Safety Study of a Cytotoxic Lymphocytes (CTL) Based Prostate Cancer Therapy (ALECSAT)
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 the patient to boost a specific immune response against the cancer cells. The aim of the study is to show safety and tolerability for this type of therapy. It is the hypothesis that the cells administered during the therapy will attack the tumour cells and in this way stop or slow down the progression of disease.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective, Open Phase I Study to Investigate the Tolerability and Efficacy of Administering ALECSAT to Prostate Cancer Patients - a First Dose in Man Study|
- The primary endpoint is to show safety and tolerability for the administration of ALECSAT to enable further clinical development of the ALECSAT therapy. [ Time Frame: Within 7 weeks ] [ Designated as safety issue: Yes ]
- The secondary endpoint for this study is to establish if any indications of a positive therapeutic effect on the prostate cancer may be observed. [ Time Frame: Within 7 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||April 2009|
|Study Completion Date:||July 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
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 CBMP that is made from the patient's own blood cells. ALECSAT contains a large amount of tumour specific cytotoxic Lymphocytes (CTL) and Natural Killer (NK) cells that are isolated activated and amplified in number.
The CBMP is given as a slow i. v. injection to patients with prostate cancer. The patients are in the late stage of the disease where they have received hormone treatment but their disease is progressing.
The primary objective of the study is to observe if any side effects or tolerability issues occur as a consequence of the cell administration, secondarily it will be observed if any positive anti tumour effect may be observed. The study has the purpose to investigate whether treatment with ALECSAT in any way is toxic.
Trial Design: The study is an open, prospective phase I safety study of ALECSAT in prostate cancer patients.
A group consisting of 6 patients will be treated with ALECSAT according to the protocol. Then an interim analysis will be done. If there are no signs of significant toxicity related to the treatment, the study will continue with 8 more patients that will be included and treated with ALECSAT according to the phase I protocol. Thus this study will include a total of 14 patients.
The patients will after a single administration of ALECSAT be hospitalised for 3 days and will furthermore be followed closely for 7 weeks by 5 planned study visits, by the investigators at Urologisk Klinik at Fredrikssund Hospital.
|Urological Clinic, Frederikssunds Hospital|
|Frederikssund, Denmark, DK-3600|
|Principal Investigator:||Hans-Henrik Meyhoff, MD||Urologisk Klinik, Frederikssund Hospital, Frederikssundsvej 30, 3600 Frederikssund|