Cancer Stem Cells Vaccine Therapy in Treating Hepatocellular Cancer Patients

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 Liver

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 distinct murine 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 anti-tumor immunity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 hepatocellular cancer. The investigators will purify T, B cells and generate DCs from the PBMCs of the hepatocellular cancer patient.On the other hand, investigators will isolate ALDHhigh and ALDHlow tumor cells from the tumor specimen of the hepatocellular cancer patient using a similar protocol as investigators reported .

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

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

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 1

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Any patients with a diagnosis of HCC based on histology or the current accepted radiological measures.
  2. Age > 18 years.
  3. Patient has an MRI or CT result (positive for HCC) up to 3 months prior to recruitment.
  4. AFP >30.
  5. Patient who is not eligible for or failed any HCC treatment.
  6. Karnofsky performance status >70%.

  7. 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 .

  8. No history of autoimmune diseases.
  9. Ability to understand the study protocol and a willingness to sign a written informed consent document.

Exclusion Criteria:

  1. Patients receiving anticoagulation therapy.
  2. Patients who have received prior gemcitabine or radiation therapy to the liver bed.
  3. Patients receiving any other investigational agents.
  4. Patients with known brain metastases will be excluded because of their poor prognosis and because they often develop progressive neurological dysfunction that would confound the evaluation of neurological and other adverse effects.
  5. Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements.
  6. Patients who test positive for Hepatitis B virus, Hepatitis C virus or HIV. 7. level 3 hypertension; 8. severe coronary disease; 9. myelosuppression; 10. respiratory disease; 11. brain metastasis; 12. 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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: non-cancer stem cell vaccine
The using dosage,frequency and duration of cancer stem cell vaccine are still undetermined.
Biological: cancer stem cell vaccine
Experimental: giving low dose vaccine
The using dosage,frequency and duration of cancer stem cell vaccine are still undetermined.
Biological: cancer stem cell vaccine
Experimental: giving middle dose vaccine
The using dosage,frequency and duration of cancer stem cell vaccine are still undetermined.
Biological: cancer stem cell vaccine
Experimental: giving high dose vaccine
The using dosage,frequency and duration of cancer stem cell vaccine are still undetermined.
Biological: cancer stem cell vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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 vaccine 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

February 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

March 16, 2014

First Submitted That Met QC Criteria

March 17, 2014

First Posted (Estimate)

March 18, 2014

Study Record Updates

Last Update Posted (Estimate)

June 3, 2015

Last Update Submitted That Met QC Criteria

June 1, 2015

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLH-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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