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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 and 6 months after last vaccination
Awards & highlights

Study Summary

This trial is testing the side effects and best dose of a cancer vaccine when given with sargramostim to treat patients with stage III-IV breast or ovarian cancer.

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.Check my eligibility
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.See study design
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
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My heart is strong enough for treatment, as shown by a heart scan.
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My cancer shows high levels of HER2, confirmed by tests.
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My kidney function is normal or only slightly impaired.
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My ovarian cancer is in the first complete remission, and my CA-125 levels are normal and stable.
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I am fully active and can carry on all pre-disease activities without restriction.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 and 6 months after last vaccination
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 and 6 months after last vaccination for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Immune response
Safety as measured by NCI CTCAE v 3.0
Secondary outcome measures
Impact of dose on immunologic response
Persistence of DNA at the injection site

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
sargramostim
1996
Completed Phase 3
~4880
protein expression analysis
2005
Completed Phase 2
~1100
biopsy
2002
Completed Phase 4
~8270

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,087 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
University of WashingtonLead Sponsor
1,738 Previous Clinical Trials
1,844,285 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are included in the research project?

"This particular clinical trial is not currently seeking any more patients, as it has already recruited the number of participants needed. This study was first posted on October 1st 2001 and was last updated on November 1st 2022. There are other ongoing trials that may be of interest; 2949 for stage iv ovarian germ cell tumor and 43 for pNGVL3-hICD vaccine."

Answered by AI

Are there other ongoing investigations using pNGVL3-hICD vaccine?

"There are currently 43 ongoing clinical trials for the pNGVL3-hICD vaccine, 5 of which have reached Phase 3. The majority of these medical studies are based in Seattle, Washington; however, there are a total of 1885 locations across the world where patients can receive this treatment."

Answered by AI

Are there any know risks associated with the pNGVL3-hICD vaccine?

"The pNGVL3-hICD vaccine is still in its first phase of trials, so there is limited data backing its safety and efficacy. We gave it a score of 1."

Answered by AI

What infections does the pNGVL3-hICD vaccine work against?

"The pNGVL3-hICD vaccine is not only useful for treating severe infection, but can also help patients with lymphoma, hodgkins disease, and leukemia."

Answered by AI

Are new patients currently being accepted to participate in this trial?

"According to the listing on clinicaltrials.gov, this trial is no longer recruiting patients. However, there are almost 3000 other trials that might be a fit for you and your needs."

Answered by AI

Who else is applying?

What site did they apply to?
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Recent research and studies
clinicaltrials.govStudy
Vaccine Therapy With Sargramostim (GM-CSF) in Treating Patients With Her-2 Positive Stage III-IV Breast Cancer or Ovarian Cancer
2001. "Vaccine Therapy With Sargramostim (GM-CSF) in Treating Patients With Her-2 Positive Stage III-IV Breast Cancer or Ovarian Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00436254.
All > Raymond A Wood > Breast
~3 spots leftby Apr 2025
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