Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
WOKVAC Trial Summary
This trial is testing a cancer vaccine to see if it can prevent the cancer from coming back in patients who have no signs or symptoms of the disease.
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.Check my eligibility
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.See study design
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.
WOKVAC Trial 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.
WOKVAC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of toxicity assessed by adverse events per Common Terminology Criteria for Adverse Events version 4.0
Secondary outcome measures
Assessment of IgG antibodies
Assessment of T helper Th1:Th2 ratio
T-Lymphocyte
+3 moreOther outcome measures
Change in mammographic density assessed using clinically available images and the automated Cumulus software program
WOKVAC 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
2008
Completed Phase 4
~710
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,738 Previous Clinical Trials
1,844,327 Total Patients Enrolled
20 Trials studying Breast Cancer
3,253 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,655 Previous Clinical Trials
40,933,195 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
University of Wisconsin, MadisonOTHER
1,182 Previous Clinical Trials
3,167,363 Total Patients Enrolled
36 Trials studying Breast Cancer
38,519 Patients Enrolled for Breast Cancer
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants still being welcomed into this experiment?
"Unfortunately, at this time the clinical trial is not recruiting any new patients. Initially posted on September 2nd 2016 and most recently updated on January 11th 2022, there are presently no openings in this medical study. However, if you search for other trials related to breast cancer or pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine, there are currently 2287 and 43 active studies respectively that may be accepting participants."
Answered by AI
What evidence exists to corroborate the efficacy of pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine in clinical trials?
"Presently, 43 clinical trials are underway to assess the efficacy of pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine. 5 of these studies have advanced to Phase 3 and there is a total of 1888 trial sites located across Seattle, Washington."
Answered by AI
What is the maximum capacity for participants in this experiment?
"Unfortunately, this experiment has already stopped recruiting participants. It was posted on September 2nd 2016 and last updated on January 11th 2022; however, there are numerous other clinical trials in need of volunteers - 2287 related to breast cancer and 43 focused specifically on the pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine."
Answered by AI
Has the FDA authorized pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine for commercial distribution?
"Given the lack of data supporting its safety and efficacy, our team at Power has assigned pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine a score of 1."
Answered by AI
What therapeutic benefits does pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine offer?
"Those suffering from severe infection, lymphoma, Hodgkin's Disease and who have had a bone marrow transplant may find relief with the pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger