The Immunotherapy of Nasopharyngeal Cancer Using Cancer Stem Cells Vaccine
Study of Cancer Stem Cell Vaccine That as a Specific Antigen in Metastatic of the Nasopharynx
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 Mar 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
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 14, 2014
CompletedFirst Posted
Study publicly available on registry
April 16, 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
April 1, 2014
1.2 years
April 14, 2014
September 10, 2019
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 are greater than 18 years of age, with advanced local disease (T3-T4N0-1M0), nodal disease (T1-T2N2-3M0) and loco-regional disease (T3-T4N2-3M0) at onset but presently controlled by standard therapy (combination of chemotherapy and radiotherapy) or with completely resected metastatic disease.
- Pathologic confirmation of nasopharyngeal carcinoma by the NCI Laboratory of Pathology (NPC).
- serum creatinine of 2.0 mg/dl or less. 4.Total bilirubin 1.6 mg/dl or less, except for patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl.
- WBC 3000/mm(3) or greater. 6.platelet count 90,000 mm(3) or greater. 7.serum AST/ALT less than three times normal. 8.ECOG performance status of 0 or 1. 9.Patients of both genders must be willing to practice effective birth control during this trial because the potential for teratogenic effects are unknown.
- Patients may have had prior adjuvant treatment or may have had treatment for metastatic disease and are now with no evidence of disease, including chemotherapy or biotherapy, as long as 1 month has elapsed since prior systemic therapy.
You may not qualify if:
- \. Patients who test positive for Hepatitis B virus, Hepatitis C virus or HIV. 2. level 3 hypertension; 3. severe coronary disease; 4. myelosuppression; 5. respiratory disease; 6. brain metastasis; 7. 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
April 14, 2014
First Posted
April 16, 2014
Study Start
March 1, 2014
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
September 12, 2019
Record last verified: 2014-04