Autologous Dendritic Cell Therapy for Hormone-Refractory Metastatic Prostate Cancer

Prostatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01171729
• Other study ID #: 2006-10-030
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 27, 2010
• Last updated: August 10, 2010
• Start date: July 2006
• Est. completion date: May 2010

Study information

• Verified date: July 2010
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostatic Cancer
• Prostatic Neoplasms

Intervention

Biological:
• Autologous dendritic cell
Autologous dendritic cells pulsed with prostate cancer antigen and KLH

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center	Gyeonggi-do	323 Ilsan-ro Ilsandong-gu Goyang-si
Korea, Republic of	Samsung Medical Center	Seoul	Gangnam-Gu, Ilwon-Dong

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PSA increment and absolute PSA response	PSA response evaluation at 12 weeks and follow up response evaluation at 21 weeks	12 weeks	Yes
Secondary	Time to Progression		DC Injection to time to progression or death	No
Secondary	Overall Survival		Patients will be followed until death	No
Secondary	Immune Response(DTH response, Interferon-gamma Elispot assay, proliferation assay, ELISA)		weeks 0, 12, 21	No
Secondary	Clinical response	Clinical course of participants as measured by bone scans and CT	week 0, 12, 21	No