What side effects are associated with this type of intervention?

Common side effects of breast cancer treatments similar to Vaccine Therapy and Sargramostim include flu-like symptoms (fever, chills, fatigue), injection site reactions (redness, swelling, pain), and gastrointestinal issues (nausea, vomiting, diarrhea). Patients may also experience bone pain, muscle aches, and headaches. Severe but less common side effects can include allergic reactions, low blood cell counts, and autoimmune reactions.

What prior FDA approvals exist?

FDA-approved treatments for breast cancer that involve stimulating the immune system include monoclonal antibodies like trastuzumab (Herceptin), which targets the HER2 protein on cancer cells, and immune checkpoint inhibitors such as pembrolizumab (Keytruda), which helps the immune system recognize and attack cancer cells. While these treatments are not identical to the combination of vaccine therapy and sargramostim, they share the common goal of enhancing the body's immune response to combat cancer.

What other types of research exist?

Promising novel alternatives for breast cancer treatment in 2024 include immune checkpoint inhibitors such as pembrolizumab and nivolumab, which enhance the immune system's ability to target cancer cells. Personalized antibody therapies and combination treatments involving monoclonal antibodies and chemotherapy are also emerging as effective options.

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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

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

No Placebo-Only Group

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

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I do not have HIV or any active immune deficiency.

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I have a history of serious heart conditions.

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I cannot have vaccines based on GM-CSF due to health reasons.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 9Eligibility criteria met

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.