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COMPLETEDPHASE1/PHASE2

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

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.

NCT00852007•Hamilton Health Sciences Corporation

View on ClinicalTrials.gov

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. 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.

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.

Eligibility

Age

19 - No limit years

Sex

MALE

Healthy Volunteers

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•For a subject who has withdrawn from anti-androgen therapy LESS than 6 months prior to study inclusion, one of the following criteria is ALSO required for eligibility: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.
+1 more criteria

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.
+18 more criteria

Locations (1)

Hamilton Health Sciences

Hamilton, Ontario, Canada

Key Dates

Start Date

February 1, 2009

Primary Completion Date

February 1, 2014

Completion Date

February 1, 2016

Last Updated

September 15, 2016

Enrollment

ACTUAL participants

Conditions

Prostate Cancer

Interventions

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

BIOLOGICAL

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RECRUITINGPHASE2

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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Metastatic Castration-Resistant Prostate Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 15, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC