Safety Study of Cancer Stem Cell Vaccinie to Treat Breast Cancer (CSC)

June 1, 2015 updated by: Fuda Cancer Hospital, Guangzhou

Study of Cancer Stem Cell Vcccinie That as a Specific Antigen in Metastatic Adenocarcinoma of the Breast

Most studies of cancer stem cells (CSC) involve the inoculation of cells from human tumors into immunosuppressed mice, preventing an assessment on the immunologic interactions and effects of CSCs. In this study, the investigators examined the vaccination effects produced by CSC-enriched populations from histologically distinctmurine tumors after their inoculation into different syngeneic immunocompetent hosts. Enriched CSCs were immunogenic and more effective as an antigen source than unselected tumor cells in inducing protective antitumor immunity.Immune sera from CSC-vaccinated hosts contained high levels of IgG which bound to CSCs, resulting in CSC lysis in the presence of complement.CTLs generated from peripheral blood mononuclear cells or splenocytes harvested from CSC-vaccinated hosts were capable of killing CSCs in vitro. Mechanistic investigations established that CSC-primed antibodies and T cells were capable of selective targeting CSCs and conferring antitumor immunity.

Study Overview

Status

Completed

Conditions

Detailed Description

To assess the feasibility of generating CSC-loaded DC vaccines for clinical use, the investigators will harvest peripheral blood and tumor specimen from patients with Breast Cancer. The investigators will purify T, B cells and generate DCs from the PBMCs of the Breast Cancer patient.On the other hand, investigators will isolate ALDHhigh and ALDHlow tumor cells from the tumor specimen of the Breast Cancer patient using a similar protocol as investigators reported .

Aim 1: To demonstrate, in vitro, the relative cellular anti-Breast Cancer CSC immunity induced by Breast Cancer CSC-DC primed cytotoxic T cells.

Aim 2: To determine, in vitro, specific binding and lysis of Breast Cancer CSCs by antibodies produced by purified B cells from PBMCs stimulated with Breast Cancer CSC-DC.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Biological treatment center in Fuda cancer hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The patients who unresectable after Cryotherapy

Description

Inclusion Criteria:

  • The patient is ≥ 30 years of age at the time the informed consent to screening has been obtained;
  • The patient has one of the following histologically confirmed breast cancer subtypes:

Estrogen receptor and/or progesterone positive tumor; Human epidermal growth factor receptor 2 (HER2)-overexpressing breast cancer; HER2-negative breast cancer.

-- The patient shows normal organ function according to the following parameters(as measured within six weeks prior to treatment allocation):

  • Hemoglobin: Within normal range according to institutional standards;
  • Absolute leukocyte count: Within normal range according to institutional standards;
  • Absolute lymphocyte count: Within normal range according to institutional standards;
  • Platelet count: Within normal range according to institutional standards;
  • Alanine aminotransferase: ≤ 2.5 x Upper Limit of Normal (ULN);
  • Aspartate aminotransferase: ≤ 2.5 x ULN;
  • Total bilirubin: ≤ 1.5 x ULN. In the case of known Gilbert's syndrome ≤ 2 x ULN;
  • Serum creatinine: 1.5 x ULN;
  • Calculated creatinine clearance: > 50 mL/min .

Exclusion Criteria:

  • The patient has inflammatory breast cancer, which is defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion.
  • Diagnosis established by incisional biopsy.
  • Prior and concomitant neoadjuvant anti-breast-cancer treatments such as chemotherapy, immunotherapy / biological response modifiers, endocrine therapy, and radiotherapy, unless authorized specifically by the protocol.
  • level 3 hypertension;
  • severe coronary disease;
  • myelosuppression;
  • respiratory disease;
  • brain metastasis;
  • chronic infections

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
non-vaccine
giving low vaccine
giving middle vaccine
giving high vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary study purpose to determine the safety of immunization with cancer stem cells vaccinie by the number of participants with adverse events
Time Frame: up to 3 months
up to 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The secondary objectives are to evaluate vaccinie immune responses to the immunizations by the data of body measurements
Time Frame: 1 month
1 month

Other Outcome Measures

Outcome Measure
Time Frame
The dose of CSC vaccine
Time Frame: up to 3 months
up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fuda Cancer Hospital, Guangzhou

Collaborators

University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

February 11, 2014

First Submitted That Met QC Criteria

February 13, 2014

First Posted (Estimate)

February 17, 2014

Study Record Updates

Last Update Posted (Estimate)

June 3, 2015

Last Update Submitted That Met QC Criteria

June 1, 2015

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLB-001
  • 201401 (Other Grant/Funding Number: The research fund of Fuda cancer hospital in Guangzhou)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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