Back to resultsDocetaxel and Immunotherapy Prior to Prostatectomy for High-Risk Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Docetaxel
CG1940/CG8711
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients must have clinical stage 1-3 disease and no radiographic evidence of metastatic disease
- Nomogram Prediction: Patients must have a Kattan nomogram predicted probability of being free from biochemical progression at 5 years after surgery of <60%.
Exclusion Criteria:
- Concurrent or prior treatment with radiation, cytotoxic or biologic therapy for prostate cancer, prior hormonal therapy (except finasteride or dutasteride for obstructive voiding symptoms)
- Male patients unwilling to use effective means of contraception are excluded. Contraception should be continued for 3 months after treatment.
- Prior malignancy will not exclude the patient. (Patients can not have active cancer or be undergoing active treatment). The Principal Investigator will make final decision regarding eligibility since the end point is pathological complete response.
Sites / Locations
- Virginia Mason Medical Center
Outcomes
Primary Outcome Measures
Number of Participants With Pathological Complete Response.
CG1940/CG8711 was given along with docetaxel over a series of treatment prior to radical prostatectomy. Pathology of resected specimen was done to determine complete response, defined as no microscopic evidence of neoplastic cells in the resected specimen
Secondary Outcome Measures
Full Information
NCT ID
NCT00577356
First Posted
December 18, 2007
Last Updated
January 18, 2011
Sponsor
Benaroya Research Institute
Collaborators
Cell Genesys, Sanofi
1. Study Identification
Unique Protocol Identification Number
NCT00577356
Brief Title
Docetaxel and Immunotherapy Prior to Prostatectomy for High-Risk Prostate Cancer
Official Title
Phase II Trial of Neoadjuvant Docetaxel and CG1940/CG8711 Followed by Radical Prostatectomy in Patients With High-Risk, Clinically Localized Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Terminated
Why Stopped
Safety reasons, though no safety issues arose.
Study Start Date
February 2008 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Benaroya Research Institute
Collaborators
Cell Genesys, Sanofi
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to find out what effects, good and bad, the combination of docetaxel with CG1940/CG8711 (immunotherapy drugs) have on destroying prostate cancer before removal the prostate (prostatectomy).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
Docetaxel 75mg/m2 will be given intravenously every 3 weeks for four cycles.
Intervention Type
Biological
Intervention Name(s)
CG1940/CG8711
Intervention Description
Immunotherapy allogeneic GM-CSF secreting cellular vaccine
Primary Outcome Measure Information:
Title
Number of Participants With Pathological Complete Response.
Description
CG1940/CG8711 was given along with docetaxel over a series of treatment prior to radical prostatectomy. Pathology of resected specimen was done to determine complete response, defined as no microscopic evidence of neoplastic cells in the resected specimen
Time Frame
The study evaluates 4 months of docetaxel and immunotherapy prior to radical prostatectomy followed by radical prostatectomy with an additional 3 months of immunotherapy after radical prostatectomy.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must have clinical stage 1-3 disease and no radiographic evidence of metastatic disease
Nomogram Prediction: Patients must have a Kattan nomogram predicted probability of being free from biochemical progression at 5 years after surgery of <60%.
Exclusion Criteria:
Concurrent or prior treatment with radiation, cytotoxic or biologic therapy for prostate cancer, prior hormonal therapy (except finasteride or dutasteride for obstructive voiding symptoms)
Male patients unwilling to use effective means of contraception are excluded. Contraception should be continued for 3 months after treatment.
Prior malignancy will not exclude the patient. (Patients can not have active cancer or be undergoing active treatment). The Principal Investigator will make final decision regarding eligibility since the end point is pathological complete response.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacqueline Vuky, MD
Organizational Affiliation
Virginia Mason Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
12. IPD Sharing Statement
Links:
URL
http://benaroyaresearch.org
Description
Related Info
Learn more about this trial
Docetaxel and Immunotherapy Prior to Prostatectomy for High-Risk Prostate Cancer
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