Status:
COMPLETED
Safety Study of Repeated Dosing of a Cytotoxic Lymphocytes (CTL) Based Prostate Cancer Therapy
Lead Sponsor:
CytoVac A/S
Conditions:
Hormone-refractory Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief 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 show...
Detailed Description
This study is a prospective open phase I study to investigate the safety and tolerability of administration of repeated doses of a cell based medicinal product (CBMP) ALECSAT. ALECSAT is an autologou...
Eligibility Criteria
Inclusion
- Serum castration levels of testosterone, (total testosterone under 1.7nmol/l).
- Three consecutive rises of PSA minimum 1 week apart, resulting in at least two 50 % increases over the PSA nadir.
- Antiandrogen withdrawal for at least 4 weeks, or PSA progression despite secondary hormonal manipulations, or progression of osseous or soft tissue lesions.
- Be over the age of 18 and capable of understanding the information and giving informed consent.
- Expected survival time (life expectancy) of over 6 months.
- Adequate performance status better than 2 (WHO/ECOG Performance status score).
Exclusion
- A low blood count (haemoglobin \< 6.0 mmol/l).
- Lymphocyte counts below 0.8 x 109/l.
- Positive tests for anti-HIV-1/2; HBsAg, anti-HBc (Hepatitis B Core Antigen) and Anti-HCV (Hepatitis C Virus).
- Syphilis i.e. being positive in a Treponema Pallidum test.
- Uncontrolled serious bacterial, viral, fungal or parasitic infection.
- Clinically significant autoimmune disorders or conditions of immune suppression.
- Treatment with corticosteroids (steroid hormones) or bisphosphonates or have been in chemotherapy or radiation treatment one month prior to inclusion in the clinical trial.
- Blood transfusions within 48 hours prior to donation of blood for ALECSAT production.
- Inclusion in other clinical trials 6 weeks prior to inclusion in the trial or enrolment in other clinical trials during the ALECSAT clinical trial.
- Any medical condition that will render participation in the study risky or, according to the Investigator will make the assessment of side effects difficult.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01422850
Start Date
August 1 2011
End Date
October 1 2012
Last Update
April 23 2014
Active Locations (1)
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1
Department of Urology
Frederikssund, Denmark, DK-3600