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| Name | Class |
|---|---|
| Memorial Sloan Kettering Cancer Center | OTHER |
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The purpose of this study is to assess the safety and activity of DC/PC3, a dendritic cell vaccine used as immunotherapy for prostate cancer. The vaccine is made with each participants' own immune cells obtained through blood donation. Dendritic cells are known to activate other immune cells such as T cells, that are able to mount an attack against cancer cells. The dendritic cell vaccine will be administered as injections every 2 weeks over a course of 2 months.
See Brief Summary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DC/PC3 vaccine | Experimental | 3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) pulsed with apoptotic PC3 cells; 2) pulsed with apoptotic PC3-M1 cells, and 3) pulsed with keyhole limpet hemocyanin (KLH, control antigen) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous dendritic cell vaccine (DC/PC3) | Biological | ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells(control apoptotic cells) and pulsed with KLH (control antigen). maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 106 DCs. Doses in the range of 105 to 10 x 106 DCs have been used clinically without toxicity |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity | adverse events | through week 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity | The Tritiated thymidine proliferation assay is used to assess samples collected pre-treatment and those collected post-treatment; the outcome measure is the change in counts per minute (post-treatment counts minus pre-treatment counts). | pre and post treatment |
| Clinical Response |
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Inclusion Criteria:
Prostate cancer
Rising prostate specific antigen (PSA, 3 values, each measured at least 2 weeks apart) post initial therapy (ie, radiation, prostatectomy) human leukocyte antigen A2.1 (HLA-A2.1)
-
Exclusion Criteria:
central nervous system metastasis
History of autoimmune disease
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| Name | Affiliation | Role |
|---|---|---|
| Robert B Darnell, MD PHD | Rockefeller University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rockefeller University Hospital | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25475068 | Derived | Frank MO, Kaufman J, Parveen S, Blachere NE, Orange DE, Darnell RB. Dendritic cell vaccines containing lymphocytes produce improved immunogenicity in patients with cancer. J Transl Med. 2014 Dec 5;12:338. doi: 10.1186/s12967-014-0338-3. |
| Label | URL |
|---|---|
| study description at Rockefeller University website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | DC/PC3 Vaccine-selected | 3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and 2) pulsed with apoptotic PC3-M1 cells (control apoptotic cells) and 3) pulsed with KLH (control antigen). Maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 10^6 DCs. DCs were made from precursors isolated using antibodies. |
| FG001 | DC/PC3- Adherent | 3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and 2) pulsed with apoptotic PC3-M1 cells (control apoptotic cells) and 3) pulsed with KLH (control antigen). Maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 10^6 DCs. DCs were made from precursors isolated using the adherence method. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DC/PC3 Vaccine | 3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) pulsed with apoptotic PC3 cells; 2) pulsed with apoptotic PC3-M1 cells, and 3) pulsed with keyhole limpet hemocyanin (KLH, control antigen) autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells(control apoptotic cells) and pulsed with KLH (control antigen). maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 106 DCs. Doses in the range of 105 to 10 x 106 DCs have been used clinically without toxicity |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Toxicity | adverse events | Posted | Number | events | through week 29 |
|
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Common toxicity criteria v4
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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 | DC/PC3 Vaccine | 3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) pulsed with apoptotic PC3 cells; 2) pulsed with apoptotic PC3-M1 cells, and 3) pulsed with keyhole limpet hemocyanin (KLH, control antigen) autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells(control apoptotic cells) and pulsed with KLH (control antigen). maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 106 DCs. Doses in the range of 105 to 10 x 106 DCs have been used clinically without toxicity |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| chest pain | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| absolute lymphocyte, low | Blood and lymphatic system disorders | Systematic Assessment | G1 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mayu Frank, MS, ANP, Clinical Research Nurse Practitioner | Rockefeller University | 212-327-7443 | frankm@rockefeller.edu |
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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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|
| Post treatment |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Immunogenicity | The Tritiated thymidine proliferation assay is used to assess samples collected pre-treatment and those collected post-treatment; the outcome measure is the change in counts per minute (post-treatment counts minus pre-treatment counts). | One other participant in DC/PC3 vaccine-Selected group not analyzed due to failed controls in assay. | Posted | Median | Full Range | counts per minute | pre and post treatment |
|
|
|
| Secondary | Clinical Response | This data was not collected due to differences in immunogenicity based on different dendritic cell preparations. This data was no longer relevant. | Posted | Post treatment |
|
|
| 2 |
| 13 |
| 13 |
| 13 |
| arrhythmia | Cardiac disorders | Systematic Assessment | hospitalization for pacemaker placement |
|
| acid phosphatase, high | General disorders | Systematic Assessment | G1 |
|
| albumin, low | Blood and lymphatic system disorders | Systematic Assessment | G1 |
|
| albumin, trace, urine | General disorders | Systematic Assessment | G1 |
|
| alkaline phosphatase, high | General disorders | Systematic Assessment | G1 |
|
| ALT, high | Gastrointestinal disorders | Systematic Assessment | G2 |
|
| ANA, high | General disorders | Systematic Assessment | G1 |
|
| ANC, low | Blood and lymphatic system disorders | Systematic Assessment | G2 |
|
| AST, high | Hepatobiliary disorders | Systematic Assessment | G1 and G3 |
|
| bacteria, urine, few | General disorders | Systematic Assessment | G1 |
|
| basophil, high | Blood and lymphatic system disorders | Systematic Assessment | G1 |
|
| bilirubin, urine, small | General disorders | Systematic Assessment | G1 |
|
| blood, urine, trace | Renal and urinary disorders | Systematic Assessment | G1 |
|
| BUN, high | General disorders | Systematic Assessment | G1 |
|
| calcium, ionized, low | General disorders | Systematic Assessment | G1 |
|
| chloride, high | General disorders | Systematic Assessment | G1 |
|
| CO2, high | General disorders | Systematic Assessment | G1 |
|
| cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | G1 |
|
| creatinine, high | Blood and lymphatic system disorders | Systematic Assessment | G1 and G2 |
|
| crystals, urine | Renal and urinary disorders | Systematic Assessment | G1 |
|
| diarrhea | Gastrointestinal disorders | Systematic Assessment | G1 |
|
| fatigue | General disorders | Systematic Assessment | G1 and G2 |
|
| glucose, high | General disorders | Systematic Assessment | G1 and G2 |
|
| glucose, low | General disorders | Systematic Assessment | G1 and G2 |
|
| headache | General disorders | Systematic Assessment | G1 |
|
| heartburn | Gastrointestinal disorders | Systematic Assessment | G1 and G2 |
|
| hematocrit, low | Blood and lymphatic system disorders | Systematic Assessment | G1 |
|
| hematoma | General disorders | Systematic Assessment | G1 |
|
| hemoglobin, low | Blood and lymphatic system disorders | Systematic Assessment | G1 |
|
| hemorrhage, GU, bladder | Renal and urinary disorders | Systematic Assessment | G1 and G2 |
|
| epistaxis | General disorders | Systematic Assessment | G1 |
|
| injection site reaction | General disorders | Systematic Assessment | G1 and G2 |
|
| INR, low | General disorders | Systematic Assessment | G1 |
|
| ketones, urine, high | General disorders | Systematic Assessment | G1 |
|
| leuko est, urine, high | General disorders | Systematic Assessment | G1 |
|
| lightheadedness | General disorders | Systematic Assessment | G1 |
|
| low back pain | General disorders | Systematic Assessment | G1 |
|
| LUC, high | General disorders | Systematic Assessment | G1 |
|
| lymphocytes, %, low | General disorders | Systematic Assessment | G1 |
|
| MCHC, high | Blood and lymphatic system disorders | Systematic Assessment | G1 |
|
| monocytes, %, high | Blood and lymphatic system disorders | Systematic Assessment | G1 |
|
| neutrophils, %, high | Blood and lymphatic system disorders | Systematic Assessment | G1 |
|
| neutrophils, %, low | Blood and lymphatic system disorders | Systematic Assessment | G1 |
|
| numbness/tingling | General disorders | Systematic Assessment | G1 |
|
| chest pain | Cardiac disorders | Systematic Assessment | G3 |
|
| pain | General disorders | Systematic Assessment | G1 |
|
| pH, urine, high | General disorders | Systematic Assessment | G1 |
|
| platelet, high | General disorders | Systematic Assessment |
|
| platelets, low | General disorders | Systematic Assessment |
|
| potassium, high | General disorders | Systematic Assessment | G1 |
|
| presyncope | General disorders | Systematic Assessment | G2 |
|
| Prolonged QTc interval | Cardiac disorders | Systematic Assessment | G2 |
|
| pulmonary nodules | General disorders | Systematic Assessment |
|
| rash | General disorders | Systematic Assessment | G1 |
|
| RBC, low | Blood and lymphatic system disorders | Systematic Assessment | G1 |
|
| RBC, urine, high | Renal and urinary disorders | Systematic Assessment | G1 |
|
| RDW, high | General disorders | Systematic Assessment |
|
| rheumatoid factor, positive | General disorders | Systematic Assessment | G1 |
|
| rosecea | Skin and subcutaneous tissue disorders | Systematic Assessment | G1 |
|
| seasonal allergies | Immune system disorders | Systematic Assessment | G1 |
|
| specific gravity, urine, high | Renal and urinary disorders | Systematic Assessment |
|
| specific gravity, urine, low | Renal and urinary disorders | Systematic Assessment | G1 |
|
| swollen glands | General disorders | Systematic Assessment | G1 |
|
| thyroid nodules | General disorders | Systematic Assessment |
|
| total bilirubin, high | General disorders | Systematic Assessment |
|
| total protein, low | General disorders | Systematic Assessment | G1 |
|
| URI | General disorders | Systematic Assessment | G1 |
|
| vasovagal episode | General disorders | Systematic Assessment | G2 |
|
| vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| WBC, low | Blood and lymphatic system disorders | Systematic Assessment | G1 |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |