Back to resultsSafety Study of a Cytotoxic Lymphocytes (CTL) Based Prostate Cancer Therapy (ALECSAT)
Primary Purpose
Hormone-refractory Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
ALECSAT
Sponsored by
About this trial
This is an interventional treatment trial for Hormone-refractory Prostate Cancer focused on measuring hormone-refractory prostate cancer, Immunotherapy
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Urological Clinic, Frederikssunds Hospital
Outcomes
Primary Outcome Measures
The primary endpoint is to show safety and tolerability for the administration of ALECSAT to enable further clinical development of the ALECSAT therapy.
Secondary Outcome Measures
The secondary endpoint for this study is to establish if any indications of a positive therapeutic effect on the prostate cancer may be observed.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00891345
Brief Title
Safety Study of a Cytotoxic Lymphocytes (CTL) Based Prostate Cancer Therapy
Acronym
ALECSAT
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CytoVac A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hormone-refractory Prostate Cancer
Keywords
hormone-refractory prostate cancer, Immunotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
ALECSAT
Intervention Description
Autologous activated CTL and NK-cells injected as a single intravenous injection.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans-Henrik Meyhoff, MD
Organizational Affiliation
Urologisk Klinik, Frederikssund Hospital, Frederikssundsvej 30, 3600 Frederikssund
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urological Clinic, Frederikssunds Hospital
City
Frederikssund
ZIP/Postal Code
DK-3600
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Safety Study of a Cytotoxic Lymphocytes (CTL) Based Prostate Cancer Therapy
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