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

NCT00852007 | Completed Phase 1

• 1 other identifier: CAN-ONC-001 CAN
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

prostate cancer; dendritic cells; MUC-1; immune therapy

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (5)

• Number of participants with adverse events

  Ongoing up to 2 years

• Time to PSA progression

  Up to 2 years

• Immune response

  Up to 2 years

• Overall survival

  Up to 2 years

• Disease-specific survival

  Up to 2 years

Study Arms (1)

DC-Tn-MUC

EXPERIMENTAL

DC-Tn-MUC1: autologous dendritic cells expressing Tn-MUC1. 1.2 x 10e7 dendritic cells per dose. 5 administrations (doses)may be given in total.

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

Interventions

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

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.).

DC-Tn-MUC

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has a histologically documented diagnosis of prostate cancer
• Subject must meet one of the following PSA criteria:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• McMaster University: collaborator

Study Sites (1)

Hamilton Health Sciences

Hamilton, Ontario, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Pierre P. Major, MD

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2009
• First Posted: February 26, 2009
• Study Start: February 1, 2009
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2016
• Last Updated: September 15, 2016

Record last verified: 2016-09

Locations

CA (1)