Phase I Clinical Trial of Cryoimmunotherapy Against Prostate Cancer

• Status: Completed
• Trial end date: 2019-08-16
• Target enrollment: 0
• Participant gender: Male

Summary

20 patients with invasive castration resistant prostate cancer and radiologically verified metastases will be enrolled into the Phase I Clinical Trial. The trial is a dendritic cell based immunotherapy. Autologous dendritic cells will be obtained by leukapheresis and elutriation and stimulation by cytokines. The induced dendritic cells will have to pass viability, immunophenotyping and sterility criteria and will be injected into a cryoablated region of the primary prostate cancer tumor. The treatment is supplemented by immunomodulatory regimens.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alden Cancer Therapy II
• Collaborators: Haukeland University Hospital; Norwegian Radium Hospital
• Treatments: Cyclophosphamide; Ipilimumab

Criteria

Inclusion Criteria:

• CRPC (castration resistant prostate cancer) with imaging study proven metastasis beyond pelvic lymph nodes and chemotherapy finished more than three months earlier

• Must be ambulatory with an ECOG performance status of 0 or 1

• No contraindications for MRI (pacemaker, claustrophobia, metal splints)

• Must be able to undergo the surgical procedure under general or regional anesthesia (spinal or epidural)

• Must be at least 18 years of age

• Must have lab values as the following :

White Blood Cells ≥ 1.5 x 10^9/L Platelets ≥ 100 x 10^9/L Hemoglobin ≥ 9g/dL (≥ 5.6 mmol/L) Creatinine ≤ 140 umol/L Bilirubin < 20% above the upper limit of normal ASAT and ALAT ≤ 2.5 the upper limit of normal Albumin ≥ 2.5 g/L sPSA < 200 ng/mL

• 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:

• 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 cell therapy product

• Patients who test positive for hepatitis B, hepatitis C or HIV (Human Immunodeficiency Virus)

• Any other ongoing anti-tumor treatment (including chemotherapy, immunotherapy, cytokines, interferons, protease inhibitors or gene therapy) administered. The use of of GnRH-agonist/antagonists with or without bicalutamide is acceptable with the exception of GnRH-agonist with or without bicalutamide started up to 6 months prior to 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