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Cancer Stem Cells Vaccine Therapy in Treating Hepatocellular Cancer Patients

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ClinicalTrials.gov Identifier: NCT02089919
Recruitment Status : Completed
First Posted : March 18, 2014
Last Update Posted : June 3, 2015
Sponsor:
Collaborator:
University of Michigan
Information provided by (Responsible Party):
Fuda Cancer Hospital, Guangzhou

Study Description
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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.

Condition or disease Intervention/treatment Phase
Neoplasms, Liver Biological: cancer stem cell vaccine Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Study of Cancer Stem Cell Vcccinie That as a Specific Antigen in Metastatic Adenocarcinoma of the Liver
Study Start Date : February 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. The number of participants with adverse events [ Time Frame: up to 3 months ]

Secondary Outcome Measures :
  1. The secondary objectives are to evaluate vaccine immune responses to the immunizations by the data of body measurements [ Time Frame: 1 month ]

Other Outcome Measures:
  1. The dose of CSC vaccine [ Time Frame: up to 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02089919


Locations
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China, Guangdong
Biological treatment center in Fuda cancer hospital
Guangzhou, Guangdong, China, 510000
Sponsors and Collaborators
Fuda Cancer Hospital, Guangzhou
University of Michigan
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Fuda Cancer Hospital, Guangzhou
ClinicalTrials.gov Identifier: NCT02089919    
Other Study ID Numbers: CLH-001
201401 ( Other Grant/Funding Number: The research fund of Fuda cancer hospital in Guangzhou )
First Posted: March 18, 2014    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: March 2014
Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Liver Diseases