A Phase I/II Study of Active Immunotherapy With Cancer Stem Cells Vaccine for Colorectal Cancer

Neoplasms,Colorectal Clinical Trial

— CSC  

Official title:

Study of Cancer Stem Cell Vaccine That as a Specific Antigen in Metastatic Adenocarcinoma of the Colorectal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02176746
• Other study ID #: CLC-001
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 2014
• Est. completion date: May 2015

Study information

• Verified date: June 2014
• Source: Fuda Cancer Hospital, Guangzhou
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age:18 and over

2. Performance status:Karnofsky 70-100%

3. Life expectancy:Greater than 6 months

4. Hematopoietic:Absolute neutrophil count at least 1000/mm 3,Hemoglobin at least 9 g/dL,Platelet count at least 100,000/mm^3

5. Hepatic:Bilirubin less than 2.0 mg/dL No chronic or acute hepatic disease Renal:Creatinine less than 2.5 mg/dL

6. Cardiovascular:

No chronic or acute cardiac disease (New York Heart Association class III or IV)

7. Pulmonary:

No chronic or acute pulmonary illness such as asthma or chronic obstructive pulmonary disease

Exclusion Criteria:

1. Patients receiving anticoagulation therapy.

2. Patients receiving any other investigational agents.

3. Patients who test positive for Hepatitis B virus, Hepatitis C virus or HIV. 4?level 3 hypertension; 5?severe coronary disease; 6? myelosuppression; 7? respiratory disease; 8? brain metastasis; 9? chronic infections

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Neoplasms,Colorectal

Intervention

Biological:
• cancer stem cell vaccine

Locations

Country	Name	City	State
China	Biological treatment center in Fuda cancer hospital	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Fuda Cancer Hospital, Guangzhou	University of Michigan

Country where clinical trial is conducted

China, 

References & 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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The dose of CSC vaccine		up to 3 months
Primary	The number of participants with adverse events		up to 3 months
Secondary	The secondary objectives are to evaluate vaccine immune responses to the immunizations by the data of body measurements		1 month

External Links

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