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AzTrials

Breast CancerPhase 1NCT02479230

Type I-Polarized Autologous Dendritic Cell Vaccine With Tumor Blood Vessel Antigen-Derived Peptides in Metastatic Breast Cancer Patients

A Phase 1 study testing tumor blood vessel antigen peptide-pulsed alpha-type-1 polarized dendritic cell vaccine and gemcitabine hydrochloride in people with Breast Cancer and Metastatic Breast Cancer, run by Joseph Baar, MD, PhD at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This pilot clinical trial studies the safety of a dendritic cell vaccine when given with gemcitabine hydrochloride in treating patients with breast cancer that has spread beyond the breast and local lymph nodes to other organs in the body. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer, Metastatic Breast Cancer
What is being tested?
tumor blood vessel antigen peptide-pulsed alpha-type-1 polarized dendritic cell vaccine and gemcitabine hydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
2 sitesUnited States
Study dates
17 Jul 2015to 1 Jul 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must be human leukocyte antigen (HLA)-A2+
  • Histologically confirmed breast cancer
  • Patients must have evidence of metastatic disease measurable by Response Evaluation Criteria in Solid Tumors (RECIST) criteria or non-measurable lytic or mixed (lytic + blastic) bone lesions in the absence of measurable disease; Note: Measurable lesions include lytic or mixed (lytic + blastic) bone lesions, with an identifiable 10 mm soft tissue component that meets the measurability criteria per RECIST
  • There is no limit to the number of prior systemic treatment regimens
  • Patients must have a life expectancy of > 3 months
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
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  • Prior GEM therapy is acceptable as long as the last dose was ≥ 3 months from registration on this study
  • Patients may have treated and stable brain metastases; they must be off steroids and must have had stable brain metastases for at least 6 months
  • White blood cell (WBC) > 3.0 x 10^9/L
  • Platelets > 100 x 10^9/L
  • Hemoglobin (Hgb) ≥ 10.0 gm/dl
  • Creatinine < 1.5 mg/dl
  • Bilirubin (total) < 2.0 ml/dl
  • Aspartate aminotransferase (AST) < 5.0 x normal institutional limits
  • Alkaline phosphatase < 2.5 upper limit of normal (ULN) (< 10 x ULN in presence of bone metastases)
  • Serum calcium ≤ 12 mg/dl
  • International normalized ratio (INR) < 1.5, except for subjects receiving warfarin therapy; for subjects who are receiving warfarin for prophylaxis or treatment of thrombosis, INR values should be carefully monitored while patients are on study
  • All patients must be informed of the investigational nature of this study and must provide written informed consent in accordance with institutional and federal guidelines; a copy of the informed consent document signed by the patient must be given to the patient
  • Patients must have a negative pregnancy test by urinalysis
  • Use of an effective means of contraception (men and women) is mandated in subjects of child-bearing potential; female subjects will be advised that they not become pregnant for at least one month after completing participation in the study; avoiding sexual activity is the only certain method to prevent pregnancy; however, if subjects choose to be sexually active, they should use an appropriate "double barrier" method of birth control (such as female use of a diaphragm, intrauterine device [IUD], or contraceptive sponge, in addition to male use of a condom) or the use of prescribed "birth control" pills, injections, or implants

Who cannot join

  • HLA-A2 negative patients
  • Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness
  • Presence of bleeding diathesis
  • Current treatment on another clinical trial
  • Patients with organ allografts
  • Pregnancy or breast-feeding; female patients must be surgically sterile or be post-menopausal, or must agree to use effective contraception during the period of therapy; all female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment; male patients must be surgically sterile or must agree to use effective contraception during the period of therapy; the definition of effective contraception will be based on the judgment of the principal investigator or a designated associate
  • Other severe acute or chronic medical or psychiatric conditions, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15232

Other trials in United States

About this study

Official title: Pilot Trial of Type I-Polarized Autologous Dendritic Cell Vaccine Incorporating Tumor Blood Vessel Antigen-Derived Peptides in Patients With Metastatic Breast Cancer

This pilot clinical trial studies the safety of a dendritic cell vaccine when given with gemcitabine hydrochloride in treating patients with breast cancer that has spread beyond the breast and local lymph nodes to other organs in the body. The vaccine is made up of natural cells found in the blood, called dendritic cells, and peptides, or small fragments of protein which are loaded onto the dendritic cells. This combination may help activate the immune system against stromal cells, which are cells that help cancer cells survive in the body. Gemcitabine hydrochloride is a chemotherapy drug that is given before the vaccine to help shrink the tumor and control cells that may interfere with the activity of the vaccine. Interfering with the stromal cells that help support the growth of cancer cells may lead to the death of the cancer cells.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Assess the safety of gemcitabine hydrochloride (GEM) + alpha-type-1 dendritic cell (αDC1)-tumor blood vessel antigen (TBVA) vaccination (tumor blood vessel antigen peptide-pulsed alpha-type-1 polarized dendritic cell vaccine).

II. Assess the clinical response of metastatic breast cancer (MBC) to GEM + αDC1-TBVA vaccination.

III. Determine the clinical efficacy of GEM + αDC1-TBVA vaccination in generating T-helper 1 cell (Tc1) immunity.

IV. Correlate changes in myeloid-derived suppressor cells (MDSC) and regulatory T cells (Tregs) with the generation of anti-TBVA T-cell immunity.

OUTLINE:

Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 3 courses. Beginning 3, 7, or 10 days later, patients receive tumor blood vessel antigen peptide-pulsed alpha-type-1 polarized dendritic cell vaccine intradermally (ID) followed by a second vaccination 7 days later. Courses may repeat after at least 4 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days.

Being tested
tumor blood vessel antigen peptide-pulsed alpha-type-1 polarized dendritic cell vaccine, gemcitabine hydrochloride
Keywords
vaccine, breast cancer, metastatic
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tumor blood vessel antigen peptide-pulsed alpha-type-1 polarized dendritic cell vaccineBiological

    Also called αDC1-TBVA vaccine

    Given ID

  • gemcitabine hydrochlorideDrug

    Also called 1-(2-oxo-4-amino-1,2-dihydropyrimidin-1-yl)-2-deoxy-2,, 2-difluororibose hydrochloride,, 103882-84-4, 2'-deoxy-2',, 2'-difluorocytidine hydrochloride,

    Given IV

Study groups in NCT02479230
Study groupRoleWhat they receive
vaccine: gemcitabine hydrochlorideExperimentalPatients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 3 courses. Beginning 3, 7, or 10 days later, patients receive tumor blood vessel antigen peptide-pulsed alpha-type-1 polarized dendritic cell vaccine ID followed by a second vaccination 7 days later. Courses may repeat after at least 4 weeks in the absence of disease progression or unacceptable toxicity.
Receives: Biological: tumor blood vessel antigen peptide-pulsed alpha-type-1 polarized dendritic cell vaccine; Drug: gemcitabine hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of toxicities

    Incidence of toxicities, evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

    Measured: 30 days after completion of study

Secondary outcomes (2)

  1. mean change in Type-1 immune function

    Average immune response as measured by the interferon gamma [IFN-γ] cluster of differentiation (CD)8+ T cell (Tc1) response to the vaccine-associated TBVA peptides.

    Measured: 24 weeks after treatment

  2. Number of patients with clinical response

    Clinical response as assessed using RECIST criteria.

    Measured: Up to 30 days after study is complete

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2015 (estimated)
  2. Study start17 Jul 2015
  3. Primary completion30 Oct 2019
  4. Study completion1 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02479230
Sponsor's protocol ID
CASE3113
Other IDs
NCI-2014-00265
Status last verified
Nov 2022
First submitted
19 Jun 2015
Last updated
22 Nov 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing tumor blood vessel antigen peptide-pulsed alpha-type-1 polarized dendritic cell vaccine and gemcitabine hydrochloride in people with Breast Cancer and Metastatic Breast Cancer, run by Joseph Baar, MD, PhD at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of toxicities (time frame: 30 days after completion of study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02479230.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2022.

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