Safety & Activity of P501-AS15 Vaccine as a First-line Treatment for Patients With Hormone-sensitive Prostate Cancer Who Show Rising PSA

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00148928
First received: September 7, 2005
Last updated: March 24, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Neoplasms, Prostate
Prostate Cancer
Biological: P501-AS15 vaccine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 [ Time Frame: During the study ] [ Designated as safety issue: No ]
  • Clinical PSA response [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • a. For patients who present a PSA response: The duration of PSA response, The duration of PSA control, The duration of log PSA response. [ Time Frame: During the study ] [ Designated as safety issue: No ]
  • b. Humoral immune response induced by P501-AS15 vaccine: Anti-CPC seropositivity. Anti-P501 seropositivity. [ Time Frame: At all points during treatment as specified in the study schedule ] [ Designated as safety issue: No ]
  • c. Cellular immune response induced by P501-AS15 vaccine. Frequency of in vitro cellular immune response to CPC P501. [ Time Frame: At all points during treatment as specified in the study schedule ] [ Designated as safety issue: No ]
  • d. Any toxicity in terms of solicited symptoms, unsolicited symptoms and serious adverse events. [ Time Frame: During the study ] [ Designated as safety issue: No ]
  • e. All adverse events, whether or not associated with toxicity. [ Time Frame: During the study ] [ Designated as safety issue: No ]
  • f. General laboratory safety variables. [ Time Frame: At all points during treatment as specified in the study schedule ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: March 2005
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: P501-AS15 vaccine
    Other Name: P501-AS15 vaccine
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 tumor treatment will be enrolled in this study. All patients will be treated as out-patients and will receive the same treatment. The maximum dose will be 16 vaccinations. Follow-up: The patients' long-term safety and PSA status will be followed over a period of 48 weeks. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00148928

Locations
Belgium
GSK Investigational Site
Bruxelles, Belgium, 1070
GSK Investigational Site
Bruxelles, Belgium, 1200
GSK Investigational Site
Turnhout, Belgium, 2300
France
GSK Investigational Site
Auxerre Cedex, France, 89011
GSK Investigational Site
Paris Cedex 05, France, 75248
GSK Investigational Site
Toulouse Cedex 4, France, 31403
GSK Investigational Site
Villejuif Cedex, France, 94805
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00148928     History of Changes
Other Study ID Numbers: 102238, 104634
Study First Received: September 7, 2005
Last Updated: March 24, 2011
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014