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This is a clinical research study of an investigational (FDA IND-BB 10091) treatment of subjects with castration-resistant prostate cancer resistant to Taxanes (docetaxel, cabazitaxel) and evidence of disease progression on androgen-axis inhibition and/or immunotherapy in the form of sipuleucel-T.
The treatment is being evaluated for its effect on tumor growth. It consists of the placement (implantation) of small beads that contain mouse renal adenocarcinoma cells (RENCA macrobeads). The cells in the macrobeads produce substances that have been shown to slow or stop the growth of tumors in experimental animals and veterinary patients. It has been tested in 31 human subjects with different types of cancers in a Phase I safety trial. Phase II studies in patients with colorectal, pancreatic or prostate cancers are in progress.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cancer macrobeads | Experimental | Cancer Macrobead placement in abdominal cavity |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cancer Macrobead placement in abdominal cavity | Biological | 8 macrobeads per kilogram |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Data was not collected. | 16 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Metastases | 16 months | |
| Progression-free Survival | No data was collected. | 16 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barry H Smith, MD | The Rogosin Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Rogosin Institute | New York | New York | 10021 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cancer Macrobeads | Cancer Macrobead placement in abdominal cavity Cancer Macrobead placement in abdominal cavity: 8 macrobeads per kilogram |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| COMPLETED |
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| NOT COMPLETED |
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No analysis was performed due to small sample size. The one baseline participant withdrew voluntarily from the study after first implantation.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cancer Macrobeads | Cancer Macrobead placement in abdominal cavity Cancer Macrobead placement in abdominal cavity: 8 macrobeads per kilogram |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| 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 | Overall Survival | Data was not collected. | Data was not collected. | Posted | 16 months |
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| Secondary | Number of Metastases | Data was not collected. No statistical analysis was performed due to the sample size of one patient. | Posted | 16 months |
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| ||||||||||||||||||||
| Secondary | Progression-free Survival | No data was collected. | Data was not collected. | Posted | 16 months |
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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 | Cancer Macrobeads | Cancer Macrobead placement in abdominal cavity Cancer Macrobead placement in abdominal cavity: 8 macrobeads per kilogram | 0 | 1 | 1 | 1 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders |
| |||
| Fever | General disorders |
| |||
| Decreased appetite | General disorders |
| |||
| Diaphoresis | General disorders | Systematic Assessment |
| ||
| Urinary urgency | General disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angelica Nazarian | The Rogosin Institute | 212-746-1551 |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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