Phase 1
N=21
Safety Study of Repeated Dosing of a Cytotoxic Lymphocytes (CTL) Based Prostate Cancer Therapy
Hormone-refractory Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01422850 ↗Enrolled (actual)
21
Serious AEs
33.3%
Results posted
Apr 2014
Primary outcome: Primary: Adverse Events — 67; 8; 9; 0 Events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- ALECSAT (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- CytoVac A/S
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events |
67; 8; 9; 0; 0 | — |
| PRIMARY Blood Pressure, Pulse and Temperature |
0; 0; 0 | — |
| SECONDARY The Secondary Endpoint for This Study is to Establish if Any Indications of a Positive Therapeutic Effect on the Prostate Cancer May be Observed. |
11; 8; 2 | — |
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
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01422850). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.