Cancer Stem Cells Vaccine Therapy in Treating Hepatocellular Cancer Patients

NCT02089919 | Completed Phase 1 DMC

• 2 other identifiers: CLH-001201401
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms, Liver

Outcome Measures

Primary Outcomes (1)

• The number of participants with adverse events

  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

  1 month

Other Outcomes (1)

• The dose of CSC vaccine

  up to 3 months

Study Arms (4)

non-cancer stem cell vaccine

PLACEBO COMPARATOR

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

Biological: cancer stem cell vaccine

giving low dose vaccine

EXPERIMENTAL

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

Biological: cancer stem cell vaccine

giving middle dose vaccine

EXPERIMENTAL

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

Biological: cancer stem cell vaccine

giving high dose vaccine

EXPERIMENTAL

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

Biological: cancer stem cell vaccine

Interventions

cancer stem cell vaccine BIOLOGICAL

giving high dose vaccine; giving low dose vaccine; giving middle dose vaccine; non-cancer stem cell vaccine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fuda Cancer Hospital, Guangzhou: lead
• University of Michigan: collaborator

Study Sites (1)

Biological treatment center in Fuda cancer hospital

Guangzhou, Guangdong, 510000, China

Location

Related Publications (1)

• 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.

  PMID: 22473314 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2014
• First Posted: March 18, 2014
• Study Start: February 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: June 3, 2015

Record last verified: 2014-03

Locations

CN (1)