Clinical trial NCT01171729: Autologous Dendritic Cell Therapy for Hormone-Refractory Metastatic Prostate Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prostatic Cancer
Keywords: Prostate cancer
PSA
Hormone refractory prostatic cancer
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Center, Korea
First posted: 2010-07-28
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: PSA increment and absolute PSA response
timeFrame: 12 weeks
Secondary outcomes:
measure: Time to Progression
timeFrame: DC Injection to time to progression or death
measure: Overall Survival
timeFrame: Patients will be followed until death
measure: Immune Response(DTH response, Interferon-gamma Elispot assay, proliferation assay, ELISA)
timeFrame: weeks 0, 12, 21
measure: Clinical response
timeFrame: week 0, 12, 21
Other outcomes:
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center
state: 323 Ilsan-ro Ilsandong-gu Goyang-si
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Gangnam-Gu, Ilwon-Dong
Study officials:
affiliation: Samsung Medical Center
name: J C W, M.D,Ph.D
role: PRINCIPAL_INVESTIGATOR
References: