Back to resultsAutologous Dendritic Cell Therapy for Hormone-Refractory Metastatic Prostate Cancer
Primary Purpose
Prostatic Cancer
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Autologous dendritic cell
Sponsored by
About this trial
This is an interventional treatment trial for Prostatic Cancer focused on measuring Prostate cancer, PSA, Hormone refractory prostatic cancer
Eligibility Criteria
Inclusion Criteria:
- 1) Histological confirmed prostatic carcinoma patient
- 2) Hormone non-respondence ex1) Although treatment PSA ≥ 5ng/ml ex2) PSA level were measured two times ex3) Prior one year radiology were processed
- 3) Just 18 years over
- 4) Has a score ≤1 on the ECOG Performance Scale
- 5) Expected survival life time ≥ 6month
- 6) Adequate bone marrow function hemoglobin ≥ 10.0g/dL , leukocyte count ≥ 4,000/mm3 thrombocyte ≥ 100,000/mm3
- 7) Adequate blood coagulation function PT(INR) < 1.5, aPTT< 1.5 x control
- 8) Adequate kidney function Normal blood upper level Creatinine ≤ 1.5 times
- 9) Adequate liver function Normal blood upper level AST/ALT ≤ 1.5 times
- 10) Autoimmune antibody system don't have disorder ex) anti-nuclear antibody, anti-thyroglobulin antibody negativity
- 11) Person who didn't treat prior 6 weeks operation, radiotherapy treatment,immunotherapy or chemotherapy
- 12) Patient who voluntarily participated clinical trial and confirmed a written consent
Exclusion Criteria:
- 1) Having other malignancy or previous history of malignancy
- 2) Brain metastases patient
- 3) Having autoimmune disease or its history
- 4) Pyrexia, rigor, leukocytosis infectious disease
- 5) HBsAg, anti-HCV, HIV positive patient
- 6) Myocardial infarction, cardiac insufficiency, other severe heart disease and non-controlled hypertension
- 7) Severe and active medical disease
- 8) Mental history disease or epilepsy
- 9) Patients participated other clinical trial within 4 weeks
- 10) Patients impossible to participate this trial by investigator's decision
- 11) Patients who received immunosuppressant such as steroid, cyclosporin A, azathioprine within 6 weeks
Sites / Locations
- National Cancer Center
- Samsung Medical Center
Outcomes
Primary Outcome Measures
PSA increment and absolute PSA response
PSA response evaluation at 12 weeks and follow up response evaluation at 21 weeks
Secondary Outcome Measures
Time to Progression
Overall Survival
Immune Response(DTH response, Interferon-gamma Elispot assay, proliferation assay, ELISA)
Clinical response
Clinical course of participants as measured by bone scans and CT
Full Information
NCT ID
NCT01171729
First Posted
July 27, 2010
Last Updated
August 10, 2010
Sponsor
Samsung Medical Center
Collaborators
National Cancer Center, Korea
1. Study Identification
Unique Protocol Identification Number
NCT01171729
Brief Title
Autologous Dendritic Cell Therapy for Hormone-Refractory Metastatic Prostate Cancer
Official Title
A Phase I/IIa Study of Autologous Cell-based Vaccine Therapy With CreaVax-PC in Hormone-Refractory Metastatic Prostate Cancer Patients With PSA Relapse to Evaluate the Safety and Efficacy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Samsung Medical Center
Collaborators
National Cancer Center, Korea
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is an open label, Phase I/IIa trial of immunotherapy with CreaVax-PC as treatment in men with hormone-Refractory Metastatic Prostate Cancer.
Detailed Description
CreaVax-PC consisted of antigen (PSA, PAP and KLH) primed dendritic cell is an investigational product designed to activate a man's immune response, so they can detect prostate cancer cells and initiate an immune response against prostate cancer antigens.
If patients decide to participate and are eligible, they will be enrolled in the study and will receive active product (CreaVax-PC). In detail, patients will receive CreaVax-PC injection at intervals of 3 weeks, maximum 6 times during 21 weeks. PSA increase rate is a primary evaluation variables and tumor suppression effect is secondary evaluation variables. We also evaluate time to progression, overall survival and immune response.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Cancer
Keywords
Prostate cancer, PSA, Hormone refractory prostatic cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Autologous dendritic cell
Other Intervention Name(s)
CreaVax-PC
Intervention Description
Autologous dendritic cells pulsed with prostate cancer antigen and KLH
Primary Outcome Measure Information:
Title
PSA increment and absolute PSA response
Description
PSA response evaluation at 12 weeks and follow up response evaluation at 21 weeks
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Time to Progression
Time Frame
DC Injection to time to progression or death
Title
Overall Survival
Time Frame
Patients will be followed until death
Title
Immune Response(DTH response, Interferon-gamma Elispot assay, proliferation assay, ELISA)
Time Frame
weeks 0, 12, 21
Title
Clinical response
Description
Clinical course of participants as measured by bone scans and CT
Time Frame
week 0, 12, 21
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1) Histological confirmed prostatic carcinoma patient
2) Hormone non-respondence ex1) Although treatment PSA ≥ 5ng/ml ex2) PSA level were measured two times ex3) Prior one year radiology were processed
3) Just 18 years over
4) Has a score ≤1 on the ECOG Performance Scale
5) Expected survival life time ≥ 6month
6) Adequate bone marrow function hemoglobin ≥ 10.0g/dL , leukocyte count ≥ 4,000/mm3 thrombocyte ≥ 100,000/mm3
7) Adequate blood coagulation function PT(INR) < 1.5, aPTT< 1.5 x control
8) Adequate kidney function Normal blood upper level Creatinine ≤ 1.5 times
9) Adequate liver function Normal blood upper level AST/ALT ≤ 1.5 times
10) Autoimmune antibody system don't have disorder ex) anti-nuclear antibody, anti-thyroglobulin antibody negativity
11) Person who didn't treat prior 6 weeks operation, radiotherapy treatment,immunotherapy or chemotherapy
12) Patient who voluntarily participated clinical trial and confirmed a written consent
Exclusion Criteria:
1) Having other malignancy or previous history of malignancy
2) Brain metastases patient
3) Having autoimmune disease or its history
4) Pyrexia, rigor, leukocytosis infectious disease
5) HBsAg, anti-HCV, HIV positive patient
6) Myocardial infarction, cardiac insufficiency, other severe heart disease and non-controlled hypertension
7) Severe and active medical disease
8) Mental history disease or epilepsy
9) Patients participated other clinical trial within 4 weeks
10) Patients impossible to participate this trial by investigator's decision
11) Patients who received immunosuppressant such as steroid, cyclosporin A, azathioprine within 6 weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J C W, M.D,Ph.D
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center
City
Gyeonggi-do
State/Province
323 Ilsan-ro Ilsandong-gu Goyang-si
ZIP/Postal Code
410-769
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Gangnam-Gu, Ilwon-Dong
ZIP/Postal Code
135-710
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Autologous Dendritic Cell Therapy for Hormone-Refractory Metastatic Prostate Cancer
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