Safety Study of Cancer Stem Cell Vaccine to Treat Pancreatic Cancer
Study of Cancer Stem Cell Vaccine That as a Specific Antigen in Metastatic Adenocarcinoma of the Pancreas
2 other identifiers
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 antitumor 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 Feb 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 25, 2014
CompletedFirst Posted
Study publicly available on registry
February 28, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedJune 3, 2015
February 1, 2014
1.1 years
February 25, 2014
June 1, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
The primary study purpose to determine the safety of immunization with cancer stem cells vaccine by 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 COMPARATORThe using dosage,frequency and duration of cancer stem cell vaccine are still undetermined.
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:
- \. Patients must have histologically or cytologically confirmed adenocarcinoma of the pancreas. The site of the primary lesion should be confirmed endoscopically, radiologically, or surgically to be in the pancreas.
- \. Patients must be deemed unresectable due to involvement of critical vasculature, adjacent organ invasion, presence of metastasis, or other medical condition making surgical resection unfavorable.
- \. Patients must have a primary or metastatic lesion measurable in at least one dimension by RECIST criteria within 4 weeks prior to entry of study .
- \. More than 4 weeks must have elapsed from the time of major surgery or completion of the last dose of chemotherapy, radiation therapy, investigational therapy and patients must adequately recover from these effects.
- \. Life expectancy of \>3 months. 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. Age \>18 years. 9. No history of autoimmune diseases. 10. Ability to understand the study protocol and a willingness to sign a written informed consent document.
You may not qualify if:
- \- 1. Patients receiving anticoagulation therapy. 2. Patients who have received prior gemcitabine or radiation therapy to the pancreatic 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.
- \. 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
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
February 25, 2014
First Posted
February 28, 2014
Study Start
February 1, 2014
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
June 3, 2015
Record last verified: 2014-02