Status:
COMPLETED
A Phase II Randomised Trial of Three Regimens of GX301 Vaccination in Castration-resistant Prostate Cancer
Lead Sponsor:
Laboratoires Leurquin Mediolanum
Collaborating Sponsors:
Universita degli Studi di Genova
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
GX301 is an experimental therapeutic vaccine directed against human telomerase, an enzyme playing an essential role in cancer cell proliferation. This clinical trial will test three different GX301 a...
Detailed Description
GX301, an experimental therapeutic (anti-cancer) vaccine, is composed of four immunogenic peptides from human telomerase and two complementary adjuvants, Montanide ISA-51 VG and imiquimod. An earlier...
Eligibility Criteria
Inclusion
- Documented patient history
- 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.
- Completion of chemotherapy with a cumulative delivered dose of 300 to 825 mg/m2 docetaxel.
- Note: Pre-chemotherapy exposure to abiraterone and prednisone does not preclude eligibility, provided that both agents have been discontinued prior to initiation of docetaxel.
- Current patient status
- Ability to understand study-related patient information and provision of written informed consent for participation in the study.
- Eastern Cooperative Oncology Group (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 with docetaxel chemotherapy.
- Absence of cancer-related symptoms suggesting clinical disease progression.
- Current castrate testosterone level (≤50 ng/dL) due to current gonadotropin-releasing hormone (GnRH) agonist or antagonist therapy or past orchiectomy.
- Haematology and blood chemistry tests within specified limits.
- Successful recovery from acute toxicities from prior chemotherapy.
- Confirmation from the immunology laboratory that the blood sample provided for baseline immunological tests is technically adequate.
Exclusion
- Known intolerance to Montanide or imiquimod.
- Known presence of brain metastatic disease or spinal cord compression.
- Radiotherapy within the past 4 weeks.
- Concomitant presence of other primary malignancy
- 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.
- Serious uncontrolled infection.
- Known presence of active autoimmune disease.
- Known presence of acquired, hereditary, or congenital immunodeficiency.
- HIV infection.
- Current need for immunosuppressive drug therapy, including systemic corticosteroids.
- Current need for denosumab therapy. (Patients under bisphosphonate treatment are eligible).
- Skin disease interfering with evaluation of local tolerance of GX301 injections.
- Participation in any interventional drug or medical device study within 30 days prior to treatment start.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2019
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT02293707
Start Date
November 1 2014
End Date
November 1 2019
Last Update
July 22 2020
Active Locations (24)
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1
S.C. di Oncologia, A.S.O. "Santi Antonio e Biagio e Cesare Arrigo"
Alessandria, Italy, 15121
2
Oncologia Medica A, Centro di Riferimento Oncologico (CRO)
Aviano, Italy, 33081
3
Oncologia Medica, Azienda Ospedaliero Universitaria - Policlinico Consorziale
Bari, Italy, 70124
4
U.O.C. Urologia 1, A.O.U. Consorziale Policlinico di Bari
Bari, Italy, 70124