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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.


Phase 1/Phase 2
19 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

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.


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.


Inclusion Criteria:



- 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.

- 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- For a subject who has withdrawn from anti-androgen therapy LESS than 6 months prior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.

Exclusion Criteria:

- 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:

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Time to radiographic progression

Outcome Description:

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.

Outcome Time Frame:

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

Safety Issue:

No

Authority:

Canada: Health Canada

Study ID:

CAN-ONC-001 CAN

NCT ID:

NCT00852007

Start Date:

February 2009

Completion Date:

March 2014

Related Keywords:

  • Prostate Cancer
  • prostate cancer
  • dendritic cells
  • MUC-1
  • immune therapy
  • Prostatic Neoplasms

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