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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.

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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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.

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

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%

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

544 Previous Clinical Trials

135,513 Total Patients Enrolled

41 Trials studying Breast Cancer

5,780 Patients Enrolled for Breast Cancer

United States Department of DefenseFED

866 Previous Clinical Trials

327,487 Total Patients Enrolled

38 Trials studying Breast Cancer

103,466 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

Recent research and studies

clinicaltrials.govStudy

A First in Human Dose Escalation of Dendritic Cell Vaccine (DCV)

2023. "A First in Human Dose Escalation of Dendritic Cell Vaccine (DCV)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05809752.