Neoplasms, Pancreas Clinical Trial
Official title:
Study of Cancer Stem Cell Vaccine That as a Specific Antigen in Metastatic Adenocarcinoma of the Pancreas
| Verified date | February 2014 |
| Source | Fuda Cancer Hospital, Guangzhou |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | China: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | March 2015 |
| Est. primary completion date | March 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - 1. 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. 2. 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. 3. 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 . 4. 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. 5. 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. Exclusion Criteria: - 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. 5. 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. 6. 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | Biological treatment center in Fuda cancer hospital | Guangzhou | Guangdong |
| Lead Sponsor | Collaborator |
|---|---|
| Fuda Cancer Hospital, Guangzhou | University of Michigan |
China,
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
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | The dose of CSC vaccine | up to 3 months | Yes | |
| Primary | 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 | Yes | |
| Secondary | The secondary objectives are to evaluate vaccine immune responses to the immunizations by the data of body measurements | 1 month | Yes |