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Cancer Vaccine

Cancer Vaccine for Breast Cancer

Phase 1

Waitlist Available

Led By Mary Disis

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 stage III-IV HER2 negative breast cancer treated with primary or salvage therapy and now have: No evidence of disease (NED), or Stable bone only disease

Patients must have Eastern Cooperative Oncology Group (ECOG) performance status score of =< 1

Must not have

Patients with any clinically significant autoimmune disease uncontrolled with treatment

Patients with any contraindication to receiving rhuGM-CSF based products

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new DNA-based vaccine for patients with advanced breast cancer that doesn't respond well to chemotherapy. The vaccine aims to help the immune system target and destroy cancer cells. Patients receive different doses of the vaccine to find the best one, and their health is monitored over time. DNA vaccination has emerged as an attractive immunotherapeutic approach against cancer due to its simplicity, stability, and safety.

Who is the study for?

This trial is for adults with HER2-negative stage III-IV breast cancer who have completed standard treatments and are not currently pregnant or breastfeeding. They should have a life expectancy over 6 months, normal organ function tests, no recent major illnesses or surgeries, and agree to use contraception. Those with autoimmune diseases, seizure disorders, significant heart conditions, or on other treatment studies can't join.

What is being tested?

The trial is testing a new DNA vaccine targeting proteins in breast cancer stem cells that resist chemotherapy and spread the disease. It aims to teach the body's immune system to destroy these tumor cells. The study will determine the safest dose of this vaccine while monitoring its effects through lab analysis.

What are the potential side effects?

Potential side effects include reactions at the injection site like pain or swelling, flu-like symptoms such as fever and chills, fatigue, headache, muscle pain. Since it's an early-phase trial assessing safety and dosage levels (phase I), detailed side effect profiles will be studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have stage III-IV HER2 negative breast cancer with no signs of the disease or only stable bone disease.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an autoimmune disease that isn't managed well, even with treatment.

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I am allergic or cannot take rhuGM-CSF based products.

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I have serious heart conditions, including unstable angina, severe heart failure, or fluid around the heart.

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I have a condition that causes seizures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of toxicity per Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events version 4.0

Secondary study objectives

Bac-TA cross-reactive T-cells

Modulation of MDSC with vaccination

Modulation of T-regulatory (Treg) cells with vaccination

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Arm 4 (STEMVAC)Experimental Treatment2 Interventions

Patients receive CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope plasmid DNA vaccine with rhuGM-CSF as 2 injections ID every 28 days for 3 months. Patients may also receive 1 additional STEMVAC vaccine at 3 months after the third vaccine in the absence of unacceptable toxicity or disease progression.

Group II: Arm 3 (STEMVAC)Experimental Treatment2 Interventions

Patients receive CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope plasmid DNA vaccine with rhuGM-CSF as 3 injections ID every 28 days for 3 months. Patients may also receive 2 additional booster STEMVAC vaccines at 3 and 9 months after the third vaccine in the absence of unacceptable toxicity or disease progression.

Group III: Arm 2 (STEMVAC)Experimental Treatment2 Interventions

Patients receive CD105/Yb-1/SOX2/CDH3/M2-polyepitope plasmid DNA vaccine with rhuGM-CSF as 2 injections ID every 28 days for 3 months. Patients may also receive 2 additional booster STEMVAC vaccines at 3 and 9 months after the third vaccine in the absence of unacceptable toxicity or disease progression.

Group IV: Arm 1 (STEMVAC)Experimental Treatment2 Interventions

Patients receive CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope plasmid DNA vaccine with rhuGM-CSF as 1 injection ID every 28 days for 3 months. Patients may also receive 2 additional booster STEMVAC vaccines at 3 and 9 months after the third vaccine in the absence of unacceptable toxicity or disease progression.

0 / 6Eligibility criteria met