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| Name | Class |
|---|---|
| Providence Health & Services | OTHER |
| Providence Cancer Center | UNKNOWN |
| Providence Cancer Center, Earle A. Chiles Research Institute | OTHER |
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This is a pilot study of the DRibble vaccine in patients with advanced prostate cancer.
The primary objective of this pilot study is to assess the safety and tolerability of DRibble vaccine, cyclophosphamide, imiquimod, and Ceravix in castrate resistant prostate cancer.
This study will also assess:
An exploratory objective is to characterize the microbiome before and after study drugs administration and correlate prostate cancer responses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DRibble Vaccine | Experimental | Patients will receive cyclophosphamide 3 days prior to the first of 9 planned DRibble vaccine injections. Imiquimod will be applied following 6 injections. Patients will receive 2 HPV vaccinations (Human papillomavirus). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclophosphamide | Drug | A single dose of cyclophosphamide, 300 mg/m2, will be administered intravenously 3 Days prior to the first vaccine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Assessment | Patients will come to clinic 10 times over a 28 week period and have blood tests and vital sign measurements at each visit. In addition, patients will have 8 physical exams and performance status evaluations during this time period to evaluate possible toxicities related to study treatment. | 28 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Immune Response | Patients will have 11 blood draws during the study to evaluate the immune response. In addition, patients will undergo two leukapheresis procedures and provide two biopsy samples (if cancer is amenable to safe biopsy) to evaluate immune response. | 28 weeks |
| Prostate Cancer Response to DRibble vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiome identification | Patients will provide 3 stool samples for microbiome identification for future research to see if there is a correlation with response to treatment. | 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brendan Curti, MD | Providence Health & Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence Health & Services | Portland | Oregon | 97213 | United States |
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| Label | URL |
|---|---|
| Providence Cancer Center | View source |
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| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D009362 | Neoplasm Metastasis |
| D012798 | Sialorrhea |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| D000077271 | Imiquimod |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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| DRibble Vaccine | Biological | DRibble vaccine will be administered at Weeks 1, 4, 7, 10, 13, 16, 19 and 22. Eight vaccinations will be administered. Week 1 and 4 vaccines will be administered by intranodal injections performed using ultrasound guidance. |
|
|
| HPV Vaccinations | Biological | Patients will receive a dose of 0.5-mL CERVARIX at week 1 (Day 4) and week 7 by intramuscular injection at a site distant from the DRibble vaccine. |
|
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| Imiquimod | Drug | Imiquimod cream (5%, 250 mg) will be self-applied topically for 5 consecutive days by patients to a 4 x 5-cm outlined area of healthy extremity skin starting on the day of the second vaccine and again during each additional vaccine cycle. |
|
Patients will have 8 Prostate-Specific Antigen (PSA) Tests over a 22-week period and 3 CT scans over a 28-week period to assess response to treatment. |
| 28 weeks |
| D009385 |
| Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |