Last updated: 11/06/2018 23:53:30
Safety & activity of P501-AS15 vaccine as a first-line treatment for patients with hormone-sensitive prostate cancer who show rising PSA
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A multicenter, open-label Phase I/II trial to evaluate the safety and activity of CPC-P501 protein formulated with the adjuvant AS15 as first-line treatment in patients with hormone-sensitive prostate cancer who show rising PSA
Trial description: 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, given over a period of approximately one year. Thereafter, the patients' long-term safety and PSA status will be followed over a period of approximately 11 months.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Vaccine-related or possibly vaccine-related Grade 3 or 4 adverse event: a. Any Grade 4 toxicity: fatigue (including lethargy, asthenia, malaise) must have a duration of at least 24 hours. b. Any Grade 3 toxicity with a duration of at least 24 hours
Timeframe: During the study
Secondary outcomes:
a. For patients who present a PSA response: The duration of PSA response, The duration of PSA control, The duration of log PSA response.
Timeframe: During the study
b. Humoral immune response induced by P501-AS15 vaccine: Anti-CPC seropositivity. Anti-P501 seropositivity.
Timeframe: At all points during treatment as specified in the study schedule
c. Cellular immune response induced by P501-AS15 vaccine. Frequency of in vitro cellular immune response to CPC P501.
Timeframe: At all points during treatment as specified in the study schedule
d. Any toxicity in terms of solicited symptoms, unsolicited symptoms and serious adverse events.
Timeframe: During the study
e. All adverse events, whether or not associated with toxicity.
Timeframe: During the study
f. General laboratory safety variables.
Timeframe: At all points during treatment as specified in the study schedule
Interventions:
Biological/vaccine: P501-AS15 vaccine
Enrollment:
25
Observational study model:
Not applicable
Primary completion date:
2006-07-11
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Neoplasms, Prostate
Product
GSK560417A
Collaborators
Not applicable
Study date(s)
March 2005 to November 2006
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
18 - 75 years
Accepts healthy volunteers
No
- Male,
- Aged between 18 and 75 years, inclusive,
- Orchiectomy,
- Received androgen-deprivation therapy, including neo adjuvant androgen-deprivation therapy,
Inclusion and exclusion criteria
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.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
2006-07-11
Actual study completion date
2006-07-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study 102238 can be found on the GSK Clinical Study Register
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