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Prostate CancerPhase 1CryoITNCT02423928

Phase I Clinical Trial of Cryoimmunotherapy Against Prostate Cancer

A Phase 1 study testing Dendritic cell based cryoimmunotherapy, Cyclophosphamide and ipilimumab in people with Prostate Cancer, run by Alden Cancer Therapy II at 1 site in Norway.

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

20 patients with invasive castration resistant prostate cancer and radiologically verified metastases will be enrolled into the Phase I Clinical Trial. The trial is a dendritic cell based immunotherapy. Autologous dendritic cells will be obtained by leukapheresis and elutriation and stimulation by cytokines. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Dendritic cell based cryoimmunotherapy, Cyclophosphamide and ipilimumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteNorway
Study dates
May 2015to 16 Aug 2019
Phase
Phase 1
Are there results?
None posted in the registry

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

  • CRPC (castration resistant prostate cancer) with imaging study proven metastasis beyond pelvic lymph nodes and chemotherapy finished more than three months earlier
  • Must be ambulatory with an ECOG performance status of 0 or 1
  • No contraindications for MRI (pacemaker, claustrophobia, metal splints)
  • Must be able to undergo the surgical procedure under general or regional anesthesia (spinal or epidural)
  • Must be at least 18 years of age
  • Must have lab values as the following :
  • White Blood Cells ≥ 1.5 x 10^9/L Platelets ≥ 100 x 10^9/L Hemoglobin ≥ 9g/dL (≥ 5.6 mmol/L) Creatinine ≤ 140 umol/L Bilirubin < 20% above the upper limit of normal ASAT and ALAT ≤ 2.5 the upper limit of normal Albumin ≥ 2.5 g/L sPSA < 200 ng/mL
  • Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH/GCP, and national/local regulations

Who cannot join

  • History of other prior malignancy, with the exception of curatively treated basal cell or squamous cell carcinoma of the skin or effectively treated malignancy that has been in remission for over 5 years and is highly likely to have been cured
  • Treatment with any other investigational medicinal product (IMP) within 4 weeks prior to first administration of study drug
  • Adverse reactions to vaccines such as anaphylaxis or other serious reactions
  • History of immunodeficiency or autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, sclerodermia, polymyositis-dermatomyositis, juvenile onset insulin-dependent diabetes, or a vasculitic syndrome
  • Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia
  • Active infection requiring antibiotic therapy
Show all 12Show fewer
  • Known hypersensitivity to any of the components of the cell therapy product
  • Patients who test positive for hepatitis B, hepatitis C or HIV (Human Immunodeficiency Virus)
  • Any other ongoing anti-tumor treatment (including chemotherapy, immunotherapy, cytokines, interferons, protease inhibitors or gene therapy) administered. The use of of GnRH-agonist/antagonists with or without bicalutamide is acceptable with the exception of GnRH-agonist with or without bicalutamide started up to 6 months prior to inclusion
  • Use of not permitted concomitant medication: chronic corticosteroids except for asthma inhalers / topical use any agent with a known effect on the immune system, unless it is being given at dose levels that are not immunesuppressive, e.g. prednisone at 10mg/day or less
  • Any alternative and complementary drugs that may affect the immune system or be potentially harmful to patients participating in phase I studies
  • Any reason why, in the opinion of the investigator, the patient should not participate

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Haukeland University Hospital Research Department

    Bergen, Hordaland, No-5021

Other trials in Norway

About this study

Official title: A Phase I Clinical Trial of Combined Cryotherapy and Intra-tumoral Immunotherapy With Autologous Immature Dendritic Cells in Men With Castration Resistant Prostatic Cancer and Metastases to Lymph Nodes and/or Bone Pre or Post Chemotherapy

20 patients with invasive castration resistant prostate cancer and radiologically verified metastases will be enrolled into the Phase I Clinical Trial. The trial is a dendritic cell based immunotherapy. Autologous dendritic cells will be obtained by leukapheresis and elutriation and stimulation by cytokines. The induced dendritic cells will have to pass viability, immunophenotyping and sterility criteria and will be injected into a cryoablated region of the primary prostate cancer tumor. The treatment is supplemented by immunomodulatory regimens.

Read the detailed description

The study treatment dendritic cells (ACT2001) will be injected into the prostate following prostatic cryoablation. It is speculated that antigen from the cryoablated cancer will be available in the vicinity of the cryoablation field immediately following the procedure. Autologous, immature dendritic cells are capable of internalizing antigen, migrating to the lymphatic system, and presenting antigenic epitopes to T lymphocytes. In this way, dendritic cells are capable of initiating a cell-mediated systemic immune response.

In concept, the cancer itself should provide a specific and potentially broad spectrum of cancer-related antigens. Regulatory T lymphocytes, which have been implicated in dampening or halting cell-mediated, antigen-specific immune responses, will be selectively depleted using a regimen of low-dose cyclophosphamide. Low-dose cyclophosphamide has been empirically shown to selectively deplete the number of circulating regulatory T cells. The second half of patients will in addition receive treatment with the the immune checkpoint inhibitor ipilimumab antibody as one additional measure to avoid cancer cell immune evasion.

Using this combination of therapies, it is thought that a clinically significant anti-cancer immune response might be elicited.

Conditions
Prostate Cancer
Being tested
Dendritic cell based cryoimmunotherapy, Cyclophosphamide, ipilimumab
Keywords
immunotherapy, cryoablation, prostate cancer, dendritic cell
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • Dendritic cell based cryoimmunotherapyBiological

    Also called ACT2001

    Autologous dendritic cells will be obtained following leukapheresis and cytokine induction and will be injected into cryoablated prostate cancer tissue under ultrasound guidance.

  • CyclophosphamideDrug

    Also called Sendoxan

    Low-dose cyclophosphamide will be given metronomically for the purpose of selective inhibition of T regulatory cells for 6 months following start of treatment.

  • ipilimumabDrug

    Also called Yervoy

    The antibody and immune checkpoint inhibitor ipilimumab (Yervoy) will be given for the last 10 patients enrolled into the study in addition to cryoimmunotherapy and low-dose cyclophosphamide.

Study groups in NCT02423928
Study groupRoleWhat they receive
CryoimmunotherapyExperimentalPatients with castration resistant prostate cancer and imaging proven metastases will be treated by autologous dendritic cell based cryoimmunotherapy of the prostatic tumor tissue assisted by immunomodulation consisting of low-dose metronomic cyclophosphamide for all patients plus ipilimumab for the latter half of all patients. Update January 2019: The protocol was changed as approved by the Norwegian Medicines Agency and the Regional Ethical Committee in Western Norway for the 3 last patients of altogether 18 patients. Consequently, the 3 last patients received 200 mg i.v. of pembrolizumab (and no ipilimumab) post-CryoIT.
Receives: Biological: Dendritic cell based cryoimmunotherapy; Drug: Cyclophosphamide; Drug: ipilimumab

What is being measured

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

  1. Composite measure of the safety and toxicity profile, including definition of the Maximum Tolerated Dose.

    Maximum dose dendritic cells administered was well tolerated by interim analysis of 13 patients with database lock September 15th 2017

    Measured: 72 weeks

  2. Pembrolizumab tested to boost dendritic cell-based immunity of patients 16 to 18 (3 last recruited patients to the trial).

    200 mg pembrolizumab i.v. post-CryoIT was well tolerated - effect is under evaluation.

    Measured: 52 weeks

Timeline

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

  1. First posted22 Apr 2015 (estimated)
  2. Study startMay 2015
  3. Primary completion16 Aug 2019
  4. Study completion16 Aug 2019

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
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02423928
Sponsor's protocol ID
ACT2001
Other IDs
2014-001898-14, 2014
Acronym
CryoIT
Status last verified
Oct 2019
First submitted
15 Apr 2015
Last updated
25 Oct 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: Abstract published at Annual Meeting AACR 2018 in Chicago: http://www.aacr.org/Meetings/Pages/MeetingDetail.aspx?EventItemID=136#.WzNomaczZaS Abstract (Online) published Annual Meeting ASCO 2018 in Chicago: http://abstracts.asco.org/214/AbstView\_214\_219341.html

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dendritic cell based cryoimmunotherapy, Cyclophosphamide and ipilimumab in people with Prostate Cancer, run by Alden Cancer Therapy II at 1 site in Norway.

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 8 inclusion and 12 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 25 Oct 2019. 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 Norway. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Composite measure of the safety and toxicity profile, including definition of the Maximum Tolerated Dose. (time frame: 72 weeks). 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 NCT02423928.

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 25 Oct 2019.

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