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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
Coincident Brain or Spinal cord metastases are allowed if stable and do not require local therapy at the time of enrollment. Individuals with previously treated stable Brain metastases are eligible to participate.
Demonstrate adequate organ function as defined in protocol. All screening labs should be performed with 14 days of treatment initiation.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

Study Summary

This trial tests a new cancer treatment, DCV, on breast cancer patients with brain involvement, to find the safest dose.

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.Check my eligibility
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.See study design
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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My brain or spinal cord cancer is stable and doesn't need immediate treatment.
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My organ functions are within normal ranges as required.
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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 cancer has spread to my brain, but I might continue my current treatment based on my doctor's advice.
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I am taking no more than 8 mg of dexamethasone daily for symptom control.
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My breast cancer is confirmed as triple-negative or HER2 positive.
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I have a disease that affects my whole body.
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I can take care of myself but can't do heavy physical work.
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I had brain radiation or surgery more than 4 weeks ago and will have a brain scan before the DC vaccine.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose of Intrathecal Dendritic Cell Vaccine
Secondary outcome measures
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

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
540 Previous Clinical Trials
135,417 Total Patients Enrolled
41 Trials studying Breast Cancer
5,780 Patients Enrolled for Breast Cancer
United States Department of DefenseFED
858 Previous Clinical Trials
225,603 Total Patients Enrolled
37 Trials studying Breast Cancer
3,466 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

Frequently Asked Questions

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

What is the current cohort size of this clinical investigation?

"Affirmative. Clinicaltrials.gov provides information that this medical trial, first posted on March 28th 2023, is actively seeking participants from one location and requires 18 patients in total."

Answered by AI

Are there any vacancies left for participants in this trial?

"Affirmative. Clinicaltrials.gov records the commencement of this trial on March 28th, 2023 and its most recent update was performed two days later. The study is endeavoring to enroll 18 individuals from one specific medical centre."

Answered by AI

Has the FDA granted authorization for a stepped-up dosage of Dendritic Cell Vaccine?

"The risk of Dendritic Cell (DC) Vaccine dose escalation is estimated to be a 1 on our team's scale, as this is an early phase trial that has provided limited evidence regarding efficacy and safety."

Answered by AI
~12 spots leftby Mar 2026