Status:
COMPLETED
Safety & Activity of P501-AS15 Vaccine as a First-line Treatment for Patients With Hormone-sensitive Prostate Cancer Who Show Rising PSA
Lead Sponsor:
GlaxoSmithKline
Conditions:
Neoplasms, Prostate
Eligibility:
MALE
18-75 years
Phase:
PHASE1
Brief Summary
Patients with hormone-sensitive prostate cancer and rising PSA, after primary tumor treatment, will be treated with the P501-AS15 vaccine as out-patients. The maximum dose will be 16 vaccinations, giv...
Detailed Description
This Phase I/II study will be conducted according to a multicenter, open-label, single-group design at approximately ten centers in Europe. At least 21 HSPC patients with rising PSA after primary tumo...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Male,
- Aged between 18 and 75 years, inclusive,
- Histologically or cytologically proven adenocarcinoma of the prostate before the initiation of therapy of the primary tumor,
- Radical prostatectomy before progression of disease by rising PSA was established,
- Primary tumor presented a Gleason sum score ≤8,
- Proven progressive hormone-sensitive prostate cancer,
- Serum testosterone level above 50 ng/dl,
- Free of clinically evaluable metastatic disease (other than the rising PSA),
- ECOG Performance Status of 0 or 1,
- Normal organ functions,
- Negative HBV antigen test,
- Negative HCV antibody test,
- The investigator believes that the patient can and will comply with the requirements of the protocol,
- Written, informed consent obtained before enrolment.
- Exclusion criteria:
- Orchiectomy,
- Received androgen-deprivation therapy, including neo adjuvant androgen-deprivation therapy,
- Any radiotherapy (external beam radiotherapy and/or brachytherapy) for prostate cancer as primary management,
- Receiving treatment with continuous systemic anticancer medications,
- Received chronic administration of immunosuppressants or other immune-modifying drugs within six months before the first vaccine dose,
- Received any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or the administration of such a product is planned during the study period,
- Receiving any immunoglobulins and/or other blood products or has received such products within the three months preceding the first dose of study vaccine or is planned to receive such products during the study period,
- Received any commercial vaccine within the week before the first study vaccination,
- Previous or concomitant malignancies at other sites, except (i) adequately treated non-melanoma skin cancers, and (ii) effectively treated malignancy that has been in remission for \>2 years and is considered by the investigator highly likely to have been cured,
- Any clinical autoimmune disease (except vitiligo),
- Family history of congenital or hereditary immunodeficiency,
- HIV-positive,
- Medical history includes splenectomy or irradiation to the spleen,
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine,
- Any known allergy or hypersensitivity to yeast or yeast products,
- The patient presents with serious acute or chronic illness(es), e.g. active infections requiring antibiotics, bleeding/coagulation disorders, clinically significant heart disease (NCIC CTG III-IV), or other conditions requiring concurrent medications not allowed during this study,
- Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule,
- History of chronic alcohol consumption and/or drug abuse,
- Acute disease at the time of enrolment. All vaccines can be administered to persons with a minor illness.
Exclusion
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 7 2006
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00148928
Start Date
March 1 2005
End Date
November 7 2006
Last Update
June 2 2017
Active Locations (8)
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1
GSK Investigational Site
Brussels, Belgium, 1070
2
GSK Investigational Site
Brussels, Belgium, 1200
3
GSK Investigational Site
Turnhout, Belgium, 2300
4
GSK Investigational Site
Auxerre, France, 89011