primary aim of the study To investigate the efficacy of PEP-223/CoVaccine HT in decreasing serum testosterone levels to below castrate levels, i.e. to < 2 nmol/l, within 8 weeks after the last of three injectionssecondary aims of the studyTo…
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
- Prostatic disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary efficacy parameter: serum testosterone levels
Secondary outcome
Secondary efficacy parameters:
- serum FSH levels, serum LH levels and serum anti-GnRH Ab levels.
Safety parameters:
- (spontaneous) reports of adverse events
- laboratory data (endocrinology, hematology, biochemistry) and urinalysis
- ECG
- blood pressures, pulse rate, respiratory rate, body temperature
- Physical examination
- serum PSA levels
Background summary
GnRH is a hormone that is produced by (part of) the brain. It stimulates a
certain gland to produce another hormone that stimulates the testes to produce
testosterone. The drugs used to date to stop the production of the male
hormone, testosterone, are the so-called GnRH (or LHRH) analogues. By
continuously administering these analogues, the gland that produces the
stimulating hormone becomes insensitive en doesn*t produce this hormone any
more. As a result, the testes aren*t stimulated any more to produce
testosterone and the testosterone blood levels decrease. A disadvantage of this
treatment modality is that the drug has to be administered continuously to
become and stay effective. The new drug that is investigated in the present
study, may offer an alternative treatment modality and could be more effective
in decreasing the tumor or inhibition of its growth than other hormone
therapies.
Study objective
primary aim of the study
To investigate the efficacy of PEP-223/CoVaccine HT in decreasing serum
testosterone levels to below castrate levels, i.e. to < 2 nmol/l, within 8
weeks after the last of three injections
secondary aims of the study
To investigate:
- the time course of testosterone suppression induced by PEP-223/CoVaccine HT
- the efficacy of PEP-223/CoVaccine HT in decreasing serum FSH and LH levels
- the antibody response to PEP-223/CoVaccine HT
- the safety and tolerability of PEP-223/CoVaccine HT
Study design
This is an open label phase I-II study in which eligible subjects will receive
three injections with the therapeutic vaccine PEP-223 on days 0 (primer), 14
and 28 (boosters), followed by an observation period of 8 weeks. PEP-223 will
be administered with the adjuvant CoVaccine HT. The total study duration for an
individual patient is 12 weeks.
Intervention
Three adminstrations (2 weeks apart) of 7 µg conjugated modified GnRH peptide
(PEP-223) in 2 ml of total vaccine (containing 0,5 ml adjuvant). This is to be
administrated as as 2 x 1 ml IM injections in the right and left upper leg,
gluteal or deltoid muscle.
Study burden and risks
The patient is asked to come to the hospital for 8 visits in 13 weeks time.
The vaccine will be administrated on three different occasions (2 weeks in
between) by means of two intramusculair injections per occasion. After the
administration of the injections the patient is kept for observation for 4
hours in the hospital.
Blood sampling takes place at each of the 8 visits. The amount of blood taken
per visit differs but in total not more than 225 ml will be taken.
At 6 visits, blood pressure, pulse, respiratory rate and temperature are
measured
At 6 visits an ECG is made and the patient will undergo a physical examination.
At 5 visits the patient must bring a urine sample.
Three times, the patient will be asked to keep a diary for 1 week long to
record possible reactions to the injections and to record twice daily the
measured temperature.
Zuidersluisweg 2
8243 RC Lelystad
NL
Zuidersluisweg 2
8243 RC Lelystad
NL
Listed location countries
Age
Inclusion criteria
1 pathological confirmed prostatic adenocarcinoma, clinical
stage (c) cT1-3, cN0-1/x, cM0;
2 baseline testosterone levels of > 4 nmol/l;
3 baseline PSA level of > 10 µg/l;
4 eligible for hormone therapy;
5 willingness to comply with the protocol conditions and procedures;
6 willing and able to give informed consent.
Exclusion criteria
1 clinical evidence of distant metastases;
2 previous (within 3 years before enrolment into the present study)hormonal therapy administered specifically for prostatic carcinoma;
3 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;
4 primary or secondary immunodeficiency, including immunosuppressive disease or use of corticosteroids or other immunosuppressive medications;
5 concomitant administration -or administration during the 12 weeks preceding study inclusion- of immune enhancing medication or testosterone supplements;
6 presence of bacterial prostatitis causing a PSA increase during the 8 weeks preceding study inclusion;
7 simultaneous participation in another clinical trial or participation in a clinical trial involving investigational drugs within 3 months before enrolment into the present study;
8 BMI > 30 kg/m2;
9 a previous serious reaction to a vaccine such as angioedema or anaphylaxis.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-005316-80-NL |
| CCMO | NL20226.000.07 |