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CompletedNCT01171729Updated Aug 11, 2010

Autologous Dendritic Cell Therapy for Hormone-Refractory Metastatic Prostate Cancer

A Phase 1/2 interventional study of Autologous dendritic cell in Prostatic Cancer, sponsored by Samsung Medical Center. Completed at 2 sites in Korea, Republic of. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-08-11.

Sponsored by Samsung Medical Center · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
12
Allocation
Non-randomized
Ages
18 Years and older
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Prostatic Cancer

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Keywords

  • Prostate cancer
  • PSA
  • Hormone refractory prostatic cancer
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 12 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

    1. Histological confirmed prostatic carcinoma patient
    1. Hormone non-respondence ex1) Although treatment PSA ≥ 5ng/ml ex2) PSA level were measured two times ex3) Prior one year radiology were processed
    1. Just 18 years over
    1. Has a score ≤1 on the ECOG Performance Scale
    1. Expected survival life time ≥ 6month
    1. Adequate bone marrow function hemoglobin ≥ 10.0g/dL , leukocyte count ≥ 4,000/mm3 thrombocyte ≥ 100,000/mm3
    1. Adequate blood coagulation function PT(INR) \< 1.5, aPTT\< 1.5 x control
    1. Adequate kidney function Normal blood upper level Creatinine ≤ 1.5 times
    1. Adequate liver function Normal blood upper level AST/ALT ≤ 1.5 times
    1. Autoimmune antibody system don't have disorder ex) anti-nuclear antibody, anti-thyroglobulin antibody negativity
    1. Person who didn't treat prior 6 weeks operation, radiotherapy treatment,immunotherapy or chemotherapy
    1. Patient who voluntarily participated clinical trial and confirmed a written consent

Exclusion criteria

Exclusion Criteria:

    1. Having other malignancy or previous history of malignancy
    1. Brain metastases patient
    1. Having autoimmune disease or its history
    1. Pyrexia, rigor, leukocytosis infectious disease
    1. HBsAg, anti-HCV, HIV positive patient
    1. Myocardial infarction, cardiac insufficiency, other severe heart disease and non-controlled hypertension
    1. Severe and active medical disease
    1. Mental history disease or epilepsy
    1. Patients participated other clinical trial within 4 weeks
    1. Patients impossible to participate this trial by investigator's decision
    1. Patients who received immunosuppressant such as steroid, cyclosporin A, azathioprine within 6 weeks
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Interventions

  • BiologicalAutologous dendritic cell

    Autologous dendritic cells pulsed with prostate cancer antigen and KLH

    Also known as: CreaVax-PC

06

What researchers measure

Primary outcomes

  1. PSA increment and absolute PSA response

    PSA response evaluation at 12 weeks and follow up response evaluation at 21 weeks

    Time frame: 12 weeks

Secondary outcomes

  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

    Clinical course of participants as measured by bone scans and CT

    Time frame: week 0, 12, 21

07

Study locations

2 sites
  • National Cancer Center
    Gyeonggi-do, 323 Ilsan-ro Ilsandong-gu Goyang-si 410-769, Korea, Republic of
  • Samsung Medical Center
    Seoul, Gangnam-Gu, Ilwon-Dong 135-710, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01171729
Lead sponsor
Samsung Medical Center
Collaborators
National Cancer Center, Korea
First posted
Jul 28, 2010
Start date
Jul 2006
Primary completion
May 2010
Completion
May 2010
Last update
Aug 11, 2010

Study contacts

J C W, M.D,Ph.D
principal investigator · Samsung Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.

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