NCT02479230

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1 breast-cancer

Timeline
Completed

Started Jul 2015

Longer than P75 for phase_1 breast-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed
23 days until next milestone

Study Start

First participant enrolled

July 17, 2015

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

November 22, 2022

Status Verified

November 1, 2022

Enrollment Period

4.3 years

First QC Date

June 19, 2015

Last Update Submit

November 21, 2022

Conditions

Breast CancerMetastatic Breast Cancer

Keywords

vaccinebreast cancermetastatic

Outcome Measures

Primary Outcomes (1)

  • Number of toxicities

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

    30 days after completion of study

Secondary Outcomes (2)

  • mean change in Type-1 immune function

    24 weeks after treatment

  • Number of patients with clinical response

    Up to 30 days after study is complete

Other Outcomes (2)

  • Change in Treg levels

    24 weeks after treatment

  • Changes in MDSC levels

    24 weeks after treatment

Study Arms (1)

vaccine: gemcitabine hydrochloride

EXPERIMENTAL

Patients 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.

Biological: tumor blood vessel antigen peptide-pulsed alpha-type-1 polarized dendritic cell vaccineDrug: gemcitabine hydrochloride

Interventions

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

Given ID

Also known as: αDC1-TBVA vaccine
vaccine: gemcitabine hydrochloride
gemcitabine hydrochlorideDRUG

Given IV

Also known as: 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,, 2'deoxy-2',, 47762,, 613327,, dFdC,, dFdCyd,, difluorodeoxycytidine hydrochloride,, gemcitabine,, Gemzar,, LY-188011
vaccine: gemcitabine hydrochloride

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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)
  • +5 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Cleveland, Ohio, 44106, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsNeoplasm Metastasis

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Joseph Baar, MD, PhD

    Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor, Medicine, CWRU School of Medicine

Study Record Dates

First Submitted

June 19, 2015

First Posted

June 24, 2015

Study Start

July 17, 2015

Primary Completion

October 30, 2019

Study Completion

July 1, 2022

Last Updated

November 22, 2022

Record last verified: 2022-11

Locations

US(2)