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

66 Participants Needed

Trial Summary

What is the purpose of this trial?

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 cells, while another component increases the number of defense cells. Researchers aim to find the safest dose and see if it effectively triggers the body's defense system. This type of treatment has shown promise in previous studies for its safety and ability to stimulate the body's defense system.

Research Team

Mary L. Disis

Principal Investigator

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+