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Prostate CancerPhase 1/2MUC1NCT00852007

A Study Evaluating Vaccination of Prostate Cancer Patients With Self Dendritic Cells Expressing MUC1

A Phase 1/2 study testing DC-Tn-MUC1: autologous dendritic cells expressing Tn-MUC1 in people with Prostate Cancer, run by Hamilton Health Sciences Corporation at 1 site in Canada.

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 investigates the use of the patients own immune cells to treat prostate cancer. Cells are taken from the patient and grown in the laboratory to become specialized immune cells called dendritic cells. Read more about this study

Who is it for?
Ages 19 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
DC-Tn-MUC1: autologous dendritic cells expressing Tn-MUC1
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteCanada
Study dates
Feb 2009to Feb 2016
Phase
Phase 1/2
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 19 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject has a histologically documented diagnosis of prostate cancer
  • Subject was surgically castrated at least 3 months prior to study inclusion or has been pharmacologically castrated for a minimum of 3 months prior to study inclusion.
  • Subject must meet one of the following PSA criteria:
  • A PSA value of ≥20ng/mL (µg/L) obtained 12 months prior to study inclusion OR
  • A 50% rise in PSA values with a minimum rise of 1.0 ng/ml (µg/L), within 6 months prior to study inclusion OR
  • A rise in PSA defined by 2 sequential increases in PSA values. inclusion. There must be at least 2 weeks between each qualifying PSA value.
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  • Subjects who have received anti-androgen therapy must have a documented withdrawal period prior to study inclusion.
  • For a subject who has withdrawn from anti-androgen therapy LESS than 6 months prior to study inclusion, one of the following criteria is ALSO required for eligibility:
  • Following the completion of the anti-androgen withdrawal period, one post-withdrawal PSA value must be higher than the last pre-withdrawal PSA value OR
  • Following the completion of the anti-androgen withdrawal period, if the subject's PSA value decreased, then he can still qualify if two increases in PSA values (as described in 4c) are documented after post-withdrawal nadir.
  • At the time of screening the subject has no distant metastatic disease.

Who cannot join

  • Subject is less than 19 years of age.
  • Subject has a PSA value < 1.0 ng/mL at screening
  • Subject currently has evidence of distant metastases.
  • Subject has not, in the opinion of the investigator, a life expectancy greater than 12 months.
  • Subject has a local recurrence and is a candidate for local salvage therapy
  • Subject having previously received therapy [including radiation, steroids, radionuclides (such as rhenium, strontium or samarium), cryotherapy or cytotoxic chemotherapy] for prostate cancer are ineligible as defined below:
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  • Subjects who received previous cytotoxic chemotherapy or radionuclide therapies are ineligible
  • Subjects who received therapy to the prostatic bed (external beam radiotherapy, brachytherapy or cryotherapy) within 6 months prior to study entry are ineligible.
  • Subjects who received radiation therapy to any lesion outside the prostate bed more than 6 months after castration or hormone initiation are ineligible.
  • Subjects who received steroids for the treatment of prostate cancer within 6 months prior to study entry are ineligible.
  • Subjects having previously received opioid analgesic therapy.
  • Subjects has received any of the following within 4 weeks of study entry:
  • Cyproterone acetate, ketoconazole, PC-SPES or other hormonally active therapies (with the exception of GnRH agonists or antagonists).
  • An investigational product
  • Subject is on a concurrent steroids or immunosuppressive therapy for chronic inflammatory disease.
  • Subject has had other malignancies within the previous 5 years with the exception of non-melanoma skin cancer.
  • Subject has a score >1 on the ECOG Performance Scale (see Appendix I)
  • Subject has an inadequate hematologic function
  • Subject has inadequate liver function.
  • Subject has a creatinine clearance <40 mL/min
  • Subject has a known history of cardiovascular disability status of New York Heart Association Class ≥2.
  • Subject has a history of uncontrolled asthma
  • Subject has autoimmune disease(s)
  • Subject has active infection(s)
  • Subject is receiving antiretroviral therapy.
  • Subject has received blood transfusion within 8 weeks of study inclusion.
  • Subject has a clinically significant, unstable, uncontrolled disease that could be adversely affected by study participation.
  • Subject has known allergy to shellfish

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Hamilton Health Sciences

    Hamilton, Ontario

Other trials in Canada

About this study

Official title: A Phase I/II Study Evaluating the Safety and Efficacy of Vaccination With Autologous Dendritic Cells Loaded With Tn-MUC1 Peptide in Patients With Non-Metastatic Androgen Independent Prostatic Adenocarcinoma.

This study investigates the use of the patients own immune cells to treat prostate cancer. Cells are taken from the patient and grown in the laboratory to become specialized immune cells called dendritic cells. Dendritic cells instruct other immune cells to recognize and attack foreign substances such as bacteria, viruses, or abnormal proteins on cancer cells. A protein called Tn-MUC-1 is added to the cells.This protein is present on prostate cancer cells. The modified cells are injected back into the patient, with the intention that the dendritic cells will instruct other immune cells to attack the prostate cancer cells.

Read the detailed description

Patients undergo one standard apheresis to harvest peripheral mononuclear cells for dendritic cell vaccine preparation. The modified cells (vaccine) are frozen so that multiple injections may be given. Patients my receive up to 5 injections. The vaccine is given either intradermally or into a lymph node.

Patients will undergo blood sample collection for immune response studies on the day of treatment and 2 weeks following treatment.

Conditions
Prostate Cancer
Being tested
DC-Tn-MUC1: autologous dendritic cells expressing Tn-MUC1
Keywords
prostate cancer, dendritic cells, MUC-1, immune therapy
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • DC-Tn-MUC1: autologous dendritic cells expressing Tn-MUC1Biological

    1.2 x 10e7 dendritic cells per dose. One dose delivered intradermally (i.d.) and into a node (i.n.). Two weeks after this,two injections i.d. 2 weeks apart. Optional booster injections at 6 (i.d. and i.n.) and and 12 months (i.d.).

Study groups in NCT00852007
Study groupRoleWhat they receive
DC-Tn-MUCExperimentalDC-Tn-MUC1: autologous dendritic cells expressing Tn-MUC1. 1.2 x 10e7 dendritic cells per dose. 5 administrations (doses)may be given in total.
Receives: Biological: DC-Tn-MUC1: autologous dendritic cells expressing Tn-MUC1

What is being measured

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

  1. Time to radiographic progression

    Radiographic disease as measured by the occurence of any metastatic disease based on modified RECIST 1.0 and/or the appearance of 2 or more new lesions on a bone scan.

    Measured: Time to radiographic progression defined as the time from the first treatment to the occurence of any metastatic disease

Secondary outcomes (5)

  1. Number of participants with adverse events

    Acute and late toxicities as assessed by NCI CTCAE v 4.0

    Measured: Ongoing up to 2 years

  2. Time to PSA progression

    Measured: Up to 2 years

  3. Immune response

    Immune response defined as the induction of a cellular (CD4/CD8)response measured by CFSE or ICS assay and/or the induction of a humoral response as measured by an increase in specific antibody or the occurence of antibody isotype switching.

    Measured: Up to 2 years

  4. Overall survival

    Measured: Up to 2 years

  5. Disease-specific survival

    Measured: Up to 2 years

Timeline

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

  1. First posted26 Feb 2009 (estimated)
  2. Study startFeb 2009
  3. Primary completionFeb 2014
  4. Study completionFeb 2016

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 1/2
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00852007
Sponsor's protocol ID
CAN-ONC-001 CAN
Acronym
MUC1
Status last verified
Sep 2016
First submitted
25 Feb 2009
Last updated
15 Sep 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing DC-Tn-MUC1: autologous dendritic cells expressing Tn-MUC1 in people with Prostate Cancer, run by Hamilton Health Sciences Corporation at 1 site in Canada.

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 11 inclusion and 28 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 15 Sep 2016. 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 Canada. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Time to radiographic progression (time frame: Time to radiographic progression defined as the time from the first treatment to the occurence of any metastatic disease). 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 NCT00852007.

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 15 Sep 2016.

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