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| ID | Type | Description | Link |
|---|---|---|---|
| I-0057 | |||
| IST# 16194 |
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Safety reasons, though no safety issues arose.
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| Name | Class |
|---|---|
| Cell Genesys | INDUSTRY |
| Sanofi | INDUSTRY |
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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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | Docetaxel 75mg/m2 will be given intravenously every 3 weeks for four cycles. |
| |
| CG1940/CG8711 | Biological | Immunotherapy allogeneic GM-CSF secreting cellular vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacqueline Vuky, MD | Virginia Mason Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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Eligible patients had histologically confirmed adenocarcinoma of the prostate with clinical stage 1-3, no evidence of metastatic disease, and were appropriate candidates for radical prostatectomy with an estimated life expectancy >10 years.
Recruitment from Feb. 08 through September 08 at Virginia Mason Medical Center
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| ID | Title | Description |
|---|---|---|
| FG000 | CG1940/CG8711 (Immunotherapy Drug) | Patients were given a prime immunotherapy of 5 x 108 cells consisting of equal amounts of CG1940 and CG8711 followed 21 days later by boost immunotherapies of 3 x 108 cells consisting of equal amounts of CG1940 and CG8711 every 21 days for the first 4 immunotherapies. (given 2 to 3 days after docetaxel) for a total of 4 immunotherapies, followed by a fifth dose given at 2, 8, or 14 days prior to prostatectomy, and then beginning at 3 - 6 weeks post-operatively an additional 6 immunotherapies every 14 days for a combined total of 11 immunotherapies. Docetaxel chemotherapy was administered intravenously starting day 1 of the first week and given every 3 weeks thereafter for a total of 4 cycles. A cycle is defined as every 21 days (3 weeks). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CG1940/CG8711 (Immunotherapy Drug) | Patients were given a prime immunotherapy of 5 x 108 cells consisting of equal amounts of CG1940 and CG8711 followed 21 days later by boost immunotherapies of 3 x 108 cells consisting of equal amounts of CG1940 and CG8711 every 21 days for the first 4 immunotherapies. (given 2 to 3 days after docetaxel) for a total of 4 immunotherapies, followed by a fifth dose given at 2, 8, or 14 days prior to prostatectomy, and then beginning at 3 - 6 weeks post-operatively an additional 6 immunotherapies every 14 days for a combined total of 11 immunotherapies. Docetaxel chemotherapy was administered intravenously starting day 1 of the first week and given every 3 weeks thereafter for a total of 4 cycles. A cycle is defined as every 21 days (3 weeks). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Study was stopped before analysis occured. | Posted | Number | participants | 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. |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CG1940/CG8711 (Immunotherapy Drug) | Patients were given a prime immunotherapy of 5 x 108 cells consisting of equal amounts of CG1940 and CG8711 followed 21 days later by boost immunotherapies of 3 x 108 cells consisting of equal amounts of CG1940 and CG8711 every 21 days for the first 4 immunotherapies. (given 2 to 3 days after docetaxel) for a total of 4 immunotherapies, followed by a fifth dose given at 2, 8, or 14 days prior to prostatectomy, and then beginning at 3 - 6 weeks post-operatively an additional 6 immunotherapies every 14 days for a combined total of 11 immunotherapies. Docetaxel chemotherapy was administered intravenously starting day 1 of the first week and given every 3 weeks thereafter for a total of 4 cycles. A cycle is defined as every 21 days (3 weeks). |
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the trial was closed prior to planned accrual of 30 patients due to an external report from the randomized trial of docetaxel and CG1940/CG8711 resulting in a higher incidence of deaths compared to docetaxel alone in metastatic prostate cancer.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jacqueline Vuky, MD | Virginia Mason Medical Center | (206) 223-6193 | 32246 | Jacqueline.Vuky@vmmc.org |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| adenocarcinoma of the prostate and no radiographic evidence of metastatic disease | Mean | Standard Deviation | years |
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| Prostate Cancer | Number | participants |
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| 0 |
| 6 |
| 0 |
| 6 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |