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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT # 2006-001128-38 |
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| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
| Cyto Pulse Sciences, Inc. | INDUSTRY |
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This study will assess the feasibility and safety of vaccination with increasing doses of xenogenic DNA administered intradermally in combination with electroporation in patients with relapse of prostate cancer. The DNA encodes prostate specific antigen (PSA) from Rhesus Macaque (Macaca mulatta), a protein that is 89% homologous to human PSA. The study will also assess the safety and functionality of the DERMA VAX™ (Cyto Pulse Sciences) DNA vaccine delivery system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort I | Experimental | 50 µg DNA/dose, 3 patients |
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| Cohort II | Experimental | 150 µg DNA/dose, 3 patients |
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| Cohort III | Experimental | 400 µg DNA/dose, 3 patients |
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| Cohort IV | Experimental | 1000 µg DNA/dose, 3 patients |
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| Cohort V | Experimental | Optimal dose to be determined, 6 patients |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pVAXrcPSAv53l (DNA encoding rhesus PSA) | Biological | 5 doses, 4 weeks apart |
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| Measure | Description | Time Frame |
|---|---|---|
| Assess the feasibility and safety of escalating doses of pVAXrcPSAv53l DNA vaccine, administered intradermally in combination with electroporation in patients with relapse of prostate cancer. | From start of treatment to 30 days (safety) or up to 12 months (immunological & clinical) post last vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the safety and functionality of the DERMA VAX™ in vivo electroporation DNA vaccine delivery system. | From start of treatment to 30 days (safety) or up to 12 months (immunological & clinical) post last vaccination | |
| Evaluate the PSA-specific immune response induced by the vaccine. |
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Inclusion Criteria:
Male patients. Age >18 years.
HLA-A*0201 positive.
Histologically confirmed prostate cancer.
Minimum two (2) and maximum four (4) years after treatment with curative or salvage radiotherapy.
Serum testosterone within normal range.
Increasing PSA from a previous reference value on two (2) consecutive occasions at least one month apart and with a minimum of 2 ng/mL above nadir.
PSA doubling time is one (1) year or less.
No evidence of metastatic prostate cancer.
Karnofsky performance status ≥ 80.
Adequate organ function:
Life expectancy ≥ 12 months.
Swedish or English speaking subjects only.
Written informed consent (subjects must be capable of providing their own informed consent).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Yachnin, MD, PhD | Department of Oncology, University Hospital Uppsala | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oncology, University Hospital Uppsala | Uppsala | 751 85 | Sweden |
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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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| DERMA VAX™ intradermal DNA delivery system | Device | in vivo electroporation is applied after each DNA injection |
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| From start of treatment to 30 days (safety) or up to 12 months (immunological & clinical) post last vaccination |
| Identify an anti-tumor effect of the vaccine. | From start of treatment to 30 days (safety) or up to 12 months (immunological & clinical) post last vaccination |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |