A Phase I/II Study of Active Immunotherapy With Cancer Stem Cells Vaccine for Colorectal Cancer
CSC
Study of Cancer Stem Cell Vaccine That as a Specific Antigen in Metastatic Adenocarcinoma of the Colorectal
1 other identifier
interventional
40
1 country
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jun 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 25, 2014
CompletedFirst Posted
Study publicly available on registry
June 27, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedSeptember 12, 2019
June 1, 2014
11 months
June 25, 2014
September 10, 2019
Conditions
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 COMPARATORThis is no cancer stem cells vaccine in this group
giving low dose vaccine
EXPERIMENTALThe using dosage,frequency and duration of cancer stem cell vaccine are still undetermined.
giving middle dose vaccine
EXPERIMENTALThe using dosage,frequency and duration of cancer stem cell vaccine are still undetermined.
giving high dose vaccine
EXPERIMENTALThe using dosage,frequency and duration of cancer stem cell vaccine are still undetermined.
Interventions
Eligibility Criteria
You may qualify if:
- Age:18 and over
- Performance status:Karnofsky 70-100%
- Life expectancy:Greater than 6 months
- Hematopoietic:Absolute neutrophil count at least 1000/mm 3,Hemoglobin at least 9 g/dL,Platelet count at least 100,000/mm\^3
- Hepatic:Bilirubin less than 2.0 mg/dL No chronic or acute hepatic disease Renal:Creatinine less than 2.5 mg/dL
- Cardiovascular:
- No chronic or acute cardiac disease (New York Heart Association class III or IV)
- Pulmonary:
- No chronic or acute pulmonary illness such as asthma or chronic obstructive pulmonary disease
You may not qualify if:
- Patients receiving anticoagulation therapy.
- Patients receiving any other investigational agents.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fuda Cancer Hospital, Guangzhoulead
- University of Michigancollaborator
Study Sites (1)
Biological treatment center in Fuda cancer hospital
Guangzhou, Guangdong, 510000, China
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: 22473314RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
June 25, 2014
First Posted
June 27, 2014
Study Start
June 1, 2014
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
September 12, 2019
Record last verified: 2014-06