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Autologous Dendritic Cell Therapy for Hormone-Refractory Metastatic Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Center, Korea
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01171729
First received: July 27, 2010
Last updated: August 10, 2010
Last verified: July 2010
History of Changes
  Purpose

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 Intervention Phase
Prostatic Cancer
 Biological: Autologous dendritic cell
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • PSA increment and absolute PSA response [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    PSA response evaluation at 12 weeks and follow up response evaluation at 21 weeks


Secondary Outcome Measures:
  • Time to Progression [ Time Frame: DC Injection to time to progression or death ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Patients will be followed until death ] [ Designated as safety issue: No ]
  • Immune Response(DTH response, Interferon-gamma Elispot assay, proliferation assay, ELISA) [ Time Frame: weeks 0, 12, 21 ] [ Designated as safety issue: No ]
  • Clinical response [ Time Frame: week 0, 12, 21 ] [ Designated as safety issue: No ]
    Clinical course of participants as measured by bone scans and CT


Enrollment: 12
Study Start Date: July 2006
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Autologous dendritic cell
    Autologous dendritic cells pulsed with prostate cancer antigen and KLH
    Other Name: CreaVax-PC
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01171729

Locations
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
Principal Investigator: J C W, M.D,Ph.D Samsung Medical Center
  More Information

No publications provided

Responsible Party: Chul Won Jung, MD, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01171729     History of Changes
Other Study ID Numbers: 2006-10-030
Study First Received: July 27, 2010
Last Updated: August 10, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Samsung Medical Center:
Prostate cancer
PSA
Hormone refractory prostatic cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
 Prostatic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2012