Cancer Vaccine + GM-CSF and Cyclophosphamide for Triple Negative Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a special cancer vaccine, combined with the drug cyclophosphamide and the immune booster sargramostim (GM-CSF), can prevent triple negative breast cancer from returning after surgery and standard treatments. The vaccine is designed to help the immune system recognize and fight cancer cells, while cyclophosphamide stops cancer cells from growing and spreading. Women who have undergone surgery for triple negative breast cancer and completed their treatments, but still face a risk of recurrence, might be suitable for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but it does allow the use of common medications like aspirin, NSAIDs, and statins. However, you cannot take systemic corticosteroids or immune-modulating drugs within 7 days before starting the trial, and you cannot be on other experimental drugs or systemic anticancer therapies.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the multi-epitope folate receptor alpha peptide vaccine is generally safe. Studies indicate it can strengthen the immune system, with only minor side effects reported. Sargramostim (GM-CSF), often used to enhance immune responses, also has a strong safety record and is well-tolerated in many cancer treatments.
Cyclophosphamide, a chemotherapy drug used for many years, is effective but can cause side effects such as nausea or a decrease in blood cells, which doctors closely monitor.
Overall, the treatments in this trial have been used in other settings, and safety data show they are generally tolerable. However, since this is a clinical trial, monitoring for any adverse events is important.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they offer a new approach to tackling triple negative breast cancer. Unlike traditional chemotherapy, which broadly attacks all fast-growing cells, this investigational treatment uses a cancer vaccine combined with GM-CSF (sargramostim) to specifically target cancer cells expressing folate receptor alpha. This tailored approach could potentially lead to fewer side effects and improved effectiveness. Additionally, the use of cyclophosphamide in this combination may enhance the immune system's response to the vaccine, offering a promising new strategy compared to existing treatments like surgery, radiation, and non-specific chemotherapy.
What evidence suggests that this trial's treatments could be effective for triple negative breast cancer?
This trial will evaluate a new vaccine that might help the immune system fight triple-negative breast cancer. Participants in one arm of the trial will receive the multi-epitope folate receptor alpha peptide vaccine, which targets a protein often found in large amounts on these cancer cells. Studies have shown that this vaccine can safely boost the body's defense against this protein. To enhance the vaccine's effectiveness, Sargramostim (GM-CSF) increases white blood cells. Another arm of the trial involves a placebo vaccine with Sargramostim. Both arms include Cyclophosphamide, a type of chemotherapy that can kill or stop cancer cells from growing, potentially helping to prevent the cancer from returning. Together, these treatments could effectively reduce the risk of cancer recurrence.12678
Who Is on the Research Team?
Kathryn J Ruddy
Principal Investigator
Academic and Community Cancer Research United
Are You a Good Fit for This Trial?
This trial is for women aged 18+ with stage 1-3 triple negative breast cancer who've completed surgery and other treatments within the past 90 to 546 days. They must have a good performance status, adequate organ function, and no evidence of metastatic disease or recurrence. Women must not be pregnant, nursing, immunocompromised on antiretroviral therapy, or have active autoimmune diseases.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive cyclophosphamide and either the multi-epitope folate receptor alpha peptide vaccine with sargramostim or a placebo vaccine with sargramostim. Treatment repeats every 28 days for cycles 2-7 and every 6 months for cycles 8-14.
Follow-up
Participants are monitored for disease-free survival and adverse events every 6 months for 3 years after completion of study treatment.
What Are the Treatments Tested in This Trial?
Interventions
- Cyclophosphamide
- Multi-epitope Folate Receptor Alpha Peptide Vaccine
- Sargramostim
Cyclophosphamide is already approved in United States, European Union, Canada, Japan for the following indications:
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Academic and Community Cancer Research United
Lead Sponsor
National Cancer Institute (NCI)
Collaborator