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Prostatic CancerPhase 1/2NCT01171729

Autologous Dendritic Cell Therapy for Hormone-Refractory Metastatic Prostate Cancer

A Phase 1/2 study testing Autologous dendritic cell in people with Prostatic Cancer, run by Samsung Medical Center at 2 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostatic Cancer
What is being tested?
Autologous dendritic cell
How many people
12 participants
Where
2 sitesSouth Korea
Study dates
Jul 2006to May 2010
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

  • National Cancer Center

    Gyeonggi-do, 323 Ilsan-ro Ilsandong-gu Goyang-si, 410-769

  • Samsung Medical Center

    Seoul, Gangnam-Gu, Ilwon-Dong, 135-710

Other trials in South Korea

About this study

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

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.

Being tested
Autologous dendritic cell
Keywords
Prostate cancer, PSA, Hormone refractory prostatic cancer
Medical subject headings
Prostatic Neoplasms, Prostatic Neoplasms, Castration-Resistant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous dendritic cellBiological

    Also called CreaVax-PC

    Autologous dendritic cells pulsed with prostate cancer antigen and KLH

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PSA increment and absolute PSA response

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

    Measured: 12 weeks

Secondary outcomes (4)

  1. Time to Progression

    Measured: DC Injection to time to progression or death

  2. Overall Survival

    Measured: Patients will be followed until death

  3. Immune Response(DTH response, Interferon-gamma Elispot assay, proliferation assay, ELISA)

    Measured: weeks 0, 12, 21

  4. Clinical response

    Clinical course of participants as measured by bone scans and CT

    Measured: week 0, 12, 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2010 (estimated)
  2. Study startJul 2006
  3. Primary completionMay 2010
  4. Study completionMay 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01171729
Sponsor's protocol ID
2006-10-030
Status last verified
Jul 2010
First submitted
27 Jul 2010
Last updated
11 Aug 2010
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Autologous dendritic cell in people with Prostatic Cancer, run by Samsung Medical Center at 2 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PSA increment and absolute PSA response (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01171729.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2010.

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