Efficacy and Safety Study of the Therapeutic Vaccine PEP223 in Prostate Cancer Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Pepscan Therapeutics.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
TFS Trial Form Support
Information provided by:
Pepscan Therapeutics
ClinicalTrials.gov Identifier:
NCT00895466
First received: May 6, 2009
Last updated: May 7, 2009
Last verified: May 2009
  Purpose

The purpose of this trial is to investigate whether treatment with this new drug will result in lower testosterone levels in men with prostate cancer. At the same time it will be investigated whether the drug induces side effects, and if so, which ones.


Condition Intervention Phase
Prostate Cancer
Biological: PEP-223/CoVaccine HT
Phase 1
Phase 2

Study Type: Interventional
Official Title: A Phase I-II Open Label Clinical Trial, Evaluating the Efficacy and Safety of Administration of the Therapeutic Vaccine PEP-223/CoVaccine HT, to Hormone Treatment naïve, Immunocompetent Subjects With T1-3, N0-1/x, M0 Prostate Cancer, Eligible for Hormone Therapy.

Resource links provided by NLM:


Further study details as provided by Pepscan Therapeutics:

Primary Outcome Measures:
  • Testosterone suppression [ Time Frame: after 12 weeks treatment as compared to baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The time course of testosterone suppression [ Time Frame: after 2, 4, 6, 8, 10 and 12 weeks treatment as compared to baseline ] [ Designated as safety issue: No ]
  • Effects on LH and FSH levels [ Time Frame: after 2, 4, 6, 8, 10 and 12 weeks treatment as compared to baseline ] [ Designated as safety issue: No ]
  • Effects on PSA levels [ Time Frame: after 2, 4, 6, 8, 10 and 12 weeks treatment as compared to baseline ] [ Designated as safety issue: No ]
  • Antibody response to PEP223/CoVaccine HT [ Time Frame: after 2, 4, 6, 8, 10 and 12 weeks treatment as compared to baseline ] [ Designated as safety issue: No ]
  • Safety (adverse events, laboratory values, injection site reactions) [ Time Frame: as applicable ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Study Start Date: October 2008
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Detailed Description:

Prostate cancer growth is influenced by the male hormone testosterone. Treatment with drugs that stop the production of testosterone often results in a decrease of the tumor or inhibition of its growth. This is particularly important prior to radiotherapy, since radiation can better be focused on the prostate with as a result less frequent or less severe side effects of the radiation.

Most of the drugs used to date to stop the production of testosterone have the disadvantage that initially they may cause a rise of testosterone levels before the production is effectively blocked. The new drug that will be investigated in this trial is a vaccine. The vaccine offers a different treatment modality since it interferes at a different level of the hormonal axis that drives the testosterone production; it will not cause an initial surge.

In this trial the vaccine will be administered three times, testosterone levels will be monitored for a total period of three months.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • pathological confirmed prostatic adenocarcinoma, clinical stage (c) cT1-3, cN0-1/x, cM0
  • baseline testosterone levels of > 4 nmol/l
  • baseline PSA level of > 10 microg/l
  • eligible for hormone therapy
  • willingness to comply with the protocol conditions and procedures
  • willing and able to give informed consent

Exclusion Criteria:

  • clinical evidence of distant metastases
  • previous hormonal therapy administered specifically for prostatic carcinoma
  • development of another invasive neoplastic disease during the previous 5 years, or concomitant presence of another invasive neoplastic disease, except basal cell carcinoma or squamous cell carcinoma of the skin
  • primary or secondary immunodeficiency, including immunosuppressive disease or use of corticosteroids or other immunosuppressive medications
  • concomitant administration - or administration during the 12 weeks preceding study inclusion - of immune enhancing medication or testosterone supplements
  • concomitant radiotherapy for prostate cancer
  • presence of bacterial prostatitis causing a PSA increase during the 8 weeks preceding study inclusion
  • simultaneous participation in another clinical trial or participation in a clinical trial involving investigational drugs within 3 months before enrollment into the present study
  • BMI > 30 kg/square meter
  • previous serious reaction to a vaccine such as angioedema or anaphylaxis
  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: NCT00895466

Contacts
Contact: Drug Development info@pepscan.com

Locations
Netherlands
UMC Groningen Recruiting
Groningen, Netherlands, 9713 GZ
UMC Nijmegen Recruiting
Nijmegen, Netherlands
Sponsors and Collaborators
Pepscan Therapeutics
TFS Trial Form Support
  More Information

No publications provided

Responsible Party: Chief Medical Officer, Pepscan Therapeutics
ClinicalTrials.gov Identifier: NCT00895466     History of Changes
Other Study ID Numbers: PEP223-NL-0701
Study First Received: May 6, 2009
Last Updated: May 7, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Ministry of Health, Welfare and Sport

Keywords provided by Pepscan Therapeutics:
prostatic diseases
neoplasms
prostatic neoplasms
hormones
androgen antagonists
vaccines
peptide vaccines
adjuvants, immunological

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

ClinicalTrials.gov processed this record on September 18, 2014