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.
- 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- For a subject who has withdrawn from anti-androgen therapy LESS than 6 months prior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
- 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.
- 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
- 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
- Subjects who received therapy to the prostatic bed (external beam radiotherapy,
brachytherapy or cryotherapy) within 6 months prior to study entry are
- 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
- 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