Safety Study of Repeated Dosing of a Cytotoxic Lymphocytes (CTL) Based Prostate Cancer Therapy
Condition: Hormone-refractory Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: ALECSAT
Intervention description: Autologous activated CTL and NK-cells injected as three intravenous injections interspaced by 5 weeks.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hormone-refractory prostate cancer; Immunotherapy

Summary:

      This study is a phase I study of a cell based prostate cancer therapy, Autologous Lymphoid
      Effector Cells Specific Against Tumor-cells (ALECSAT). Safety and tolerability of a single
      dose has been shown in 13 prostate cancer patients. In this study 20 prostate cancer patients
      will receive 3 doses of the ALECSAT treatment. In this therapy specific cells from the
      patient's own immune system are isolated, activated and re-administered to the patient to
      boost a specific immune response against the cancer cells. The aim of the study is to show
      safety and tolerability for repeated dosing of this type of therapy. It is the hypothesis
      that the cells administered during the therapy will attack the tumor cells and in this way
      stop or slow down the progression of disease.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Serum castration levels of testosterone, (total testosterone under 1.7nmol/l).

          2. Three consecutive rises of PSA minimum 1 week apart, resulting in at least two 50 %
             increases over the PSA nadir.

          3. Antiandrogen withdrawal for at least 4 weeks, or PSA progression despite secondary
             hormonal manipulations, or progression of osseous or soft tissue lesions.

          4. Be over the age of 18 and capable of understanding the information and giving informed
             consent.

          5. Expected survival time (life expectancy) of over 6 months.

          6. Adequate performance status better than 2 (WHO/ECOG Performance status score).

        Exclusion Criteria:

          1. A low blood count (haemoglobin < 6.0 mmol/l).

          2. Lymphocyte counts below 0.8 x 109/l.

          3. Positive tests for anti-HIV-1/2; HBsAg, anti-HBc (Hepatitis B Core Antigen) and
             Anti-HCV (Hepatitis C Virus).

          4. Syphilis i.e. being positive in a Treponema Pallidum test.

          5. Uncontrolled serious bacterial, viral, fungal or parasitic infection.

          6. Clinically significant autoimmune disorders or conditions of immune suppression.

          7. Treatment with corticosteroids (steroid hormones) or bisphosphonates or have been in
             chemotherapy or radiation treatment one month prior to inclusion in the clinical
             trial.

          8. Blood transfusions within 48 hours prior to donation of blood for ALECSAT production.

          9. Inclusion in other clinical trials 6 weeks prior to inclusion in the trial or
             enrolment in other clinical trials during the ALECSAT clinical trial.

         10. Any medical condition that will render participation in the study risky or, according
             to the Investigator will make the assessment of side effects difficult.