What side effects are associated with this type of intervention?

Common treatments for breast cancer that involve immune system activation include immune checkpoint inhibitors and dendritic cell vaccines. Known side effects of these treatments often involve immune-related adverse events. For immune checkpoint inhibitors, such as pembrolizumab and nivolumab, side effects can include skin reactions (rash, pruritus), gastrointestinal issues (diarrhea, colitis), and endocrine disorders (hypothyroidism). Dendritic cell vaccines, like the one being studied in the trial, may cause local reactions at the injection site, flu-like symptoms, and potentially more severe immune-related effects depending on the dose and individual patient response.

What prior FDA approvals exist?

The FDA has approved several immunotherapies for the treatment of breast cancer, focusing on immune system activation. One notable example is pembrolizumab (Keytruda), a PD-1 inhibitor, which has been approved for use in combination with chemotherapy for patients with locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors express PD-L1. Another example is atezolizumab (Tecentriq), a PD-L1 inhibitor, approved for use with nab-paclitaxel in patients with PD-L1-positive, metastatic triple-negative breast cancer. These treatments work by enhancing the body's immune response against cancer cells, similar to the mechanism of action being studied with the Dendritic Cell Vaccine (DCV).

What other types of research exist?

Promising novel alternatives to Dendritic Cell Vaccine for breast cancer patients include: 1) Immune checkpoint inhibitors such as pembrolizumab and nivolumab, which have shown efficacy in various cancers and are being explored for breast cancer. 2) CAR-T cell therapy, which involves modifying a patient's T cells to target cancer cells. 3) PARP inhibitors like olaparib, particularly for patients with BRCA mutations. 4) Antibody-drug conjugates (ADCs) such as trastuzumab deruxtecan, which deliver cytotoxic agents directly to cancer cells. These therapies represent cutting-edge approaches that harness the immune system or target specific cancer pathways.

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Cancer Vaccine

DCV for Breast Cancer

Phase 1

Recruiting

Led By Peter A Forsyth, MD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Trial participants must have a diagnosis of LMD with the presence of malignant cells in the CSF (CSF+; note now cytology is considered diagnostic of LMD if the cytology is read as positive or suspicious; OR characteristic radiographic abnormalities of LMD). Signs and symptoms of LMD in and of themselves are not sufficient for inclusion.

Pregnancy test: negative serum or urine pregnancy test at screening for women of childbearing potential. Must be repeated once-monthly during treatment. Contraception: Highly effective contraception for both male and female subjects throughout the study and for at least 90 days after last treatment administration, if the risk of conception exists.

Must not have

Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. Current COVID vaccines are not live vaccines.

Unable or unwilling to have a contrast-enhanced brain MRI.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a special vaccine made from a patient's own immune cells to help fight breast cancer that has spread to the brain and spinal cord. The goal is to find the safest highest dose that can be given.

Who is the study for?

This trial is for breast cancer patients with Leptomeningeal Disease who have malignant cells in their CSF or radiographic abnormalities of LMD. They must not be pregnant, agree to use effective contraception, and have a life expectancy of at least 8 weeks. Participants should have stable brain/spinal cord metastases if present, an ECOG performance scale ≤3, and adequate organ function.

What is being tested?

The study is testing the safety and highest tolerable dose of Dendritic Cell Vaccine (DCV) in breast cancer patients with Leptomeningeal Disease. It involves administering DCV through a device that allows access to the cerebrospinal fluid.

What are the potential side effects?

Potential side effects are not explicitly listed but may include typical vaccine-related reactions such as injection site pain, fever, fatigue, headache, chills, muscle or joint pain. Since it's a first-in-human trial for this treatment, close monitoring for any adverse effects is critical.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have LMD confirmed by positive CSF test or specific radiographic signs.

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I am not pregnant and will use effective birth control during and after the study.

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My breast cancer is confirmed as triple-negative or HER2 positive.

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I can take care of myself but can't do heavy physical work.

Exclusion Criteria

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

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I have not received a live vaccine in the last 30 days.

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I cannot or do not want to have a brain MRI with contrast.

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I have a shunt with an on/off device and can tolerate it being off for about 4 hours without issues.

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I have not used any immunotherapy in the last four weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum Tolerated Dose of Intrathecal Dendritic Cell Vaccine

Secondary study objectives

Overall Survival

Progression Free Survival

Side effects data

From 2013 Phase 2 trial • 11 Patients • NCT00323115

10%

Pain, neck, unilateral, Grade 2

100%

80%

60%

40%

20%

Study treatment Arm

Vaccine

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: Dendritic Cell (DC) Vaccine dose escalationExperimental Treatment1 Intervention

HER2/3 peptide-pulsed DC1 will be administered intrathecally (IT) weekly for 6 doses /cycle for a maximum of two cycles, and then re-staged. If there are sufficient DC1s this may be continued weekly thereafter. There are 1 safety cohort (1 million DCV cells) and 3 escalating doses (2 million, 10 million and 50 million DCV cells) possible.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dendritic Cell Vaccine

2011

Completed Phase 2

~140

0 / 8Eligibility 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

Breast cancer treatments often include surgery, radiation, chemotherapy, hormone therapy, and targeted therapy. A novel approach being studied is the Dendritic Cell Vaccine (DCV), which aims to activate the immune system. DCVs work by using dendritic cells, which are key antigen-presenting cells, to stimulate the body's immune response against cancer cells. This is achieved by loading dendritic cells with tumor antigens, which then present these antigens to T-cells, triggering a targeted immune attack on the cancer. This method is significant for breast cancer patients as it offers a potential for a more personalized and less toxic treatment option compared to traditional therapies, potentially improving outcomes and quality of life.