E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with relapse of prostate cancer. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Assess the feasibility and safety of vaccination with pVAXrcPSAv53l, administered intradermally in combination with electroporation in patients with relapse of prostate cancer. |
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E.2.2 | Secondary objectives of the trial |
Assess the safety and functionality of the DERMA VAX™ in vivo electroporation DNA vaccine delivery system.
Identify optimal application parameters for DERMA VAX™ DNA vaccine delivery system.
Identify the variation in human skin resistance to be used in future trials as a quality measure of electric field applied.
Evaluate the PSA-specific immune response induced by the vaccine.
Evaluate vaccine effect on PSA doubling time
Identify an anti-tumor effect of the vaccine.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 metastastatic prostate cancer. • Karnofsky performance status minimum 80. • Adequate organ function: o AST and ALT <2.0 x upper limit of normal (ULN); total serum bilirubin <1.5 x ULN o Calcium <2.6 mmol/L, serum creatinine <1.5 x ULN o Hb >100 g/L; absolute leukocyte count >3.0 x 109 /L; platelets >100 x 109 /L • Life expectancy > or equal to 12 months. • Swedish or English speaking subjects only. • Written informed consent (subjects must be capable of providing their own informed consent)
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E.4 | Principal exclusion criteria |
• Previous ablation of testis. • Radiologic evidence of metastatic disease. • Prior chemotherapy or investigational therapy/agents within 4 weeks. • Active bacterial, viral or fungal infection. • Carrier of HIV, HBV, or HCV. • Immunosupppressed (post splenectomy, post stem cell transplantation) or on immunosuppressive therapy other than inhaled or replacement corticosteroids. • Any other major illness or peripheral blood vein status that, in the investigator’s judgment, will substantially increase the risk associated with sampling or participation in this study. • Subjects with cardiac demand pacemakers. • Any reason why, in the opinion of the investigator, the patient should not participate.
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary end point • Safety of pVAXrcPSAv53l, administered intradermally with DERMA VAX™ EP graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], Version 3.0).
Secondary end point • Detection of in vitro PSA-specific immune response. • Clinical PSA-response in vivo. • Optimization of application parameters for DERMA VAX™ device
Time-to endpoints For the purposes of endpoint definitions, the term “on study” includes the period of androgen deprivation, vaccination and follow-up. Follow-up continues every 6 months until PSA progression or, maximum one (1) year after the patient’s fifth vaccination.
Time to PSA progression Is defined - from day 0 when treatment with Bicalutamide is initiated until PSA increases 50 % above the nadir or 25 % over baseline, provided that either increase is a minimum of 3 mg/L. All end dates require a confirmatory PSA. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | Yes |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
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E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |