EUCTR2010-018770-20-NO
Active, not recruiting
Not Applicable
Phase I/II trial of vaccine therapy in curative resected prostate cancer patients using autologous dendritic cells loaded with mRNA from primary prostate cancer tissue, hTERT and surviving.
Oslo University Hospital0 sites30 target enrollmentMarch 30, 2010
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostatic cancer patients who have received curative surgery.
- Sponsor
- Oslo University Hospital
- Enrollment
- 30
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Radical prostatectomy with negative resection margins. Preferably accessible tumor tissue with enough volume and quality for vaccine production (extraction of tumor mRNA).
- •Pathological stage pT2 \- pT3b and Gleason score 7B\-10, pN0, pN\+ or pNx.
- •Must be ambulatory with an ECOG performance status 0 or 1\.
- •Tumor cells detected in bone\-marrow samples (micrometastatic disease). Patients with Gleason score 9\-10 may also be included with negative bone\-marrow aspiration. Bone\-marrow aspirates and plasma for microRNA will be obtained before start of surgery.
- •Must be at least 18 years of age and less than 75 years.
- •PSA \< 0\.2µg/L within 6 weeks after surgery.
- •Must have lab values as the following:
- •ANC \= 1\.5 x 109/L
- •Platelets \= 100 x 109/L
- •Hb \= 9 g/dL (\= 5\.6 mmol/L)
Exclusion Criteria
- •Previous treatment with LHRH agonist.
- •Previous anti\-androgen treatment (Casodex).
- •History of prior malignancy within the last 5 years, with the exception of curatively treated basal cell carcinoma.
- •Active infection requiring antibiotic therapy.
- •Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia.
- •Adverse reactions to vaccines such as asthma, anaphylaxis or other serious reactions.
- •History of immunodeficiency or autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis\-dermatomyositis, juvenile onset insulin dependent diabetes, or a vasculitic syndrome.
- •Use of systemic glucocorticoids.
- •Negative testing for HIV, Hepatitis B and C
- •Any reason why, in the opinion of the investigator, the patient should not participate.
Outcomes
Primary Outcomes
Not specified
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