Docetaxel and Immunotherapy Prior to Prostatectomy for High-Risk Prostate Cancer
This study has been terminated.
(Safety reasons, though no safety issues arose.)
Sponsor:
Benaroya Research Institute
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
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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:
Genetics Home Reference related topics:
prostate cancer
MedlinePlus related topics:
Prostate Cancer
Drug Information available for:
Docetaxel
U.S. FDA Resources
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 (Adult, Senior) |
| 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
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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
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:
| 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 Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 28, 2016