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Completed

NCT Number: NCT02089919

Cancer Stem Cells Vaccine Therapy in Treating Hepatocellular Cancer Patients

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Biological treatment center in Fuda cancer hospital

Guangzhou, Guangdong, 510000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cancer stem cell vaccine

Biological

Primary outcomes

  1. The number of participants with adverse events

    Time frame: up to 3 months

Secondary outcomes

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

    Time frame: 1 month

Other outcomes

  1. The dose of CSC vaccine

    Time frame: up to 3 months

Sponsors and collaborators

Lead sponsor

Fuda Cancer Hospital, Guangzhou

Other

Collaborators

  • University of Michigan

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 18, 2014
Registry last updated
Jun 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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