A randomised, parallel-group, open-label Phase II trial of the immunological effects of three regimens of GX301 vaccination in castration-resistant prostate cancer patients who have achieved response or disease stability with first-line chemotherapy.
- Conditions
- Castration-resistant prostate cancer (patients who have achieved response or disease stability with first-line docetaxel chemotherapy).MedDRA version: 18.1 Level: PT Classification code 10062904 Term: Hormone-refractory prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-000095-26-ES
- Lead Sponsor
- aboratoires Leurquin Mediolanum S.A.S.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 120
Patient history
Eligible patients will have a documented history of the following:
? Histologically confirmed diagnosis of prostate cancer, with an available Gleason score.
? Diagnosis of progressive, castration-resistant prostate cancer (CRPC), leading to inception of first-line chemotherapy with a docetaxel-based regimen.
CRPC is defined as progression in PSA levels and/or in bone lesions or soft-tissue (visceral, nodal) lesions that has occurred during therapy with: front-line concurrent LHRH agonist and anti-androgen (maximal androgen blockade); or an anti-androgen added to front-line LHRH agonist following failure of the latter; or an LHRH-agonist replacing, or added to, front-line anti-androgen following failure of the latter.
Progression must have been observed: in all cases, in the presence of castrate serum testosterone levels (?50 ng/dL or 1.7 nmol/L); in patients receiving anti-androgen therapy, following 6 or more weeks from discontinuation of the anti-androgen agent.
Pre-chemotherapy therapeutic exposure to abiraterone acetate and prednisone does not preclude eligibility, provided that abiraterone and prednisone have been discontinued prior to initiation of docetaxel.
? Completion of chemotherapy with a cumulative delivered dose of 300 to 825 mg/m2 docetaxel.
Current patient status
? Age ?18 years.
? Ability to understand study-related patient information and provision of written informed consent for participation in the study.
? Symptomatic or asymptomatic status (as for cancer-related symptoms).
? ECOG performance status of 0 or 1.
? Life expectancy of at least 6 months.
? An interval ?4 weeks elapsed from the last docetaxel administration.
? Documented achievement of response or disease stability upon completion of docetaxel chemotherapy, in the absence of cancer-related symptoms suggesting clinical disease progression. Response is defined as post-chemotherapy PSA and imaging findings showing the following, as compared with the pre-chemotherapy documentation:
a) a PSA decrease ?50% confirmed in two consecutive determinations obtained approximately 4 weeks apart;
b) absence of new bone lesions at radionuclide bone scan;
c) a status of soft-tissue (nodal, visceral) lesions meeting RECIST criteria for complete response or partial response.
Condition a) must be met in all cases. Conditions b) and c) must additionally be met in those patients having bone and/or soft-tissue lesions in the pre-chemotherapy documentation.
Patients who fail to meet the above response definition will be considered to have stable disease if post- vs pre-chemotherapy findings show the following:
a) PSA decreased by <50% or unchanged; or a PSA increase <25% and <2ng/mL in absolute value; there is no need for a second confirmatory determination;
b) absence of new bone lesions at radionuclide bone scan;
c) soft-tissue (nodal, visceral) lesions meeting RECIST criteria for stable disease.
Applicability of conditions a), b) and c) is the same as stated above.
? Current castrate testosterone level (?50 ng/dL or 1.7 nmol/L) due to current GnRH agon
? Known intolerance to Montanide or imiquimod. Montanide adjuvants are found as ingredients of experimental human vaccines. Imiquimod is the active ingredient of Aldara, a medicinal product for topical use.
? Known presence of brain metastatic disease or spinal cord compression.
? Radiotherapy within the past 4 weeks.
? Concomitant presence of other primary malignancy except for non-melanomatous skin cancer, unless it was diagnosed and successfully treated ? 5 years ago with no subsequent evidence of recurrence.
? Major surgery within 4 weeks prior to randomisation.
? Cardiovascular illness or complication which, in Investigator?s judgment, compromises prognosis at 6 months or prevents the patient from following study procedures, including a recent history of stroke or myocardial infarction or presence of NYHA class III-IV heart failure or severe arrhythmia.
? Serious (NCI CTCAE grade 3-4) uncontrolled infection.
? Known presence of active autoimmune disease (e.g. rheumatoid arthritis, systemic lupus erythematosus, ulcerative colitis, Crohn's Disease, multiple sclerosis, ankylosing spondylitis).
? Known presence of acquired, hereditary, or congenital immunodeficiency, (e.g. cellular immunodeficiencies, hypogammaglobulinemia, dysgammaglobulinemia).
? HIV infection.
? Current need for immunosuppressive drug therapy, including systemic corticosteroids. Previously exposed patients are eligible following a wash-out period ?4 weeks before randomisation.
? Current need for denosumab therapy. (Patients under bisphosphonate treatment are eligible).
? Skin disease interfering with evaluation of local tolerance of GX301 injections.
? Any condition which, in the judgment of the Investigator, would place the subject at undue risk or interfere with the results of the study.
? Inability to regularly access centre facilities for logistical or other reasons.
? Participation in any interventional drug or medical device study within 30 days prior to treatment start.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method