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Autologous Dendritic Cell Therapy for Hormone-Refractory Metastatic Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01171729
Recruitment Status : Completed
First Posted : July 28, 2010
Last Update Posted : August 11, 2010
Sponsor:
Collaborator:
National Cancer Center, Korea
Information provided by:
Samsung Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Prostatic Cancer Biological: Autologous dendritic cell Phase 1 Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2006
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • Biological: Autologous dendritic cell
    Autologous dendritic cells pulsed with prostate cancer antigen and KLH
    Other Name: CreaVax-PC

Outcome Measures
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Primary Outcome Measures :
  1. PSA increment and absolute PSA response [ Time Frame: 12 weeks ]
    PSA response evaluation at 12 weeks and follow up response evaluation at 21 weeks


Secondary Outcome Measures :
  1. Time to Progression [ Time Frame: DC Injection to time to progression or death ]
  2. Overall Survival [ Time Frame: Patients will be followed until death ]
  3. Immune Response(DTH response, Interferon-gamma Elispot assay, proliferation assay, ELISA) [ Time Frame: weeks 0, 12, 21 ]
  4. Clinical response [ Time Frame: week 0, 12, 21 ]
    Clinical course of participants as measured by bone scans and CT


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01171729


Locations
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Korea, Republic of
National Cancer Center
Gyeonggi-do, 323 Ilsan-ro Ilsandong-gu Goyang-si, Korea, Republic of, 410-769
Samsung Medical Center
Seoul, Gangnam-Gu, Ilwon-Dong, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
National Cancer Center, Korea
Investigators
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Principal Investigator: J C W, M.D,Ph.D Samsung Medical Center
More Information
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Responsible Party: Chul Won Jung, MD, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01171729    
Other Study ID Numbers: 2006-10-030
First Posted: July 28, 2010    Key Record Dates
Last Update Posted: August 11, 2010
Last Verified: July 2010
Keywords provided by Samsung Medical Center:
Prostate cancer
PSA
Hormone refractory prostatic cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases