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Overview - Onyvax-P trials
Trial: Vaccine Therapy in
Treating Patients With Stage D0 Prostate Cancer
Trial Number: ONY-P1-07-01
Location: National Cancer Institute, USA
This study is currently recruiting
participants who have not yet received hormone therapy.
For
further information, click here:
ClinicalTrials.gov Identifier: NCT00514072 (Opens
in a new window)
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Trial: ONY-P FOR THE TREATMENT OF
PROSTATE CANCER
Trial Number: ONY-P1-06-01
 
This trial is fully enrolled and is not recruiting
additional patients.
Objectives
This trial aims to determine the effectiveness
and safety of ONY-P vaccines in the management of hormone-resistant
prostate cancer. The trial will compare the time to disease progression
between three groups: those receiving ONY-P1, those receiving ONY-P2
and those receiving a dummy vaccine (placebo).
Key Eligibility Criteria
There is no age limit for patients in this
trial, but patients must be able to attend the Hospital for all
trial treatments and assessments for the duration of the trial.
In addition, patients must agree to be followed up irrespective
of whether they left the trial early or they are discontinued from
the trial or they completed the trial.
To be eligible for the trial, the following
are absolutely necessary:
• Confirmed prostate cancer (by histology)
• Previously treated with hormone therapy
• Rising serum PSA (Prostate Specific
Antigen)
• No evidence of disease visible on
CT (Computerised Tomography), MRI (Magnetic Resonance Image) or
bone scan
Patients will not be eligible to enter this
trial if:
• PSA is below 2ng/ml
• There is evidence of disease visible
on CT, MRI or bone scan
• They have received chemotherapy (other
than hormone therapy) or have been involved in another clinical
trial up to three months prior to screening
• They have received any other cancer
vaccine or immunotherapy
Trial Centres
Trial centres are located in the UK, Estonia,
Lithuania, Latvia and Ukraine.
Treatment
Patients will be enrolled in one of three
groups:
1. ONY-P1
2. ONY-P2
3. Dummy vaccine (placebo)
Up to 28 patients will be recruited into
each group, and the allocation of patients to the groups will be
randomized. The trial is double-blinded meaning that neither the
patient not his doctor will know which group the patient has been
allocated to. There is a one in three chance of receiving the placebo.
The study will last for 14 months, including
an initial 1 month period during which patients will be assessed
to make sure they are suitable to take part in the trial.
Patients taking part in this study will be
treated as follows after the initial 1 month assessment:
You would be given eight (8) small injections
into your skin every two (2) weeks during the first month of the
study (a total of 3 sets of injections). Two (2) injections into
each armpit and two (2) injections into each groin. Then more injections
at monthly intervals for up to a further 11 months as long as your
cancer is not progressing, i.e. a total of 15 sets of injections
over the year.
If you are in one of the groups receiving
a vaccine, then the first two (2) sets of injections would consist
of the cell vaccine plus BCG (Bacillus of Calmette and Guerin vaccine
that is used for controlling tuberculosis). All subsequent injections
would contain the cell vaccine alone.
If you are in the group receiving the placebo,
then you would only be injected with the dummy treatment.
As well as receiving the injections, we would
perform a number of investigations to see how you were responding
to the treatment.
Patients will not receive payment for participation
in this study. However, reasonable travel expenses will be covered
for the visits to the hospital that are necessary as part of your
involvement in the trial.
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