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Hormone-refractory Prostate CancerPhase 1ALECSATNCT01422850

Safety Study of Repeated Dosing of a Cytotoxic Lymphocytes (CTL) Based Prostate Cancer Therapy

A Phase 1 study testing ALECSAT in people with Hormone-refractory Prostate Cancer, run by CytoVac A/S at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Hormone-refractory Prostate Cancer
What is being tested?
ALECSAT
Type of treatment
Injection or infusion
How many people
21 participants
Where
1 siteDenmark
Study dates
Aug 2011to Oct 2012
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Department of Urology

    Frederikssund, DK-3600

Other trials in Denmark

About this study

Official title: A Prospective, Open Phase I Study to Investigate the Tolerability and Efficacy of Administering Repeated Doses of ALECSAT to Prostate Cancer Patients.

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.

Read the 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 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 repeated administration of ALECSAT, secondarily it will be observed if changes in Prostate-Specific Antigen (PSA) levels or any positive anti tumor effect may be observed. The study has the purpose to investigate whether repeated 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 4 patients will be treated twice 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 to the third treatment for these patients and with 14 more patients that will be treated with ALECSAT according to the protocol. Thus this study will include a total of 20 patients.

The patients will after the first administration of ALECSAT be hospitalized for 2 days. Five and 10 weeks later the patients will be hospitalized for 1 day and receive the second and third administration of ALECSAT. Each patient will furthermore be followed closely for 12 weeks after the third treatment. During the course of the entire study the patients will be monitored by 11 planned study visits, by the investigators at Department of Urology, Fredrikssund Hospital, Denmark.

Being tested
ALECSAT
Keywords
hormone-refractory prostate cancer, Immunotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ALECSATBiological

    Autologous activated CTL and NK-cells injected as three intravenous injections interspaced by 5 weeks.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events

    To show safety and tolerability patients was monitored closely after administration of ALECSAT and during the follow up period. Heart rate, temperature, blood pressure, Performance status was monitored. Blood samples analysed were: PSA, Alkaline Phosphatase (ALP), Lactate DeHydogenase (LDH), Creatinine (CREAT) and Standard haematology: Blood picture (complete blood count, haemogram), leucocytes, Differential count, electrolytes, renal function, and liver count (liver enzymes).

    AE and SAE was reported during the study period and the Investigator was urged to judge whether the event was related to the study product or not.

    Measured: At planned study visit´s at study week 0, 4, 5, 6, 7, 9, 10, 11, 12, 14, 15, 16, 18, 21, 24 and at study visit week 25

  2. Blood Pressure, Pulse and Temperature

    Blood pressure, pulse and temperature were monitored frequently during 48 hours post injection of the study product, and thereafter at each follow up visit.

    Measured: At planned study visit´s at study week 0, 4, 5, 6, 7, 9, 10, 11, 12, 14, 15, 16, 18, 21, 24 and at study visit week 25

Secondary outcomes (1)

  1. The Secondary Endpoint for This Study is to Establish if Any Indications of a Positive Therapeutic Effect on the Prostate Cancer May be Observed.

    No significant conclusion of efficacy is possible due to the study design with only one group of patients. However by analyzing and comparing the outcome with the data the individual patient presented at baseline some trends of efficacy, defined as stable disease or partial response, are possible. Trends towards possible treatment response were measured by monitoring PSA, a potential marker for prostate cancer disease progression; by other blood markers; and by Quality of life questionnaire (EORTC QLQ-C30) and WHO/ECOG (Eastern Cooperative Oncology Group). Control of any bone metastases were followed by hotspots and bone scan index measured by skeletal scintigraphy.

    Measured: Within 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionSep 2012
  4. Study completionOct 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01422850
Sponsor's protocol ID
CV002
Acronym
ALECSAT
Status last verified
Mar 2014
First submitted
23 Aug 2011
Last updated
23 Apr 2014
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ALECSAT in people with Hormone-refractory Prostate Cancer, run by CytoVac A/S at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (time frame: At planned study visit´s at study week 0, 4, 5, 6, 7, 9, 10, 11, 12, 14, 15, 16, 18, 21, 24 and at study visit week 25). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01422850.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2014.

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