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
Recruitment status was Recruiting
Sponsor:
Pepscan Therapeutics
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
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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) |
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| Ages Eligible for Study: | Child, Adult, Senior |
| 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
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
| 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 Diseases Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms |
Genital Diseases, Male Vaccines Hormones Immunologic Factors Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on September 30, 2016