A Phase I/IIa Study of UV1 Vaccine in Patients With Prostate Cancer (UV1/hTERT2012P)

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate, cancer, vaccine Read More

Inclusion Criteria:

• Patients with advanced oligometastatic prostate cancer (PCa) without lung and/or liver metastases who are eligible to CAB (GnRH-agonist combined with anti-androgen)
• Patients already on GnRH-agonist must have a history sPSA < 200 ng/mL prior to start of GnRH-agonist treatment. GnRH-agonist with or without bicalutamide can have been initiated up to 6 months prior inclusion.
• Must be ambulatory with an ECOG performance status of 0 or 1 and not have contraindications for MRI (pacemaker, claustrophobia, metal splints).
• Must be at least 18 years of age.

• Must have lab values as follows:

  • White Blood Cells ≥ 1.5 x 109/L
  • Platelets ≥ 100 x 109/L
  • Hemoglobin ≥ 9g/dL (≥ 5.6 mmol/L)
  • Creatinine ≤ 140 µmol/L; if creatinine is borderline, the creatinine clearance ≥ 40 mL/min;
  • Bilirubin < 20% above the upper limit of normal
  • ASAT and ALAT ≤ 1.5 the upper limit of normal
  • Albumin ≥ 2.5 g/L
  • Normal NSE
  • sPSA < 200 ng/mL.
• Signed informed consent

Exclusion Criteria:

• History of other prior malignancy, with the exception of curatively treated basal cell or squamous cell carcinoma of the skin or effectively treated malignancy that has been in remission for over 5 years and is highly likely to have been cured.
• Treatment with any other investigational medicinal product (IMP) within 4 weeks prior to first administration of study drug.
• Adverse reactions to vaccines such as anaphylaxis or other serious reactions.
• History of immunodeficiency or autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, sclerodermia, polymyositis-dermatomyositis, juvenile onset insulin-dependent diabetes, or a vasculitic syndrome.
• Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia.
• Active infection requiring antibiotic therapy.
• Known hypersensitivity to any of the components of the vaccine
• Known hypersensitivity to Leukine®, yeast derived products or any component of the product
• Patients who test positive for hepatitis B, C or HIV
• Any other anti-tumor treatment (including chemotherapy, immunotherapy, cytokines, interferons, protease inhibitors and gene therapy) administered with the exception of GnRH-agonist with or without bicalutamide started up to 6 months prior inclusion.

• Use of not permitted concomitant medication:

  • chronic corticosteroids except for asthma inhalers / topical use
  • any agent with a known effect on the immune system, unless it is being given at dose levels that are not immunesuppressive, e.g. prednisone at 10mg/day or less
  • any alternative and complementary drugs that may affect the immune system or be potentially harmful to patients participating in phase I studies.
• Any reason why, in the opinion of the investigator, the patient should not participate.