NL-OMON41305已完成3 期
A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F ± GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic, Castrate-Resistant Prostate Cancer - BNIT-PRV-301
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1.Signed Informed Consent
- •2. Men, * 18 years of age with documented asymptomatic or minimally symptomatic metastatic Castration-Resistant Prostate Cancer
- •3. Castrate testosterone level < 50 ng/dl
- •4. Documented progressive disease post-surgical castration or during androgen suppression therapy or during complete androgen blockade therapy and withdrawal. Documented by either criterion a (Radiological progression), OR criterion b (PSA progression).
- •Radiological progression defined as any new / enlarging bone metastases or new / enlarging lymph node disease, consistent with prostate cancer.
- •b. PSA progression defined by sequence of rising values separated by > 1 week (2 separate increasing values) over a threshold minimum of 2.0 ng/ml. (PCWG2 PSA eligibility criteria).
- •5. Chemotherapy naïve. No prior chemotherapy for metastatic prostate cancer. Neo-adjuvant or adjuvant chemotherapy for primary prostate cancer is permissible if >3 years prior.
- •6. Vaccinia-experienced (previous smallpox vaccination)
- •7. ECOG Performance Score of 0 or 1
- •8. Life expectancy * 1 year
- •9. Bone Marrow function:
- •* Absolute neutrophil count * 1,500/mm3
- •* Hemoglobin * 10 g/dL
- •* Platelet count * 100,000/mm3
- •10. Hepatic Function:
- •* AST and ALT * 2.5 times upper limit of normal (ULN)
- •* Bilirubin * 1.5 times ULN
- •11. Renal Function:
- •* Creatinine * 2.0 times ULN
- •12. Currently using a GnRH agonist or antagonist (unless surgically castrated)
排除标准
- •1.Cancer-related pain requiring scheduled opioid narcotics for control (as needed, * 2x per week is allowed)
- •2. Metastasis to organ systems other than lymph nodes and/or bone
- •3. LDH * 2 times ULN
- •4. Alkaline phosphatase * 2 times ULN
- •5. Estimated PSA doubling time of <1 month as established within 6 months of the anticipated first dose of vaccine or placebo. A minimum of 3 PSA level determinations, at least 2 weeks apart (over a 6 month time-period), are required for assessment.
- •6. Concurrent or prior Provenge (sipuleucel-T) immunotherapy for prostate cancer
- •7. Receipt of an investigational agent within 30 days (or 60 days for an antibody-based therapy) of the first planned dose of PROSTVAC-V/F. There is no exclusion to previous experimental therapy provided dosing/treatment is completed at least 30 days prior to the first planned dose of vaccine unless otherwise noted.
- •8. History of prior malignancies other than prostate cancer within the past 3 years, excluding successfully resected basal or squamous cell carcinoma of the skin
- •9. Congestive heart failure (NYHA Class II, III, or IV), unstable angina, ventricular or hemodynamically significant atrial arrhythmia, or cardiovascular disease such as stroke or myocardial infarction (current or within the past 6 months)
- •10. Confirmed positive for HIV, hepatitis B, and /or hepatitis C
- •11. Prior solid organ or bone marrow transplant
- •12. Immunodeficiency or splenectomy
- •13. Chronic immunosuppressive therapy within 30 days of screening
- •14. Inflammatory eye disease requiring steroid treatment
- •15. Chronic administration (defined as daily or every other day for continued use > 14 days) of systemic corticosteroids within 28 days of the first planned dose of PROSTVAC-V/F. Use of inhaled steroids, nasal sprays, and topical creams for small body areas is allowed.
- •16. History of or active autoimmune disease (e.g. autoimmune neutropenia, thrombocytopenia, or hemolytic anemia, systemic lupus erythematosis, Sjogren*s syndrome, scleroderma, myasthenia gravis, Goodpasture*s syndrome, Addison*s disease, Hashimoto*s thyroiditis, or Graves disease). Persons with vitiligo are not excluded. Diabetics are not excluded if the condition is well controlled.
- •17. Known allergy to eggs, egg products, aminoglycoside antibiotics (for example, gentamicin or tobramycin), or GM-CSF. Subjects with a known or suspected allergy to radiological contrast agents are eligible, but this must be noted in the subject*s medical history and in the chart notes.
- •18. History of atopic dermatitis or active skin condition (acute, chronic, exfoliative) that disrupts the epidermis
- •19. Previous adverse reactions to smallpox vaccination
- •20. Unable to avoid close contact or household contact with the following high-risk individuals for three to four weeks after the Day 1 vaccination or until the vaccination site heals completely: (a) children < 3 years of age, (b) pregnant or nursing women, (c) individuals with prior or concurrent extensive eczema or other eczemoid skin disorders, or (d) immunocompromised individuals, such as those with HIV.
- •21. Significant medical abnormality (defined as a pre-existing condition AE/condition * Grade 3 according to NCI CTCAE v 4.0 and any condition which, in the opinion of the investigator, would prevent full participation in this trial (including the Long-Term Follow-Up), or would interfere with the evaluation of the trial endpoints
研究者
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