Cancer Vaccine for Breast Cancer

Recruiting in Palo Alto (17 mi)

Overseen byMary L. Disis

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: University of Washington

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

I've finished my standard treatment and have little to no side effects.

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

I am currently taking bisphosphonates, denosumab, or hormone therapy.

See 14 more

Exclusion Criteria

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

I am at risk for stomach bleeding due to ulcers or long-term use of NSAIDs.

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

See 4 more

Treatment Details

Interventions

CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine (Cancer Vaccine)

Trial OverviewThe 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.

Participant Groups

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.

CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine is already approved in United States for the following indications:

🇺🇸 Approved in United States as STEMVAC for: