DRKS00000194招募中1 期
Phase 1/2 study of recombinant vaccinia-NY-ESO-1 (rV-NY-ESO-1) and recombinant fowlpox-NY-ESO-1 (rF-NY-ESO-1) in patients with NY-ESO-1 or LAGE positive cancers - LUD 00-014
Krankenhaus Nordwest 2. Medizinische Klinik0 个研究点目标入组 60 人开始时间: 2009年9月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Patients will be eligible for enrollment if they fulfill the following criteria:
- •1.Histologically confirmed metastatic, measurable cancer or resected high risk Stage 3 or 4 with no evidence of disease with failure or refusal of standard chemotherapy or other proven treatment.
- •2.Histologically confirmed malignant melanoma, AJCC stage III (unresectable) or IV (Applicable for cohort 6 only).
- •3.Measurable disease using RECIST criteria (Appendix 4) (Applicable for cohort 6 only).
- •4.Tumor expression of NY-ESO-1 determined by RT-PCR analysis (see Appendix 1), preferably, or by immunohistochemistry (see Appendix 2) or LAGE by RT-PCR or serum antibody against NY-ESO-1 measured by Western Blot or ELISA (see section 7.2.1 and reference17)
- •5.HLA-A2 positive (applies only for entry to Cohorts 1, 2, 3, and 4).
- •6.Expected survival of at least five months.
- •7.Full recovery from surgery.
- •8.Karnofsky scale performance status of 70% or more.
- •9.The following laboratory results:
- •Neutrophil countgreater or equal 2.0 x 109/L
- •Lymphocyte countgreater or equal 0.5 x 109/L
- •Platelet countgreater or equal 100 x 109/L
- •Serum creatinineless or equal 2 mg/dL
- •Serum bilirubinless or equal 2 mg/dL
- •10.Ability to avoid close contact with children < 3 years of age; pregnant or breast feeding women; individuals with active, or a history of, eczema or other skin disorders; and immunocompromised individuals.
- •11.Have been informed of other treatment options.
- •12.Age: 18 years or older and able to give written informed consent (see Section 12.2).
排除标准
- •Patients will be excluded from the study if they fulfill any of the following criteria:
- •1.Clinically significant heart disease (NYHA Class III or IV).
- •2.Other serious illnesses (eg, serious infections requiring antibiotics, bleeding disorders).
- •3.History of immunodeficiency disease or autoimmune disease.
- •4.Metastatic disease to the central nervous system for which other therapeutic options, including radiotherapy, may be available.
- •5.Known HIV positivity.
- •6.Chemotherapy, radiation therapy, or immunotherapy within 4 weeks before study entry (6 weeks for nitrosoureas).
- •7.Known allergy to eggs, determined by history.
- •8.Concomitant treatment with steroids, antihistaminic drugs, or nonsteroidal anti-inflammatory drugs (unless used as in low doses for prevention of an acute cardiovascular event or for pain control). Topical or inhalational steroids are permitted.
- •9.Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.
- •10.Pregnancy or lactation.
- •11.Women of childbearing potential who are not using a medically acceptable means of contraception.
- •12.Eczema or a history of eczema; other acute, chronic or exfoliative skin disorders (eg, atoptic dermatitis, burns, impetigo, or varicella zoster).
- •13.Psychiatric or addictive disorders that may compromise the ability to give informed consent.
- •14.Lack of availability of a patient for immunological and clinical follow-up assessment.
研究者
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