PROSTVAC® - VF Synopsis (PDF)
Prostate Cancer Vaccine - Patients Brochure (PDF)
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PROSTVAC® - VF Eligibility Criteria
Inclusion Criteria
THIS TRIAL IS NO LONGER RECRUITING PATIENTS.
The following requirements are mandatory for patients interested in participating in Therion's PROSTVAC-VF Phase II study:
1. Male patients >= 18 years of age;
2. Evidence of metastatic disease including either of the following:
a. Lymph node metastasis measurable by CT and/or;
b. bone metastasis evaluable by bone scan;
3. Refractory to hormone therapy defined by: evidence of two consecutive increases in PSA documented over a previous reference value, the first occurring a minimum of 1 week from the reference value, with one value of at least 5 ng/mL;
4. Castrate testosterone levels < 50 ng/dL consistent with orchiectomy or continuous treatment with GnRH agonists for the duration of the study;
5. Gleason Score <= 7 (at initial diagnosis).
Exclusion Criteria
Patients with any of the below conditions are not eligible to participate in Therion's PROSTVAC-VF Phase II study:
1. Concurrent or prior biologic therapy or immunotherapy for cancer;
2. Concurrent therapy such as palliative radiation or opioid analgesics for tumor-associated pain;
3. Radiation therapy within 28 days prior to registration;
4. Antiandrogen therapy or any other hormone therapy within 42 days of registration;
5. Prior chemotherapy for prostate cancer;
6. Metastasis to organ systems other than lymph nodes and bone;
7. Hypersensitivity to eggs or egg products;
8. Prior or concurrent extensive eczema or acute, chronic, or exfoliative skin disorders (e.g., extensive psoriasis, burns, impetigo, or disseminated zoster, varicella zoster, severe acne, or other open rashes or wounds).
Additional Information
Please note that there are additional exclusion criteria.
The study center nearest to you will determine if you meet all of the criteria.
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