Status:
COMPLETED
Safety Study 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 new cell based prostate cancer therapy (ALECSAT). In this therapy specific cells from the patient's own immune system are isolated, activated and re-administered to ...
Detailed Description
This study is a prospective open phase I study to investigate the safety and tolerability of administration of a single dose of a cell based medicinal product (CBMP) ALECSAT. ALECSAT is an autologous...
Eligibility Criteria
Inclusion
- Hormone-refractory prostate cancer patients
- Three consecutive rises of PSA min. 2 weeks 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.
- Serum castration levels of testosterone.
- Be capable of understanding the information and giving informed consent.
- Expected survival time (life expectancy) of over 4 months.
- Adequate performance status (WHO / ECOG Performance status score 2 or less).
Exclusion
- Patients with a low blood count (haemoglobin \< 6.0 mmol/l).
- Patients with lymphocyte-numbers below 0.8.
- Patients known to be HIV and/or hepatitis positive i.e. patients positive in tests for anti-HIV-1/2; HBsAg, anti-HBc and Anti-HCV.
- Patients known to have syphilis i.e. being positive in a Treponema Pallidum test.
- Patients with uncontrolled serious bacterial, viral, fungal or parasitic infection.
- Patients must have no clinically significant autoimmune disorders or conditions of immune suppression.
- Patients that have been treated with corticosteroids (steroid hormones) or bisphosphonates or have been in chemotherapy or radiation treatment one month prior to inclusion in the clinical trial.
- Fertile patients.
- Patients that have received blood transfusions within 48 hours prior to donation of blood for ALECSAT production.
- Patients must not have been included in other clinical trials 6 weeks prior to inclusion in the trial or be enrolled 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 in charge, will make the assessment of side-effects difficult.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00891345
Start Date
April 1 2009
End Date
July 1 2010
Last Update
April 27 2012
Active Locations (1)
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1
Urological Clinic, Frederikssunds Hospital
Frederikssund, Denmark, DK-3600