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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

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 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%
0%
Study treatment Arm
Vaccine

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

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.

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
558 Previous Clinical Trials
144,522 Total Patients Enrolled
42 Trials studying Breast Cancer
5,796 Patients Enrolled for Breast Cancer
United States Department of DefenseFED
891 Previous Clinical Trials
332,460 Total Patients Enrolled
38 Trials studying Breast Cancer
103,344 Patients Enrolled for Breast Cancer
Peter A Forsyth, MDPrincipal InvestigatorMoffitt Cancer Center
1 Previous Clinical Trials
16 Total Patients Enrolled

Media Library

Breast Cancer Research Study Groups: Dendritic Cell (DC) Vaccine dose escalation
~10 spots leftby Mar 2026
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