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

This study has been terminated.
(Safety reasons, though no safety issues arose.)
Sponsor:
Collaborators:
Cell Genesys
Sanofi
Information provided by:
Benaroya Research Institute
ClinicalTrials.gov Identifier:
NCT00577356
First received: December 18, 2007
Last updated: January 18, 2011
Last verified: November 2010
  Purpose

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).


Condition Intervention Phase
Prostate Cancer
Drug: Docetaxel
Biological: CG1940/CG8711
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Neoadjuvant Docetaxel and CG1940/CG8711 Followed by Radical Prostatectomy in Patients With High-Risk, Clinically Localized Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Benaroya Research Institute:

Primary Outcome Measures:
  • Number of Participants With Pathological Complete Response. [ 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. ] [ Designated as safety issue: Yes ]
    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


Enrollment: 6
Study Start Date: February 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Docetaxel
    Docetaxel 75mg/m2 will be given intravenously every 3 weeks for four cycles.
    Other Name: Taxotere
    Biological: CG1940/CG8711
    Immunotherapy allogeneic GM-CSF secreting cellular vaccine
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00577356

Locations
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Benaroya Research Institute
Cell Genesys
Sanofi
Investigators
Principal Investigator: Jacqueline Vuky, MD Virginia Mason Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Jacqueline Vuky, MD, Virginia Mason Medical Center
ClinicalTrials.gov Identifier: NCT00577356     History of Changes
Other Study ID Numbers: IRB07028, I-0057, IST# 16194
Study First Received: December 18, 2007
Results First Received: September 13, 2010
Last Updated: January 18, 2011
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014