin level is at least 10 grams per deciliter.You have a certain amount of white blood cells in your body.Your AST/SGOT levels are not more than two times the upper limit of normal.My kidney function is normal or only slightly impaired.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (WOKVAC with sargramostim)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.