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Overview - Onyvax-P trials

Information about the status Onyvax prostate cancer clinical trials can be obtained through Alacrita, a specialist pharma consulting firm.

Trial: Vaccine Therapy in Treating Patients With Non-Metastatic Prostate Cancer

Trial Number: ONY-P1-08-01

Location: Mayo Clinic, USA

This study is not recruiting additional patients.

For further information, click here:
ClinicalTrials.gov Identifier: NCT00814892 (Opens in a new window)

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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 not recruiting additional patients.

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 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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