Docetaxel and Immunotherapy Prior to Prostatectomy for High-Risk Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Phase II Trial of Neoadjuvant Docetaxel and CG1940/CG8711 Followed by Radical Prostatectomy in Patients With High-Risk, Clinically Localized Prostate Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00577356
• Other study ID #: IRB07028
• Secondary ID: I-0057IST# 16194
• Status: Terminated
• Phase: Phase 2
• First received: December 18, 2007
• Last updated: January 18, 2011
• Start date: February 2008
• Est. completion date: September 2008

Study information

• Verified date: November 2010
• Source: Benaroya Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Docetaxel
Docetaxel 75mg/m2 will be given intravenously every 3 weeks for four cycles.

Biological:
• CG1940/CG8711
Immunotherapy allogeneic GM-CSF secreting cellular vaccine

Locations

Country	Name	City	State
United States	Virginia Mason Medical Center	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Benaroya Research Institute	Cell Genesys, Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Yes

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