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Trial of Vaccine Therapy in Curative Resected Prostate Cancer Patients Using Autologous Dendritic Cells Loaded With mRNA From Primary Prostate Cancer Tissue, hTERT and Survivin


Phase 1/Phase 2
18 Years
75 Years
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Trial of Vaccine Therapy in Curative Resected Prostate Cancer Patients Using Autologous Dendritic Cells Loaded With mRNA From Primary Prostate Cancer Tissue, hTERT and Survivin


Inclusion Criteria:



- Radical prostatectomy. 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 or pT3b Gleason score 8 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 < 0.2 µg/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); Creatinine ≤ 140
μmol/L (1.6 mg/dL)- if borderline, the creatinine clearance ≥ 40 mL/min; Bilirubin within
the upper limit of normal; ASAT and ALAT ≤ 2.5 the upper limit of normal; Albumin levels
above lower normal value

- No metastasis on bone scans or MRI, last 3 months before inclusion.

- Signed informed consent and expected cooperation of the patients for the treatment
and follow up must be obtained and documented according to ICH/GCP, and
national/local regulations.

Exclusion Criteria:

- Previous treatment with LHRH (Luteinizing Hormone-Releasing Hormone) 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.

- Positive testing for syphilis (treponema pallidum), HIV, Hepatitis B and C

- Use of systemic glucocorticoids.

- Any reason why, in the opinion of the investigator, the patient should not
participate.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Time to treatment failure defined by two different measurement of PSA levels >0.5 µg/L with minimum of 4 weeks interval

Outcome Time Frame:

From date of vaccination until the date of first documented treatment failure, assessed up to 8 years

Safety Issue:

No

Principal Investigator

Svein Dueland, M.D PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oslo University Hospital - Norwegian Radium Hospital

Authority:

Norway: Norwegian Medicines Agency

Study ID:

DC-005

NCT ID:

NCT01197625

Start Date:

September 2010

Completion Date:

September 2021

Related Keywords:

  • Prostate Cancer
  • Vaccination treatment, dendritic cells
  • Prostatic Neoplasms

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