NCT00673829

Brief Summary

The purpose of this study is to collect data on the safety and effectiveness of 2nd generation designer T cells in patients with breast cancer. Designer T cells are prepared by collecting white blood cells from the participant, and then modifying these cells in the laboratory so that they recognize the tumor antigen (CEA). These modified cells are then given back to the participant so that they can attack and kill tumor cells.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
26

participants targeted

Target at P25-P50 for phase_1 breast-cancer

Timeline
Completed

Started May 2008

Longer than P75 for phase_1 breast-cancer

Geographic Reach
1 country

2 active sites

Status
suspended

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

Study Start

First participant enrolled

May 1, 2008

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2008

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

June 17, 2016

Status Verified

June 1, 2016

Enrollment Period

9.6 years

First QC Date

May 5, 2008

Last Update Submit

June 16, 2016

Conditions

Breast Cancer

Keywords

Breast CancerT cellsGene Transfer

Outcome Measures

Primary Outcomes (2)

  • Phase Ia:Determine the safety of using modified T-cells by documenting the type and severity of any side effects and establishing the maximum tolerated dose (MTD).

    1 Month

  • Phase Ib: Determine optimal biologic dose (OBD) in terms of value of added interleukin 2.

    1 Month

Secondary Outcomes (3)

  • Tumor Response

    1 Month

  • Pharmacokinetic

    1 month

  • Pharmacodynamic

    1 Month

Study Arms (2)

Phase Ia

EXPERIMENTAL
Biological: Gene Modified T Cells

Phase Ib: Control

EXPERIMENTAL
Biological: Gene Modified T Cells and Interleukin 2

Interventions

Gene Modified T CellsBIOLOGICAL

Gene Modified T Cells Phase Ia: One time infusion Modified TCells given through a vein in the arm or a catheter over a 30-60 minute period

Also known as: Designer T-Cells, CEA
Phase Ia
Gene Modified T Cells and Interleukin 2BIOLOGICAL

One time infusion Modified T Cells without or with (randomized) continuous infusion outpatient interleukin 2 (IL2) for two weeks

Also known as: Designer T-Cells, CEA
Phase Ib: Control

Eligibility Criteria

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

You may qualify if:

  • Must have cancer of the breast
  • Must have metastatic or unresectable locally advanced disease
  • Tumor must express CEA by tumor staining or by elevated serum CEA (\>10 ng/ml)
  • Must have measurable disease radiologically or by physical exam
  • Must have failed potentially curative standard therapy
  • Must be 18 years of age or older
  • Good performance status (PS 0-1)

You may not qualify if:

  • Requiring systemic steroids
  • Serious medical conditions
  • Concurrent malignancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tufts University Medical Center

Boston, Massachusetts, 02115, United States

Location

Roger Williams Medical Center

Providence, Rhode Island, 02908, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Interleukin-2

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsLymphokinesProteinsBiological Factors

Study Officials

  • Richard P Junghans, PhD, MD

    Roger Williams Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2008

First Posted

May 7, 2008

Study Start

May 1, 2008

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

June 17, 2016

Record last verified: 2016-06

Locations

US(2)