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Cancer Stem Cells Vaccine Therapy in Treating Hepatocellular Cancer Patients

Primary Purpose

Neoplasms, Liver

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

cancer stem cell vaccine

About this trial

This is an interventional treatment trial for Neoplasms, Liver

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Any patients with a diagnosis of HCC based on histology or the current accepted radiological measures.
Age > 18 years.
Patient has an MRI or CT result (positive for HCC) up to 3 months prior to recruitment.
AFP >30.
Patient who is not eligible for or failed any HCC treatment.
Karnofsky performance status >70%.
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 .
No history of autoimmune diseases.
Ability to understand the study protocol and a willingness to sign a written informed consent document.

Exclusion Criteria:

Patients receiving anticoagulation therapy.
Patients who have received prior gemcitabine or radiation therapy to the liver bed.
Patients receiving any other investigational agents.
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.
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.
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

Sites / Locations

Biological treatment center in Fuda cancer hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

non-cancer stem cell vaccine

giving low dose vaccine

giving middle dose vaccine

giving high dose vaccine

Arm Description

The using dosage,frequency and duration of cancer stem cell vaccine are still undetermined.

Outcomes

Primary Outcome Measures

The number of participants with adverse events

Secondary Outcome Measures

The secondary objectives are to evaluate vaccine immune responses to the immunizations by the data of body measurements

Full Information

NCT ID

NCT02089919

First Posted

March 16, 2014

Last Updated

June 1, 2015

Sponsor

Fuda Cancer Hospital, Guangzhou

Collaborators

University of Michigan

1. Study Identification

Unique Protocol Identification Number

NCT02089919

Brief Title

Cancer Stem Cells Vaccine Therapy in Treating Hepatocellular Cancer Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Completed

Study Start Date

February 2014 (undefined)

Primary Completion Date

February 2015 (Actual)

Study Completion Date

February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fuda Cancer Hospital, Guangzhou

Collaborators

University of Michigan

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neoplasms, Liver

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

non-cancer stem cell vaccine

Arm Type

Placebo Comparator

Arm Description

The using dosage,frequency and duration of cancer stem cell vaccine are still undetermined.

Arm Title

giving low dose vaccine

Arm Type

Experimental

Arm Description

The using dosage,frequency and duration of cancer stem cell vaccine are still undetermined.

Arm Title

giving middle dose vaccine

Arm Type

Experimental

Arm Description

The using dosage,frequency and duration of cancer stem cell vaccine are still undetermined.

Arm Title

giving high dose vaccine

Arm Type

Experimental

Arm Description

The using dosage,frequency and duration of cancer stem cell vaccine are still undetermined.

Intervention Type

Biological

Intervention Name(s)

cancer stem cell vaccine

Primary Outcome Measure Information:

Title

The number of participants with adverse events

Time Frame

up to 3 months

Secondary Outcome Measure Information:

Title

The secondary objectives are to evaluate vaccine immune responses to the immunizations by the data of body measurements

Time Frame

1 month

Other Pre-specified Outcome Measures:

Title

The dose of CSC vaccine

Time Frame

up to 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Any patients with a diagnosis of HCC based on histology or the current accepted radiological measures. Age > 18 years. Patient has an MRI or CT result (positive for HCC) up to 3 months prior to recruitment. AFP >30. Patient who is not eligible for or failed any HCC treatment. Karnofsky performance status >70%. 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 . No history of autoimmune diseases. Ability to understand the study protocol and a willingness to sign a written informed consent document. Exclusion Criteria: Patients receiving anticoagulation therapy. Patients who have received prior gemcitabine or radiation therapy to the liver bed. Patients receiving any other investigational agents. 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. 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. 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

Facility Information:

Facility Name

Biological treatment center in Fuda cancer hospital

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510000

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

22473314

Citation

Ning N, Pan Q, Zheng F, Teitz-Tennenbaum S, Egenti M, Yet J, Li M, Ginestier C, Wicha MS, Moyer JS, Prince ME, Xu Y, Zhang XL, Huang S, Chang AE, Li Q. Cancer stem cell vaccination confers significant antitumor immunity. Cancer Res. 2012 Apr 1;72(7):1853-64. doi: 10.1158/0008-5472.CAN-11-1400.

Results Reference

result

Links:

URL

http://www.fudahospital.com/

Description

Related Info

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Cancer Stem Cells Vaccine Therapy in Treating Hepatocellular Cancer Patients

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