Cancer Vaccine + Sargramostim for Breast Cancer or alternatively, Cancer Vaccine + Sargramostim for Ovarian Cancer

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: University of Washington

Must be taking: Trastuzumab

Disqualifiers: Cardiac disease, Pulmonary disease, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new cancer vaccine (pNGVL3-hICD vaccine) combined with sargramostim to determine its effectiveness in helping the immune system fight breast and ovarian cancer. The study aims to find the best dose and identify any side effects when these treatments are used together. It seeks participants with stage III or IV breast or ovarian cancer who are in remission (no signs of disease). Participants should have completed their main cancer treatments and not be on chemotherapy or steroids. This study could suit those who are currently stable and have HER2-positive cancer. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop taking cytotoxic chemotherapy and corticosteroids at least 1 month before enrolling. However, you can continue taking trastuzumab, hormonal, and bisphosphonate therapies.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the pNGVL3-hICD vaccine, combined with sargramostim (a substance that boosts immune cells), may help treat breast and ovarian cancers. Studies have found that this combination is generally well-tolerated, with manageable side effects. In earlier studies, patients received the vaccine with sargramostim once a month for three months.

Most reported side effects were mild, such as redness or swelling at the injection site. Serious side effects were rare, and no widespread evidence of severe harm was found. This information provides reassurance about the safety of these treatments for those considering participation in a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike traditional treatments for breast or ovarian cancer, which often involve chemotherapy, radiation, or hormone therapy, the pNGVL3-hICD vaccine operates on a novel mechanism by leveraging the body's own immune system. This vaccine is combined with sargramostim, also known as GM-CSF, to enhance the immune response, directly targeting cancer cells. Researchers are excited about this approach because it represents a shift toward personalized, immune-based therapies that may offer fewer side effects and improved outcomes by promoting an immune attack specifically against cancer cells.

What evidence suggests that this trial's treatments could be effective for breast cancer and ovarian cancer?

Research shows that the pNGVL3-hICD vaccine, used with the drug sargramostim (GM-CSF), may help the immune system identify and attack cancer cells in breast and ovarian cancer patients. Studies suggest that sargramostim increases the number of immune cells, potentially enhancing the body's ability to combat cancer. Early results indicate that cancer vaccines like pNGVL3-hICD can help the immune system better target tumors. Although the effectiveness of this combination is still under investigation, the approach is grounded in strong scientific principles of boosting the immune system to fight cancer. ^{2 3 4 5 6}

Who Is on the Research Team?

Mary L. Disis

Principal Investigator

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

This trial is for adults with stage III-IV breast or ovarian cancer that overexpresses HER2 and are in remission. They must have normal heart, kidney, liver function, blood counts within specific ranges, and no ability to bear children. Excluded are those with autoimmune diseases, active infections like HIV, severe heart or lung conditions, or on other treatment studies.

Inclusion Criteria

Your SGOT blood test result is less than two times the upper limit of normal.

I finished my main cancer treatment and haven't had chemotherapy or steroids for over a month.

Your blood test results for ANA, anti-dsDNA, and C3 are normal.

Exclusion Criteria

I have a history of lung disease, but not asthma or my asthma is under control.

You have an ongoing autoimmune disease.

Subjects cannot be simultaneously enrolled on other treatment studies

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pNGVL3-hICD vaccine admixed with GM-CSF intradermally once a month for 3 months

3 months

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 15 years

What Are the Treatments Tested in This Trial?

Interventions

• pNGVL3-hICD vaccine
• Sargramostim

Trial Overview The study tests a vaccine therapy combined with GM-CSF (sargramostim) to see if it can stimulate the immune system to fight cancer cells effectively in patients with advanced breast or ovarian cancer. It's a phase I trial focused on determining side effects and the best dose of this combination therapy.

How Is the Trial Designed?

Group I: Arm I Experimental Treatment 7 Interventions

Patients receive pNGVL3-hICD vaccine admixed with GM-CSF intradermally once a month for 3 months in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05163223

Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in ... The purpose of this study is to evaluate the efficacy and safety of an adjuvant treatment of therapeutic cancer vaccine (AST-301, pNGVL3-hICD) in patients with ...

2. ctv.veeva.com ctv.veeva.com/study/vaccine-therapy-with-sargramostim-gm-csf-in-treating-patients-with-her-2-positive-stage-iii-iv-bre

Vaccine Therapy With Sargramostim (GM-CSF) in Treating ... ... sargramostim may be an effective treatment for breast cancer and ovarian cancer. PURPOSE: This phase I trial is studying the side effects ...

3. patlynk.com patlynk.com/trial/NCT00436254

Vaccine Therapy With Sargramostim (GM-CSF) in Treating ... Patients receive pNGVL3-hICD vaccine admixed with GM-CSF intradermally once a month for 3 months in the absence of disease progression or unacceptable toxicity.

4. withpower.com withpower.com/trial/phase-1-neoplasms-germ-cell-and-embryonal-9-2001-df5c2

Cancer Vaccine + Sargramostim for Breast ... This trial is testing a new treatment for advanced breast and ovarian cancer. The treatment helps the body's defense system recognize and attack cancer ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8608270/

Therapeutic vaccines for breast cancer: Has the time finally ... Overall, during a 20-year period (2000–2019) of BC vaccine clinical trials, the estimated objective response rate (ORR) was around 9%, without a clear survival ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT00436254

NCT00436254 | Vaccine Therapy With Sargramostim (GM- ... Patients receive pNGVL3-hICD vaccine admixed with GM-CSF intradermally once a month for 3 months in the absence of disease progression or unacceptable toxicity.