← Back to Search

Cancer Vaccine

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

Phase 1
Waitlist Available
Led By Mary L. 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 on trastuzumab monotherapy must have adequate cardiac function as demonstrated by normal ejection fraction (EF) of MUGA scan or echocardiogram
HER2 overexpression by immunohistochemistry (IHC) of 2+ or 3+ in their primary tumor or metastasis, and if overexpression is 2+ by IHC or in the absence of IHC, then patients must have documentation of HER2 gene amplification by FISH
Must not have
Prior known history of pulmonary disease other than controlled asthma
Subjects cannot have active immunodeficiency disorder, e.g., HIV
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include reactions at the injection site such as redness and pain, flu-like symptoms including fever and chills, fatigue, weakness in muscles or joints due to an immune response. Since it's an early-phase trial assessing safety and dosage levels; exact side effects will be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My heart is strong enough for treatment, as shown by a heart scan.
Select...
My cancer shows high levels of HER2, confirmed by tests.
Select...
My kidney function is normal or only slightly impaired.
Select...
My ovarian cancer is in the first complete remission, and my CA-125 levels are normal and stable.
Select...
I am fully active and can carry on all pre-disease activities without restriction.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a history of lung disease, but not asthma or my asthma is under control.
Select...
I do not have HIV or any active immune deficiency.
Select...
I have a history of serious heart conditions.
Select...
I cannot have vaccines based on GM-CSF due to health reasons.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

1Treatment groups
Experimental Treatment
Group I: Arm IExperimental Treatment7 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
protein expression analysis
2005
Completed Phase 2
~1080
sargramostim
1996
Completed Phase 3
~4880
biopsy
2002
Completed Phase 4
~8270

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for breast cancer include surgery, chemotherapy, radiation therapy, hormone therapy, targeted therapy, and immunotherapy. Vaccine therapy aims to stimulate the immune system to recognize and kill tumor cells, while sargramostim (GM-CSF) increases the number of immune cells, enhancing the body's ability to fight cancer. These treatments are crucial for breast cancer patients as they offer a way to harness the body's natural defenses, potentially leading to more effective and personalized cancer care.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,934 Total Patients Enrolled
945 Trials studying Breast Cancer
1,543,964 Patients Enrolled for Breast Cancer
University of WashingtonLead Sponsor
1,791 Previous Clinical Trials
1,905,440 Total Patients Enrolled
20 Trials studying Breast Cancer
3,253 Patients Enrolled for Breast Cancer
Mary L. DisisPrincipal InvestigatorFred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Media Library

pNGVL3-hICD vaccine (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT00436254 — Phase 1
Breast Cancer Research Study Groups: Arm I
Breast Cancer Clinical Trial 2023: pNGVL3-hICD vaccine Highlights & Side Effects. Trial Name: NCT00436254 — Phase 1
pNGVL3-hICD vaccine (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00436254 — Phase 1
~3 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top